Drugs
Pfizer and BioNTech say they are planning to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 after a final analysis showed a vaccine efficacy rate of 95%, which was a significant improvement from the 90% reported in a preliminary analysis last week (see
Drugs
The HHS Office of Inspector General (OIG) says it has significant concerns about companies offering or paying remuneration, and healthcare professionals (HCP) soliciting or receiving remuneration, in connection with speaker programs. “Based on our investigations and enforcement actions,” an OIG fraud alert says, “this remuneration is often offered or paid
Drugs
An 11/13 petition filed by Epstein Becker Green on behalf of an unnamed client asks FDA to require that adequate cardiovascular safety and all-cause mortality data be submitted to the agency for review before approving roxadustat for treating anemia in patients with chronic kidney disease. The petition also
Drugs
The American Geriatrics Society (AGS) says FDA should consistently use the word “older” in a draft guidance on geriatric information in human prescription drug and biological product labeling rather than “elderly” or any similar term. In an 11/9 comment letter, AGS says that terms like “elderly,” “elders,” “the aged,
Drugs
FDA has accepted for review a BLA submitted by Samsung Bioepis and Biogen for their SB11, a proposed biosimilar referencing Genentech’s Lucentis (ranibizumab). Lucentis is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders. Samsung Bioepsis said in 11/2019 that it had entered into a
Drugs
CDER researchers say they have determined that adding a cyclin-dependent kinase (CDK) 4/6 inhibitor to a hormonal agent appears to show a consistent benefit for all subgroups analyzed in a study of hormone receptor-positive, HER2-negative metastatic breast cancer. An agency online Regulatory Science Impact Story says
Drugs
FDA has announced a 1/26 virtual workshop to communicate current regulatory thinking and considerations on non-clinical assays for comparative immunogenicity risk assessment for generic peptide products. The agency says the workshop will discuss the following four topics: * In silico methods to assess binding affinity to major histocompatibility complex
Drugs
FDA commissioner Stephen Hahn says that the agency is increasing transparency for Covid-19 emergency use authorizations (EUAs) by posting CDER and CBER reviews of the scientific data and information supporting the issuance, revision, or revocation of EUAs for all drug and biological products, including vaccines. Such a move was
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) has added a new chapter, “Enhancing Diversity in Clinical Trial Participation,” to its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. A PhRMA statement says the revised principles take effect 4/14/21. With the revision, the statement says,
Drugs
FDA has posted safety-related labeling changes for five biologics. The change for Merck’s Keytruda (pembrolizumab) involves the potential for infusion reactions added to the Warning and Precautions section of the labeling. Changes were also posted for EMD Serono/Pfizer’s Bevencio (avelumab), Lilly’s Erbitux (cetuximab), AstraZeneca’s
Drugs
A 2/3-2/12 FDA inspection at Family Pharmacy of Statesville, Statesville, NC, found multiple drug compounding violations. An 11/6 Warning Letter discusses violations relating to compounded drug products under the Federal Food, Drug, and Cosmetics Act, failing to meet the conditions of Section 503A, adulterated drug products,
Drugs
FDA has issued a final guidance on Certificates of Confidentiality, which describes the agency’s implementation of revised provisions under the 21st Century Cures Act (Cures Act). A Certificate of Confidentiality (CoC) is intended to help protect the privacy of human subject research participants when identifiable, sensitive information is being
Drugs
FDA has issued a complete response letter (CRL) for the Alkermes NDA for its ALKS 3831 (olanzapine/samidorphan) for treating adults with schizophrenia and bipolar 1 disorder. The letter indicates that FDA requires the resolution of certain conditions related to the tablet coating process at the firm’s Wilmington, OH,
Drugs
FDA meetings with industry on product development issues are suffering from fewer interactions and participation due to Covid-19 and the necessary move to virtual presentations and discussions, CDER deputy Center director for clinical science Bob Temple told the virtual Prevision Policy/Friends of Cancer Research Biopharma Congress last month.
Drugs
An 11/19 Biosimilar User Fee Act (BsUFA) reauthorization public meeting is likely to hear proposals for potential enhancements or efficiencies for the biosimilar product development and review process. That’s an expectation voiced by CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim in a CDER Conversation. She
Drugs
Representatives Brendan Boyle (D-PA), Scott Perry (R-PA) and Madeleine Dean (D-PA) have introduced the Alternatives to Animals for Regulatory Fairness (AARF) Act to modernize the drug approval process. “The AARF Act ensures that pharmaceutical companies are allowed to use high-tech and humane alternatives to outdated testing
Drugs
Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring board interim analysis. The COVE study, which enrolled more than 30,000 participants to evaluate the company’s messenger RNA vaccine (mRNA-1273) has reached 95 Covid-19
Drugs
FDA has issued Adamis Pharmaceuticals another complete response letter (CRL) on its NDA for Zimhi, a high-dose naloxone injection product for treating opioid overdose. The letter provided recommendations to support the NDA’s resubmission. “The questions raised by the FDA related generally to new chemistry, manufacturing and controls issues,
Drugs
Federal Register notice: FDA has made available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Analysis Programs. The document provides recommendations for documenting electronic data files and statistical analyses submitted to CVM to support new animal drug applications. To view the notice, click here.
Drugs
FDA has issued Sanofi a complete response letter (CRL) on its BLA for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with cold agglutinin disease. The letter refers to deficiencies identified by the agency during a pre-license inspection of an unnamed third-party facility responsible for manufacturing,
Drugs
Boston Scientific has agreed to pay $75 million for some of the manufacturing assets and capabilities of Neovasc, which makes products for the cardiovascular market, including components for transcatheter heart valves such as Boston Scientific’s Lotus Valve System. Boston Scientific developed Lotus for transcatheter aortic valve replacement in order
Drugs
CDER director Janet Woodcock, who has been temporarily assigned to work with the Trump administration’s Operation Warp Speed, says the nation’s medical infrastructure has learned things during the Covid-19 pandemic that should lead to changes in the way things are organized for future infectious disease problems. Participating