The market for allogeneic stem-cell transplants continues to grow. “We’re seeing an increased interest in allogeneic approaches and being able to have something readily available off the shelf,” said Joy Aho, senior product manager at Be The Match BioTherapies. The momentum of this growth is likely to continue for allogeneic therapies into 2022 as researchers…
FDA approves Bristol Myers Squibb drug to prevent graft versus host disease
The FDA today approved Bristol Myers Squibb’s Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD). According to an FDA release, this is the first FDA drug approval for aGVHD prevention, incorporating real-world evidence as a component of the determination of clinical effectiveness. Orencia — originally approved by the FDA in…
Pfizer and BioNTech win EUA for booster for individuals 16 and older
Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have received emergency use authorization for BNT162b2 mRNA COVID-19 vaccine for individuals at least 16 years old. To coincide with the announcement, CDC Director Dr. Rochelle Walensky recommended that everyone 16 and older receive a booster. “Although we don’t have all the answers on the Omicron…
FDA authorizes COVID-19 antibody cocktail for younger children
The FDA will allow the use of Lilly’s (NYSE:LLY) bamlanivimab and etesevimab antibodies for younger pediatric patients, including newborns. The revised expanded emergency use authorization (EUA) specifically includes children with mild-to-moderate COVID-19 who face a high risk of disease progression. The EUA previously covered children at least 12 years of age who weigh at least…
FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron
Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests,…
FDA advisory committee votes in favor of COVID-19 pill molnupiravir
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.…
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…
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…
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…
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…
Why legacy data management systems can’t support the directions biopharma is headed
Earlier this fall, the FDA detected potential issues in data generated by two contract research organizations (CROs). Specifically, the agency’s statement noted “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA.” Accordingly, the agency advised that all affected sponsor organizations repeat any bioequivalence and…
Biden says he’ll nominate Robert Califf as FDA commissioner
Former FDA Commissioner Dr. Robert Califf could return to his old job if President Joe Biden has his way. Biden today announced his intention to nominate Califf to serve as FDA commissioner — a job he previously held during the Obama administration from 2016-17. A cardiology professor at Duke University and a member of the…
Pfizer and BioNTech file for FDA authorization of COVID-19 vaccine boosters for all adults
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older. The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old. FDA did not accept the supplemental Biologics License…
Moderna pursues EU authorization of its COVID-19 vaccine in children aged 6 to 11
Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union. Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union. Last week, the company announced that FDA…
Harnessing the power of real-world data requires careful consideration
The use of real-world data (RWD) has boomed during the pandemic, but the pharmaceutical industry has only scratched the surface in terms of tapping its potential. The use of such data, however, is set to grow, given the FDA’s recent release of new guidance concerning the use of electronic health records and medical claims data for…
Tightening regulations in Japan drive PMDA compliance with integrated pharmacovigilance ecosystems
Pharmaceutical regulations in Japan are continuously expanding and updating to improve the safety of pharmaceutical drugs. Throughout history, the detection and understanding of harmful side effects of pharmaceutical drugs have led to new enhancements of regulations to allow regulatory agencies to find adverse events more effectively. In turn, this has led to stricter regulations. Likewise,…
Why FDA optimized for flexibility with COVID-19 vaccine booster choice
Early data seem to suggest that mRNA vaccine boosters are more effective than additional doses of the adenovirus-vector COVID-19 vaccines from AstraZeneca and Johnson & Johnson. But scientists don’t currently have “any real clinical effectiveness data on this question,” said Dr. Janet Woodcock, acting FDA commissioner. To date, vaccine developers have heavily relied on antibody…
Why COVID-19 booster criteria will remain complicated for now
The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated. Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility. The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or…
White House reveals plan to vaccinate children aged 5 to 11
The White House says that vaccine doses will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them. The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination. Pfizer (NYSE:PFE) recently asked FDA to…
FDA advisory panel unanimously backs Moderna boosters
All 19 members of the Vaccines and Related Biological Products Advisory Committee voted to expand emergency use authorization of the Moderna COVID-19 vaccine to include boosters. The recommendation, however, limited its use to three main groups, including those 65 and older and individuals 18 to 64 with an elevated risk of developing severe COVID-19. In…
FDA appears to be lukewarm on Moderna COVID-19 vaccine boosters
To date, FDA has been cautious in its consideration of COVID-19 vaccine boosters. Now, the agency seems to be staying the course. In a recently published document summarizing its current view of Moderna’s booster application, the agency concluded that Moderna had not met all of its criteria for authorization. Rather than taking a position, the…
Roche’s amyloid-targeting gantenerumab wins breakthrough therapy designation for Azheimer’s
Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA. The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in…
Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids
Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand the authorization of their COVID-19 vaccine to younger children. Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older,…
AstraZeneca seeks EUA for COVID-19 prophylaxis
AstraZeneca (LON:AZN) has filed paperwork with the FDA for an emergency use authorization (EUA) for AZD7442, a long-acting antibody (LAAB) cocktail, as a COVID-19 prophylaxis. The paperwork filed for the EUA request includes data from the PROVENT and STORM CHASER Phase 3 trials. A Phase 3 trial of AZD7442 showed statistically significant protection against COVID-19 infection. Compared…