Drugs
A bipartisan group of nine senators led by Sens. Elizabeth Warren (D-MA) and Marco Rubio (R-FL) are asking the Department of Defense (DoD) for an update on its efforts to address risks to the military pharmaceutical supply chain. A statement from Warren (includes a link to a letter
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA efforts to further enhance the adoption of advanced manufacturing technologies (AMTs) in drug manufacturing, including through the implementation of the new AMT designation program. Commenting on an agency draft guidance on the designation program, the association says FDA should:
Drugs
GSK says “statistically significant and clinically meaningful” overall survival and progression-free survival data were observed in its RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial involving Jemperli (dostarlimab) in adult patients with primary advanced or recurrent endometrial cancer. GSK says the data will form the basis of a regulatory
Drugs
A 2/29-completed FDA inspection of Eugia SEZ Private Ltd.’s Telangana, India sterile drug manufacturing facility has resulted in a seven-item Form FDA 483 that cites significant GMP deficiencies. According to the just-posted inspection report, the Eugia facility did not follow procedures that are designed to
Drugs
Sleepnet has recalled its CPAP and BIPAP sleep apnea masks with magnets due to potential interference with certain medical devices. “When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant, potentially resulting in serious
Drugs
FDA has completed a pre-license inspection of Abeona’s Cleveland, OH manufacturing facility concerning the company’s BLA for pz-cel (prademagene zamikeracel) for treating recessive dystrophic epidermolysis bullosa (RDEB). The firm was issued a Form 483 that cited observations related to process controls. “During the inspection, the FDA
Drugs
FDA has granted Biotronik a beakthrough device designation for the Freesolve below-the-knee (BTK) resorbable magnesium scaffold, intended for use in individuals suffering from chronic limb-threatening ischemia, which the company describes as the most severe form of peripheral arterial disease. The device relies on the design of the
Drugs
FDA has launched a new Web page to highlight how the agency uses inspections to help ensure drug safety and quality. “In order to efficiently share relevant information about inspections for human drugs and make it more accessible, FDA is bringing certain data together on a single public Web page,
Drugs
FDA is providing additional information through a just-posted question-and-answer document about its new Quality Manufacturing Maturity (QMM) Prototype Assessment Protocol Evaluation Program, which is described as the next phase in CDER’s QMM program. A 1/25 Federal Register announcement said the agency was seeking nine drug
Drugs
FDA has released a final guidance entitled “Controlled Correspondence Related to Generic Drug Development.” The document provides information on how generic drug manufacturers can submit controlled correspondence requesting information related to generic drug development. It also describes the agency’s process for providing responses related to such correspondence. The document
Drugs
The API Innovation Center makes these recommendations on an FDA draft guidance on the advanced manufacturing technologies (AMT) designation program: * consider whether to limit AMT designations to the U.S. and whether to include an accelerated review component; * distinguish incentives between generic and branded manufacturers; * expand the definition of AMT
Drugs
FDA has granted Poseida Therapeutics an orphan drug designation for its P-BCMA-ALLO1, a BCMA-targeted allogeneic, T stem cell chimeric antigen receptor (CAR)-T therapy candidate for treating multiple myeloma. Poseida is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and recently shared early safety
Drugs
A Science report supported by the Science Fund for Investigative Reporting details FDA’s concerns about the results of tests conducted in a City University of New York (CUNY) laboratory run by pharmacologist Hoau-Yan Wang on Cassava Sciences’ potential Alzheimer’s drug simufilam. The article says (includes a link
Drugs
FDA has approved a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). “NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver
Drugs
FDA has published an International Council for Harmonization (ICH) draft guidance, E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports, with guidance on definitions and standards for post-approval individual case safety reporting and good case management practices. The document says
Drugs
The FDA Oncology Drugs Advisory Committee (ODAC) will consider on 3/14 whether the benefits of Geron’s imetelstat (proposed trade name Rytelo) in treating some blood cancers outweigh its risks. The company is seeking an indication to treat transfusion-dependent anemia in adults with low-to intermediate-1 risk
Drugs
FDA is asking the Oncologic Drugs Advisory Committee to discuss on 3/15 an increased number of deaths in two cancer drugs whose manufacturers have submitted sBLAs for a new indication. The committee will consider the sBLA submitted by Celgene for its Abecma (idecabtagene vicleucel) to treat adults with relapsed
Drugs
A petition filed by a Charles Ludlam (identifying information redacted) asks FDA to (1) require that additional clinical trials of Novo Nordisk’s Ozempic/Wegovy (semaglutide) and Lilly’s Mounjaro/Zepbound (terzepatide) be conducted on the loss of lean muscle mass, setting the ideal goal weight for patients and maintenance
Drugs
FDA has granted MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disorder (GAD). The designation comes as the company is announcing results from a Phase 2b study of MM120 in GAD that met its key secondary endpoint. Data also “demonstrated clinically and statistically
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should take a more flexible approach to implementing its proposed rule on patient medication information (PMI) by waiving the one-page format requirement when needed to include key information in a drug’s PMI. “Although complying with this strict page limitation
Drugs
FDA has accepted for review an Xcovery Holdings NDA for ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor for treating adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The submission is based on data from the Phase 3 eXalt3 study evaluating ensartinib vs crizotinib in the first-
Drugs
Par Pharmaceutical is recalling one lot of treprostinil injection 20mg/20mL (1mg/mL) due to the potential for the presence of silicone particulates in the product solution. The prostacyclin vasodilator is indicated for treating pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from