Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says Congress may be readying a “significant blow” to the Waxman-Hatch Act and the generic drug industry through passage of the Lower Health Care Costs Act of 2019. In a post in his firm’s FDA Law Blog, Karst says the bipartisan,
Drugs
BIO president Jim Greenwood is criticizing the Trump administration and House Speaker Nancy Pelosi for surrendering a “powerful tool for reining in foreign free riding.” In a statement on the apparent agreement on the USMCA trade pact with Mexico and Canada, Greenwood said the renegotiated pact eliminates provisions that prohibit
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) have written to acting FDA commissioner Brett Giroir asking for the status of proposed rules on over-the-counter hearing aids. In a 12/5 letter, Grassley and Warren note that President Donald Trump signed the Over-the-Counter Hearing
Biologics
Verax Biomedical is asking that FDA: * refrain from clearing, approving, recommending, or issuing a “safety measure” designation for large volume delayed sampling (LVDS) as a single step bacterial culture technology for dating beyond Day 5 without first obtaining statistically conclusive data supporting the safety and effectiveness from clinical evidence on
Biologics
A report by the Alliance for Cell Therapy Now says there is a need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for National Institutes of Health research and expanded capacity at FDA to support the rapidly growing field. The
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Rempex Pharmaceuticals’ Vabomere (vaborbactam and meropenem), indicated for treating patients 18 years and older with complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria. The regulatory review period has been determined to be
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0605). FDA’s regulations specify the criteria and procedures for requesting MUMS designation as well as
Drugs
A 4/22-5/20 FDA inspection at Teligent Pharma, Buena, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/26 Warning Letter says the inspection also revealed that the firm failed to submit NDA field alert reports as required by law and
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