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
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
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
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
Drugs
Edwards Lifesciences has recalled (Class 1) its Optisite Arterial Cannula due to complaints received about its 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. The company says the device provides or establishes arterial perfusion in the extracorporeal circuit. The company recently sent a recall
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update the drug’s U.S. label to include data from the Phase 3 ZENITH trial, which demonstrated a significant reduction in mortality and morbidity among patients with pulmonary arterial hypertension (PAH). Approved in
Drugs
FDA has issued Capricor Therapeutics a complete response letter on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The letter cited a lack of “substantial evidence of effectiveness” and called for additional clinical data, according to the company, adding that it also
Drugs
FDA has cleared an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci systems. The device is described by the company as a “fully wristed, advanced bipolar electrosurgical instrument designed to seal, cut, grasp, and dissect tissue,” such as for transection
Drugs
A day after releasing hundreds of past complete response letters (see earlier story) as part of FDA’s “radical transparency” efforts, FDA commissioner Marty Makary is now pledging to release newer letters in “real time.” Addressing criticism by some FDA watchers that the letters were too old to be useful
Drugs
FDA has accepted for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered treatment for paroxysmal supraventricular tachycardia (PSVT). The agency has set a user fee review action target date of 12/13. The resubmission addresses a March FDA complete response letter and includes the
Drugs
Avanos Medical is recalling (Class 1) its Ballard Closed Suction Systems due to a failure in the sterilization process. “Use of the affected product may cause serious adverse health consequences, including infection, airway injury, prolonged inflammation, sepsis, or death,” a recall notice says. To date, Avanos says it has not
Drugs
FDA says it is demonstrating “radical transparency” with the publication of over 200 complete response letters (CRLs) issued between 2020 and 2024. The letters were issued in response to applications for approval of new drugs or biologics. An agency statement (contains a link to the letters) says the public “now