FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks. A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions. FDA generally follows the advice of its advisory committees. “This was clearly…
Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir
Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir. If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting.…
Early data suggest COVID-19 monoclonal antibodies offer less protection against Omicron variant
The antibody cocktails from Regeneron (NSDQ:REGN) and Eli Lilly (NYSE:LLY) may provide less protection against the Omicron COVID-19 variant than earlier circulating variants. Independent researchers at the Fred Hutchinson Cancer Research Center (Seattle) concluded that bamlanivimab and etesevimab had a decrease in protection against Omicron, according to The Wall Street Journal. Omicron could be more resistant…
FDA advisory panel to weigh in on molnupiravir
An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19. Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations. The benefit-risk calculation for molnupiravir has grown more complicated recently. Over the…
Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant
Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I…
Hutchmed and AstraZeneca launch Phase 3 to test Orpathys and Tagrisso in lung cancer
Hutchmed (HKG:0013) and AstraZeneca (LON:AZN) have announced the launch of the SACHI Phase 3 study to test the combination of Orpathys (savolitinib) and Tagrissso (osimertinib) as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Specifically, the study will focus on patients with amplification of the MET…
Pfizer says employee stole confidential COVID-19 vaccine documents
Pfizer (NYSE:PFE) accused a former employee Chun Xiao (Sherry) Li of uploading 12,000 documents from a company-issued laptop to a personal Google Drive account and various personal devices. In a complaint filed in the U.S. District Court for the Southern District of California, Pfizer also accuses Li of misleading the company about what she did with…
FDA approves novel treatment for post-transplant CMV infection
FDA has approved Takeda Pharmaceutical’s (NYSE:TAK) Livtencity (maribavir) for use in patients at least 12 years old with post-transplant cytomegalovirus (CMV) infection or disease that does not respond to available antiviral therapy. The indication covers patients weighing at least 35 kilograms. Livtencity blocks virus replication by blocking the activity of the human cytomegalovirus enzyme pUL97.…
Senator Markey pushes U.S. to develop universal COVID-19 vaccine
Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine. NIAID had awarded $36.3 million to academic institutions to working on coronavirus vaccines that potentially protect against multiple types of coronaviruses. Coronavirus…
European regulators approve Janssen’s twice-yearly schizophrenia treatment
Two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Janssen has won approval from the European Commission for Byannli, a six-month formulation of paliperidone palmitate. Indicated as a maintenance treatment for adults with schizophrenia, Byannli won approval based on results from the Route 6 study, which found…
Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose. The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In…
Flywheel working with Roche and Genentech to sift through medical imaging data
The research data platform Flywheel has announced that Roche (OTCMKTS:RHHBY) and its subsidiary Genentech are using its cloud-scale informatics platform to ingest, standardize and analyze medical imaging data to streamline drug discovery. Minneapolis-based Flywheel says the process provides a swifter and more efficient means to curate data at the terabyte and petabyte scales. Specifically, Roche and…
GSK could pay Arrowhead $1B to develop NASH RNAi therapeutic
Arrowhead Pharmaceuticals (NSDQ:ARWR) has signed an exclusive license agreement with GlaxoSmithKline (NYSE:GSK) related to Arrowhead’s experimental RNA interference (RNAi) therapeutic ARO-HSD. The drug is now the subject of a Phase 1/2 study focusing on the drug’s potential as a treatment for nonalcoholic steatohepatitis (NASH), which involves liver inflammation and can cause cirrhosis and liver failure.…
Janssen shares positive Phase 2 Tremfya data in Crohn’s
Johnson & Johnson’s Janssen division (NYSE:JNJ) has released topline results from the Phase 2 GALAXI 1 clinical study testing the potential of TREMFYA (guselkumab) in patients with moderately to severely active Crohn’s disease (CD). The study found that nearly two-thirds (65%) of TREMFYA (guselkumab) recipients achieved clinical remission at week 48. The trial used the…
FDA postpones decision on Bristol Myers Squibb’s mavacamten
FDA has informed Bristol Myers Squibb (NSDQ:GILD) that it has extended its review of mavacamten, an allosteric modulator of cardiac myosin. Bristol Myers Squibb aims to win an FDA nod for the drug as a treatment for obstructive symptomatic hypertrophic cardiomyopathy (oHCM), a disease associated with heart muscle thickening. Mavacamten addresses the molecular defect involved…
CDC’s ACIP supports COVID-19 boosters for all adults
The Advisory Committee on Immunization Practices (ACIP) at the CDC voted unanimously to allow all fully vaccinated adults to receive a COVID-19 booster at least six months after receiving a primary series. All 11 members of the panel also voted on Nov. 19 to recommend boosters for adults 50 and older. Last week, FDA authorized…
Why Novartis is upbeat about the future of CAR-Ts and TCRs
The life sciences industry has just scratched the surface in terms of chimeric antigen receptor (CAR) T-cell therapy’s potential, according to a session at the Novartis Breakthrough Science media event held on November 10. CAR-T therapy, which has emerged as one of the most promising new treatments for multiple myeloma, certain lymphomas and B-cell acute lymphoblastic leukemia,…
GSK touts DREAMM clinical trial headway in multiple myeloma
GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep. The drug won FDA approval…
How an airway-on-a-chip model can help identify promising antivirals for COVID-19
One of the first focuses of organ-chip specialist Emulate (Boston) was to reduce the need for animal testing over time. Its technology can simulate tissue-tissue interfaces within organs using human cells. But the potential of the organ chips to yield mechanistic insights for drug discovery and understanding toxicities has become more evident over time. The…
FDA authorizes Pfizer-BioNTech and Moderna boosters for all adults
FDA has authorized booster shots of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines for everyone 18 and older. Assuming CDC backs the decision, tens of millions of American adults who received two doses of the two mRNA COVID-19 vaccines at least six months ago will be eligible for boosters. “Authorizing the use of a single…
U.S. insurers hesitant to cover aducanumab
Health insurers in the U.S. are seeking more data from Biogen regarding its $56,000-per-year Alzheimer’s treatment Aduhelm (aducanumab) before agreeing to pay for the treatment, according to Bloomberg. None of the 25 large insurers that took part in a Bloomberg News survey found that the drug was “medically necessary.” Humana Inc. is, however, covering Aduhelm…
Fountain Therapeutics closes $15 million in Series A-2 financing
South San Francisco–based biopharma Fountain Therapeutics has pulled in $15 million in Series A-2 financing, bringing its total Series A funding to $26 million. The company focuses on drug development for chronic degenerative diseases. Eli Lilly and Company (NYSE:LLY), Alexandria Venture Investments and R42 Group joined as new investors in the funding round. Prior investors…
Janssen upbeat about latest guselkumab data for patients with psoriatic arthritis
Janssen (NYSE:JNJ) recently presented new data on Tremfya (guselkumab) related to active psoriatic arthritis (PsA) at the American College of Rheumatology (ACR) Convergence while also publishing data in Arthritis & Rheumatology. Notably, guselkumab provided durable joint symptom and disease activity improvement with a consistent safety profile through week 100 in adults with active psoriatic arthritis (PsA).…
Small Pharma Inc. plans Phase 2b trial of DMT for depression
Small Pharma Inc. (TSXV:DMT) is prepping a Phase 2b clinical study to test the use of its lead candidate, SPL026, an N, N-dimethyltryptamine (DMT) in treating major depressive disorder (MDD). DMT is present in Ayahuasca, a South American psychedelic brew. The company has announced that it has had positive discussions with FDA regarding the planned…
EMA gives thumbs down to Biogen’s Alzheimer’s drug aducanumab
Biogen (NSDQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) have announced that the European Medicines Agency (EMA) has given its marketing authorization application for Aduhelm (aducanumab) a “negative trend vote.” The Committee for Medicinal Products for Human Use (CHMP) with the EMA will likely adopt a formal opinion on the application during meetings scheduled for December…