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The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Psoriasis – March 30, 2020

March 30, 2020

ANB019 / AnaptysBio
ANB019: “Both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy”; Generalized pustular psoriasis (Cowen & Co. 40th Annual Health Care Conference 2020, AnaptysBio) – Mar 24, 2020 – “Patients demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113” 
[Screenshot]

 

Taltz (ixekizumab) / Eli Lilly
Taltz approved for pediatric patients with moderate to severe plaque psoriasis (eMPR) – Mar 27, 2020 – “The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy….The approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 study (IXORA-Peds) that evaluated the efficacy and safety of ixekizumab in 171 patients aged 6 to less than 18 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.”

 

AVT02 (adalimumab biosimilar) / Alvotech, Cipla
Alvotech and DKSH partner on adalimumab in Asia (Generics Bulletin – Informa) – Mar 26, 2020 – “Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020.”

 

vunakizumab (SHR-1314) / Jiangsu Hengrui Medicine
A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults (clinicaltrials.gov) – Mar 23, 2020 – P2; N=120; Suspended; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial completion date: Jun 2021 –> Dec 2020; Not yet recruiting –> Suspended; Trial primary completion date: Mar 2021 –> Jun 2020

 

BMS-986165 / BMS
Epidemic ‘secondary’ impact: Clinical trials and CDMO industry pressing the pause button [Google translation] (Sina Corp) – Mar 26, 2020 – “In the face of the epidemic, clinical trials can also respond in some ways, but the biggest risk may be that patients cannot follow up, and a large number of clinical trials are being threatened by the epidemic, and the delay has become a reality….At least five of these blockbusters were affected, including…Bristol-Myers Squibb’s BMS-986165 (Tyk2)….On March 23, Galapago’s founder and CEO Onno van de Stolpe also said that he would “suspend clinical trials of filgo to protect patient safety.”

 

 Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
IMMpact2: A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (clinicaltrials.gov) – Mar 27, 2020 – P3; N=444; Active, not recruiting; Sponsor: AbbVie; Trial primary completion date: Jun 2020 –> Jan 2021

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COVID-19 Top News – March 29, 2020

March 29, 2020

aviptadil intravenous (RLF-100) / Relief Therap, NeuroRx
Relief Therapeutics, NeuroRx get FDA nod to start coronavirus trial (Reuters) – Mar 29, 2020 – “The U.S. Food & Drug Administration has authorised the start of a mid-stage trial by U.S.-Israeli NeuroRx and Relief Therapeutics for the use of Aviptadil to treat Acute Respiratory Distress in coronavirus patients….They are recruiting study sites and pharmacies to begin a phase 2 trial. The FDA issued a ‘study may proceed’ letter 24 hours after their investigational new drug application.”

 

chloroquine phosphate / Generic mfg.
Covid-19: NIMR begins test trial tomorrow – Prof Salako (Vanguard Media Limited) – Mar 29, 2020 – “…Nigerian Institute of Medical Research, NIMR, will begin clinical trials on three rapid testing kits for the disease tomorrow. Also, the institute will commence clinical trials on the efficacy of chloroquine on people who tested positive to COVID-19 and those showing symptoms but not confirmed yet.”

 

hydroxychloroquine / Generic mfg.; azithromycin / Generic mfg.
US coronavirus: Trump asks FDA to immediately approve malaria drug and antibiotic combo (InfoSurHoy.com) – Mar 29, 2020 – “…the president urged the Food and Drug Administration in a tweet to speed approval for a malarial drug and an antibiotic to treat coronavirus patients…‘HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine’….”

 

azithromycin / Generic mfg.; hydroxychloroquine / Generic mfg.
Covid 19 treatment: French expert says second study shows malaria drug helps fight coronavirus (Financialexpress) – Mar 29, 2020 – “Dr Philippe Gautret, who was part of the team behind Raoult’s latest findings, admitted that they only used the combination of drugs on ‘patients who had not been showing signs of being seriously ill after admission’ to the hospital….They said the testing was not carried out in a controlled study and that the results were purely ‘observational’. Dr Raoult…said his new study of 80 patients showed that four out of five of those treated with the drug had ‘favourable’ outcomes.”

 

Fighting Covid-19: Houston hospital first in US to try coronavirus blood transfusion therapy (New Indian Express) – Mar 29, 2020 – “A prominent US hospital here has infused the blood of a patient, who has recovered from COVID-19, into a critically ill patient, becoming the first medical facility in the country to try the experimental therapy….Methodist…began recruiting blood plasma donors from among 250 patients who have tested positive for the virus at the system’s hospitals.”

 

UofL researchers focus on coronavirus treatment, testing cells growing quickly in host tobacco plants (NKyTribune) – Mar 29, 2020 – “The University of Louisville’s biocontainment laboratory is being called upon in research efforts focusing on the coronavirus and the disease it causes, COVID-19, and a Kentucky crop could be a key….The research goal is to identify the best potential treatment option that could eventually be tested in humans, first at UofL to gauge its safety and efficacy and then later at the University of Pittsburgh and other clinical trial sites to continue to test its effectiveness….Some of the compounds are already showing promise in the laboratory.”

 

Telehealth, new social media sources and a glimmer of hope that Covid-19 curve is flattening (The RiotACT) – Mar 29, 2020 – “The Prime Minister’s major announcement today concerned the immediate rollout of Telehealth from Monday morning and ways to distribute official information via a new What’s App feature and the Apple coronavirus app….Health Minister Greg Hunt described ‘a time of profound and understandable stress, anxiety, depression, isolation, and need for access to services’, but said the telehealth changes enacted in 10 days would otherwise have taken 10 years to accomplish and would mean substantial assistance was available during the crisis.”

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COVID-19 Top News – March 28, 2020

March 28, 2020

lopinavir/ritonavir / Generic mfg.; hydroxychloroquine / Generic mfg.; remdesivir (GS-5734) / Gilead; chloroquine phosphate / Generic mfg.
A patient in Norway is the first to enroll in a global ‘solidarity trial’ testing 4 coronavirus treatments (Business Insider) – Mar 28, 2020 – “Hoie said the trial starts today, and that the first patient is somone at Oslo Universoty Hospital….The trial…includes more than 45 countries around the world…”

 

US biotech firm wants to test its pneumonia treatment in Covid-19 patients – Mar 28, 2020 – “BioAegis Therapeutics has been testing a protein called gelsolin to treat pneumonia….BioAegis has applied to the FDA for rapid authorization to begin a clinical trial of its treatment for COVID-19 patients that are on or nearly to the point of needing ventilators.”

 

Study shows good results with plasma treatment for Covid-19 (The Hindu) – Mar 28, 2020 – “…Convalescent plasma transfusion may be helpful in the treatment of critically ill patients with COVID-19 and ARDS….While the cohort is small, there is less scepticism about the study results, experts argue, because the method (convalescent plasma) has worked well for other conditions….’Following plasma transfusion, body temperature normalised within 3 days in 4 of 5 patients, the Sequential Organ Failure Assessment score decreased, and the ratio that determines severity of ARDS increased within 12 days….Viral loads also decreased and became negative within 12 days after the transfusion’.”

 

lopinavir/ritonavir / Generic mfg.; chloroquine phosphate / Generic mfg.; hydroxychloroquine / Generic mfg.; remdesivir (GS-5734) / Gilead
India to participate in WHO solidarity trial for developing potential drugs for Covid-19 – Mar 28, 2020 – “Mr Gangakhedkar also informed that India has indicated willingness to go for vaccine trials for country’s population….Our correspondent reports that WHO’s Solidarity trial is expected to witness participation from many countries including Thailand, Argentina, Canada, France, Iran, and Spain. The trial will not only test different drugs but will also compare their effectiveness.”

 

lopinavir/ritonavir / Generic mfg.; hydroxychloroquine / Generic mfg.; remdesivir (GS-5734) / Gilead; chloroquine phosphate / Generic mfg.
WHO enrolls Spain and Norway for Covid-19 initial clinical trial (Biospectrumasia) – Mar 28, 2020 – “Spain and Norway are ready to enrol their patients for COVID-19 clinical trial….’More the countries join the trial, the faster we will have results. In the meantime, we call on individuals & countries to refrain from using therapeutics that have not been demonstrated to be effective in the treatment of COVID-19′.”

 

mRNA-1273 / Moderna Therapeutics
US coronavirus vaccine trial expands to second test location – Mar 28, 2020 – “A coronavirus vaccine study has expanded to a second location, with new volunteers for the potentially COVID-19-preventing injection being sought in Atlanta….Now, Emory University in Atlanta plans to enroll a second cohort as the Phase 1 trial expands its footprint. In total it’s expected to amount to 45 participants spread across both sites.”

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COVID-19 Top News – March 27, 2020

March 27, 2020

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi; remdesivir (GS-5734) / Gilead
N.J. hospital flooded by Covid-19 patients begins clinical drug trials (NJ.com) – Mar 27, 2020 – “Holy Name Medical Center…is conducting trials of two drugs to treat the disease caused by the novel coronavirus. ‘We are trying to do clinical trials of a drug, Kevzara, and expanded access (compassionate use) of the drug remdesivir,’ Saggar said.”

 

ChAdOx1 nCoV-19 / Jenner Institute, University of Oxford
Oxford Covid-19 vaccine programme opens for clinical trial recruitment (Mirage News) – Mar 27, 2020 – “University of Oxford researchers…have started screening healthy volunteers (aged 18-55) today for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region….The team will enrol healthy volunteers aged between 18 – 55….The trial…will recruit up to 510 volunteers, who will receive either the ChAdOx1 nCoV-19 vaccine or a control injection for comparison.”

 

AdCOVID (COVID-19 vaccine) / Altimmune
Altimmune announces financial results for the year ended December 31, 2019 and provides a corporate update (GlobeNewswire, Altimmune, Inc.) – Mar 27, 2020 – “…Company began development of AdCOVID, a vaccine candidate to protect against COVID-19. The Company designed and created the vaccine candidate…and plans to begin animal testing in Q2 2020. The Company is engaged in discussions with a number of organizations who are addressing this crisis, including The United States Medical Countermeasures Task Force, The World Health Organization, academia, and other institutions engaged in the effort.”

 

leronlimab (PRO 140) / CytoDyn, Vyera Pharma
CytoDyn files FDA-suggested modifications to IND and protocol for phase 2 clinical trial for Covid-19 patients with mild to moderate indications and a second randomized protocol for all Covid-19 patients in severe condition will be filed next week per FDA recommendation (GlobeNewswire, CytoDyn Inc.) – Mar 27, 2020 – “CytoDyn Inc….announced today that, at the suggestion of the U.S. Food and Drug Administration (FDA), the Company filed another round of modifications to its IND and protocol for a Phase 2 clinical trial with leronlimab (PRO 140). In addition, the FDA suggested the Company file a second randomized protocol for all COVID-19 patients in severe condition, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab….The first Phase 2 clinical trial…is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States.”

 

Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Two clinical studies to treat Covid-19 launched (Medical Xpress) – Mar 27, 2020 – “UC Davis is one of up to 50 sites in the U.S. assessing sarilumab….Approximately 400 hospitalized patients age 18 and older with acute COVID-19 infection can be enrolled in the study nationwide….The researchers will be determining whether the health of individuals with high IL-6 levels and severe/critical levels of infection improve with the drug. The study is sponsored by the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. Timothy Albertson, professor and chair of the Department of Internal Medicine, is leading the study at UC Davis.”

 

Arcturus Covid-19 vaccine to benefit from Duke-NUS genetic correlation system (GlobeNewswire, Arcturus Therapeutics, Inc.) – Mar 27, 2020 – “Arcturus Therapeutics…today provided details about the Company’s strategy to rapidly learn about the safety and efficacy profile of its COVID-19 vaccine using Duke-NUS’ genetic correlation system….Arcturus’ COVID-19 vaccine, LUNAR-COV19, is based on its STARR™ and LUNAR® technologies.”

 

EIDD-2801 / Emory University, Ridgeback Biotherap
Emory-discovered antiviral is poised for Covid-19 clinical trials (Chemical & Engineering News) – Mar 27, 2020 – “A small-molecule antiviral discovered by Emory University chemists could soon start human testing against COVID-19….That’s the plan of Ridgeback Biotherapeutics, which licensed the compound, EIDD-2801, from an Emory nonprofit….EIDD-2801 lacks human safety data. Ridgeback founder and CEO Wendy Holman says she expects the US Food and Drug Administration to give the green light for a Phase I study in COVID-19 infections within “weeks, not months.””

 

remdesivir (GS-5734) / Gilead
Two clinical studies to treat Covid-19 launched (Medical Xpress) – Mar 27, 2020 – “UC Davis Health has two clinical trials underway for hospitalized patients with severe COVID-19….UC Davis is one of approximately 75 sites worldwide evaluating the benefits of remdesivir for severe COVID-19 infection….The study will enroll up to 440 patients over the next several months, including about 10 or more at UC Davis….It is part of the study recently launched at the University of Nebraska.”

 

leronlimab (PRO 140) / CytoDyn, Vyera Pharma
Leronlimab used in seven patients with severe Covid-19 demonstrated promise with two intubated patients in ICU, removed from ICU and extubated with reduced pulmonary inflammation (GlobeNewswire, CytoDyn Inc.) – Mar 27, 2020 – “CytoDyn Inc….announced today the three-day results post-leronlimab treatment of the first four patients under an Emergency Investigational New Drug (EIND)….’We found that patients with severe COVID-19 disease are in the midst of immunologic chaos which includes the cytokine storm. Our companion diagnostics showed that after three days of therapy, the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm were much improved’.”

 

Rare case of Pulmonary Necrotic Rhodococcus equi infection in a Kidney Pancreas Transplant Recipient. (NKF-CSM 2020) – Mar 27, 2020 – Abstract #463; “At the time of presentation, he was on tacrolimus, mycophenolate mofetil, prednisone and basiliximab for immunosuppression…He was prescribed azithromycin, doxycycline, and ciprofloxacin by his local providers with no improvement…He was started on IV vancomycin, meropenem for 6 weeks and his symptoms improved…He recieved voriconazole for his aspergilllus for 12 months… R.equi is a unique Acid fast positive cocci and a intracellular pathogen.We report a very rare case of Rhodococcus infection in a kidney pancreas transplant recipient which was successfully treated without surgical intervention. Choice of antibiotics was challenging while maintaining dual organ transplant function and avoiding acute rejection.”

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COVID-19 Top News – March 26, 2020

March 26, 2020

Berkeley Lights announces the creation of the Global Emerging Pathogen Antibody Discovery Consortium (GEPAD) to address Covid-19 and other viruses (PRNewswire) – Mar 26, 2020 – “In collaboration with Vanderbilt University Medical Center, La Jolla Institute for Immunology and Emory University , viral neutralization workflows using the Berkeley Lights platform are being accelerated in response to the epidemic coronavirus….The consortium will use the Berconey Lights Beacon platform to discover antibodies using blood from patients in remission as the basis for treatment, COVID-19 being the first target.”

 

ExThera’s affinity blood filter is used to treat Covid-19 Patients – Mar 26, 2020 – “Treatment of COVID-19 with ExThera’s Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) has begun in hospitals in Germany and Italy. Seraph 100 treatments of COVID-19 are also expected to begin soon in France and the USA….ExThera has received clinician interest in individual emergency use of Seraph 100 in the USA and we expect COVID-19 treatments to begin here soon, when they meet the criteria outlined in the FDA Guidance.”

 

Relief Therapeutics and NeuroRx, Inc. file FDA IND for Aviptadil to treat Covid-19-induced respiratory distress (PRNewswire) – Mar 26, 2020 – “RELIEF THERAPEUTICS Holding AG…filed an Investigational New Drug (IND) Application with the US FDA for a phase 2 trial of RLF-100 (Aviptadil) in the treatment of Acute and Moderate Respiratory Distress in patients infected by the COVID-19 coronavirus….Relief also holds a US patent for Aviptadil and proprietary manufacturing processes for its synthesis.”

 

remdesivir (GS-5734) / Gilead
Gilead rescinds orphan status request for Covid-19 drug (pharmaphorum) – Mar 26, 2020 – “Gilead decided to rescind the request for orphan status after drug pricing campaigners accused the company of gaming US drug laws to maximise any profits made from remdesivir should it get approved….While Gilead did not acknowledge the pricing row in its brief statement saying it had rescinded the request, the company noted that orphan status also waives the need for a paediatric study plan that can take 210 days to review.”

 

FDA grants VERO Biotech expanded access emergency use for the treatment of patients with COVID-19, with the Genosyl DS, the first and only FDA-approved tankless system for the delivery of inhaled nitric oxide (PRNewswire) – Mar 26, 2020 – “VERO Biotech LLC…announced that the U.S. Food and Drug Administration (FDA) has granted ‘expanded access emergency use’ allowing its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS, to immediately be used for the treatment of cardiopulmonary symptoms associated with COVID-19.”

 

Beroni Group announces submission of Emergency Use Authorization to US FDA for its COVID-19 rapid test detection kit (GlobeNewswire) – Mar 26, 2020 – “Beroni Group….announces submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its IgG/IgM antibody SARS-CoV-2 rapid test detection kit.”

 

Dynavax and CEPI announce collaboration to support global effort to develop a vaccine for coronavirus (COVID-19) (GlobeNewswire, Dynavax Technologies Corporation) – Mar 26, 2020 – “Dynavax Technologies Corporation…and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a collaboration supporting the global effort to develop a vaccine to prevent the coronavirus (COVID-19). Dynavax will make the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018TM, available for the development of effective vaccines against COVID-19….CEPI and Dynavax will work together to identify and coordinate engagements with entities around the world working on COVID-19 vaccines. The focus of this collaboration is to identify programs that could benefit from combination with CPG 1018 to provide a more rapid or robust immune response.”

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