Drugs
Cassava Sciences says it is discontinuing the development of its Alzheimer’s disease (AD) drug simufilam after announcing disappointing topline data from the Phase 3 ReThink-ALZ study in mild-to-moderate AD patients. In the study, data show that the drug did not meet any of the pre-specified
Drugs
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Drugs
Based on favorable data and the recommendation of an independent data monitoring committee, Merck is stopping early its Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class III or IV at high risk of mortality. “In the study, WINREVAIR
Drugs
Endo is recalling (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength on the carton. An ongoing Endo investigation has identified the possibility that several clonazepam product lots contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC)
Drugs
FDA researchers have identified potential links between the widely prescribed asthma drug montelukast (Organon’s Singulair) and serious mental health issues, including depression and suicidal behavior, according to Reuters. FDA’s research findings, which are preliminary and have not been released publicly, were presented to a limited audience at the
Drugs
FDA says MXBBB has recalled one lot of Umary Acid Hyaluronic, 30 caplets 850 mg, to the consumer level. An agency notice says the product contains undeclared diclofenac and omeprazole, as confirmed by FDA laboratory analysis. Umary was distributed nationwide by Amazon, the notice says. It says MXBBB had not
Drugs
The more than 200 special agents working in the field for the FDA Office of Criminal Investigations (OCI) executed more than 290 arrests and achieved over 300 convictions in FY 2023. Writing in an FDA Voices post, assistant commissioner Justin Green, who heads OCI, says the group’s work “sends
Drugs
CDER deputy director for regulatory programs Doug Throckmorton is retiring in early January after 27 years at the agency. While there has been speculation that some FDA employees may be seeking the exit door based on anticipated disruptions from the incoming Trump Administration (see earlier story), CDER director Patrizia Cavazzoni
Drugs
FDA has used the Oncology Center of Excellence’s Project Renewal to approve labeling changes for Sandoz’ fludarabine phosphate cancer drug injection. An agency announcement says this is the third drug to receive a Project Renewal labeling update. Project Renewal is aimed at updating labeling information for certain older oncology
Drugs
Sage Therapeutics says the Phase 2 DIMENSION study of dalzanemdor in participants with cognitive impairment associated with Huntington’s disease failed to meet its primary endpoint. A company statement says secondary endpoints also did not show statistically significant or clinically meaningful differences in participants treated with dalzenemdor compared to placebo.
Drugs
A 5/20-5/24 FDA inspection at the Originitalia SRL drug manufacturing facility in Vicenza, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/7 Warning Letter says specific violations were: * failure to test samples of each component for full identity and
Drugs
Novo Nordisk is supporting its 10/22 nomination of semaglutide drugs to the lists of drug products that present demonstrable difficulties for compounding (DDC) lists with an 11/13 petition calling on FDA to take three specific actions to promulgate regulations to place the products on the lists. The petition
Drugs
A 4/22-4/25 FDA inspection at the Silliker contract testing laboratory, doing business as Merieux NutriSciences in Gainesville, FL, found violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/12 Notice of Violation says specific violations were: * failure to establish adequate written responsibilities and
Drugs
A 5/1-5/14 FDA inspection at the Unexo Lifesciences drug manufacturing facility in New Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/6 Warning Letter says specific violations were: * failure of the firm’s quality control unit to exercise
Drugs
A 5/7-5/22 FDA inspection at the Colgate-Palmolive/Tom’s of Maine over-the-counter drug manufacturing facility in Sanford, ME, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/5 Warning Letter says specific violations were: * failure to follow appropriate
Drugs
FDA has issued Astellas Pharma a complete response letter (CRL) on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) seeking revised drug labeling for its use in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company says the agency’s comments in the CRL are
Drugs
Friends of Cancer Research says an FDA draft guidance on considerations for generating clinical evidence from oncology multiregional clinical development programs is “valuable for addressing key challenges in oncology clinical trials and global drug development programs. We appreciate FDA’s focus on population representativeness, patient diversity, and region-specific analysis.
Drugs
Merck is reporting “positive topline results” from the pivotal Phase 3 MK-3475A-D77 trial that evaluated the noninferiority of subcutaneous administration of Keytruda (pembrolizumab) and berahyaluronidase alfa, a hyaluronidase variant manufactured by Alteogen administered with chemotherapy versus intravenous (IV) Keytruda administered with chemotherapy for the first-line treatment of
Drugs
FDA is seeking input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZeneca’s Andexxa (coagulation factor Xa recombinant, inactivated-zhzo) and an increased risk of thrombosis relative to the therapy’s benefits. The therapy was granted accelerated approval in 2018 for patients treated with blood
Drugs
GSK is announcing that its Phase 3 GLISTEN trial evaluating linerixibat, an investigational targeted inhibitor of the ileal bile acid transporter (IBAT), in adults with cholestatic pruritus (relentless itch) associated with primary biliary cholangitis met its primary endpoint. “GLISTEN met its primary endpoint, with linerixibat resulting in an improvement in
Drugs
DA is has issued Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firm’s Yamaguchi, Japan manufacturing facility. Agency investigators found that the facility’s investigations into unexplained discrepancies did not result in written records being created. They also cited Takeda for failing to thoroughly review any
Drugs
FDA has accepted for review an Aldeyra Therapeutics NDA for reproxalap, a first-in-class investigational topical new drug candidate for treating signs and symptoms of dry eye disease. The agency has set a user fee review action target date of 4/2/2025. Reproxalap is described as a small-