Drugs
FDA has released a final guidance entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.” The document describes how the agency intends to evaluate a request for a waiver, concerning a pH adjuster, of the regulatory requirement that a drug
Drugs
Gilead Sciences says its investigational single-tablet regimen combining bictegravir and lenacapavir met its primary endpoint in a pivotal Phase 3 trial, marking a potential advance for people with HIV who rely on complex, multi-pill treatments. The open-label ARTISTRY-1 study tested the once-daily tablet, which combines
Drugs
NYU Grossman School of Medicine ethicist Arthur Caplan says he is concerned that reductions in force at FDA and HHS can adversely affect clinical trial oversight and participant protections. In a Medscape video, Caplan says, “I am extremely worried about what’s been taking place at FDA and at HHS
Drugs
An 11/7 Wiley Rein petition submitted on behalf of a client asks FDA to order the complete and immediate withdrawal of the Wells Pharma compounded 100 mg indomethacin suppository. The petition also calls on the agency to require Wells to cease manufacturing and distribution of the suppository until it
Drugs
CDER has qualified glutamate dehydrogenase (GLDH) as a safety biomarker to detect possible drug-induced liver injury in conjunction with alanine aminotransferase (ALT) and other standard liver injury markers in clinical trials, particularly in participants with elevated transaminases due to muscle injury. An agency notice says innovation in biomarker development
Drugs
FDA has accepted for review an ITM Isotope Technologies NDA for 177Lu-edotreotide (ITM-11), a targeted radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 177Lu-edotreotide is described by the company as a no-carrier-added lutetium-177–based radiotherapeutic designed to deliver targeted radiation to somatostatin receptor–positive
Drugs
The CDER Office of Generic Drugs (OGD) has published a MAPP, Using Four-Part Harmony in OGD-Related Assessment Communications, that describes how OGD assessors can apply the principles of four-part harmony to enhance the clarity of OGD-related communications. (In this context, four-part harmony refers to the
Drugs
Alkermes says that its investigational once-daily therapy alixorexton significantly improved wakefulness and reduced daytime sleepiness in patients with narcolepsy Type 2 (NT2), meeting both primary endpoints in the company’s Vibrance-2 Phase 2 clinical trial. The company says the data highlight alixorexton — the first oral orexin 2 receptor
Drugs
Cumberland Pharmaceuticals has petitioned FDA to decline to accept or approve any ANDAs or 505(b)(2) applications that cite its Acetadote (acetyleysteine) as the reference-listed drug with labeling that omits the branded prescribing information relating to a two-bag dosing regimen. The company’s petition also asks that
Drugs
FDA is joining the United States Pharmacopeia (USP) and the Association for Accessible Medicines (AAM) on 12/11 for a public workshop focused on how compendial standards can strengthen drug quality, streamline development, and improve regulatory predictability across the pharmaceutical industry. According to an FDA notice, the workshop aims to
Drugs
A 5/19-5/21 FDA inspection at the Miers Laboratories drug manufacturing facility in Wellington, New Zealand, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/3 Warning Letter says the two specific violations were: * failure to conduct at least one test
Drugs
Neurocrine Biosciences is reporting that its Phase 2 study of NBI-1070770, an investigational NMDA receptor modulator for major depressive disorder (MDD), failed to meet its primary endpoint. The 73-patient, placebo-controlled trial tested three dose levels of the oral NR2B-selective negative allosteric modulator as adjunctive treatment. Neurocrine
Drugs
A 3/10-3/14 FDA inspection at the Taizhou Kangping Medical Science and Technology Co. drug manufacturing facility in Jiangsu, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished over-the-counter drugs. A just-released 10/9 Warning Letter says the specific violations were:
Drugs
FDA has appointed longtime oncology regulator Richard Pazdur as the new CDER director, replacing George Tidmarsh after he stepped down earlier this month amid an internal ethics investigation and a defamation lawsuit tied to a public post criticizing a company’s drug (see story). Tidmarsh’s abrupt exit came just
Drugs
FDA has granted Avenzo Therapeutics a fast track designation for AVZO-1418, the company’s investigational EGFR/HER3 bispecific antibody-drug conjugate being developed for certain patients with non-small cell lung cancer (NSCLC). The designation covers adults with unresectable, locally advanced or metastatic NSCLC harboring common EGFR-activating mutations
Drugs
In what it describes as one of the most sweeping policy shifts in women’s health in decades, FDA says it will begin removing broad boxed warnings from menopause-related hormone replacement therapy (HRT) products. HHS secretary Robert F. Kennedy Jr. and FDA commissioner Marty Makary unveiled the changes at
Drugs
Roche says its investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib showed the strongest late-stage results yet reported for the drug class in multiple sclerosis, meeting primary endpoints in two pivotal Phase 3 studies and positioning the oral therapy as a potential competitor — and possible successor — to some of
Drugs
FDA has cited Alvotech’s Reykjavik, Iceland, manufacturing site for widespread sterility assurance, environmental monitoring, and quality-system failures following a June–July inspection, according to a 13-page Form 483. Investigators from CDER’s Office of Pharmaceutical Quality identified fundamental lapses in aseptic processing controls, cleaning programs, water-system
Drugs
Merck is reporting positive Phase 3 results for its oral PCSK9 inhibitor enlicitide, showing LDL-cholesterol reductions approaching 60% with a safety profile comparable to placebo. In the 2,900-patient study, adults with or at risk for atherosclerotic cardiovascular disease (ASCVD) taking once-daily enlicitide saw a 55.8%
Drugs
Fresenius Kabi has recalled (Class 1) three lots of its famotidine injection after reserve samples from one lot tested out of specification for endotoxin levels. According to the company, elevated endotoxin levels in injectable drugs can trigger serious systemic reactions, including sepsis, septic shock, and life-threatening inflammatory responses. One
Drugs
A group of leaders from government, academia, and the pharmaceutical industry is calling for sweeping federal action to stabilize the U.S. drug supply, warning that persistent shortages now pose risks not just to public health but to national security. At a National Academies workshop held last month at the
Drugs
Cogent Biosciences is reporting positive data from a Phase 3 study of its KIT inhibitor bezuclastinib, saying that the drug combined with standard therapy sunitinib significantly extended progression-free survival in patients with imatinib-resistant or intolerant gastrointestinal stromal tumors (GIST). It is the first successful Phase 3 study in