Drugs
Compass Pathways says it will accelerate by nine to 12 months the planned launch of its COMP360 psilocybin treatment for treatment-resistant depression. A company statement says moving up the projected launch follows completion of the COMP006 trial enrollment and a positive meeting with FDA on NDA submission strategies, including
Drugs
Otsuka ICU Medical has recalled (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap label was incorrectly printed as 10 mEq, creating a dosing error risk. The company says the error was due to a manufacturing issue. Because the overwrap conceals the inner
Drugs
A new report from the Reagan-Udall Foundation for the FDA is calling for broad operational and policy reforms to improve the efficiency, representativeness, and success rates of oncology multi-regional clinical trials. The report, Improving Oncology Multi-Regional Clinical Trials, summarizes findings from a 9/4 roundtable that brought
Drugs
FDA has lifted a clinical hold against a Rein Therapeutics Phase 2 (RENEW) trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis, allowing the company to resume enrollment in the U.S. The FDA action follows a review of Rein’s complete response submission, which addressed all outstanding regulatory
Drugs
Aurinia Pharmaceuticals’ lawsuit against CDER director George Tidmarsh includes screenshots of troubling text messages and emails from Tidmarsh to Kevin Tang, a biotech investor who chairs Aurinia’s board and heads Tang Capital Partners, the company’s largest investor. Tidmarsh resigned on Sunday, the day the lawsuit was filed in
Drugs
CDER director George Tidmarsh has stepped down after being placed on administrative leave amid an internal ethics investigation and a defamation lawsuit tied to a public post criticizing a company’s drug. Tidmarsh’s abrupt exit — just four months after his appointment to lead the agency’s drug center — comes
Drugs
FDA has approved UCB’s Kygevvi (doxecitine and doxribtimine), which the company describes as the first treatment for thymidine kinase 2 deficiency (TK2d), a life-threatening genetic mitochondrial disease characterized by progressive muscle weakness. The approval covers adults and pediatric patients whose symptoms begin at or before 12 years of
Drugs
FDA is preparing to introduce a new, accelerated pathway for approving custom gene-editing therapies, aimed at treating patients with rare diseases. The announcement, highlighted in an interview with CBER director Vinay Prasad, signals a major shift in the agency’s regulatory approach. Prasad told Bloomberg News that advances in
Drugs
FDA is announcing new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs. The agency sent notices to four companies signaling its intent to take enforcement action against products marketed for children under age three, or for older children at low to moderate risk of tooth decay, according
Drugs
Eli Lilly says its investigational weight-loss pill met most criteria for FDA’s new national priority voucher program, suggesting it is a strong candidate for a significantly accelerated approval review. The company says it will submit before the end of the year an NDA for orforglipron, and the agency
Drugs
A Friends of Cancer Research working group on determining a standard of care (SOC) comparator in multi-regional oncology trials says that while perfect solutions may not be attainable, “a thoughtful and ongoing process can improve applicability and transparency in comparator selection, ensuring trials remain feasible, meaningful, and representative across
Drugs
FDA has released the form FDA-483 issued following an 8/4-8/13 inspection at the Zydus Lifesciences drug manufacturing facility in Baddi, Himachal, Pradesh, India. The inspection observations were: * failure to fully follow the responsibilities and procedures applicable to the quality control unit; * procedures describing the handling of
Drugs
FDA has granted Dewpoint Therapeutics an orphan drug designation for DPTX3186, a first-in-class condensate modulator being developed to treat gastric cancer. The designation comes on the heels of the agency’s recent acceptance of Dewpoint’s IND to launch the first in-human study of a condensate-modulating
Drugs
FDA has accepted for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotreotide injection, indicated for use with positron emission tomography imaging for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients. Submitted under FDA’
Drugs
Senate Special Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) have asked three group purchasing organizations (GPOs) for information on vulnerabilities in the U.S. pharmaceutical supply chain involving generic drugs made overseas. In a statement (contains a link to the letter sent
Drugs
Speaking at the 10/27 Biotechnology Innovation Organization’s Patient Advocacy Changemaker’s Event, new CDER director George Tidmarsh said his immediate goals are to improve staff morale, hire additional reviewers, and reduce the number of Investigational New Drug (IND) applications by reforming the process. Tidmarsh told attendees that FDA
Drugs
FDA has granted a fast-track designation for Alphamab Oncology’s biparatopic HER2-targeting antibody drug conjugate JSKN003 to treat advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted by HER2 expression. A company statement says the designation follows FDA approval
Drugs
A U.S. District Court in Hawaii ruled 10/20 that FDA acted unlawfully by imposing certain restrictions on mifepristone. The court found the FDA failed to provide a reasoned explanation for its restrictive regulation of the medication. The case centered on an agency-mandated Risk Evaluation and Mitigation Strategy
Drugs
Reporting on the FDA 9/30 public meeting on onshoring manufacturing of drugs and biological products, attorneys Mark Schwartz and Julie Kim (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that if the agency can rapidly implement a PreCheck program that formalizes early, durable engagement; modernizes
Drugs
A new Friends of Cancer Research white paper, “Seamless Clinical Trial Designs in Rare Cancers: Leveraging Operational and Adaptive Strategies to Accelerate Drug Development,” concludes that when thoughtfully designed, such trials can accelerate timelines, reduce redundancy, and generate robust evidence from limited populations without compromising scientific integrity. The paper is
Drugs
FDA has granted Revolution Medicines an orphan drug designation for its investigational therapy daraxonrasib (also known as RMC-6236) for treating pancreatic cancer. Daraxonrasib is currently being evaluated in a global Phase 3 study (RASolute 302) in patients with second-line metastatic pancreatic ductal adenocarcinoma (PDAC). The company says it
Drugs
Unicycive says that after discussions with FDA and the company’s third-party manufacturing vendor, it plans to resubmit its NDA for oxylanthanum carbonate (OLC) to FDA before the end of 2025. FDA had issued a 6/30 complete response letter (CRL) citing concerns about the compliance status of Unicycive’