Drugs
FDA has ordered a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies. The increased warning follows a 11/2023-posted safety communication about reports of T cell malignancies received from
Drugs
FDA has approved Takeda’s Entyvio (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease after induction therapy with intravenous Entyvio. Approval is based on data from the VISIBLE 2 Study, a Phase 3, placebo-controlled trial. “In VISIBLE 2, about half
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should hold more meetings on innovative clinical trial approaches. In comments submitted to the agency following a workshop last month on such approaches, PhRMA says more discussion would be helpful on model-informed drug development, global harmonization, real-world evidence, novel
Drugs
AbbVie is announcing what it calls “positive” top-line results from SELECT-GCA, a Phase 3, placebo-controlled study, that showed the company’s arthritis drug Rinvoq (upadacitinib) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remission from week 12 through week 52
Drugs
GlaxoSmithKline says data from the ZOSTER-049 long-term follow-up Phase 3 trial of its Shingrix (recombinant zoster vaccine) demonstrated that it maintains efficacy against shingles for more than a decade in adults over age 50. A company statement says the trial found 79.7% efficacy in participants aged
Drugs
FDA has approved Lumicell’s Lumisight (pegulicianine) for use in adults with breast cancer to assist in the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during a lumpectomy. An agency statement says Lumisight is a fluorescent imaging drug that is administered through
Drugs
FDA’s new Patient Medication Information (PMI), proposed in 5/2023, will eventually replace Medication Guides and Patient Package Inserts, according to CDER Office of Medical Policy regulatory counsel Christopher Diamant. Interviewed for a CDER Conversation, Diamant says PMI was developed after research showed that the existing Consumer Medication Information
Drugs
The Supreme Court has declined to hear an appeal of a 1st Circuit Court of Appeals decision holding that state consumer protection claims that rely on violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) are impliedly preempted. Attorneys Gina Tincher and Stacy Carpenter (Polsinelli) write in an online
Drugs
Former FDA principal deputy commissioner Janet Woodcock is playing an advisory role at the Haystack Project, the nonprofit group has confirmed on its Web site. The group says it is dedicated to ensuring patient access to treatment options for the rare and especially ultra-rare community. Formed in 2016, Haystack
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it recognizes that data monitoring committees (DMCs) have a unique role in clinical trial oversight and can provide specialized expertise to evaluate emerging safety and efficacy data for ongoing clinical trials. Responding to an FDA draft guidance on the use of data
Drugs
FDA has approved a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. “With an unprecedented 76% reduction in the risk of disease recurrence or death versus
Drugs
FDA has released the form FDA-483 issued following a 3/28-4/5 inspection at the Eugia Steriles Private Limited drug manufacturing facility in Andhra, Pradesh, India. It was the third form FDA-483 issued to a Eugia facility in 2024 so far. The three inspection observations on the
Drugs
FDA has posted its official notice that Oncopeptides’ accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has been withdrawn for failure to demonstrate clinical benefit and safety and effectiveness. In February, the agency denied an Oncopeptides appeal seeking to stop CBER action aimed at causing the company to voluntarily withdraw
Drugs
FDA has denied an 11/2/2023 petition submitted by Hyman, Phelps & McNamara seeking permission to submit an ANDA for loperamide HCl capsules 1 mg and 4 mg, citing a reference to Johnson & Johnson’s Imodium capsules 2 mg. The agency’s 4/17 denial letter says that
Drugs
Eli Lilly says it will file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea (OSA) based on just-announced data from the SURMOUNT-OSA Phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI)
Drugs
Novartis’ Advanced Accelerator Applications is asking FDA to impose restrictions on ANDAs or 505(b)(2) NDAs that reference and rely on Novartis’ Lutathera (lutetium Lu 177 dotatate) for approval. The petition asks FDA to ensure that any applicants demonstrate that their product contains the same amount of the active
Drugs
A two-week December FDA inspection of Sun Pharmaceutical Industries’ Dadra, Dadra & Nagar Haveli and Daman, India facilities led to a six-observation FDA Form-483 that has cited the firm for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Drugs
A 10/9-10/18/2023 FDA inspection at the Natco Pharma drug manufacturing facility in Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/8 Warning Letter says specific violations were: * failing to clean, maintain, and, as appropriate for the nature
Drugs
FDA has issued a safety alert on unsafe counterfeit versions of AbbVie’s Botox (botulinum toxin) have been found in multiple states and administered to consumers for cosmetic purposes. “FDA is aware of adverse events, including hospitalizations, linked to the counterfeit Botox. Symptoms included blurred or double vision, difficulty swallowing,
Drugs
FDA is expanding its partnership with the Lupus Research Alliance (LRA) by including CBER in the Lupus Accelerating Breakthroughs Consortium (Lupus ABC). LRA says the addition of CBER to Lupus ABC “will enhance the consortium’s focus on engineered cell therapies, a promising new area in therapeutic development.” Lupus ABC
Drugs
An 11/6-11/10/2023 FDA inspection at the C&T Dream Co. drug manufacturing facility in Cheonan-si, South Korea, identified repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/11 Warning Letter says specific violations were: * failing to conduct at
Drugs
FDA has placed a clinical hold on a Neumora Therapeutics Phase 1 clinical trial for NMRA-266 for treating brain diseases. NMRA-266 is described as a positive allosteric modulator of the M4 muscarinic receptor. The hold follows recently reported pre-clinical data showing convulsions in rabbits. About 30 participants