Drugs
A 6/26-6/30/2023 FDA Bioresearch Monitoring Program inspection at ISOThrive, Inc., in Healdsburg, CA, found objectionable conditions in its role as sponsor of two trials of an investigational drug. A 2/4 Warning Letter says the specific issue was ISOThrive’s failure to submit an IND application
Drugs
A 9/2-9/6/2024 FDA inspection at the Wuhu Nuowei Chemistry drug manufacturing facility in Xuancheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/4 Warning Letter says the specific deviations were: * failure to ensure that all specifications
Drugs
AnaptysBio is reporting positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis (RA). The 424-patient Phase 2b RENOIR trial achieved its primary endpoint of the mean change from baseline in its disease activity score at Week 12 for all three doses of
Drugs
A 7/8-8/1/2024 FDA inspection at the Strukmyer Medical drug manufacturing facility in Mesquite, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/30 Warning Letter says specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure of
Drugs
An FDA review of records supplied by Chengdu Innovation Pharmaceutical Co. in Sichuan Sheng, China, following an agency 4/29/2024 request, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 2/5 Warning Letter says specific deviations were: * failure to test the identity
FDA Policy/General
DC federal judge John Bates has issued a temporary restraining order (TRO) requiring FDA and the Centers for Disease Control and Prevention (CDC) to restore Web pages they removed to comply with President Donald Trump’s executive order on gender ideology that mandated the recognition of only male and female
Drugs
National Center for Health Research president Diana Zuckerman and George Washington University and University of Maryland professor John Powers III say FDA should be focusing on how new antibiotics work in patients rather than looking at how they kill bacteria in a test tube. Writing in a STAT First Opinion
Drugs
FDA has accepted for priority review a Biohaven NDA for troriluzole for treating adult patients with spinocerebellar ataxia (SCA), a rare genetic neurodegenerative disease. The company says the agency will take a review action on the NDA within six months or sometime during the third quarter. The submission is based
Drugs
FDA has approved a SpringWorks Therapeutics NDA for Gomekli (mirdametinib), a kinase inhibitor for treating adult and pediatric patients two years of age and older with neurofibromatosis Type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. Approval was based on data from the ReNeu (NCT03962543)
Drugs
FDA has accepted for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/refractory multiple myeloma (R/R MM) that has progressed after at least three prior therapies. The user fee review action target date was set for 7/10. Last August, the agency issued
Drugs
FDA says Jeremy Brown of Simi Valley, CA has been sentenced for introducing unapproved drugs into interstate commerce. He was sentenced to one year of supervised release and ordered to pay $100,000 in forfeiture for selling the drugs through his company, Warrior Labz SARMs and associated Web sites, according
Drugs
Pliant Therapeutics says it has paused enrollment and dosing due to an undisclosed safety concern in its ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The pause was recommended following a prespecified data review by the trial’s independent data safety monitoring board.
Drugs
Boehringer Ingelheim says it will submit an NDA for nerandomilast for treating progressive pulmonary fibrosis following the company’s reporting of positive data from its FIBRONEER-ILD trial. The study met its primary endpoint, which was the absolute change from baseline in lung function (forced vital capacity) at week 52
Drugs
FDA has granted Tempest Therapeutics a fast track designation for amezalpat (TPST-1120), a small molecule, selective PPAR⍺ antagonist for treating patients with hepatocellular carcinoma (HCC). The company says the designation is based on positive data across multiple key study endpoints in a global randomized Phase 1b/2 study evaluating
Drugs
Roche says it is sharing with FDA positive data from the Phase 3 REGENCY trial of Gazyva (obinutuzumab) in people with active lupus nephritis (LN). “The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR), showing that 46.4% of people
Drugs
Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) are urging FDA to take enforcement action against a planned direct-to-consumer (DTC) commercial that will run during the Super Bowl 2/9 which omits safety or side effect information. The commercial promotes Hims & Hers’ compounded version of
Drugs
FDA has approved an AbbVie NDA for Emblaveo (aztreonam and avibactam), a fixed-dose monobactam/β-lactamase inhibitor combination antibiotic. The intravenous antibiotic is approved for combination use with metronidazole in patients 18 years and older who have limited or no alternative options for treating complicated intra-abdominal infections, including
Drugs
FDA has accepted for priority review an Insmed NDA for brensocatib for treating patients with non-cystic fibrosis bronchiectasis. The agency has set a review action target date of 8/12. The submission is based on data from the Phase 3 ASPEN study, which met its primary endpoint with both
Drugs
A Pacific Research Institute white paper explains why it believes drug manufacturers should present preemption claims when they are charged under state laws with failing to market as quickly as possible a drug that allegedly presents fewer side effects than other FDA-approved drugs already on the market. The paper
Drugs
A Cooley Alert says a recent 4th Circuit Court of Appeals decision in a Medicare fraud case may embolden the government to reject the “practice of medicine” defense whenever a healthcare practitioner uses an approved or cleared medical device for off-label uses, under the theory that any device that
Drugs
FDA has granted Onc.AI a breakthrough device designation for its Serial CT Response Score (Serial CTRS) AI model, which the company describes as an artificial intelligence (AI)-based prognostic tool that uses deep learning to analyze CT scans and stratify lung cancer patients into high- or low-mortality risk
Drugs
A Buchanan Ingersoll & Rooney petition asks FDA to impose two restrictions on ANDAs citing Waylis Therapeutics’ Tabloid (thioguanine) 40 mg tablets as the reference-listed drug. The 2/3 petition asks FDA to: * maintain and strictly apply the requirements of the current product-specific guidance (PSG) for thioguanine, which