Drugs
FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentech’s pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, expanding treatment options for patients with advanced disease. The approval covers patients whose tumors are HER2-positive — defined
Drugs
FDA has released updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practices, and adopt more flexible trial designs to ensure clinical studies better reflect the patients who will ultimately use approved medicines. The guidance, Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and
Drugs
A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clinical trials used to secure FDA drug approvals fail to reflect the racial and ethnic makeup of the U.S., and that representation has worsened in recent years. Published in
Drugs
FDA and drug-industry negotiators exchanged early feedback on the agency’s proposed “America First” fee incentives for domestic drug development during an 11/13 Prescription Drug User Fee Act (PDUFA) reauthorization steering committee meeting, according to newly released minutes. The proposal, first outlined by FDA at an 11/6
Drugs
FDA has approved Janssen’s Akeega — a fixed-dose combination of niraparib and abiraterone acetate — with prednisone for adults with metastatic castration-sensitive prostate cancer (mCSPC) harboring deleterious or suspected deleterious BRCA2 mutations. The approval requires use of an FDA-authorized companion diagnostic to confirm BRCA2 status. The decision marks
Drugs
Senior FDA officials have urged agency reviewers to speed up the review of Eli Lilly’s NDA for its oral weight loss pill orforglipron after the drugmaker pushed for a faster review timeline, according to a report from Reuters. It says the shorter review would fall under the Commissioner’s
Drugs
FDA has released the form FDA-483 issued following a 6/2-6/6 inspection at the Astellas Pharma sterile drug manufacturing facility in Takaoka, Toyama, Japan. The two inspection observations were: * failure to establish adequate written procedures for production and process controls designed to assure that drug products have
Drugs
Eli Lilly’s investigational triple-agonist retatrutide produced substantial weight loss and meaningful reductions in knee osteoarthritis pain in a pivotal Phase 3 trial, positioning the once-weekly injectable as a potential next-generation therapy for obesity complicated by musculoskeletal disease, according to the company. In the 445-patient TRIUMPH-
Drugs
Serina Therapeutics says it has filed a complete response to an FDA clinical hold issued 11/25 on SER-252, the company’s lead investigational therapy for advanced Parkinson’s disease. The hold was placed after the agency requested additional information about a commonly used formulation excipient. The agency did
Drugs
Roche says results from the Phase 3 lidERA breast cancer study evaluating its investigational giredestrant as adjuvant endocrine treatment for people with estrogen receptor-positive, human epidermal growth factor receptor 2-negative early-stage breast cancer showed the treatment significantly reduced the risk of invasive disease recurrence or death by
Drugs
The U.S. government has asked the Supreme Court to take up a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and brand-name company Amarin to decide whether generic drugmakers may face liability for inducement of patent infringement when they market a drug under a so-called
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Researchers from several universities say the enhanced safety-related regulatory authorities in the FDA Amendments Act (FDAAA) of 2007 were not associated with differences in time to first postmarket safety-related action. Writing in JAMA Internal Medicine, the researchers said (subscription required) that among therapeutics with postmarket safety-related actions
Drugs
The Washington Legal Foundation (WLF) is cautioning that the Trump administration’s ongoing crackdown on direct-to-consumer (DTC) pharmaceutical advertising is on a collision course with First Amendment protections. In a new Legal Backgrounder, WLF senior litigation counsel Zac Morgan argues that the agency’s recent wave of Warning
Drugs
FDA has approved Italian non-profit Fondazione Telethon’s BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome (WAS), a rare, life-threatening immune disorder. Approved for children as young as six months and for adults with confirmed WAS gene mutations, Waskyra is intended for patients
Drugs
Four Hogan Lovells attorneys say that recent Department of Justice (DoJ) subpoenas and the so-called Hsiao Declaration “signal a potential redefinition of enforcement boundaries under the Federal Food, Drug, and Cosmetic Act (FFDCA). By asserting that off-label prescribing may itself constitute an FFDCA violation and that scientific exchange
Drugs
A 5/18-6/18 FDA inspection at the Seaway Pharma drug manufacturing facility in Massena, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/1 Warning Letter says the specific violations were: * failure to establish adequate written responsibilities and procedures applicable to
Drugs
FDA has approved Augmentin XR (amoxicillin–clavulanate potassium) through the new Commissioner’s National Priority Voucher (CNPV) pilot program, permitting new U.S.-based production capacity at a domestic facility. This is the first product approved under the initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience.
Drugs
CDER has published a Manual of Policies and Procedures (MAPP), “Prescription to Nonprescription Switches and Abbreviated New Drug Applications,” describing the policies and procedures for the Office of Generic Drugs (OGD) when a reference-listed drug switches from prescription to nonprescription marketing status. The MAPP specifically describes the procedures for
Drugs
FDA says it has qualified the AI-Based Histologic Measurement of NASH (AIM-NASH), the first artificial intelligence (AI) drug development tool, intended to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials. An agency announcement says the cloud-based tool helps pathologists score liver biopsy
Drugs
FDA has released a final guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” which is aimed at clarifying how pharmaceutical companies should promote prescription biologics, including biosimilars and interchangeable biosimilars, in advertising and labeling. The guidance, presented
Drugs
FDA has informed the manufacturers of protective RSV (respiratory syncytial virus) therapies for infants that it will be conducting additional safety evaluations of the therapies following concerns raised by vaccine skeptics. Multiple sources confirmed the agency action to Reuters. The sources indicated that inquiries by senior FDA staff into the
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BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for patients with advanced squamous non–small cell lung cancer (sqNSCLC) who had exhausted standard treatment options. Results from the first stage of the global Phase 3 PRESERVE-003 trial show that gotistobart, a selective T-regulatory cell modulator