FDA Policy/General
FDA commissioner Robert Califf says some postmarketing evidence-generating studies are so important that they may need public funding to ensure they get completed. Speaking in a Yahoo! Finance video interview, Califf says he prefers to consider postmarketing evidence-generation as a way of looking forward rather than looking back.
Drugs
Bayer is recalling one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles, indicated for treating solid tumors that are NTRK gene fusion positive, due to microbial contamination identified as Penicillium brevicompactum that was detected during routine stability testing. While there are limited data on human
Drugs
A bipartisan group of nine senators led by Sen. Rand Paul (R-KY) is asking FDA for information on the specific steps the agency is taking to update its animal testing regulations and the timeline for the implementation of a revised regulatory framework under the FDA Modernization Act 2.0.
Drugs
FDA has delayed a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene vicleucel) and its use in earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM). The agency has elected to seek input from its Oncologic Drugs
Drugs
Bayer says it is stopping its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibb’s Eliquis) in patients with atrial fibrillation at risk for stroke due to an “inferior efficacy” comparison. The decision is based on the recommendation of the study’s independent data monitoring
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution after disease progression on or
Drugs
FDA has issued Dr. Reddy’s Laboratories a 10-item Form FDA-483 after concluding an inspection 10/27 at the firm’s Telangana, India manufacturing facility. Agency investigators cited Dr. Reddy’s for not maintaining/cleaning equipment and utensils at appropriate intervals. They also took issue with the facility’
Drugs
FDA has approved an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test
Drugs
FDA has approved a Merck NDA for Keytruda (pembrolizumab) and its use with fluoropyrimidine- and platinum-containing chemotherapy for treating (first line) adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Approval was based on data from KEYNOTE-859 (NCT03675737), a multicenter, randomized, double-
Drugs
FDA has approved Astellas Pharma’s Xtandi (enzalutamide) for an expanded use — treating non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Approval was based on data from EMBARK (NCT02319837), a randomized, controlled clinical trial involving almost 1,100 patients with
Drugs
FDA says it has published 40 product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The latest batch includes 22 new and 18 revised PSGs, FDA says. There are 30 PSGs for products with approved ANDAs, including 16 complex products. Some 22
Drugs
A new Iqvia Institute report says drug shortages continue to increase in the U.S., with more shortages being reported than resolved. As of June, the report says, there were 132 active shortages, with 75% of them having been active for more than one year and 58% ongoing for more
Drugs
FDA commissioner Robert Califf says the Healthcare Distribution Alliance, which has provided aggregate information on the distribution of Covid vaccines from distributors into the field, could be of even greater assistance to FDA by also providing aggregate information on the distribution of Covid-19 therapeutics. “This kind of added transparency,
Drugs
SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdametinib, an investigational MEK inhibitor, indicated for use in pediatric and adult patients with neurofibromatosis Type 1-associated plexiform neurofibromas. The company says its move follows just-announced “positive topline results” from the pivotal Phase
Drugs
After 37 years at FDA, second-in-command and principal deputy commissioner Janet Woodcock is retiring early next year. In confirming her departure, FDA commissioner Robert Califf called her a legend for making an “indelible mark on so many of us, and on public health.” Califf said that while no
Drugs
FDA has approved a Bristol Myers Squibb NDA for Augtyro (repotrectinib) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. The tyrosine kinase inhibitor (TKI) works by targeting ROS1 oncogenic fusions, according to the company. The approval is based on data from the
Drugs
FDA has launched a Web page devoted to its efforts to research and promote alternative methods for product testing. The page says alternative methods “have the potential to provide more timely and more predictive information to assess certain aspects of FDA-regulated products while also replacing, reducing, and/or refining
Drugs
FDA says its review of records submitted by Saruhan Kimya Va Temizlik Urunieri Sanayi Ticaret Anonim Sirketi Corlu Subesi, an over-the-counter drug manufacturer in Tekirdag, Turkey, in response to three FDA requests, found significant violations of current good manufacturing practice (CGMP) regulations. An 11/6 Warning Letter says
Drugs
FDA has granted SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-cell lymphoma. “Unlike B-cell lymphomas and classical Hodgkin Lymphoma, many T-cell lymphoma subtypes do not have a suitable drug target, and approved cellular immuno-therapy is currently unavailable in
Drugs
FDA reviewers say that making an assessment on the clinical meaning of “complicated” data presentations in a Merck NDA resubmission for chronic cough medicine gefapixant is a challenge and will be submitted to an 11/17 Pulmonary-Allergy Drugs Advisory Committee meeting for discussion. An earlier NDA was issued an
Drugs
FDA has approved CorMedix’s Defencath (taurolidine and heparin) catheter lock drug to reduce catheter-related bloodstream infections in adult patients with kidney failure who are receiving chronic hemodialysis through a central venous catheter. The agency says it is the third drug approved under the Limited Population Pathway for Antibacterial
Drugs
FDA commissioner Robert Califf says “the time is right” to address the post-market evidence generation recommendations in a new Reagan-Udall Foundation report. In the prepared text of a speech to be given to an unidentified group, Califf says the post-market questions “stretch beyond the direct purview of