Drugs
FDA has issued Daiichi Sankyo and Merck a complete response letter on their BLA for patritumab deruxtecan (HER3-DXd) for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The letter cited findings from an
Drugs
Rep. Jan Schakowky (D-IL) has introduced the Affordable and Safe Prescription Drug Importation Act that would amend the Federal Food, Drug, and Cosmetic Act to allow American wholesalers, pharmacies, and individuals to import “affordable and safe drugs from Canada, the United Kingdom, the European Union, and Switzerland.” In a
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CDER director Patrizia Cavazzoni says the Support for clinical Trials Advancing Rare disease Therapeutics (START) pilot program started by CDER and CBER is helping to accelerate the development of novel drugs and biologics. In an online post, Cavazzoni says the two Centers created START “with hopes that the insight gained
Drugs
FDA has released the form FDA-483 issued following a 6/3-6/12 inspection at the Torrent Pharmaceuticals finished product and non-sterile active pharmaceutical ingredient manufacturing facility in Indrad, Gujarat, India. The inspection observations were: * failure to have a testing program to assess the stability characteristics of drug
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FDA has published a draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, to assist sponsors conducting certain clinical studies involving drugs, biological products, and medical devices to meet the requirements for the submission of diversity action plans under the Federal Food, Drug,
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FDA has approved a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is described as the “first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.” Approval
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BrainStorm Cell Therapeutics says it has reached “alignment” with FDA on chemistry, manufacturing, and controls (CMC) aspects of the company’s upcoming Phase 3b clinical trial for NurOwn, its investigational therapy for treating amyotrophic lateral sclerosis (ALS). A recent Type C meeting between the company and FDA helped the company
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FDA says it received 14 submissions to CDER in FY 2023 that contained real-world evidence (RWE). An online statement, provided to fulfill a PDUFA 7 commitment, says 10 of the submissions were for IND protocols and four were for NDAs or BLAs. For the protocols, the post says, nine
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A 10/31-11/3/2023 FDA inspection at the Sani-Care Salon Products drug manufacturing facility in Cartersville, GA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/24 Warning Letter says the specific violations were: * failure of the firm’s
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The CDER New Drug Regulatory Program (NDRP) has had some successes since its inception in 2017 and is now a permanent initiative, according to Office of New Drugs Special Program Staff associate director Yoni Tyberg. Writing in an online CDER Conversation, Tyberg says the modernization aimed to increase the efficiency
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Regeneron says FDA should consider developing a late-stage precision medicine guidance focused on common diseases to enable the application of “-omics” in late-stage clinical development (Phase 3). Commenting on an FDA notice soliciting comments on “Promoting Effective Drug Development: Identifying Opportunities and Priorities for FDA’s Office of
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Glenmark Pharmaceuticals is recalling (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg) 10 mEq K, due to dissolution failures. “The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can
Drugs
FDA has issued AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson’s disease. In the letter, the agency cited observations that were identified during an inspection of a third-party manufacturer listed in the
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FDA has accepted for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treating adults with post-traumatic stress disorder (PTSD). The agency has set a 2/8/2025 user fee review action target date. The submission is based on data from
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FDA has approved Halozyme Therapeutics’ Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Previously, the product was approved for treating adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive. CIDP is a rare immune-mediated, inflammatory, peripheral nerve disorder
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FDA has converted Janssen’s Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory trial verified clinical benefit. Sirturo is indicated for treating pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis that is resistant to at least rifampin and isoniazid. The agency says the National TB Surveillance
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FDA has posted a guidance entitled “Laboratory Developed Tests: Small Entity Compliance Guide.” The document discusses the agency’s phase-out approach for laboratory-developed tests (LDTs) so that in-vitro diagnostics manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs (i.e., FDA’
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The House Energy and Commerce Committee is seeking additional inspection records from FDA after a recent committee analysis of the foreign drug inspection program found troubling issues. In looking at inspections in India and China from 1/2014 to 4/2024, the committee says its analysis revealed “tremendous variation in
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FDA has denied a 4/2023 petition (see earlier story) that called on the agency to withdraw approval for Harmony Biosciences’ Wakix (pitolisant) and take other actions against the drug. Wakix has been indicated to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The petition said Scorpion founder
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FDA is announcing a 7/22 public workshop on “Best Practices for Meeting Management Under PDUFA VII.” The agency says that with increasing interaction meetings available to industry, “optimizing meeting management practices has become more important to facilitate the conduct of efficient and effective drug development programs.” Under the user
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Eli Lilly says it has submitted an NDA for weight loss therapy Mounjaro (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) and obesity, and it expects a regulatory decision by the end of the year. The submission is based on data from the SURMOUNT-OSA Phase 3 clinical
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Lexicon Pharmaceuticals says that after receiving recent FDA feedback it has resubmitted its NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease (CKD). In 2021, CDER issued a Federal Register notice proposing