Drugs
FDA says it will accept applications until 2/10/2026 for the Office of Orphan Products Development’s Natural History Studies Grant Program. A grant notice says the funding opportunity is intended to support prospective or retrospective, efficient, and innovative natural history studies with a focus on collaborative and standardized
Drugs
FDA has released the form FDA-483 issued following a 6/9-6/19 inspection at Natco Pharma Limited, a Rangareddy, Telangana, India, sterile and non-sterile drug manufacturer. The seven inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * failure to maintain equipment
Drugs
FDA has published a draft guidance, Development of Cancer Drugs for Use in Novel Combination—Determining the Contribution of the Individual Drugs’ Effects, with recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in treating cancer. The document says the guidance is
Drugs
FDA has granted Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT carcinoma in patients who have previously received chemotherapy. NUT carcinoma is a rare but underdiagnosed cancer that typically affects the midline structures of the body, including the head,
Drugs
In advance of a 7/18 Psychopharmacologic Drugs Advisory Committee meeting, FDA has released a briefing document questioning the efficacy of Otsuka’s brexpiprazole, whose NDA will be considered by the committee as a treatment for post-traumatic stress disorder (PTSD). Otsuka is proposing to use brexpiprazole (Rexulti) in combination
Drugs
FDA has lifted a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH). “We continue to believe that zetomipzomib has the potential to positively transform the lives of patients
Devices
FDA has cleared a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operative guidance for transcatheter heart valve implantation. The device is intended to enhance implant procedure precision and improve patient outcomes, according to the company, adding that the
Drugs
Sandoz has expanded a 6/25 recall of cefazolin for injection, USP, 1 gram per vial to include one additional lot after the company received a customer complaint indicating that four vials were incorrectly labelled as penicillin g potassium for injection. Sandoz has confirmed that the vials incorrectly labelled as
Drugs
A 1/6-1/15 FDA inspection at the Daewoo Pharmaceutical Co. drug manufacturing facility in Busan, South Korea, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/2 Warning Letter says specific violations were: * failure to establish and follow appropriate written procedures designed
Drugs
With Health Canada conducting only 15% of the country’s inspections of drug manufacturers, Canada has relied on international inspectors, primarily from FDA, which has accounted for 70% of Canada’s inspection reliance. In an online post, Benefits and Pensions Monitor says the backlog in FDA international inspections can hurt
Drugs
FDA reviewers are weighing concerns about ocular toxicity seen in trial data submitted by GSK in its BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma in combination with other therapies in patients who have received at least one prior line of therapy. Blenrep was originally granted accelerated
Drugs
A 4/9-4/17/2024 FDA Bioresearch Monitoring Program inspection at the San Francisco Research Institute operated by Dr. Mark Savant found the site did not adhere to the law and regulations governing the conduct of clinical investigations and the protection of human subjects in its conduct of a
Drugs
FDA has approved a Biocon Biologics BLA for its rapid-acting interchangeable biosimilar insulin product, Kirsty (insulin aspart-xjhz), a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novo Nordisk’s Novolog (insulin aspart). Kirsty is a rapid-
Drugs
FDA has just released the form FDA-483 issued following a 6/1-6/13 inspection at the Sun Pharmaceutical Industries drug manufacturing facility in Halon, Gujarat, India. The eight inspection observations were: * failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be
Drugs
CBER director Vinay Prasad and researchers from U.S. and international universities say results of their study of oncology follow-on drugs suggest a need for regulators to incentivize within-class randomized clinical trials (RCTs). Writing in a JAMA Internal Medicine Research Letter, the authors say they analyzed all anticancer
Devices
BD and subsidiary CareFusion have issued an “Urgent Medical Device Recall (Correction)” letter about performance issues, under certain use cases, for the BD Alaris Pump Module model 8100 when used with a subset of compatible pump infusion sets. “BD stated that they have identified a subset of compatible pump infusion
Biologics
CBER director Vinay Prasad has again overridden medical reviewers to limit a Covid vaccine’s use, according to a just-posted “decisional memo.” The latest incident involves the agency’s 7/9 approval of Moderna’s sBLA for Spikevax, the company’s Covid-19 vaccine, in children aged six months
FDA Policy/General
HHS has notified over 3,000 FDA employees who were told that they were placed on administrative leave 4/1 under government-wide reduction-in-force (RIF) efforts that their employment has been officially terminated effective 7/14. The notification follows the Supreme Court’s decision authorizing the Trump-ordered
Drugs
FDA has issued Ultragenyx Pharmaceutical a complete response letter (CRL) on its BLA for UX111 (ABO-102), an investigational gene therapy for Sanfilippo syndrome Type A, a rare and fatal neurodegenerative disorder affecting children. The letter cites outstanding issues related to chemistry, manufacturing, and controls (CMC), particularly observations from recent
Drugs
Atara Biotherapeutics has resubmitted its BLA for Ebvallo (tabelecleucel or tab-cel), seeking approval for its use as monotherapy for treating adult and pediatric patients two years of age and older with Epstein-Barr virus (EBV)-positive post-transplant lymphoproliferative disease who have received at least one prior therapy. “The
FDA Policy/General
FDA is facing new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal Supreme Court decision, both issued last week. Under a new executive order (Ensuring Accountability and Prioritizing Public Safety in Federal Hiring) signed by president Trump, a government-wide civilian hiring freeze
Drugs
FDA has approved a Bayer supplemental NDA to expand the labeling of Kerendia (finerenone) for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (LVEF) that is 40% or greater. Since 2021, Kerendia