Biologics
Two university professors say it appears FDA assigned too few reviewers to key elements of the Pfizer/BioNTech Covid-19 vaccine application, possibly as a way to stifle internal dissent. Writing in an online Stat opinion column, University of Maryland School of Pharmacy associate professor Peter Doshi and Dalhousie University
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee voted 12/17 to recommend an Emergency Use Authorization (EUA) for Moderna’s investigational Covid-19 vaccine (mRNA-1273). Panel members voted 20 to 0 that the totality of available scientific evidence demonstrated that the vaccine’s benefits outweigh its risks
Biologics
Federal officials told a 10/16 news media call that Pfizer has experienced some unexpected issues in rolling out its Covid-19 vaccine. They reported that at least two trays of vaccine doses delivered to California had to be replaced after their storage temperatures fell below manufacturer requirements, Reuters reports.
Biologics
FDA briefing information released in advance of a 12/17 advisory committee meeting confirms that Moderna’s investigational Covid-19 vaccine (mRNA-1273) efficacy in preventing Covid-19 was 94.5%. There were five Covid-19 cases in the vaccine group and 90 cases in the placebo group, the agency
Biologics
Some 20 U.S. Senate Democrats are asking the leaders of Operation Warp Speed to respond to questions about reports that the federal government declined to exercise its option to purchase additional doses of the Pfizer Covid-19 vaccine earlier this year. “We are concerned the failure to secure an
Biologics
FDA late Friday (12/11) granted an emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. The agency action comes after the White House reportedly ordered FDA commissioner Stephen Hahn to grant the EUA or submit his resignation by the end of the day. “Today’s action follows
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee has voted to recommend an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. Panel members voted 17 to 4 that: based on the totality of scientific evidence available, the benefits of the vaccine outweigh its risks for use
Biologics
FDA plans to warn patients who’ve had previous severe reactions after being vaccinated about such risks with Pfizer-BioNTech’s Covid-19 vaccine if granted an Emergency Use Authorization, according to CBER director Peter Marks. The vaccine is headed to an advisory committee review and vote 12/10. Addressing
Biologics
FDA has accepted for priority review a Pfizer BLA for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate and its use for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults ages 18 years and older. The submission is based on data from Pfizer’s clinical program
Biologics
A panel of three former FDA commissioners told the Milken Institute 2020 Future of Health Summit that FDA has been acting properly to oversee the development of Covid-19 vaccines. Former commissioners Robert Califf, Mark McClellan, and Margaret Hamburg appeared in a 12/8 online discussion that centered on the
Biologics
Just-released FDA advisory committee briefing information is suggesting that it could be easy sailing for a Pfizer-BioNTech Emergency Use Authorization (EUA)submission for their Covid-19 vaccine. On 12/10, FDA will convene its Vaccines and Related Biological Products Advisory Committee to review and discuss the submitted data.
Biologics
Former CBER Division of Manufacturing and Product Quality reviewer and investigator John Godshalk has joined NDA Partners as an expert consultant. An NDA announcement says Godshalk is an expert in chemistry, manufacturing, and controls, quality, and facility issues for cell and gene therapies, and has experience with biologics, vaccines, drugs,
Biologics
Janssen Pharmaceutical has submitted a BLA for amivantamab for treating patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody
Biologics
TG Therapeutics has begun a rolling BLA submission for ublituximab, a glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the company’s dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia. The submission is based on data from the UNITY-CLL
Biologics
Moderna has filed an emergency use authorization (EUA) for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vaccine efficacy. The vaccine’s primary efficacy analysis was based on 196 Covid cases, of which 185 were observed in the placebo group versus 11 in the
Biologics
FDA has deferred its review decision on a Revance Therapeutics BLA for daxibotulinumtoxinA for injection, an investigational neuromodulator for treating moderate to severe glabellar (frown) lines. The agency said a required inspection could not be conducted at the company’s northern California manufacturing facility due travel restrictions associated with the
Biologics
Merck has submitted BLA for V114, an investigational 15-valent pneumococcal conjugate vaccine for use in adults 18 years of age and older. The submission is based on data from Phase 2 and Phase 3 clinical studies in healthy adults and those at increased risk, such as adults with chronic
FDA Policy/General
Three Covington & Burling attorneys say a stronger regulatory focus can be expected at FDA in the administration of president-elect Joe Biden. In an online post, the attorneys outline their expectations by Center and program. CBER and CDER * additional effort to promote generic and biosimilar competition; * supply chain and
Biologics
FDA has accepted for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis. Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. Recurrent pericarditis is a painful and debilitating autoinflammatory cardiovascular disease
Biologics
Pfizer and BioNTech have submitted an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 data showing a vaccine efficacy rate of 95%. The latest analysis is based on 170 Covid cases, of which 162 were observed in the placebo group versus eight in
Biologics
FDA has posted a page to give vaccine product manufacturers information about electronically submitting postmarket individual case safety reports to the Vaccine Adverse Events Reporting System (VAERS). The notice says CBER has implemented the International Council on Harmonization’s Individual Case Study Report specification to support electronic reporting of vaccine
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by the Regenerative Cell Institute, Las Vegas, NV, indicates the firm markets cellular products derived from either human adipose tissue or umbilical cord to consumers to treat various diseases or conditions. An 11/10