Drugs
An 11/1-11/7/22 FDA inspection at the Pharmedica USA drug manufacturing facility in Phoenix, AZ, determined that drug products manufactured there are adulterated in that they have been prepared, packed, or held under insanitary conditions. As a result, the company said it would shut down all manufacturing
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Intact Vascular’s Tack Endovascular System, indicated for use in the superficial femoral and proximal popliteal arteries to repair post-percutaneous transluminal balloon angioplasty dissections. The review period was 1,338 days, of which
Drugs
FDA has just released the form FDA-483 issued following a 4/18-4/26 inspection at the Ipca Laboratories drug manufacturing facility in Haveli, India. The three inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to
Devices
An 8/22-9/8/2022 FDA inspection at Sea-Long Medical Systems in Waxahachie, TX, found Quality System Regulation and other issues in the firm’s manufacturing of several varieties of its Sea-Long Medical Treatment Hoods. A just-released 4/4 Warning Letter lists these Quality System violations:
Drugs
The Accelerating Medicines Partnership Bespoke Gene Therapy Consortium, a public-private partnership between FDA, the National Institutes of Health, biopharmaceutical and life science companies, and nonprofit and other organizations to help speed the development and delivery of customized or “bespoke” gene therapies that could treat the millions of people affected
Drugs
Alliance for Pharmacy Compounding CEO Scott Brunner says Congress should include in any legislation addressing drug shortages provisions that “will equip state-licensed pharmacy compounders to provide urgent-use medications to hospitals and for in-clinic administration, within tight regulatory guardrails, when those drugs are demonstrably in shortage and unavailable
Drugs
A BMJ investigation asks whether FDA broke its own rules requiring substantial evidence that a drug is effective when it approved in 7/2019 Merck’s antibiotic Recarbrio (relebactam and imipenem-cilastin). “Despite the absence of any clinical studies to provide substantial evidence of its effectiveness, the agency approved the
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Cipla USA’s Zemdri (plazomicin), indicated for treating patients 18 years of age or older with complicated urinary tract infections. The review period was 3,447 days, of which 3,203 days occurred during
Drugs
Viking Therapeutics says top-line results from its Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) show that it met the primary endpoint — statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo. NASH is a liver
Devices
A Minnesota federal judge has entered a $487 million judgment against Cameron-Ehlen Group, which does business as Precision Lens, for violations of the False Claims Act and Anti-Kickback Statute. The judgment stems from a jury finding earlier this year that the defendants violated the statutes by paying kickbacks
Devices
FDA has approved an expanded indication for Abbott spinal cord stimulation (SCS) devices — treating chronic back pain in those who have not had or are not eligible to receive back surgery. Previously, the devices were approved for treating intractable pain of the trunk and limbs. The expanded use was approved
Drugs
Pharmaceutical Research and Manufacturers of America says it appreciates FDA providing the updated guidance and recognizing the “advances in technology” that require additional recommendations. “In general,” it says, “we believe the draft guidance provides useful information to sponsors and other regulated entities regarding FDA’s electronic signatures to be trustworthy,
Biologics
FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee 5/12 voted 8 to 6 to recommend approval of a Sarepta BLA seeking accelerated approval for its SRP-9001 (delandistrogene moxeparvovec), an adeno-associated virus vector-based gene therapy product, to treat ambulatory patients with Duchenne muscular dystrophy (DMD) with
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Sanofi’s Cablivi (caplacizumab-yhdp), indicated for treating adult patients with acquired thrombotic thrombocytopenic purpura in combination with plasma exchange and immunosuppressive therapy. The review period for Cablivi is 2,998 days, of which 2,
FDA Policy/General
FDA has approved Allergan Aesthetics’ Skinvive by Juvéderm and its use to improve skin smoothness of the cheeks in adults over the age of 21. The company says it is the first hyaluronic acid intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six
Drugs
FDA has cleared a Waypoint Orthopedics 510(k) for the Waypoint GPS, a smart bone awl for use during pedicle screw pilot hole drilling. The device is designed to provide operators with additional information via visual feedback through its proprietary color-sensing technology. The visual feedback is displayed wirelessly to
Drugs
FDA has issued a final guidance entitled “Reporting and Mitigating Animal Drug Shortages.” The document provides recommendations on the information sponsors should submit to CVM to report and mitigate animal drug shortages. The agency notes that while reporting animal drug shortages is voluntary, receiving information about shortages allows it to
Drugs
FDA has granted Globus Medical a humanitarian device exemption to allow the marketing of the Reflect Scoliosis Correction System, which the company says is designed to correct progressive scoliosis in young patients while preserving motion, maintaining stability, and allowing for future modulated growth. “Unlike rigid metal rods for fusion, Reflect
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals’ Onpattro (patisiran), indicated for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. The review period for Onpattro is 1,901 days, of which 1,658 days occurred during the testing phase and
Biologics
FDA has issued Byondis a complete response letter on its BLA for SYD985 ([Vic-] trastuzumab duocarmazine) for use in patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC). The letter requests additional information that “requires time and resources that extend beyond the current evaluation period,” the company
Drugs
The U.S. Supreme court has declined to hear a closely watched appeal of a lower court’s ruling in a so-called “skinny label” case won by GlaxoSmithKline (GSK) against Teva over a generic form of GSK’s heart drug Coreg (carvedilol). The question at issue was: If a
Drugs
FDA’s Pulmonary-Allergy Drug Advisory Committee 5/11 voted to recommend approval for ARS Pharmaceuticals’ neffy (epinephrine) nasal spray for treating severe allergic reactions in adults and children. If approved, neffy would become the first needle-free epinephrine product. Panel members voted 16 to 6 to back approval for