The Digest

Pharma news roundup and Larvol updates

Contact Us
Category: COVID-19 News

COVID-19 Top News – September 28, 2020

September 28, 2020

Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
India trials for Russia’s ‘Sputnik-V’ vaccine could start in next few weeks: exec (Reuters) – Sep 22, 2020 – “Dr Reddy’s Laboratories Ltd could begin late-stage Indian clinical trials of Russia’s potential coronavirus vaccine in the next few weeks….Indian trials of the Sputnik-V vaccine candidate…will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country….Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India….The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India.”

 

remdesivir / Generic mfg.
Veklury: “The Committee adopted a positive opinion recommending the granting of a conditional marketing authorization by consensus together with the CHMP assessment report and translation timetable [Coronavirus disease]” (European Medicines Agency) – Sep 25, 2020 – CHMP Final Minutes of the meeting on 22-25 June 2020

 

aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRx
Relief partner NeuroRx submits request for Emergency Use Authorization for RLF-100 (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy (PharmiWeb) – Sep 23, 2020 – P=NA, N=51; SAMICARE (NCT04453839); Sponsor: NeuroRx, Inc.; “…NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments….The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement.”

 

favipiravir / Generic mfg.
Japanese approval sought for Avigan to treat COVID-19 (Nikkei) – Sep 21, 2020 – “Fujifilm Holdings will soon apply to produce and sell its Avigan antiviral drug as a treatment for the new coronavirus in Japan….The health ministry could give the go-ahead this year, making Avigan the third drug overall and the first domestically developed drug to receive such approval….The health ministry has said it plans to fast-track approval for the drug. ‘If the data from the clinical trials looks good, we could approve it in a month from when Fujifilm submits an application,’ a ministry source said.”

 

remdesivir / Generic mfg.
Cabinet may reduce remdesivir injection price (Dawn) – Sep 22, 2020 – “According to sources in the Ministry of National Health Services (NHS), the cabinet will consider reducing the price of remdesivir 100mg injection which is given to Covid-19 patients. ‘At present, each injection is being sold for Rs10,873 but it has been decided to reduce the price to ensure that it would become affordable for all patients,’ an official of the health ministry said requesting not to be quoted….The official said the cabinet will also consider the grant of exemption from section 23(1)(a)(VII) of the Drugs Act 1976.”

 

favipiravir / Generic mfg.
Hetero launches pack of generic COVID-19 drug favipiravir at Rs 2,640 (The Economic Times) – Sep 26, 2020 – “Drug firm Hetero…said it has launched a pack of its generic oral antiviral drug– Favivir 800/200– for the treatment of mild-to-moderate symptomatic COVID-19 patients in India. Favivir 800/200 will be available in a pack containing 16 tablets of favipiravir 800 mg and 2 tablets of favipiravir 200 mg priced at Rs 2,640 per pack….The higher strength of Favipiravir 800 mg by the company has been approved by the Drug Controller General of India (DCGI). The product will be marketed and distributed by Hetero Healthcare Ltd, it added.”

 

Early Covid-19 treatments could be ‘bridge’ to vaccine, says Anthony Fauci (Hindustan Times) – Sep 27, 2020 – “Anthony Fauci said 100 million doses of vaccine may be produced by December, with all six companies supplying the US slated to have made 700 million doses by next April.”

 

Coronavirus vaccines: US, China and Russia absent from WHO’s equal access COVAX coalition – Sep 22, 2020 – “However, numerous countries that have signed their own bilateral deals with vaccine makers have declined to participate or to use the facility to secure their own vaccines, including China, Russia, and the United States….Tedros Adhanom Ghebreyesus said the Covax facility, which WHO is heading up alongside with vaccines alliance GAVI and the Coalition for Epidemic Preparedness and Innovations (CEPI), will help bring the COVID-19 pandemic under control. Dr Richard Hatchett…said that ‘COVID-19 cannot be beaten one country at a time. We must be able to share lifesaving vaccines globally at the same time.'”

 

CDC’s Messonnier Says She Trusts COVID Vaccine Process (WebMD) – Sep 21, 2020 – “Nancy Messonnier, MD…We are working in partnership with Operation Warp Speed and my colleagues say that there will be vaccine available this fall but that they expect the quantities of vaccine to be limited. By next year, we should have much larger quantities of vaccine available. So, on the delivery side, we’re working to ready the country for the first implementation of vaccine this fall, but then also getting ready for a much larger availability of vaccine next year.”

Read More …

COVID-19 Top News – September 21, 2020

September 21, 2020

Actemra IV (tocilizumab) / Roche, JW Pharma
Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia (GlobeNewswire) – Sep 18, 2020 – P3, N=379; EMPACTA (NCT04372186); Sponsor: Genentech, Inc.; “Roche plans to share these results with health authorities, including the US FDA; Roche…today announced that the phase III EMPACTA study met its primary endpoint…patients with COVID-19 associated pneumonia who received Actemra®/RoActemra®…plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care….The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra….The majority of patients were Hispanic, with significant representation of Native American and Black populations.”

 

dexamethasone / Generic mfg.
EU regulator backs dexamethasone as COVID-19 treatment (Reuters) – Sep 18, 2020 – “Europe’s healthcare regulator has endorsed using dexamethasone to treat COVID-19 patients with breathing difficulties….The European Medicines Agency (EMA) said…drug could be an option to treat adults and adolescents needing oxygen therapy or mechanical ventilation….It said the recommended dose in adults and adolescents, from the age of 12 years and weighing at least 40 kilograms, was 6 milligrams once a day for up to 10 days.”

 

BBIBP-CorV / Wuhan Institute of Virology, Sinopharm
UAE announces emergency approval for use of COVID-19 vaccine (Reuters) – Sep 14, 2020 – “The United Arab Emirates on Monday granted emergency approval for use of a coronavirus vaccine, six weeks after human trials in the Gulf Arab state started….Emergency use of the vaccine, which is still being tested, was granted after a set criteria and after it had been tested on 31,000 volunteers, it said.”

 

CoronaVac / Sinovac, Bio Farma Indonesia; Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) / CanSino
China coronavirus vaccine may be ready for public in November: official (Reuters) – Sep 15, 2020 – “Coronavirus vaccines being developed in China may be ready for use by the general public as early as November….China has four COVID-19 vaccines in the final stage of clinical trials. At least three of those have already been offered to essential workers….Phase 3 clinical trials were proceeding smoothly and the vaccines could be ready for the general public in November or December, CDC chief biosafety expert Guizhen Wu said in an interview with state TV late on Monday.”

 

Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
Russia completes volunteer recruitment for COVID-19 vaccine trial: fund (Reuters) – Sep 14, 2020 – “Russia has recruited sufficient participants for its large-scale COVID-19 vaccine trial, known as a Phase III trial, the head of Russia’s sovereign wealth fund, which is backing the vaccine, said on Monday….Initial results are expected in October or November this year, officials have said.”

 

Coronavirus Vaccine / Sanofi, GSK
EU pays $384 million for Sanofi-GSK COVID vaccine as WHO scheme deadline looms (Reuters) – Sep 18, 2020 – “The European Union has agreed to buy a potential COVID-19 vaccine from Sanofi and GSK in its second such deal to secure supplies….The deal will see the French and British drugmakers…provide the EU with up to 300 million doses in exchange for a down payment of 324 million euros ($384 million)….Sanofi and GSK started clinical trials of their vaccine this month and aim to reach the final testing stage by December.”

 

Dr. Fauci Says ‘There Will Be an End’ to Covid-19 – Sep 20, 2020 – “Covid-19 can be removed as a public-health threat with good, widely administered vaccines and strong public-health measures, and a degree of normality might return by the end of 2021, Dr. Anthony Fauci said Wednesday.”

 

Actemra SC (tocilizumab SC) / Roche, Halozyme, Frederiksberg University Hospital
Roche rises on word of COVID trial win, new test and European cancer drug nod (Reuters) – Sep 18, 2020 – “‘The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia,’ said Levi…Empacta is the first global phase III COVID-19 clinical trial using minority patients, Roche said, adding this group, including Hispanic, Black and Native American patients, is often underrepresented in studies and has been hit harder by the pandemic than other groups.”

 

Coronavirus vaccine: EU seals second coronavirus vaccine deal (The Financial Express) – Sep 18, 2020 – “The EU Commission has finalised a deal with Sanofi and GSK allowing its 27 member states to buy up to 300 million doses of a potential COVID-19 vaccine. It’s the second contract signed by the bloc’s executive arm after a first agreement was reached last month with AstraZeneca for up to 400 million doses. ‘With several countries in Europe experiencing new outbreaks after the summer period, a safe and effective vaccine is more instrumental than ever to overcome this pandemic and its devastating effects on our economies and societies,’ said Stella Kyriakides…”

Read More …

COVID-19 Top News – September 14, 2020

September 14, 2020

Multitope Peptide-Based Coronavirus Vaccine / United Biomedical; CoronaVac / Sinovac, Bio Farma Indonesia; AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford; Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
Brazil Trials of Sinovac COVID-19 Vaccine Show Promising Results: Governor (US News and World Report) – Sep 9, 2020 – “…Phase 3 clinical trials of a potential COVID-19 vaccine developed by China’s Sinovac Biotech Ltd have shown promising results and it may be available to Brazilians as early as December….Phase 2 trials of the potential vaccine had shown an immune response of 98% in the elderly….Trials for the AstraZeneca vaccine on 5,000 volunteers in Brazil are well advanced and have not produced any problems in participants….At the start of next year, Phase 3 trials of Russia’s ‘Sputnik-V’ COVID-19 vaccine will also be conducted on 10,000 volunteers…Brazilian lab and hospital group DASA SA said on Wednesday it had agreed to conduct Phase 2 and 3 trials in Brazil for a COVID-19 vaccine developed by COVAXX…”

 

CT-P59 / Celltrion
Celltrion Announces Positive Interim Results From Phase I Trial of CT-P59, an Anti-COVID-19 Monoclonal Antibody Treatment Candidate (Businesswire) – Sep 11, 2020 – P1, N=32; NCT04525079; Sponsor: Celltrion; “Celltrion has also launched commercial production of CT-P59 as part of the preparation process; The results demonstrated no significant drug-related adverse events (AEs), and importantly there were no adverse events from the maximum tolerated dose cohort…..’We intend to request emergency use authorisation’….Celltrion…plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea. Celltrion anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial….The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021.”

 

Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
Helping Russia Conduct Sputnik V Vaccine Trials, Make It In India: Centre (NDTV) – Sep 8, 2020 – “India has received Russia’s request for conducting phase 3 human trials and manufacturing the Sputnik V coronavirus vaccine, the government said today. It said India is working to facilitate Russia’s request….Russian Health minister Mikhail Murashko said the country will start mass inoculation from November or December, with a focus on high-risk groups.”

 

AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Serum Institute pauses India trials of AstraZeneca’s COVID-19 vaccine (Reuters) – Sep 10, 2020 – “Serum Institute of India has put on hold trials of AstraZeneca’s AZN.L potential COVID-19 vaccine in the country until the British drugmaker restarts them, the company said on Thursday….The move to pause the trials in India comes after the Drugs Controller General of India (DCGI) V.G. Somani asked Serum for details on the suspension of trials overseas, in a show-cause notice….Somani asked the company to explain why the trials should not be suspended in India until patient safety is established…”

 

AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
AstraZeneca COVID-19 vaccine on track for 2020 filing despite delay: Soriot (FierceBiotech) – Sep 10, 2020 – “AstraZeneca is still on track to file for approval of its COVID-19 vaccine this year, according to its CEO….It is unclear how long the trial will be paused in response to a recent adverse event, but a 2020 approval is still on the cards….AstraZeneca said it was on track to show whether its COVID-19 vaccine worked by September. Hopes of a fall approval had begun to fade long before AstraZeneca placed development of the vaccine on hold….Depending on how quickly regulators review the filing, that could enable AstraZeneca to win approval this year.”

 

AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Oxford Vaccine Trials Resume In UK, Were Paused Over Volunteer’s Illness (NDTV) – Sep 12, 2020 – “Pharma giant AstraZeneca on Saturday said it had resumed a Covid-19 vaccine trial after getting the all-clear from British regulators, following a pause caused by a UK volunteer falling ill….An independent committee was drafted in to review safety, in what the company and the World Health Organization described as a routine step. The committee ‘has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume’, AstraZeneca said.”

 

Dr Anthony Fauci Discusses the Systemic Effects of COVID-19 (AJMC) – Sep 7, 2020 – “While coronavirus disease 2019 (COVID-19) is largely a respiratory disease, it is actually a systemic disease that has a wide range of effects and postinfection sequelae that aren’t yet fully known, said Anthony S. Fauci, MD…”

 

Dr Anthony Fauci Speaks to the Likelihood of Vaccines for HIV and COVID-19 (AJMC) – Sep 10, 2020 – “In an interview to mark the 25th anniversary of The American Journal of Managed Care®, Anthony S. Fauci, MD…noted how there’s never a guarantee with vaccinology but that he and other officials feel fairly confident that we’ll get a vaccine for coronavirus disease 2019 (COVID-19), possibly by the end of the year and the beginning of 2021”

 

COVID-19: Fauci says he takes vitamin D and C supplements to reduce his ‘susceptibility to infection’ (Times Now) – Sep 13, 2020 – “‘If you’re deficient in vitamin D, that does have an impact on your susceptibility to infection. I would not mind recommending, and I do it myself, taking vitamin D supplements,’ he said. ‘The other vitamin that people take is vitamin C because it’s a good antioxidant, so if people want to take a gram or so of vitamin C, that would be fine.'”

 

Vaccine scientist: ‘Smart business practice’ for companies to not seek premature FDA approval (The Hill) – Sep 7, 2020 – “Vaccine scientist Peter Hotez on Monday called a safety pledge by pharmaceutical companies for the development of a coronavirus vaccine ‘smart business.’ ‘What they’re doing is a smart business practice to make certain they’re releasing a vaccine that’s both safe and effective, because they know that if there’s a mistake, and if things don’t go well, it could bring down the entire company,’ he added.”

 

Coronavirus expert Dr. Peter Hotez reveals when we can expect a vaccine (Houston Chronicle) – Sep 11, 2020 – “Peter Hotez…explains the COVID-19 vaccine development process to the Houston Chronicle Thursday, June 18, 2020, in Houston. Hotez predicted COVID-19 vaccine will be available for general public by quarter three of 2021, if they are safe and work.”

 

Coronavirus: Commission completes vaccines portfolio following talks with a sixth manufacturer (European Commission) – Sep 9, 2020 – “Stella Kyriakides, Commissioner for Health and Food Safety, said: ‘Today’s final talks with BioNTech-Pfizer is yet another important step in our efforts to build a sound and diverse portfolio of vaccine candidates. This was the objective of our EU Vaccine Strategy, and we are delivering on it. We are optimistic that among these candidates there will be a safe and effective vaccine against COVID-19 to help us defeat this pandemic.'”

 

GSK and Sanofi: another COVID-19 vaccine in the testing phase (Born2Invest) – Sep 9, 2020 – “In the global race, Sanofi and GSK would appear to be running a few months behind AZ, Pfizer, Moderna and the Chinese CanSino and SinoVac, who have already begun Phase III studies. However, John Shiver…said they can still catch up with their competitors thanks to the French company’s experience with ‘very similar viruses.’ Shiver also said that many clinical trials so far have recruited mostly white people. Meanwhile, Sanofi and GSK are going to select a ‘tremendous diversity’ of participants in the clinical trials, across multiple countries for their final research stage in December.”

Read More …

COVID-19 Top News – September 7, 2020

September 7, 2020

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Sanofi provides update on Kevzara (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S. (GlobeNewswire) – Sep 1, 2020 – P3, N=409; NCT04327388; Sponsor: Sanofi; “Sanofi today announced that the global Phase 3 trial investigating intravenously administered Kevzara…did not meet its primary endpoint and key secondary endpoint….Although not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes….A trend was observed towards reduced mortality in the critical patient group which was not seen in the severe patient group….At this time, Sanofi and Regeneron do not anticipate conducting further clinical studies for Kevzara in COVID-19.”

 

Coronavirus Vaccine / Sanofi, GSK
Sanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate (GlobeNewswire) – Sep 3, 2020 – “Sanofi and GSK today started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The companies anticipate first results early December 2020 which will support the initiation of a Phase 3 trial in December 2020. If data are sufficient for licensure application, the plan is to request regulatory approval in the first half of 2021….Preclinical data showed an acceptable reactogenicity profile….The partners plan to supply a significant portion of total worldwide available supply in 2021/2022 to COVAX…”

 

BNT162b1 / Fosun Pharma, BioNTech, Pfizer; BNT162b2 / Pfizer, Fosun Pharma, BioNTech
COVID-19 Vaccine Could Come In Late October; White House Says No Pressure On Timing (News18 India) – Sep 3, 2020 – “U.S. public health officials and Pfizer Inc said a COVID-19 vaccine could be ready for distribution as soon as late October….Pfizer on Thursday said it should know by the end of October whether a COVID-19 vaccine it is developing with German partner BioNTech SE is safe and effective. The U.S. drugmaker said it will seek approval immediately if trial results are positive. It has already manufactured hundreds of thousands of doses.”

 

remdesivir / Generic mfg.
Remdesivir prices may rise after Gilead gets full authorisation from USFDA (Business Standard) – Sep 5, 2020 – “Prices of a key drug used to treat hospitalised Covid-19 patients, remdesivir, may rise once the innovator, Gilead, gets a full approval from the US drug regulator….Currently, generic manufacturers make and sell remdesivir in India under a voluntary licensing agreement and are not required to pay any royalty to the innovator….Company had met all requirements for a full authorisation for remdesivir, and expected the approval to come soon.”

 

AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Oxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222 (GlobeNewswire) – Sep 1, 2020 – “Oxford Biomedica plc…announced today that it has signed an 18 month supply agreement under a three year Master Supply and Development Agreement (‘the Agreement’) with AstraZeneca UK Ltd (‘AstraZeneca’) for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period for AZD1222 by a further 18 months into 2022 and 2023 by mutual agreement. Under the terms of the Agreement, AstraZeneca will pay Oxford Biomedica £15million upfront as a capacity reservation fee.”

 

Coronavirus: What Is Herd Immunity And Is It A Possibility For The UK? (The Independent) – Sep 2, 2020 – “Professor Paul Hunter…added that herd immunity is ‘an indication of the proportion of people who are immune in a population’. ‘The relationship of the proportion of people that are immune that you need to prevent an epidemic varies from infection to infection,’ he outlined….In Professor Hunter’s opinion, herd immunity is unlikely to happen until next year ‘when we hopefully will have a vaccine’. ‘I am just making effectively educated guesses at this point, but I suspect we won’t see the last of it this year,’ he stated.”

 

Despite CDC’s Changed Advice, WHO Confirms Anyone Exposed to COVID-19 Should Be Tested – Aug 31, 2020 – “When asked about the shift…Maria Van Kerkhove did not mention the US situation specifically but told reporters the UN health agency recommends that contacts, if feasible, should be tested, regardless of the development of symptoms….While the main focus of testing is on those who develop symptoms, Van Kerkhove said that especially when investigating clusters of cases, ‘testing may need to be expanded to look for individuals who are on the more mild end of the spectrum or who may indeed be asymptomatic.'”

Read More …

COVID-19 Top News – August 24, 2020

August 24, 2020

Vyrologix (leronlimab) / CytoDyn, Vyera Pharma
CytoDyn Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results (GlobeNewswire) – Aug 19, 2020 – “CytoDyn Inc….announced today the Company provided its Top-line Report from its recently completed Phase 2 clinical trial…to Medicines and Healthcare Products Regulatory Agency….Company requested the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial….’We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August.'”

 

favipiravir / Generic mfg.
Dr Reddy’s launches antiviral drug Avigan in India, to launch remdesivir in September (The Economic Times) – Aug 19, 2020 – “Generic drugmaker Dr Reddy’s Laboratories launched antiviral drug Avigan (favipiravir) tablets….Company’s US arm is currently taking up a multi-centre, randamised, double blind, placebo controlled clinical trials to further evaluate the efficacy and safety of favipiravir….The study in collaboration with GRA obtained approval for the protocol to be initiated this month, beginning the study on the first patient on Wednesday. The generic drugmaker hopes to complete the multi-ethnic trials on over 700 patients during the 10-12 weeks….Pricing Avigan in 200mg dosages at Rs 99 a tablet in a complete therapy pack of 122 tablets with a two-year shelf life….Dr Reddy’s will initiate phase-IV study for Avigan in India to further establish its efficacy….The company is also looking at coming up with Avigan in 400mg dosages for the benefit of patients.”

 

Vyrologix (leronlimab) / CytoDyn, Vyera Pharma
CytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval (GlobeNewswire) – Aug 17, 2020 – “CytoDyn Inc….has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients…to the U.S. Food and Drug Administration (FDA), and requested emergency use approval. In addition, CytoDyn has sent…to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines….The Company is preparing a Phase 3 protocol and will file it as soon as possible.”

 

FDA’s emergency approval of blood plasma as COVID-19 treatment on hold – NYT (Reuters) – Aug 19, 2020 – “The emergency approval of blood plasma as a potential COVID-19 treatment by the U.S. Food and Drug Administration has now been put on hold….A group of top federal health officials including Anthony Fauci have argued that the emerging data on the treatment was too weak the report said, adding that an emergency approval could still be granted in the near future. The authorization is on hold for now…”

 

ArtemiC / MGC Pharma
MGC Pharmaceuticals interim results of ArtemiC in Phase II trial on COVID-19 infected patients meet all primary objectives (Proactiveinvestors) – Aug 19, 2020 – P2, N=50; NCT04382040; Sponsor: MGC Pharmaceuticals d.o.o; “The Phase II double-blind, placebo-controlled clinical trial has met all the primary objectives, with all 10 patients showing significant improvement. Shares jumped 43% on release of the news to A$0.037 and are up from A$0.021 at the market close on July 31….The statistically proven results show two important clinical outcomes: A significant improvement in the clinical parameters of patients in the treatment group; and; No adverse events occurred, demonstrating the safety of the treatment.”

 

azithromycin / Generic mfg.
COVID-19 pandemic ‘could be quite damaging’ to efforts to end other diseases (Healio) – Aug 21, 2020 – “According to Peter J. Hotez, MD, PhD…Because of the COVID-19 pandemic, however, Hotez worries these efforts may be slowed, interrupted or halted. ‘The Mass Drug Administration’s program is huge in continuing eradication efforts toward lymphatic filariasis, river blindness and trachoma. It’s really important,’ Hotez said. ‘Now we’re finding it extends to yaws, scabies and some of the others. So, continuing those programs of preventive treatment for the Mass Drug Administration is a top priority’….Hotez named azithromycin, a common antibiotic for strep throat and sinusitis that can also be used for trachoma, as an example. However, efforts to use this drug may be slowed because of the pandemic, he said.”

 

Dr. Fauci: Long-term effects of COVID-19 ‘really troublesome’ (The Denver Channel) – Aug 18, 2020 – “Dr. Anthony Fauci has a warning for young adults who think they will bounce back from COVID-19….’We’d better be careful when we say ‘Young people who don’t wind up in the hospital are fine, let them get infected, it’s OK.’ No, it’s not OK,’ Dr. Fauci said during the briefing….He called these findings ‘really troublesome’ because they are constantly evolving as the world learns more about COVID-19 and the long-term impacts on the human body.”

 

Coronavirus: Vaccine will not be mandatory in US, says health expert Anthony Fauci – Aug 20, 2020 – “United States’ top infectious disease expert Dr Anthony Fauci on Wednesday said any future coronavirus vaccine would not be mandatory for the general public in the America, AFP reported. He, however, said that states can make it obligatory for some groups. ‘You can mandate [the vaccine] for certain groups of people like health workers, but for the general population you can’t,’ he said. Fauci, who was speaking at a video conference organised by the George Washington University, added that at the National Institutes of Health, health workers need to have a flu shot before they can treat patients.”

 

WHO hopes COVID-19 pandemic ends within 2 years, says chief Tedros Adhanom Ghebreyesus – Aug 22, 2020 – “Tedros Adhanom Ghebreyesus described COVID-19 as a once-in-a-century health crisis and said that while globalisation had allowed the virus to spread quicker than the flu did in 1918, there was also now the technology to stop it that hadn’t been available a century ago….’We hope to finish this pandemic (in) less than two years, especially if we can pool our efforts,’ he said during a press briefing on Friday.”

 

COVID-19: Herd immunity requires effective vaccine, says WHO (The Tribune) – Aug 18, 2020 – “WHO’s emergencies chief Dr Michael Ryan largely dismissed that theory at a press briefing on Tuesday, saying we should not live ‘in hope’ of achieving herd immunity. ‘As a global population, we are nowhere close to the levels of immunity required to stop this disease transmitting,’ he said. ‘This is not a solution and not a solution we should be looking to.’ Most studies conducted to date have suggested only about 10 per cent to 20 per cent of people have antibodies.”

Read More …

COVID-19 Top News – August 17, 2020

August 17, 2020

remdesivir / Generic mfg.
Armenian Health Minister Approves Use of Remdesivir to Treat Severe Covid-19 Cases (Hetq) – Aug 12, 2020 – “Armenia’s Minister of Health Arsen Torosyan…approved use of the drug in the medical centers that have been refitted for Covid-19 treatment. Physicians must prescribe (sic) the drug for their patients.”

 

NVX-CoV2373 / Novavax
Novavax and UK Government Announce Collaboration and Purchase Agreement for Novavax’ COVID-19 Vaccine Candidate (GlobeNewswire) – Aug 14, 2020 – “Novavax, Inc….today announced it has signed a Heads of Terms (Term Sheet) with the Government of the United Kingdom (UK) for the purchase of 60 million doses…and a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population…..Novavax will also expand its collaboration with FUJIFILM Diosynth Biotechnologies….The FUJIFILM Diosynth Biotechnologies site in the UK is expected to produce up to 180 million doses annually….The trial is expected to begin in the third quarter of this year…”

 

remdesivir / Generic mfg.; favipiravir / Generic mfg.
Egypt approves requests from 61 companies to produce Favipiravir (Egypt Independent) – Aug 11, 2020 – “The Egyptian Drug Authority (EDA) announced Tuesday that it has granted its initial approval to 61 national pharmaceutical companies to begin production for the antiviral drug Favipiravir….EDA explained that these companies have been given the clear to begin all administrative and technical steps towards registering Favipiravir….The authority also approved the applications submitted by 27 national pharmaceutical companies to finalize registration of the Remdesivir drug….One national company obtained EDA documents to start manufacturing Remdesivir…”

 

remdesivir / Generic mfg.
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (Remdesivir) for the Treatment of COVID-19 (Businesswire) – Aug 10, 2020 – “Gilead Sciences…announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury® (remdesivir), an investigational antiviral for the treatment of patients with COVID-19….The filing is supported by data from two randomized, open-label, multi-center Phase 3 clinical studies of Veklury conducted by Gilead and the Phase 3 randomized, placebo-controlled study of Veklury conducted by the National Institute of Allergy and Infectious Diseases (NIAID).”

 

remdesivir / Generic mfg.; Olumiant (baricitinib) / Incyte, Eli Lilly, University of Colorado
UNMC to start third phase of federal COVID-19 drug trial (Omaha World-Herald) – Aug 9, 2020 – “The Omaha-based arm of a new phase of an international drug trial testing medications for people hospitalized with COVID-19 is expected to begin this week….The third phase of the trial…will pair the antiviral drug remdesivir with a type of interferon used to treat multiple sclerosis and some kinds of hepatitis….Researchers then paired remdesivir with an anti-inflammatory drug, Kalil said. That portion of the trial closed a month ago, and researchers hope to have the results by the end of the month.”

 

favipiravir / Generic mfg.
FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19 at U.S. Long-Term Care Facilities (Businesswire) – Aug 10, 2020 – “Appili Therapeutics…today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of an investigational new drug (IND) application for broad-spectrum antiviral favipiravir. Appili is expanding its Phase 2 clinical trial into the U.S. to evaluate the safety and efficacy of favipiravir tablets…Appili intends to enroll up to 760 participants in this Phase 2 clinical trial across both the U.S. and in Canada.”

 

Gam-COVID-Vac Lyo / Gamaleya Research Institute
Coronavirus: Putin says vaccine has been approved for use (BBC) – Aug 11, 2020 – “Russian President Vladimir Putin has said a locally developed vaccine for Covid-19 has been given regulatory approval after less than two months of testing on humans. Mr Putin said the vaccine had passed all the required checks, adding that his daughter had already been given it. Officials have said they plan to start mass vaccination in October….WHO said it had been in talks with Russian authorities about undertaking a review of the vaccine, which has been named Sputnik-V….Vaccine’s approval by Russian regulators comes before the completion of a larger study involving thousands of people, known as a phase-three trial.”

 

remdesivir / Generic mfg.
Zydus Cadila launches COVID-19 drug Remdesivir in India (Outlookindia.com) – Aug 13, 2020 – “Drug firm Zydus Cadila on Thursday said it has launched Remdesivir under the brand name Remdac, used to treat patients suffering from severe symptoms of COVID-19, in the Indian market. Priced at Rs 2,800 per 100 mg vial, Remdac is the most economical Remdesivir brand in India, Zydus Cadila said in a regulatory filing.”

 

AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
Argentina, Mexico to produce AstraZeneca COVID-19 vaccine (Reuters) – Aug 13, 2020 – “Argentina and Mexico will produce the AstraZeneca COVID-19 vaccine for most of Latin America, Argentine President Alberto Fernandez said on Wednesday…An agreement signed between British pharmaceutical company AstraZeneca and the biotechnology company mAbxience of the INSUD Group includes transfer of technology to initially produce 150 million doses of the vaccine to supply all of Latin America with the exception of Brazil, the Argentine government said….AstraZeneca…signed a deal with the foundation of Mexican billionaire Carlos Slim for production of the vaccine, which is expected to be delivered in the first half of 2021…”

 

Vyrologix (leronlimab) / CytoDyn, Vyera Pharma
CytoDyn Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients (GlobeNewswire) – Aug 11, 2020 – P2, N=75; NCT04343651; Sponsor: CytoDyn Inc; “At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo)….In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223). Similar, statistically significant, results were observed at Day 3 and Day 14 in the analysis of per protocol population (p<0.03 and p<0.02, respectively).”

 

remdesivir / Generic mfg.
Iran eyes regional market for homegrown remdesivir (Tehran Times) – Aug 15, 2020 – “The Iranian remdesivir medicine has been formulated and produced to cure COVID-19 patients and is currently undergoing legal registration with the Food and Drug Administration to enter the market by the next two weeks, IRNA quoted Hossein Vatanpour as saying on Saturday.”

 

CERC-002 / Kyowa Hakko Kirin, Sanofi, Cerecor
Cerecor Announces Peer-Reviewed Publication Highlighting the Role of the Inflammatory Cytokine, LIGHT, in COVID-19 ARDS (GlobeNewswire) – Aug 13, 2020 – P=NA, N=47; “Cerecor Inc….today announced the publication of a peer-reviewed paper demonstrating significantly elevated free LIGHT levels in the serum of hospitalized patients with severe COVID-19 infection. The publication…highlights the potential role of the inflammatory cytokine, LIGHT in the development of COVID-19 ARDS….Publication supports its clinical program evaluating CERC-002….’This study is now well underway, and we expect topline results in the fourth quarter of 2020. We are further exploring the potential role of LIGHT as a driver of and biomarker for ARDS in additional studies…'”

 

favipiravir / Generic mfg.
MSN plans to roll out cheapest Covid-19 drug at Rs 33 per tablet (Deccan Herald) – Aug 13, 2020 – “…MSN Group has planned to launch the cheapest Covid-19 treatment drug – Favipiravir 200 mg, for Rs 33, according to multiple reports. The affordable version of the anti-viral drug will be marketed under the brand name ‘Favilow’….The 400 mg version of Favilow will also be launched soon….’Favilow’ will be available in 200 mg tablets….The company will be launching the drug on August 15…”

 

An effective vaccine can help restore normalcy by end of 2021: Anthony Fauci (The Hindu Business Line) – Aug 16, 2020 – “‘I do not think it is going to be 2024. I think it’s going to be more like the end of 2021,’ Fauci said in the interview. ‘If you synergise and superimpose good, solid, careful, prudent public health measures with a vaccine that is effective – it doesn’t have to be 100 per cent effective,’ he said. ‘If you get a vaccine into 2021, throughout the year, I believe, by the year 2021, the end of the year, we will be as good back to normal as we possibly can,’ he added.”

 

Covid re-infection not confirmed, says WHO – Aug 14, 2020 – “Maria Van Kerkhove, technical lead on Covid-19 response at the WHO Health Emergencies Program, told a virtual press conference that some people could have PCR (polymerase chain reaction) positivity for many weeks, not just days, and it doesn’t necessarily mean that they are infectious for that long.”

 

EU reaches 1st deal to buy potential COVID-19 vaccine – Aug 15, 2020 – “The advance purchase agreement was reached after weeks of negotiations with AstraZeneca, according to Stella Kyriakides…Kyriakides had earlier said that the first vaccine against COVID-19 may be available towards the end of this year or early next year.”

Read More …

COVID-19 Top News – August 3, 2020

August 3, 2020

bucillamine / Revive Therap
Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19 (GlobeNewswire) – Jul 31, 2020 – “Revive Therapeutics Ltd…is pleased to announce that the U.S. Food & Drug Administration (‘U.S. FDA’) has approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19….’We are now focused on executing on our plans for initiating the clinical trial in an expeditious manner’….The Phase 3 confirmatory clinical study…will enroll up to 1,000 patients…”

 

remdesivir / Generic mfg.
Health Canada Grants Marketing Authorization with Conditions (NOC/c) for Gilead’s Veklury (Remdesivir) for the Treatment of Coronavirus Disease 2019 (COVID-19) (Canada Newswire) – Jul 28, 2020 – “Gilead Sciences Canada, Inc. today announced that Health Canada has issued a marketing authorization with conditions (Notice of Compliance with Conditions, or NOC/c) for Veklury® (remdesivir). Under this conditional authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents aged 12 years and older and weighing at least 40 kg, with pneumonia requiring supplemental oxygen….Gilead is working with the Public Health Agency of Canada (PHAC) and Health Canada to provide Veklury for Canadians over the coming weeks.”

 

Actemra IV (tocilizumab) / Roche, JW Pharma
Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia (GlobeNewswire) – Jul 29, 2020 – P3, N=450; COVACTA (NCT04320615); Sponsor: Hoffmann-La Roche; “…COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints…were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra….There was no difference between Actemra/RoActemra and placebo in the percentage of patients that died by week four…”

 

interferon beta inhalation (SNG001) / Synairgen
Undercutting severe COVID-19 with inhaled interferon beta (Ophthalmology Times) – Jul 31, 2020 – “SNG001, the inhaled formulation of interferon beta, significantly decreased the chances of hospitalized patients developing severe COVID-19 compared to placebo….Synairgen is now working with regulators and other key groups to obtain approval of this potential COVID-19 treatment.”
 

BNT162b2 / Pfizer, Fosun Pharma, BioNTech
Pfizer and BioNTech to Supply Japan with 120 Million Doses of their BNT162 mRNA-based Vaccine Candidate (Businesswire) – Jul 31, 2020 – “Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and regulatory approval….As requested by the Government of Japan, deliveries of the vaccine candidate are planned for the first half of 2021….Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020…”

 

BNT162b2 / Pfizer, Fosun Pharma, BioNTech
Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study (Businesswire) – Jul 27, 2020 – “Pfizer…announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2….Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen….If the Phase 2/3 trial is successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020.”

 

dexamethasone / Generic mfg.
EMA initiates review of dexamethasone for treating COVID-19 (European Pharmaceutical Review) – Jul 28, 2020 – P2/3, N=15,000; RECOVERY (NCT04381936); “The European Medicines Agency (EMA) has announced it is reviewing results from the RECOVERY study arm that involved the use of dexamethasone….This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation….Compared with usual care, dexamethasone: reduced mortality by about 35 percent in patients on invasive mechanical ventilation; reduced mortality by about 20 percent in patients receiving oxygen without invasive ventilation; did not reduce death in patients who were not receiving oxygen therapy.”

 

Ii-Key Peptide-based Covid-19 vaccine / Shandong Academy of Sciences, Generex
Generex Biotechnology Announces That FDA has Accepted the Pre-IND Briefing Package for the Company’s Ii-Key-SARS-CoV-2 Vaccine and Will Provide a Written Response by August 24, 2020 (GlobeNewswire) – Jul 27, 2020 – “Generex Biotechnology Corporation…today announced that the FDA has accepted their pre-IND briefing package for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, and will provide a written response by August 24, 2020….With their response, the FDA will comment on the Phase I/II clinical trial plan and will provide guidance on the overall development program for the Ii-Key-SARS-CoV-2 vaccine.”

 

remdesivir / Generic mfg.
Colombia started studies with Remdesivir and Interferon Beta in patients with Covid-19 (Valora Analitik) – Jul 27, 2020 – “…in Colombia, the Ministry of Health decided to do the studies with two drugs: Remdesivir and Interferon Beta….The inclusion of the first patient in the study began at the Colombia University Clinic in Bogotá. Participation in this procedure was completely voluntary. In the coming weeks, other patients…are expected to agree to be treated with one of these two drugs….The National Institute of Surveillance and Medicines (Invima) approved the ‘Solidarity’ study…and, currently, there are about 20 more medical institutions in administrative processes typical of clinical research to start the research.”

 

mRNA-1273 / Moderna
Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19 (Businesswire) – Jul 26, 2020 – “Moderna, Inc….today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million….Company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding….Under the terms of the revised contract, BARDA is expanding their support of the Company’s late stage clinical development….The total value of the award is now approximately $955 million….The Phase 3 COVE study…is expected to begin tomorrow, July 27.”

 

Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR Pharma
Mesoblast Provides Remestemcel-L Update and Quarterly Activity Report (GlobeNewswire) – Jul 30, 2020 – “The independent Data Safety Monitoring Board (DSMB) has set a date for early September to complete the first interim analysis of the Phase 3 trial of remestemcel-L in ventilator-dependent COVID-19 patients….The clinical protocol evaluating remestemcel-L in patients in the Phase 3 trial was based on results from a pilot study…Up to 30 leading medical centers across the United States are expected to participate in the trial, which is expected to complete recruitment in September 2020.”

Read More …

COVID-19 Top News – July 20, 2020

July 20, 2020

BNT162b1 / Fosun Pharma, BioNTech, Pfizer; BNT162b2 / Pfizer, Fosun Pharma, BioNTech
PFIZER AND BIONTECH GRANTED FDA FAST TRACK DESIGNATION FOR TWO INVESTIGATIONAL MRNA-BASED VACCINE CANDIDATES AGAINST SARS-COV-2 (Pfizer Press Release) – Jul 13, 2020 – “Pfizer Inc. (NYSE: PFE) and BioNTech…today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program…received Fast Track designation from the U.S. Food and Drug Administration (FDA)….The Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities….Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects….Companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.”

 

BNT162b1 / Fosun Pharma, BioNTech, Pfizer
Fosun Pharma Announces its Licensed COVID-19 Vaccine Product Receives Acceptance Notice of Clinical Trial Application by NMPA (PRNewswire) – Jul 14, 2020 – “…Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (‘Fosun Pharmaceutical Industrial’) has received the acceptance notice of clinical trial application for the licensed COVID-19 vaccine product candidate BNT162b1 (the ‘Vaccine’). The clinical trial application of the Vaccine was accepted by the National Medical Products Administration (the ‘NMPA’)….’We hope that the clinical trial will be initiated in China as soon as possible, and the global pandemic will be defeated eventually with the launch of a safe and effective vaccine.'”

 

mosedipimod (EC-18) / Enzychem Lifesci
Enzychem Lifesciences Files IND Application to FDA for Phase 2 Study of EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 Pneumonia (PRNewswire) – Jul 13, 2020 – “Enzychem Lifesciences…today announced that it has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of EC-18….A Phase 2 study for EC-18 in Preventing ARDS due to novel coronavirus pneumonia is currently ongoing in South Korea….The study duration is 12 months from the FDA approval date. The study plans to enroll a total of 60 subjects in total, 30 patients in the EC-18 arm and the other 30 patients on the placebo arm….’We are preparing plans for initiating the Phase 2 study upon the IND becoming active by the U.S. FDA…'”

 

Yeliva (opaganib) / RedHill
RedHill Biopharma Receives Approval for Phase 2/3 COVID-19 Study in Russia (GlobeNewswire) – Jul 16, 2020 – P=Obs, N=23; NCT04435106; “The Phase 2/3 study aims to enroll 270 subjects in up to 40 clinical sites; enrollment planned to be initiated later this month with potential submission of Emergency Use Authorization application planned for Q4/2020; In parallel, the U.S. Phase 2a study with opaganib in patients with severe COVID-19 is advancing rapidly with more than 25% of patients enrolled; Approval also received for a clinical study with opaganib in Israel in up to 50 patients with severe COVID-19; Treatment of patients with severe COVID-19 under compassionate use showed substantial benefit to such patients compared to a matched case-control group; RedHill Biopharma Ltd….today announced approval from the Ministry of Health of the Russian Federation for its Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib…”

 

brilacidin (PMX-30063) / Innovation Pharma
Innovation Pharmaceuticals – Clinical Trial Testing of Brilacidin Against SARS-CoV-2 (COVID-19) Targeted to Commence Q4 2020 (GlobeNewswire) – Jul 13, 2020 – “Innovation Pharmaceuticals…today provides perspectives on the planned clinical trial testing of Brilacidin, administered intravenously (IV), for the treatment of COVID-19. The exigencies of the pandemic coupled with Brilacidin’s multiple therapeutic properties…have the Company working vigilantly to advance Brilacidin into human trials against COVID-19 during fourth-quarter 2020….Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19….Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020.”

 

WP1122 / Moleculin, CNS Pharma, WPD Pharma
Moleculin Announces Agreement to Produce WP1122 for Expanded Development of Potential COVID-19 and Oncology Drug Candidate (PRNewswire) – Jul 15, 2020 – “Moleculin Biotech, Inc….today announced that it has entered into an agreement with Sterling Pharma USA LLC for US production of WP1122 to support its expanded development efforts in preparation for submitting a request to the US Food and Drug Administration (‘FDA’) for Investigational New Drug (‘IND’) status for WP1122 for the potential treatment of COVID-19.”

 

Akebia Announces Initiation of Investigator-Sponsored Study Evaluating Vadadustat for Prevention and Treatment of ARDS in Patients Hospitalized with COVID-19 (PRNewswire) – Jul 14, 2020 – “Akebia Therapeutics, Inc….today announced the initiation of an investigator-sponsored study evaluating the use of vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS)….The randomized, double-blind, placebo-controlled study is intended to evaluate the safety and efficacy of vadadustat in up to 300 adult patients….This study is being conducted under a U.S. Food and Drug Administration Investigational New Drug (IND) application.”

 

Heron Therapeutics Announces Initiation of Phase 2 Clinical Study of CINVANTI for the Treatment of COVID-19 (PRNewswire) – Jul 16, 2020 – “Heron Therapeutics, Inc….today announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron’s Investigational New Drug application for CINVANTI for the treatment of COVID-19….The use of remdesivir through the Emergency Use Authorization and dexamethasone as standard of care are both permitted in the study.”

 

Daklinza (daclatasvir) / BMS
Hep C Sofosbuvir/Daclatasvir Combo Promising for COVID-19 (Medscape) – Jul 13, 2020 – “These findings are hopeful, ‘provocative, and encouraging,’ said Anthony Fauci, MD…But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.”

 

Fauci is optimistic that a new treatment for Covid will be available by October (ThePrint) – Jul 17, 2020 – “US infectious disease expert Anthony Fauci said he expects results for a clinical trial on monoclonal antibodies, which can be used as a treatment to fight the virus….A monoclonal antibody is a laboratory-produced protein that can potentially be used to treat sick patients as well as for prophylaxis. Fauci, the top U.S. infectious disease expert, described them as ‘precise bullets’ that can be developed from antibodies from other people who’ve been infected and used as a treatment to fight the virus at multiple stages.”

Read More …

COVID-19 Top News – July 13, 2020

July 13, 2020

PiCoVacc / Sinovac
Chinese COVID-19 vaccine approved to enter Phase III clinical trial in Brazil (Globaltimes) – Jul 7, 2020 – “The Brazilian National Regulatory Agency, Anvisa, granted approval to a phase III clinical trial sponsored by Instituto Butantan… to test the efficacy and safety of the inactivated COVID-19 vaccine developed by Sinovac Life Sciences Co in Brazil. This trial aims to be a pivotal study to support the licensing of the product….The trial will recruit nearly 9,000 healthcare professionals to work in COVID-19 specialized facilities in 12 clinical sites in several states in Brazil. The recruitment is scheduled to start this month after ethical approval is obtained from each clinical site.”

 

desidustat (ZYAN 1) / Zydus Cadila
Zydus receives approval from COFERIS, Mexico to study Desidustat in the management of COVID-19 (Equitybulls) – Jul 5, 2020 – “Zydus…today announced that it has received approval from the regulatory authority of Mexico…Desidustat to be tested in the management of COVID-19….The company will be conducting a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study….Zydus had initiated two Phase III trials of Desidustat. The DREAM-ND Phase III trial is being conducted in 588 CKD patients not-on-dialysis. The DREAM-D Phase III trial is being conducted in 392 CKD patients on Dialysis’.”

 

remdesivir / Generic mfg.
Australia approves Gilead’s remdesivir for COVID-19 treatment (Yahoo News) – Jul 10, 2020 – “Australia has granted provisional approval to Gilead Sciences Inc’s remdesivir as the first treatment option for COVID-19 in the country….The approval is for adults and adolescent patients with severe COVID-19 symptoms and have been hospitalised…”

 

Alzumab (itolizumab) / Biocon, Equillium
Biocon Biologics’ itolizumab gets DCGI nod for emergency use to treat covid-19 (Livemint) – Jul 11, 2020 – “Biocon Biologics has received an emergency use authorisation (EUA) for its monoclonal antibody Itoliuzumab from the Drug Controller General of India (DCGI) to treat cytokine storms….As per the DCGI, the novel drug can be used only in a hospital set-up, and requires informed consent of patients and a risk management plan.”

 

Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR Pharma
Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19 (GlobeNewswire) – Jul 6, 2020 – “Mesoblast Limited…today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP….The protocol was filed with the United States Food and Drug Administration (FDA)…”

 

Constant Therapeutics’ TXA127 to be tested in Multiple Clinical Trials for COVID-19 Patients (PRNewswire) – Jul 8, 2020 – “Constant Therapeutics today announced that its peptide drug TXA127 will be tested in a series of Phase 2 clinical trials in hospitalized COVID-19 patients who are not in the Intensive Care Unit (ICU). The trials will be conducted at medical centers in the United States, including the Brigham and Women’s Hospital in Boston, Massachusetts; Policlinico S. Orsola-Malpighi Hospital in Bologna, Italy; and at sites in Israel affiliated with Bar-Ilan University and Technion Israel Institute of Technology. Over 400 patients are expected to be recruited.”

 

cryopreserved cord blood derived T-regulatory cells (CK0802) / Cellenkos
Johns Hopkins Reports Promising Clinical Data in COVID-19 ARDS Treated with Cellenkos’ Cord Blood T-Regulatory Cells (PRNewswire) – Jul 7, 2020 – P=NA, N=2; “Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy….Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. Clinical improvement was evident within 48 hours of first infusion and correlated with concurrent dampening of the cytokine storm….The multicenter clinical trial is set to launch in Q3 2020…”

 

REGN10933/REGN10987 / Regeneron
Regeneron Announces Manufacturing and Supply Agreement for BARDA and U.S. Department of Defense for REGN-COV2 Anti-Viral Antibody Cocktail (PRNewswire) – Jul 7, 2020 – “Regeneron Pharmaceuticals, Inc….today announced that, as part of Operation Warp Speed… Executive Office for Chemical, Biological, Radiological and Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2. REGN-COV2 is Regeneron’s investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial….Regeneron continues to work to maximize manufacturing capacity of REGN-COV2 within Regeneron and with potential partners.”

 

beraprost isomer (GP1681) / CytoAgents
CytoAgents Receives Funding to Accelerate COVID-19 Clinical Trials for Cytokine Storm Treatment From Richard King Mellon Foundation (Businesswire) – Jul 7, 2020 – “CytoAgents…announced today that it has received an investment to accelerate the development of its lead drug candidate, GP1681, an investigational new drug to treat ‘cytokine storm’ induced by COVID-19, from the Richard King Mellon Foundation. The Program Related Investment is part of the foundation’s $25 million Pandemic Solutions Package to jump-start COVID-19 response strategies….The $250,000 investment will accelerate the development of GP1681, which will be going into Phase 1 and Phase 2 human clinical trials in 2020.”

 

COVID-19: Moderna’s vaccine has shown “very promising results”, says Dr. Anthony Fauci (The Economic Times) – Jul 9, 2020 – “Dr. Anthony Fauci…says he is cautiously optimistic a vaccine ‘with some degree’ of effectiveness will be successfully developed by the beginning of 2021. He said Moderna’s vaccine has shown ‘very promising’ results’ which makes me cautiously optimistic, although you could never, ever predict with any certainty whether a vaccine is going to be safe and effective.”

Read More …

COVID-19 Top News – July 6, 2020

July 6, 2020

Sylvant (siltuximab) / BeiGene, Jazz
EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (Businesswire) – Jul 2, 2020 – “EUSA Pharma…today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS)….The multicentre trial will aim to enrol approximately 400 patients with viral ARDS and elevated serum levels of IL-6.”

 

Sarconeos (BIO101) / Biophytis
Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure (GlobeNewswire) – Jul 2, 2020 – “Biophytis SA…today announces that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to proceed with its clinical development program COVA. This Phase 2/3 program will assess Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19….’We have already initiated the work to start this key Phase 2/3 trial as soon as possible in the US, and in the European countries where we received approval, and will update the market shortly on our planned timelines.'”

 

BNT162b1 / Fosun Pharma, BioNTech, Pfizer
Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-CoV-2 (GlobeNewswire) – Jul 1, 2020 – P1/2, N=7,600; NCT04368728; Sponsor: Biontech SE; “Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020….Companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021; Pfizer Inc. (NYSE: PFE) and BioNTech SE…today announced preliminary U.S. data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program….Preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity.”

 

remdesivir / Generic mfg.
Gilead’s $2,340 Price for Coronavirus Drug Remdesivir Draws Criticism (The Times) – Jun 29, 2020 – “…it will charge $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries. Gilead Sciences announced the price Monday for remdesivir, and said the price would be $3,120 for patients with private insurance….The treatment courses that the company has donated to the U.S. and other countries will run out in about a week, and the prices will apply to the drug after that…In 127 poor or middle-income countries, Gilead is allowing generic makers to supply the drug; two countries are doing that for around $600 per treatment course….The Institute for Clinical and Economic Review…said remdesivir would be cost-effective in a range of $4,580 to $5,080 if it saved lives.”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Regeneron and Sanofi Provide Update on Kevzara (sarilumab) Phase 3 U.S. Trial in COVID-19 Patients (PRNewswire) – Jul 2, 2020 – P2/3, N=2,500; NCT04315298; Sponsor: Sanofi; “Regeneron Pharmaceuticals, Inc…and Sanofi today announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints….Based on the results, the U.S.-based trial has been stopped….A separate Sanofi-led trial outside of the U.S. in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing. The same Independent Data Monitoring Committee (IDMC) is overseeing both the Regeneron-led U.S. trial and the Sanofi-led trial outside of U.S. and has recommended that the trial outside of the U.S. continue. The companies expect to report results of the trial outside of the U.S. in Q3 2020.”

 

INO-4800 / Inovio, The Wistar Institute
INOVIO Announces Positive Interim Phase 1 Data For INO-4800 Vaccine for COVID-19 (Inovio Press Release) – Jun 30, 2020 – P1, N=120; NCT04336410; Sponsor: Inovio Pharmaceuticals; “INOVIO…today announced positive interim clinical data of INO-4800…from the first two Phase 1 clinical trial cohorts….INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government’s Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021….INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial….An independent Data Safety Monitoring Board reviewed the safety data. INO-4800 was generally safe and well-tolerated in all participants in both cohorts through week 8; all ten reported adverse events (AEs) were grade 1 in severity, and most were local injection site redness. There were no reported serious adverse events (SAEs).”

 

Coronavirus Vaccine / Sinopharm; BBIBP-CorV / Wuhan Institute of Virology, Sinopharm
Covid-19 vaccine candidate shows promising results in human trials, says Chinese firm (The Hindu Business Line) – Jun 28, 2020 – P1/2, N=1,120; “China National Biotec Group (CNBG) said on Sunday that early human trials of its second Covid-19 vaccine candidate has shown promising results suggesting that it could be safe and effective….The two shots developed by CNBG had previously been tested with 2,000 volunteers in phase I and II trials conducted in China. One of the vaccines had been declared safe while the data for the second shot was expected to be released on June 28….The experimental vaccine candidate developed by the Chinese firm has induced high-level antibodies in participants in a Phase 1/2 clinical trial involving 1,120 healthy volunteers…”

 

BRIEF-U.S. FDA To Issue Guidance On Covid-19 Vaccine Approval – WSJ (Reuters) – Jun 30, 2020 – “U.S. FDA TO ISSUE GUIDANCE ON COVID-19 VACCINE APPROVAL ON TUESDAY – WSJ; U.S. FDA’S CONDITIONS FOR APPROVING COVID-19 VACCINE INCLUDE REQUIREMENT THAT ANY VACCINE BE AT LEAST 50% MORE EFFECTIVE THAN A PLACEBO.”

 

remdesivir / Generic mfg.
European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury (remdesivir) for the Treatment of COVID-19 (Businesswire) – Jul 3, 2020 – “Gilead Sciences, Inc….today announced that the European Commission has granted conditional marketing authorization for Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection….The conditional marketing authorization was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting data that began in April 2020. Under this authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen. ‘We appreciate the European Medicines Agency’s rapid review of remdesivir in recognition of the unprecedented nature of this pandemic,’ said Merdad Parsey, MD, PhD…”

 

The coronavirus may have mutated to become more infectious, Dr. Anthony Fauci says (cnbc) – Jul 2, 2020 – “Research is underway to confirm the possible mutation and its implications, Fauci said, adding that ‘there’s a little dispute about it.’ Viruses naturally mutate and scientists have previously said they have observed minor mutations in the coronavirus that have not impacted its ability to spread or cause disease in any significant way.”

Read More …
« Older Entries