Drugs
Intercept Pharmaceuticals says it is withdrawing Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis (PBC), following an FDA request that cited liver injury concerns. Last December, FDA issued a drug safety communication, saying its review of postmarket clinical trial data identified cases of serious liver
Drugs
While rapid scientific advances are accelerating the development of medical innovations, significant FDA policy and regulatory reforms are needed to fully use the potential of the new technologies. That’s the conclusion in a white paper issued by the University of Southern California Schaeffer Center for Health Policy and Economics.
Drugs
The Securities and Exchange Commission (SEC) says it has accepted an offer from FibroGen to resolve a cease-and-desist order covering false and/or materially misleading statements about the results of certain cardiovascular safety analyses of the firm’s anemia drug roxadustat. A commission order details how the firm’
Drugs
The Clinical Trials Transformation Initiative (CTTI) held a 5/22 “State of Clinical Trials” meeting for influential leaders, high-level agency officials, policymakers, and key CTTI members to hold “solution-driven conversations about advancing the clinical trial enterprise,” to identify concrete, realistic ways to improve efficiency and quality in clinical
Devices
FDA has scheduled an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence (AI) in digital mental health medical devices, signaling heightened concern from the agency about the technology’s risks and regulatory gaps. AI-based mental health devices are increasingly being promoted as
FDA Policy/General
Capsida Biotherapeutics has halted enrollment in its SYNRGY clinical trial that is evaluating CAP-002, an investigational intravenous (IV)-administered gene therapy for treating STXBP1 developmental and epileptic encephalopathy, due to a patient death in the trial. The company says CAP-002 is the first IV-delivered, adeno-associated virus
Biologics
CBER director Vinay Prasad has been reassigned his previous additional duties as FDA’s chief medical and scientific officer, a combination role for commissioner Marty Makary’s closest advisor. In this capacity, “he will serve as a trusted advisor to the FDA commissioner and other senior officials on cross-cutting
Drugs
FDA has issued a draft guidance, Development of Non-Opioid Analgesics for Chronic Pain, to assist sponsors in developing such drugs. The document says it is intended to address two agency priorities — fostering the development of novel analgesic products, and decreasing opioid analgesic exposure and preventing new addiction. The guidance
Devices
FDA has cleared a new indication for neurocare group AG’s Apollo TMS (transcranial magnetic stimulation) therapy device to treat adolescents with major depressive disorder. A company statement says there are currently only two oral antidepressants approved for this age group, and both have Boxed Warnings for an increased risk
Drugs
FDA has approved a Johnson & Johnson NDA for Inlexzo (gemcitabine intravesical system), offering a new treatment option for adults with non-muscle invasive bladder cancer (NMIBC) who do not respond to standard Bacillus Calmette-Guérin (BCG) therapy. The therapy is the first intravesical drug-releasing system designed to deliver
Drugs
FDA has granted Greenwich LifeSciences fast track status for GLSI-100, an investigational immunotherapy aimed at preventing breast cancer recurrences. The designation applies to HLA-A*02-genotype patients with HER2-positive breast cancer who have completed standard HER2-targeted therapy. The company says GLSI-100 has already shown promise
FDA Policy/General
FDA has ordered pharmaceutical companies to remove any “noncompliant ads” and bring all promotional communications into compliance with the Federal Food, Drug, and Cosmetic Act. Thousands of letters have now been sent to companies warning that the agency is moving to “take aggressive action” against violative ads, citing longstanding concerns
Drugs
FDA has accepted and will consider a Corcept Therapeutics NDA for relacorilant to treat patients with platinum-resistant ovarian cancer. The agency set 7/11/2026 as the PDUFA action date for the NDA. A company statement says the NDA is based on data from its pivotal Phase 3 ROSELLA
FDA Policy/General
Former FDA Digital Health Center of Excellence acting director Sonja Fulmer has left the agency to accept a position at Mayo Clinic as senior director of health policy. Fulmer had been at the agency for 11 years, and assumed her role as acting director in April after director Troy Tazbaz,
Drugs
FDA has approved AstraZeneca’s Koselugo (selumetinib) granules and capsules for pediatric patients one year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic inoperable plexiform neurofibromas (PN). The agency previously approved Koselugo for pediatric patients aged two and older with NF1 who have symptomatic, inoperable PN.
Drugs
A 2/3-2/7 FDA inspection at the Hikal Limited drug manufacturing facility in Jigani, Karnataka, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. An 8/20 Warning Letter says the specific deviations were: * failure of the firm’s quality unit to
Drugs
An FDA 8/5-8/23/2024 Bioresearch Monitoring inspection at the clinical site maintained by Dr. Shirish Gadgeel, a lung cancer medical oncologist, in Detroit, MI, found violations in the conduct of three clinical investigations. A 9/4 Warning Letter says the specific violations were: * failure to ensure that
Drugs
Former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her post and placed on administrative leave in June, has been hired by Eli Lilly as associate VP, global regulatory policy and strategy — genetic medicine. “In my new role I will be working to advance
Drugs
Lexicon Pharmaceuticals says it has submitted new clinical data to FDA in an effort to advance its stalled NDA for its diabetes drug Zynquist (sotagliflozin). The company is seeking to address concerns raised in a 12/2024 complete response letter that cited an elevated risk of diabetic ketoacidosis (DKA) with
Drugs
Capricor Therapeutics says it is posting on its Web site the company’s “comprehensive preliminary response” to an FDA complete response letter (CRL) for the BLA for Bytreldo (deramiocel), an investigational cell therapy intended to treat cardiomyopathy associated with Duchenne muscular dystrophy (DMD). While acknowledging in a statement FDA’s
Drugs
NRx Pharmaceuticals has petitioned FDA seeking a ban on all ketamine products formulated with the preservative benzethonium chloride, arguing that the substance poses unnecessary health and environmental risks. In the petition, the company says the preservative was included in early formulations of ketamine hydrochloride (marketed as Ketalar) in the 1970s
Drugs
The 7th Circuit Court of Appeals has affirmed a lower court’s dismissal of a False Claims Act (FCA) retaliation suit against AbbVie (formerly Allergan) that was brought by a former company sales representative. The sales rep, Jeffrey Lewis, said he was denied a promotion and given onerous assignments after