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Daily Top News – June 11, 2020

June 11, 2020

tralokinumab (CAT 354) / LEO Pharma, AstraZeneca
LEO Pharma announces European Medicines Agency acceptance of Marketing Authorization Application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (Businesswire) – Jun 11, 2020 – “LEO Pharma A/S…today announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for tralokinumab….The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).”

 

Tecentriq (atezolizumab) / Roche; Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Exelixis announces initiation of CONTACT-01 phase 3 pivotal trial of cabozantinib in combination with atezolizumab in previously treated metastatic non-small cell lung cancer (Businesswire) – Jun 11, 2020 – “Exelixis, Inc…announced the initiation of CONTACT-01, a global phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with metastatic non-small cell lung cancer (NSCLC) who have been previously treated with an immune checkpoint inhibitor (ICI) and platinum-containing chemotherapy. Two additional phase 3 pivotal trials in metastatic castration-resistant prostate cancer (CRPC; CONTACT-02) and renal cell carcinoma (RCC; CONTACT-03) are planned as part of the clinical trial collaboration between Exelixis and Roche.”

 

mRNA-1273 / Moderna
Moderna advances late-stage development of its vaccine (mRNA-1273) against Covid-19 (Businesswire) – Jun 11, 2020 – “Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S….The Company expects dosing in the Phase 3 study to begin in July….The first cohort of healthy adults ages 18-54 years (n=300) in the Phase 2 study of mRNA-1273 is fully enrolled….Funding from the Biomedical Advanced Research and Development Authority (BARDA)…partially supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273…”

 

berubicin (RTA 744) / CNS Pharma, WPD Pharma
CNS announces the FDA has granted Orphan Drug Designation for brain cancer drug berubicin (PRNewswire) – Jun 11, 2020 – “CNS Pharmaceuticals, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead product Berubicin for the treatment of malignant gliomas…We look forward to continuing to execute on our strategic plan and initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year. ‘”

 

Nyvepria (pegfilgrastim-apgf) / Pfizer
FDA approves Pfizer’s oncology supportive care biosimilar, Nyvepria (pegfilgrastim-apgf) (Businesswire) – Jun 11, 2020 – “Pfizer…announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim). NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.”

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COVID-19 Top News – June 8, 2020

June 8, 2020

ifenprodil (NP-120) / Algernon Pharma
Algernon receives U.S. FDA clearance for multinational phase 2b/3 human study to evaluate ifenprodil as a potential therapeutic for Covid-19 (GlobeNewswire) – Jun 4, 2020 – “Algernon Pharmaceuticals Inc….announce that it has received, on June 3rd, 2020, clearance from the U.S. FDA for its recently submitted Investigational New Drug (IND) application for its planned multinational Phase 2b/3 study of its re-purposed drug NP-120….’We have already begun the background work to start the Phase 2 trial in the U.S. and other countries as soon as possible and we will update the market shortly on our planned timelines.'”

 

 

TJM2 / I-Mab
I-MAB advances repositioned RA drug in early trial to treat Covid-19 cytokine storm (FierceBiotech) – Jun 1, 2020 – “Studies of COVID-19 patients have documented high levels of both GM-CSF and IL-6 in the bloodstream of those who become severely ill….I-MAB’s executives said during the call that if the results of part two of the TJM2 study in COVID-19 are positive, it will consult with the FDA to develop a plan to speed the drug to market. The company is also accelerating a manufacturing plan to ensure it will have enough of the drug for further clinical trials…”

 

 

AdCOVID (COVID-19 vaccine) / Altimmune, University of Alabama
Altimmune Launches Clinical Trial of T-COVID, an Investigational Intranasal Immune Modulator for the Treatment of Patients with Early COVID-19 (GlobeNewswire, Altimmune, Inc.) – Jun 1, 2020 – “Clearance of IND application received from the U.S. FDA; Planned Phase 1/2 outpatient clinical trial will focus on patients with early SARS-CoV-2 infection; Placebo-controlled trial expected to commence in June with data readout expected in Q4 2020; Therapeutic development program will complement Company’s single-dose intranasal COVID-19 vaccine candidate, AdCOVID; The planned clinical trial will evaluate the potential of T-COVID to prevent clinical worsening in patients with early COVID-19.”

 

 

astegolimab (RG 6149) / Amgen, Roche
BARDA, Genentech to accelerate phase 2 clinical trial for two investigational Covid-19 treatments (Homeland Preparedness News) – Jun 3, 2020 – “A partnership between the Biomedical Advanced Research and Development Authority (BARDA) and biotechnology company Genentech will yield a phase 2 clinical trial to evaluate two investigational drugs for the treatment of severe COVID-19 cases: anti-ST2 and IL-22-Fc. The drugs will be tested on approximately 300 patients with severe COVID-19 pneumonia that has forced them to take supplemental oxygen.”

 

 

remdesivir / Generic mfg.
Gilead announces results from phase 3 trial of remdesivir in patients with moderate Covid-19 (Gilead Press Release) – Jun 1, 2020 – P3, N=237; SIMPLE (NCT04257656); “Gilead Sciences, Inc….today announced topline results from the Phase 3 SIMPLE trial….The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement at Day 11 compared with those in the standard of care group….No new safety signals were identified with remdesivir across either treatment group….Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups.”

 

 

Lilly begins world’s first study of a potential Covid-19 antibody treatment in humans (PRNewswire) – Jun 1, 2020 – “First patients have been dosed in a Phase 1 study of LY-CoV555, the lead antibody from Lilly’s collaboration with AbCellera; The placebo-controlled study will assess safety and tolerability in patients hospitalized with COVID-19 with results anticipated by the end of June; Should Phase 1 results show the antibody can be safely administered, Lilly will initiate a Phase 2 proof of concept study to assess efficacy in vulnerable populations….The company also plans to study the drug in a preventative setting, focusing on vulnerable patient populations…”

 

 

Fauci: Moderna’s Phase 3 Covid-19 Vaccine Trial Of 30,000 Individuals Will Begin In July (Forbes) – Jun 2, 2020 – “In an interview Tuesday with the editor of JAMA, Fauci said the trial will include primarily U.S. sites, but also include international sites enrolling 30,000 individuals in a ‘randomized placebo’ controlled trial of Moderna’s vaccine against the Coronavirus strain Covid-19. Moderna’s vaccine candidate is considered in the lead among several efforts by drug and vaccine makers in the battle against the deadly virus….But Fauci confirmed Tuesday the work to begin a much larger phase 3 trial are well underway and will begin early next month.”

 

US has two million Covid-19 vaccine doses “ready to go” upon approval, says Trump (The Hindu Business Line) – Jun 6, 2020 – “Moderna, Novavax and Pfizer are amid the five companies shortlisted. Moderna currently seems to be in the lead. The company is planning to enter phase three testing in July, Fauci had said earlier this week according to a Forbes report.”

 

Experts Voice Concerns Over US Government’s Program For COVID-19 Vaccine – Jun 6, 2020 – “In a televised interview with the CNN, Dr Peter Hotez…said on June 6 that there is a lot of ‘chaos and confusion’ regarding the federal government’s program. According to the sources cited by the international media outlet, the Warp Speed program under the Trump administration has selected five companies that would most likely to manufacture the COVID-19 vaccine…dr Anthony Fauci has said that he expects at least 100,000 doses of one vaccine made by the Moderna to be available in the US by 2020.”

 

AstraZeneca Targeting Over 2 Billion COVID-19 Vaccine Doses After Latest Deals (Eyewire News) – Jun 5, 2020 – “The deals include a $750-million agreement with CEPI and Gavi to support the manufacturing, procurement and distribution of 300 million doses of AZD1222, with delivery to begin by year’s end. CEPI said the doses would be ‘ringfenced’ for the so-called COVID-19 Vaccine Global Access Facility, if the vaccine is found to be safe and effective. Richard Hatchett…said ‘this partnership demonstrates how the COVID-19 Vaccine Global Access Facility will bring the private, public and third sectors together to make COVID-19 vaccines available to those who need them most.'”

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COVID-19 Top News – May 7, 2020

May 7, 2020

VIR-2703 / Vir Biotech, Alnylam
Vir and Alnylam identify RNAi therapeutic development candidate, VIR-2703 (ALN-COV), targeting SARS-CoV-2 for the treatment of Covid-19 (Alnylam Press Release) – May 4, 2020 – “Vir Biotechnology, Inc….and Alnylam Pharmaceuticals, Inc….today announced the selection of a development candidate (DC) for VIR-2703 (also referred to as ALN-COV)….The companies plan to soon meet with the U.S. Food and Drug Administration (FDA) and other regulatory authorities to discuss a potential accelerated path for filing an Investigational New Drug (IND) or IND equivalent application at or around year-end 2020….The companies plan to advance VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19….We will further accelerate our efforts and plan to begin studies in humans at or around year-end…”

 

PPP003 / Tetra Bio-Pharma
Tetra Bio-Pharma provides PPP003 inflammatory cytokine reduction drug program (Tetra Bio-Pharma Press Release) – May 6, 2020 – “Tetra Bio-Pharma Inc….is pleased to announce that it has now completed the modifications to the nonclinical safety program of PPP003 to ensure the launch of a Phase 1 trial in healthy volunteers later this year and subsequently be able to initiate a Phase 2 trial in patients with COVID-19 immediately after….The phase I study will enroll approximately 100 healthy volunteers….The study will include standard safety assessments, pharmacokinetics and cardiovascular evaluations. The phase II study will enroll approximately 100 covid-19 infected patients in several hospitals.”

 

GLS-1200 / GeneOne, University of Pennsylvania
GeneOne Life Science announces US FDA approval of a phase 2 study of GLS-1200 nasal spray for Covid-19 prevention (PRWeb) – May 4, 2020 – “GeneOne Life Science, Inc. announces today an Investigational New Drug (IND) approval by the U.S. Food and Drug Administration of a Phase 2 study of GLS-1200, its nasal spray for the prevention of COVID-19 infection. This study will recruit hospital personnel and other frontline healthcare workers who are at significantly higher risk for infection with COVID-19. In this study, GLS-1200 will be topically self-administered as a spray to the nose, the primary entry point for COVID-19 infection….This study of GLS-1200 will enroll a total of 225 participants into a randomized, double-blind, placebo-controlled clinical trial. The study will investigate whether three-times daily nasal administration of GLS-1200 over 4 weeks can prevent infection with COVID-19 while in use.”

 

llllllllll Organicell Announces FDA Approval of IND Application for the Treatment of SARS Due to COVID-19 (GlobeNewswire, ORGANICELL REGENERATIVE MEDICINE, INC) – May 5, 2020 – “Organicell Regenerative Medicine, Inc….announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Organicell Flow, for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection. This trial will be the first randomized, double-blinded, placebo-controlled, phase I/II multi-center clinical trial investigating the safety and potential efficacy of amniotic fluid sourced components for COVID-19.”

 

Coronavirus Vaccine / AdaptVac, Bavarian Nordic
Bavarian Nordic Enters Agreement with AdaptVac to Advance COVID-19 Vaccine Program (GlobeNewswire, Bavarian Nordic A/S) – May 6, 2020 – “Bavarian Nordic A/S…today announced that it has entered into an exclusive head of terms agreement with AdaptVac…to license AdaptVac’s proprietary capsid virus like particle (VLP) based SARS-CoV-2 subunit vaccine. The parties seek to enter into the final license agreement within the next two months…. AdaptVac’s technology has the potential to mimic a virus to the body’s immune system, giving the optimal stimulus to generate a fast, long-lasting immune response that offers a highly efficacious protection….AdaptVac is working with AGC Biologics for the manufacture and scale-up of the vaccine. Bavarian Nordic will support the consortium to achieve clinical proof of concept and takes responsibility for clinical development and global commercialization of the vaccine. Current plan is to initiate a clinical study later this year.”

 

TerraCoV2 / Oragenics, National Institute of Allergy and Infectious Diseases
Oragenics acquires Noachis Terra Inc., to develop its TerraCoV2 NIH-generated SARS-CoV-2 (Covid19) vaccine candidate utilizing “Spike Protein” (Businesswire) – May 4, 2020 – “Oragenics, Inc….today announced its acquisition of Noachis Terra Inc., following its entry into a stock purchase agreement…to develop and commercialize TerraCoV2, a vaccine candidate which could provide specific immunity from the novel coronavirus….Noachis Terra Inc., holds a worldwide, nonexclusive license to the TerraCoV2 vaccine candidate from the National Institute of Allergy and Infectious Diseases (NIAID)…”

 

Jakafi oral (ruxolitinib) / Novartis, Incyte
Novartis, Incyte will take Jakafi into 2nd trial for Covid-19 patients on ventilators (Fierce Pharma) – May 5, 2020 – “Novartis and Incyte have already pitted their blockbuster JAK inhibitor Jakafi against COVID-19 as a possible treatment for a severe respiratory immune reaction….Partners will take Jakafi into a second late-stage trial. The partners plan to test Jakafi in a second phase 3 trial for COVID-19 patients with acute respiratory distress syndrome (ARDS)….The U.S. trial will evaluate Jakafi’s safety and efficacy over standard of care in ARDS patients who’ve needed ventilators….In the first quarter, Jakafi posted global revenues of $459 million, Incyte said.”

 

remdesivir (GS-5734) / Gilead
U.S. firm Gilead files for remdesivir approval in Japan (Japan Times) – May 5, 2020 – “Gilead Sciences Inc. is seeking Japanese regulatory approval for remdesivir, a drug that potentially can reduce the impact of the coronavirus in some patients, according to sources. The health ministry is expected to move quickly and approve remdesivir using a fast-track process that allows for substantially shortened screening procedures on condition that the drug has already been approved overseas.”

 

‘Cytokine storms’: Why doctors are exploring extreme inflammatory response in severe coronavirus patients (Cleveland) – May 6, 2020 – “Cleveland Clinic is researching how markers in the blood could indicate whether a patient is going to have a severe inflammatory response…..The Cleveland Clinic is exploring the use of rheumatology drugs to treat inflammation in COVID-19 patients. University Hospitals is hosting a clinical trial of a stem cell treatment for acute respiratory distress syndrome, linked to inflammation…..Goetz is partnering with McCall on research testing the effectiveness of different chemicals to prevent cytokine storms. The team received a $100,000 grant…for the study. Research will test five compounds that limit the activity of GSK-3 enzymes…”

 

Lilly and Junshi Biosciences to co-develop antibody therapies for the prevention and treatment of Covid-19 (Eli Lilly Press Release) – May 4, 2020 – “Junshi Biosciences…and Eli Lilly and Company…announced today they have entered into an agreement to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19….Multiple neutralizing antibodies have been engineered, with the lead asset poised to enter clinical testing in the second quarter….Lilly will receive an exclusive license to conduct clinical development, manufacturing and distribution of products outside of Greater China. Junshi Biosciences will maintain all rights in Greater China.” 

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COVID-19 Top News – March 25, 2020

March 25, 2020

FDA now allows treatment of life-threatening Covid-19 cases using blood from patients who have recovered (TechCrunch) – Mar 25, 2020 – “The U.S. Food and Drug Administration (FDA)…include use of ‘convalescent plasma’, in cases where the patient’s life is seriously or immediately threatened. This isn’t an approval of the procedure as a certified treatment, but rather an emergency clearance that applies only on a case-by-case basis, and only in extreme cases….FDA has granted this temporary authorization under its Investigational New Drug Applicants (eINDS) exemption.”

 

Study tests proven blood clot buster against Covid-19 (Drug Discovery & Development) – Mar 25, 2020 – “In a clinical trial being planned for hospitals in Massachusetts and Colorado, patients with severe cases of COVID-19 would be given the blood thinner tissue plasminogen activator (tPA), a protein prescribed for heart attack and stroke victims….The researchers will test tPA in patients under the FDA’s ‘compassionate use’ program….BARDA ( the Biomedical Advanced Research and Development Authority) will fund the trial. Genentech is donating the drug for the initial trial.”

 

remdesivir (GS-5734) / Gilead
Lives are on the line: Science matters in finding coronavirus treatments (NBC News) – Mar 25, 2020 – “In Nebraska, researchers are studying whether an experimental drug, remdesivir, can treat COVID-19, the illness that results from coronavirus infection.”

 

trabedersen (OT-101) / Autotelic, Mateon Therapeutics
Mateon report positive results for multiple COVID-19 drug candidates (GlobeNewswire) – Mar 25, 2020 – “OT-101 continued to show significant activity against coronaviruses and in the new testing results, two additional therapeutic oligonucleotides designed to target COVID-19 also demonstrated potent anti-viral activity….OT-101 and the other candidates work by inhibiting virus binding to its target, thereby stopping the virus from replicating itself and stopping viral induced pneumonia, which often leads to patient complications….The Company has begun preparations to submit an Investigational New Drug Application (IND) to the Food and Drug Administration (FDA) for OT-101 against COVID-19 to expedite testing in COVID-19 patients.”

 

BioSig subsidiary NeuroClear acquires license for a broad-spectrum anti-viral agent that may treat Covid-19. Laboratory results demonstrate high level of activity against Covid-19 in cell culture (GlobeNewswire) – Mar 25, 2020 – “BioSig Technologies, Inc…acquired the rights to develop a novel pharmaceutical to treat Coronavirus Disease 2019 (COVID-19)….Anti-viral agent Vicromax(tm) demonstrated strong activity against COVID-19 in cell cultures in laboratory testing….The Company intends to pursue development of this agent for the treatment of COVID-19 through FDA-approved clinical trials….The Company intends to develop Vicromax(tm) and take it through clinical trials under a new NeuroClear subsidiary, ViralClear Pharmaceuticals, Inc.”

 

CytoSorb used to treat more than 70 critically-ill Covid-19 patients and specifically added to coronavirus treatment guidelines in Italy and Panama (PRNewswire) – Mar 25, 2020 – “CytoSorb use has generally been associated with a marked reduction in cytokine storm and inflammation, improved lung function, weaning from mechanical ventilation, and a reversal of shock. Certainly not all treatments have been successful in this critically-ill patient population that verges on death, particularly when used too late.”

 

Nu-Med Plus closely monitoring outcomes on two new human clinical trials using inhaled nitric oxide in treatment of Covid-19 (GlobeNewswire, Nu-Med Plus Inc.) – Mar 25, 2020 – “Nu-Med Plus, Inc…today announced that the Company is closely monitoring two new clinical trials that are testing Nitric Oxide Gas Inhalation Therapy for the treatment of mild/moderate COVID-19….Data on SARS-CoV suggest that iNO could have a similar effect on COVID-19 due to the genomic similarities between the two coronaviruses.”

 

Eurobio Scientific gets CE marking for its proprietary COVID-19 test (GlobeNewswire) – Mar 25, 2020 – “Eurobio Scientific…is today announcing the CE marking for its EBX 041 SARS CoV2 proprietary test, developed specifically for the clinical diagnosis of COVID-19. The EBX 041 SARS CoV2 proprietary kit follows the design recommended by the French National Reference Center (CNR) and has been approved based on clinical samples with an independent hospital. This is a multiplex kit with three targets: two for identifying the virus and one target for a control integrated into each patient test.”

 

Sorrento Launches Novel I-Cell COVID-19 Cellular Vaccine Program (GlobeNewswire, Sorrento Therapeutics, Inc.) – Mar 25, 2020 – “STI-6991 is an I-CellTM COVID-19 cellular vaccine made of replication-deficient human erythroleukemia K562 cells expressing membrane-bound S1 protein of the SARS-CoV-2 virus….The I-Cell vaccine is expected to elicit both T cell and B cell immunities against SARS-CoV-2.”

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COVID-19 Top News – March 24, 2020

March 24, 2020

remdesivir (GS-5734) / Gilead
Gilead’s potential coronavirus treatment gets FDA’s Orphan Drug label (cnbc) – Mar 24, 2020 – “Gilead Sciences’ experimental drug remdesivir…received the orphan drug designation from the U.S. Food and Drug Administration….The announcement comes days after U.S. President Donald Trump called on the FDA to streamline its approval process for treatments such as remdesivir….It was temporarily putting new emergency access to remdesivir on hold due to an exponential increase in so-called compassionate-use requests for the drug.”

 

CpG 1018 / Dynavax, University of Queensland
Dynavax and Clover Biopharmaceuticals announce research collaboration to evaluate coronavirus (COVID-19) vaccine candidate with CpG 1018 adjuvant (GlobeNewswire) – Mar 24, 2020 – “Dynavax Technologies Corporation…and Clover Biopharmaceuticals…announced that they have entered into a research collaboration to develop a vaccine candidate to prevent COVID-19. Clover is advancing evaluation of its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer) in preclinical studies. Dynavax is providing technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support this initiative…Utilizing its patented Trimer-Tag© technology, Clover has produced a COVID-19 S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system….Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.”

 

eTheRNA launches an international consortium and starts development of cross-strain protective CoV-2 mRNA vaccine for high risk populations (PRNewswire) – Mar 24, 2020 – “eTheRNA Immunotherapies nv…announced that a consortium has been formed with North American and European partners to develop a novel mRNA vaccine against CoV-2 and preclinical development has started. Chinese partners may be added in the consortium in due course…eTheRNA and its partners EpiVax, Nexelis, REPROCELL and CEV* have extensive experience in the mRNA vaccine field and this will help accelerate progress towards clinical trials with patient enrolment expected in early 2021.”

 

Actemra IV (tocilizumab) / Roche, JW Pharma
Roche response to Covid-19 pandemic (GlobeNewswire, F. Hoffmann-La Roche Ltd) – Mar 24, 2020 – “The study, COVACTA, will evaluate the safety and efficacy of intravenous Actemra®/RoActemra® (tocilizumab) on top of standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo on top of standard of care….This is the first global study of Actemra/RoActemra in this setting.”

 

hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.
New York to start clinical trials for Covid-19 treatment after a go signal from the FDA (Tech Times) – Mar 24, 2020 – “…Food and Drug Administration has already approved one of the drugs that are involved in the clinical trials for the state of New York….New York Gov. Andrew Cuomo has stated…they have now acquired 10,000 doses of Zithromax, 70,000 doses of hydroxychloroquine and 750,000 doses of chloroquine….The main drug that was approved by the FDA for clinical trials was Chloroquine…brand-name antibiotic called Zithromax was included, and another one named hydroxychloroquine….These drugs are all considered as potential treatments for coronavirus.”

 

COVID-19 immunotherapy / CEL-SCI
Embattled Cel-Sci to tackle Covid-19 with immunotherapy platform tech LEAPS (FierceBiotech) – Mar 24, 2020 – “Cel-Sci announced…it has formed a research partnership with the University of Georgia’s Center for Vaccines and Immunology to develop a drug candidate for patients at high risk of dying from COVID-19.”

 

Sorrento collaborates with Mabpharm on development and commercialization of ACE-MAB to potentially treat COVID-19 (GlobeNewswire, Sorrento Therapeutics, Inc.) – Mar 24, 2020 – “Sorrento Therapeutics, Inc…today announced it has entered into an exclusive license agreement with China-based antibody biopharmaceutical company, Mabpharm Limited…for the clinical development and commercialization of the ACE-MAB fusion protein (Sorrento’s product code name STI-4920 and Mabpharm’s product code name CMAB020) for the potential treatment of COVID-19, the disease caused by the SARS-CoV-2 virus. Mabpharm has generated a fusion protein (CMAB020) that binds to the spike protein of the SARS-CoV-2 virus.”

 

 

Ampio is preparing an expanded access FDA protocol to study nebulized Ampion as a treatment for moderate to severe acute respiratory distress syndrome associated with Covid-19 (PRNewswire) – Mar 24, 2020 – “Ampio Pharmaceuticals…announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2….The anticipated aim of a preliminary protocol for FDA review would be to evaluate patients with moderate to severe ARDS, triggered by COVID-19 for (1) reduced ventilator time; (2) reduction in mortality and (3) improvements in oxygenation parameters compared to non-Ampion treated patients.”

 

Cell>Point plans to expedite research program on 99mTc-EC-Amifostine and 177Lu-EC-Amifostine as a potentially effective theranostic technology for Covid-19 (PRNewswire) – Mar 24, 2020 – “Cell>Point announced today its plans to move forward with its research program to clinically develop 99mTc-EC-Amifostine and 177Lu-EC-Amifostine to assess, treat and follow-up with confirmatory imaging for people who contract COVID-19.”

 

VERO Biotech announces first patient with Covid-19 infection complicating pulmonary hypertension treated with GENOSYL DS, the first and only FDA-approved tankless system for the delivery of Inhaled Nitric Oxide (PRNewswire) – Mar 24, 2020 – “VERO Biotech…today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS at home….The patient was treated under an emergency IND filed by a qualified Investigator and approved by the US FDA.”

 

Soligenix’s Covid-19 vaccine (Pharmaceutical-technology.com) – Mar 24, 2020 – “Soligenix has collaborated with the University of Hawaiʻi at Mānoa (UH Mānoa) to study Covid-19 vaccine candidates….The company will assess the use of its heat-stable technology platform against coronaviruses, including SARS-CoV-2.”

 

INO-4800 / Inovio
Ology Bioservices, Inovio Partner to manufacture COVID-19 DNA vaccine with $11.9 million department of defense grant (PRNewswire) – Mar 24, 2020 – “Ology Bioservices Inc…and Inovio Pharmaceuticals Inc…announced today that the Department of Defense (DOD) has awarded Ology Bioservices with a contract valued at $11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture DNA vaccines….Under this program, Ology Bioservices will work with Inovio Pharmaceuticals to manufacture Inovio’s DNA vaccine (INO-4800) for prevention of infection with the COVID-19 virus.”

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COVID-19 Top News – March 23, 2020

March 23, 2020

Actemra IV (tocilizumab) / Roche, JW Pharma
Genentech announces FDA approval of clinical trial for Actemra to treat hospitalized patients with severe COVID-19 pneumonia (Businesswire) – Mar 23, 2020 – “Genentech…announced….the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.”

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite: Piclidenoson is submitted for Compassionate Use treatment for coronavirus patients in Israel (Businesswire) – Mar 23, 2020 – “Can-Fite BioPharma Ltd…announced today that it has submitted Piclidenoson for a compassionate use program to treat coronavirus patients to the Institutional Review Board at Rabin Medical Center. If approved, the compassionate use program will be led by Dr. Dror Diker….Patients would be treated at Rabin’s Golda Hasharon Campus which is currently positioned to treat coronavirus patients in a specialized setting.”

 

Avigan (favipiravir) / Fujifilm Holdings
A U​.​S. phase III study of favipiravir, large scale, in New York, commencing immediately – Mar 23, 2020 – “The time is now to clear impediments, begin large-scale phase III studies in the US, and partner with FujiFilm to increase worldwide production of this vital substance.”

 

Celltrion accelerates development of Covid-19 antiviral treatment and aims to launch rapid self-testing kit (Businesswire) – Mar 23, 2020 – “Celltrion has successfully completed the first step of developing an antiviral treatment to fight COVID-19 and aims to launch a rapid self-testing diagnostic kit….Celltrion has been selected as a preferred developer for a monoclonal antibody project…by the Korea Centers for Disease Control (KCDC)….Once identified these will form the basis of the antiviral treatment to be tested through pre-clinical and clinical trials around the world in the third quarter of 2020….Celltrion plans to apply for device authorisation from the FDA in the US and other regulatory authorities after acquiring relevant data.”

 

Sorrento and Smartpharm to collaborate to develop novel gene-encoded antibody vaccine intended to protect against COVID-19 (GlobeNewswire, Sorrento Therapeutics, Inc.) – Mar 23, 2020 – “In response to the government call for rapidly deployable countermeasures, Sorrento Therapeutics, Inc (Nasdaq: SRNE, Sorrento) and SmartPharm Therapeutics Inc (SmartPharm) today announced a research and development collaboration to develop a next-generation, gene-encoded antibody vaccine for COVID-19. The collaboration will utilize monoclonal antibodies against SARS-CoV-2 virus discovered and/or generated by Sorrento that will be encoded into a gene for delivery utilizing SmartPharm’s non-viral nanoparticle platform.”

 

Hoth Therapeutics announces agreement to joint development of a self-assembling vaccine (SAV) for the potential treatment of the coronavirus (Covid-19) (PRNewswire) – Mar 23, 2020 – “Hoth Therapeutics…today announced it has reached an agreement with Voltron Therapeutics, Hoth Therapeuticsto form a joint venture entity (to be named HaloVax) to commence preclinical studies for the development of vaccine prospects to prevent…(COVID-19) based upon VaxCelerate….Hoth shall be granted the right to receive single digit royalties from the sale of any products developed, and shall have the right to acquire up to a 30% equity interest in HaloVax.”

 

DCGI to fast-track approval for Covid-19 drug, vaccine (The Economic Times) – Mar 23, 2020 – “The Drugs Controller General of India (DCGI) has said that it will fast-track approval of all companies which have a drug or vaccine for Covid-19 treatment….The DCGI has offered seven measures for speeding up the process, from giving fast-track approval for repurposed drug to waiving animal study….The DCGI also said that applications to import a drug for test and analysis used to check efficacy with original molecules will be processed within seven days.”

 

AlloVir expands its research collaboration with Baylor College of Medicine to discover and develop allogeneic, off-the-shelf, virus-specific T-cell therapies for Covid-19 (Businesswire) – Mar 23, 2020 – “AlloVir…collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2….AlloVir aims to develop a therapy for CoVs that can be used as a stand-alone treatment or incorporated into the company’s multi-respiratory virus investigational therapy, ALVR106.”

 

Hoth Therapeutics announces agreement to joint development for a Self-Assembling Vaccine (SAV) for the potential prevention of the coronavirus (COVID-19) (PRNewswire) – Mar 23, 2020 – “Hoth Therapeutics, Inc…today announced it has reached an agreement with Voltron Therapeutics, Inc. (Voltron) to form a joint venture entity, to be named HaloVax, to commence preclinical studies for the development of vaccine prospects to prevent the Coronavirus (COVID-19) based upon VaxCelerate, a self-assembling vaccine (SAV) platform exclusively licensed by Voltron from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH).”

 

Avigan (favipiravir) / Fujifilm Holdings
Favipiravir alleviated the pneumonia symptom of COVID-19 patients with high tolerance and few adverse reactions (Biospectrumasia) – Mar 23, 2020 – P=NA, N=NA; “…Favipiravir alleviated the pneumonia symptom of COVID-19 patients with high tolerance and few adverse reactions, potentially through a mechanism that can quickly eliminate the coronaviruses from their bodies. [P=NA, N=120]…effectiveness in experimental group was significantly better than that in the control group, which was 71.43% and 55.86%, respectively. The same significant advantage went to the average antipyretic and cough remission time.”

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COVID-19 Top News – March 21, 2020

March 21, 2020

China starts clinical trials of Covid-19 vaccine (UrduPoint) – Mar 21, 2020 – “108 volunteers were divided into three groups of 36 persons each. The first group will receive a low dose of the developed vaccine, the second group will get a medium dose and the last group a high dose. The trials…will continue until the end of December….After getting the vaccine, the participants will be quarantined for 14 days and placed under constant medical supervision….Upon lifting the quarantine, they will be regularly examined for six months.”

 

Cepheid receives Emergency Use Authorization from FDA for rapid SARS-CoV-2 test (PRNewswire) – Mar 21, 2020 – “Cepheid…announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2…The test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes.”

 

Avigan (favipiravir) / Fujifilm Holdings
Study shows an anti-viral flu drug to be effective in treating Covid-19 (Gilmore Health – The Brux10 Health Trust) – Mar 21, 2020 – “Favipiravir…has been found to be effective in treating COVID-19….They had found promising results from the use of Favipiravir or Avigan in 340 coronavirus patients. Zhang said the antiviral drugs proved to be effective and highly safe in the clinical trial conducted in Wuhan and Shenzhen….Additionally, the clinical trial in Wuhan reported a shorter febrile period from 4.2 days to 2.5 days.”

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COVID-19 Top News – March 20, 2020

March 20, 2020

Cardax releases white paper on the potential role of astaxanthin in the treatment of coronavirus disease (PRNewswire) – Mar 20, 2020 – “Cardax…released a white paper outlining the potential role of astaxanthin in the treatment of coronavirus disease and is seeking strategic collaborations to further develop astaxanthin for COVID-19….Astaxanthin has been shown to (i) significantly attenuate pathological elevation…(ii) decrease the resulting elevated proinflammatory cytokine levels, (iii) reduce immune cell infiltration of the lung, and (iv) positively influence macrophage polarization in humans and animal models of disease….Company filed a patent application yesterday.”

 

Smartphone enabled rapid test for Covid 19 approved for at home use (Speciality Medical Dialogues) – Mar 20, 2020 – “A smartphone-enabled rapid serology test for Covid 19 for at-home use has been approved….The test takes 15 minutes to complete using the Scanwell Health app….The test developed by INNOVITA shall be distributed by Scanwell Health which has secured exclusive rights to license and distribute a SARS-CoV-2 test….Scanwell is anticipating that the SARS-CoV-2 rapid test kits will be available within 6 to 8 weeks after Scanwell obtains Emergency Use Authorization (EUA) from the FDA for at-home use of serology tests.”

 

Sorrento Develops STI-4398 (COVIDTRAP Protein) for potential prevention and treatment of SARS-COV-2 coronavirus disease (Covid-19) (GlobeNewswire, Sorrento Therapeutics, Inc.) – Mar 20, 2020 – “Sorrento Therapeutics…announced it has produced a preclinical batch of the STI-4398 (COVIDTRAP) protein to immediately commence testing its neutralization and blocking activity in preventing SARS-CoV-2 virus from infecting ACE2-expressing cells….In vitro cell studies for SARS-CoVID-2 virus infection and neutralization are expected to be conducted in the next few weeks in collaboration with world-leading coronavirus experts….Sorrento currently anticipates it will complete the enabling studies for an expedited IND filing in the next few months.”

 

hydroxychloroquine / Generic mfg.
Anti-new crown pneumonia both drugs U.S. FDA proposes antimalarial drugs and recovery plasma (GeneOnline) – Mar 20, 2020 – U.S. FDA Commissioner Stephen Hahn said…that FDA is carefully considering Plaquenil (hydroxychloroquine)…as a new treatment for new coronary pneumonia (COVID-19)….Recovery plasma and the immunoglobulins it contains are another possible treatment that the FDA is considering….If the subject has been exposed to the coronavirus and your blood is free of the virus and symptoms, clinical researchers can collect blood….Once there is no pathogen, the FDA has the ability to treat other patients with COVID-19.”

 

WP1122 / WPD Pharma, Moleculin
Moleculin announces patent filing to cover new coronavirus drug candidate (PRNewswire) – Mar 20, 2020 – “Moleculin Biotech, Inc…announced that a new patent application has been filed covering the use of WP1122 and its analogs as therapies to limit the ability of coronavirus and other viruses to replicate. The patent application covers joint discoveries which came as a result of an ongoing sponsored research agreement.”

 

Apotex donates hydroxychloroquine for a clinical study to prevent infection from Covid-19 with front line health care workers (GlobeNewswire) – Mar 20, 2020 – “The study, conducted by the University Health Network and Unity Health (St Michael’s Hospital) in Toronto, aims to gather data from randomized controlled trials which is essential for informing the best practices in protecting our health care workers at this critical time. It is a PreExposure Prophylaxis randomized placebo controlled trial for front line health care workers including emergency room staff and ICU staff.”

 

FDA grants Bellerophon emergency expanded access for INOpulse for the treatment of COVID-19 virus (GlobeNewswire) – Mar 20, 2020 – “Bellerophon Therapeutics, Inc…today announced that the U.S. Food and Drug Administration (FDA) has granted emergency expanded access allowing its proprietary inhaled nitric oxide (iNO) delivery system, INOpulse®, to immediately be used for the treatment of COVID-19.”

 

Novartis commits to donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response (GlobeNewswire) – Mar 20, 2020 – “Novartis announced today its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine, are currently under evaluation in clinical trials for the treatment of COVID-19. Novartis is supporting ongoing clinical trial efforts, and will evaluate needs for additional clinical trials.”

 

Chembio Diagnostics receives $4 million purchase order from Bio-Manguinhos for production of DPP COVID-19 IgM/IgG system in Brazil (GlobeNewswire) – Mar 20, 2020 – “Chembio Diagnostics, Inc…today announced its receipt of a $4 million order from Bio-Manguinhos for the purchase of Chembio’s DPP COVID-19 IgM/IgG System, to support the urgent needs of Brazil’s Ministry of Health. Bio-Manguinhos is a subsidiary of the Oswaldo Cruz Foundation (Fiocruz) that is responsible for the development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system.”

 

Humanigen planning phase III study of coronavirus treatment (Yahoo Finance) – Mar 20, 2020 – “Humanigen, Inc…announced that the company is seeking to conduct a Phase III, randomized, controlled, clinical trial to rapidly advance the clinical development of lenzilumab for the prevention and treatment of cytokine storm which can lead to acute respiratory distress syndrome (ARDS) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in COVID-19….Clinical trials of lenzilumab in patients with COVID-19 will commence upon approval by relevant regulatory authorities. In addition, the company is planning on making lenzilumab available on a compassionate use basis.”

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Weekly Top News – Ovarian Cancer – March 16, 2020

March 16, 2020

Recentin (cediranib) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Update on Phase 3 GY004 for cediranib and Lynparza (olaparib) in platinum-sensitive relapsed ovarian cancer (Businesswire) – Mar 12, 2020 – “AstraZeneca and Merck…announced high-level results from the Phase 3 GY004 trial, led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI), that examined primarily the efficacy and safety of investigational medicine cediranib in combination with LYNPARZA versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer….The trial did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) with cediranib in combination with LYNPARZA vs. platinum-based chemotherapy.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces acceptance of sNDA submission of Zejula (niraparib) for first-line maintenance treatment of ovarian cancer in China by the NMPA (GlobeNewswire) – Mar 16, 2020 – “Zai Lab Limited…announced the China National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy….GSK submitted a sNDA to the U.S. FDA for the use of ZEJULA in ovarian cancer as first-line maintenance treatment based on the PRIMA study…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; ceralasertib (AZD6738) / AstraZeneca
DUETTE: A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5’Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment. (clinicaltrials.gov) – Mar 10, 2020 – P2; N=256; Not yet recruiting; Sponsor: AstraZeneca; N=192 –> 256
Clinical • Enrollment change • BRCA • CA125

 

eribulin/farletuzumab ADC (MORAB-202) / Eisai
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types (clinicaltrials.gov) – Mar 9, 2020 – P1/2; N=196; Not yet recruiting; Sponsor: Eisai Inc.

 

Opdivo (nivolumab) / Ono Pharma, BMS; COM701 / Compugen
Compugen announces updated clinical data from ongoing COM701 phase 1 study (PRNewswire) – Mar 9, 2020 – P1, N=140; NCT03667716; Sponsor: Compugen Ltd; “COM701 was well-tolerated and with no reported dose-limiting toxicities in both treatment arms…A confirmed partial response in a patient from the COM701 monotherapy dose escalation arm with microsatellite stable primary peritoneal cancer, a type of challenging-to-treat ovarian cancer that was selected as a tumor type for the COM701 monotherapy expansion study based on our preclinical biomarker prediction of likely response to treatment with COM701; the patient is one of the three patients enrolled in the eighth cohort and is continuing on study treatment (more than 18 weeks).”

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Weekly Top News – Breast Cancer– January 13, 2020

January 13, 2020

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Enhertu now available in U.S. for HER2 positive unresectable or metastatic breast cancer following two or more prior anti-HER2-based regimens (Businesswire) – Jan 6, 2020 – “Daiichi Sankyo Company, Limited…announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S….ENHERTU was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on December 20, 2019 for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.”

 

margetuximab (MGAH 22) / MacroGenics
MacroGenics outlines corporate priorities for 2020 (GlobeNewswire, MacroGenics, Inc.) – Jan 9, 2020 – “Pending acceptance and review of the BLA submitted in December 2019 to the Food and Drug Administration (FDA) based on the Phase 3 SOPHIA study results, the Company anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. MacroGenics expects a Standard Review process in which the FDA will likely require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020…Initial safety and efficacy data are expected in the second half of 2020 from Module A of…phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer.”

 

letrozole / Generic mfg.; Kisqali (ribociclib) / Novartis
CompLEEment-1: Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC (clinicaltrials.gov) – Jan 8, 2020 – P3; N=3775; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed; Trial completion date: May 2021 –> Nov 2019

 

ZW25 / Zymeworks; Ibrance (palbociclib) / Pfizer
Zymeworks announces agreement with Pfizer and initiation of a new phase 2 trial evaluating ZW25 in combination with Ibrance (palbociclib) (Businesswire) – Jan 12, 2020 – “Zymeworks Inc….announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study. Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance® (palbociclib), an oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in patients with previously-treated locally advanced and/or metastatic HER2-positive, HR-positive breast cancer. Zymeworks will sponsor the study, and Pfizer will provide palbociclib….The trial will enroll up to 76 patients at sites in the United States and Canada, and expansion to Spain is planned….Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.”

 

Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer; GDC-0077 / Roche
A Study Evaluating the Efficacy and Safety of GDC-0077 + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov) – Jan 9, 2020 – P3; N=400; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting –> Recruiting

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals highlights 2020 clinical and corporate outlook (Syndax Press Release) – Jan 10, 2020 – “The Company continues to anticipate that the E2112 trial will reach 410 death events in the second quarter of 2020, triggering the final overall survival (OS) analysis…Syndax anticipates presenting initial clinical data from its Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, the Company’s potent, highly selective oral Menin inhibitor, at a medical conference in the fourth quarter of 2020.”

 

Verzenio (abemaciclib) / Eli Lilly
GSK’s Dovato, Sandoz’s Rixathon enter LatAm in Chile, Eli Lilly’s Verzenio tags along (GBI Health) – Jan 9, 2020 – “GBI analysis reveals that Chile’s Institute of Public Health (ISP) recently approved GlaxoSmithKline (GSK)’s antiretroviral Dovato (dolutegravir + lamivudine), Eli Lilly’s CDK4/CDK6 kinase inhibitor Verzenio (abemaciclib), and Novartis subsidiary Sandoz’s biosimilar Rixathon (rituximab). Dovato is indicated to treat HIV-1 infection, while Verzenio is approved for HR+/HER2- advanced or metastatic breast cancer, and Rixathon is used against granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), in addition to the indications approved for Roche’s originator MabThera, namely non-Hodgkin’s lymphoma (NHL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).”

 

Halaven (eribulin mesylate) / Eisai
Launch of anticancer agent Halaven in China (Eisai Press Release) – Jan 10, 2020 – “Eisai Co., Ltd…announced today that it has launched the in-house developed anticancer agent Halaven(R) (generic name: eribulin mesylate) in China…In a Phase III clinical study (EMBRACE) of Halaven versus treatment of physician’s choice (TPC) in 762 patients with advanced or recurrent breast cancer previously treated with an anthracycline and a taxane, Halaven showed an extended overall survival compared to TPC.”

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