Drugs
A Northern Texas federal judge has denied a preliminary injunction sought by industry trade group Outsourcing Facilities Association to delay FDA enforcement actions against compounding pharmacies that make copies of Novo Nordisk’s weight-loss drug Wegovy (semaglutide) and the diabetes medication Ozempic (semaglutide). FDA earlier allowed compounding pharmacies to
Drugs
FDA is likely to see up to a 25%, if not greater, reviewer exodus over the coming months as about 600 reviewers have currently recused themselves from working on product evaluations while they look for employment in industry or outside of the federal government. “These are people who are looking
Biologics
FDA has approved a total of 73 biosimilars across 19 unique biological molecules, but so far only 48 (66%) of these have been launched in the U.S. market, according to a new Samsung Bioepis’ biosimilar market report. On average, biosimilars have gained 52% market share within five years post
Drugs
Several anonymous current and former FDAers say the reductions in force the agency has experienced have led to key databases not being maintained and updated, meaning that healthcare professionals are unable to get basic information about drugs they prescribe. The staffers spoke with Axios for an online article. A laid-
Drugs
FDA has approved an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). The approval covers penpulimab in combination with platinum-based chemotherapy (either cisplatin or carboplatin) and gemcitabine as a first-line treatment for adults with recurrent or metastatic NPC.
Drugs
FDA has granted BrainChild Bio a breakthrough therapy designation for its investigational CAR T-cell therapy, BCB-276, for treating diffuse intrinsic pontine glioma (DIPG), a rare and fatal pediatric brain tumor. The company says the designation was granted based on encouraging clinical data from the Phase 1 BrainChild-03
Drugs
Amneal Pharmaceutical is recalling two lots of ropivacaine hydrochloride injection USP, 500 mg/100 mL, infusion bags because the products may contain an inert fiber identified as polypropylene fibers from the IV bag. The product being recalled is indicated for producing local or regional anesthesia for surgery or acute pain
Drugs
FDA is alerting health care providers about reports of falsely elevated (false positive) results that have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with LeadCare Testing Systems. “These tests may overestimate blood lead levels and give inaccurate results when processing capillary
Drugs
An 8/1-8/28/2024 FDA inspection at the Empower Pharma drug outsourcing facility in Houston, TX, found that drugs the facility compounds failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA) necessary for the facility to qualify for exemptions from
Drugs
The DC federal court has rejected Norwich Pharmaceuticals’ request for summary judgment in a case seeking FDA final approval of its ANDA for rifaximin tablets. Instead, the court granted summary judgment to FDA and also to Teva and Salix, who intervened in the proceedings as defendants. Salix owns the branded
Drugs
Speaking at the Semafor World Economy Summit, FDA commissioner Martin Makary said the agency has “no plans to take action” to restrict the availability of mifepristone, the pill used in most U.S. medication abortions. He hedged his statement a bit, saying that an ongoing set of data on the
Devices
Abbott is recalling (Class 1) its HeartMate Mobile Power Unit (MPU) because of instances where the device experiences a sudden power loss. A recall notice says the company has received reports in which the MPU experienced sudden, unexpected performance issues such as not turning on, unprompted shutdown, or suddenly turning
Drugs
The Association for Clinical Oncology (ASCO) has written to the new heads of FDA, the National Institutes of Health, and the Centers for Medicare and Medicaid Services to ensure continued progress in cancer care, research, and patient access. An ASCO statement says that in its letter to FDA commissioner Martin
Drugs
Bristol Myers Squibb says its Cobenfy (xanomeline and trospium chloride) used as an adjunctive treatment to atypical antipsychotics in the Phase 3 ARISE trial “showed a numerical improvement compared to treatment with a placebo and an atypical antipsychotic.” A company statement says the Cobenfy adjunctive treatment was associated with improvement
Drugs
Former FDA associate commissioner Peter Pitts says the agency doesn’t routinely update drug labels with safety information for people with obesity. “The agency…doesn’t know (and it seems doesn’t care) if people with obesity are dosed safely or effectively with approved products since large-scale clinical trials
Drugs
Eli Lilly says it has sued four more drug compounders for selling unapproved products containing tirzepatide, the active ingredient in its weight loss and diabetes medicines, including Mounjaro. A company statement says compounders had been permitted to produce copies of obesity drugs when FDA listed them as being in shortage.
Devices
An FDA alert says Conavi has sent an “Urgent Medical Device Product Removal” notice to customers about removing certain Novasight hybrid catheters from the market. The action is based on one reported incident involving the device’s sheath detaching from the catheter during use and was left in the patient’
Biologics
Novavax says its Covid-19 vaccine BLA, which the company is seeking to transition from an emergency use authorization to full approval, is being held up while FDA seeks to conclude a post-marketing commitment from the company. The agency had initially set a user fee-related review action target
Devices
FDA has granted CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating hydrocephalus in pediatric patients aged 12 years and older. The action was supported by data generated during pilot clinical studies, as well as original research published in the Journal of NeuroInterventional
FDA Policy/General
FDA says its Electronic Submission Gateway Next Generation (ESG NextGen) went live on 4/14 and is ready to receive submissions. The previous ESG has been retired and is no longer available for submissions, a notice says. The notice says ESG NextGen is the agency’s modernized platform for securely
Drugs
Vanda Pharmaceuticals says FDA is using recent staff cuts and a new commissioner as its “new scapegoat” to delay Vanda’s request for a hearing on the NDA approvability of tradipitant for gastroparesis. Earlier this year, FDA gave the company an opportunity for a hearing to contest an agency complete
Drugs
Akeso says its first-in-class PD-1/VEGF bispecific antibody ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung cancer. The HARMONi-6 (AK112-306) trial showed that ivonescimab combined with chemotherapy significantly outperformed a