Drugs
A 5/14-5/23 FDA inspection at OHM Pharma, Mineral Wells, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/19 Warning Letter. Specific violations were: * failing to maintain the buildings used in the manufacture, processing, packing, or holding of
Devices
FDA has cleared an OrthoGrid Systems 510(k) for its application PhantomMSK Trauma for use in orthopedic surgery. The universal software platform is intended to work with all manufacturer devices across multiple procedures using fluoroscopic imaging to assist with implant, instrument and anatomic alignment, the company says. It has software
Drugs
Preliminary findings from a new Government Accountability Office (GAO) study on FDA’s foreign inspection program acknowledge improvements but point up remaining challenges, such as staffing concerns and reliance on pre-announced inspections. GAO has been evaluating the foreign inspection program routinely for two decades and it remains on the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. OHM Pharma, Mineral Wells, TX (11/19): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, OHM failed to maintain the buildings
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.” The document addresses the recommended patient attributes for enrollment, efficacy assessments, safety assessments, and additional considerations under development programs and
Devices
FDA has cleared a LimaCorporate and TechMah Medical 510(k) for the Smart Space Shoulder 3D Planner & 3D Positioner for shoulder arthroplasty. The digital platform is intended to provide surgeons with pre-operative planning and intra-operative positioning. The companies say they are also seeking clearance for the device’
Drugs
Genus Medical Technologies has won a court decision in Washington, DC federal court to have its contrast agent Vanilla SilQ products regulated as a device as opposed to a drug. Having a product regulated as a device instead of a drug costs significantly less and subjects the company to less
Biologics
Sesen Bio has begun a rolling BLA for vicinium for treating BCG-unresponsive non-muscle invasive bladder cancer. The company says it has submitted completed non-clinical and clinical modules, and a partially completed Chemistry, Manufacturing and Controls (CMC) module. It expects to complete the BLA submission with the finalization
Drugs
FDA says that ongoing concerns about the presence of genotoxic impurities (nitrosamines) in angiotensin II receptor blockers and ranitidine have now spread to some metformin diabetes medicines after other countries reported low levels of the nitrosamine N-Nitrosodimethylamine (NDMA). “Based on the information we have available, the levels of NDMA
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Magnetic Resonance (MR) Coil — Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for MR coils to use for clearance under the agency’s Safety and Performance Based Pathway. Under the framework, if a legally
Drugs
Republican House lawmakers have introduced the Lower Costs, More Cures Act (H.R. 19) to lower drug costs for Americans without limiting access to cures. The bill “uses bipartisan reforms to lower out-of-pocket spending, protect access to new medicines and cures, strengthen transparency and accountability, and champion competition,
Drugs
FDA has granted Equillium a fast track designation for itolizumab for treating lupus nephritis. In September, Equillium initiated the EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis. The study will have two cohorts: Type A is an open-label cohort and will treat patients with
FDA Policy/General
Joint Panel to Review Nektar Back Pain Drug Federal Register notice: FDA announces a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee joint meeting to discuss a Nektar Therapeutics drug. 12/06/2019 Review Period for Biomarin’s Palynziq Federal
FDA Policy/General
Otsuka Pharmaceutical Co. has agreed to acquire Neurovance, a privately held clinical stage pharmaceutical company focused on attention-deficit hyperactivity disorder and related disorders. Under the terms of the agreement, Otsuka will provide an estimated $100 million in upfront payments at closing, up to $150 million in additional payments contingent
FDA Policy/General
Federal Register notice: FDA has announced a 1/14/2020 Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee joint meeting. The committees will discuss a Nektar Therapeutics NDA for oxycodegol, a new molecular entity full mu-opioid receptor agonist for managing chronic low
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Biomarin Pharmaceutical’s Palynziq (pegvaliase-pqpz), indicated to reduce blood phenylalanine concentrations in certain adult patients with phenylketonuria. The regulatory review period is 3,803 days, which includes 3,474 days that occurred during the
Drugs
FDA has released a draft guidance entitled “Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids.” The document is intended to assist sponsors in the clinical development of locally applied corticosteroid products (including suppositories or products that require an applicator)
Devices
FDA has posted a draft guidance on “Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for MR coils to use for clearance under the agency’s Safety and Performance Based Pathway. Under the framework, submitters planning to submit a 510(k)
Drugs
FDA has approved an Amgen BLA for Avsola (infliximab-axxq), a biosimilar of Janssen’s Remicade, indicated for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The agency says this is the fourth biosimilar of Remicade (infliximab) to gain approval. To view the
Biologics
FDA appears to be stepping up its enforcement efforts against violative cell/tissue products. On 12/6, the agency warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC (Yorba Linda, CA) for processing and distributing unapproved products derived from umbilical cord blood. They were warned also on current good tissue
Drugs
A New York physician, Gordon Freedman, has been convicted for participating in a scheme to receive bribes and kickbacks through sham educational programs (“speaker programs”) from Insys Therapeutics in exchange for prescribing millions of dollars’ worth of Subsys, a fentanyl-based spray. “As a jury of his peers has now
FDA Policy/General
Federal Register notice: FDA has announced a 1/15/2020 Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee joint meeting. During the morning session, the committees will discuss an Esteve Pharmaceuticals NDA for a combination tramadol 44 mg and celecoxib 56 mg