The European Commission and the FDA approved CSL Behring's Hizentra human immune globulin as a maintenance therapy for patients with chronic inflammatory demyelinating polyneuropathy to prevent the relapse of neuromuscular disability and impairment.
The FDA granted orphan drug status to Cellectar Biosciences' CLR 131, or 18-(p--iodophenyl) octadecyl phosphocholine, which is being developed as a treatment for patients with neuroblastoma.
The FDA's Arthritis Advisory Committee set a meeting for April 23 to review Eli Lilly and Co.'s resubmitted new drug application for Olumiant, or baricitinib, which is being developed as a treatment for moderately to severely active rheumatoid arthritis.
A regulatory filing was submitted to the FDA by Q BioMed for the approval of a new manufacturing facility that will produce Strontium Chloride Sr89 Injection USP, a nonopioid injectable radiopharmaceutical for patients with painful skeletal metastases.
The FDA approved a late-stage trial that will evaluate Adamis Pharmaceuticals' APC-1000, a metered dose inhaler containing the corticosteroid beclomethasone, in patients with asthma. The company intends to launch the trial later this year.
A voluntary recall was issued by Stampede Meat for 484,800 pounds of raw beef products because the au jus seasoning used on them tested positive for salmonella contamination. The recalled products are USDA Select or Higher Boneless Beef Top Sirloin Steaks with the establishment number EST. 19113, lot codes ranging from 05018 to 07318 and best-by dates from Feb. 19, 2019, to Mar. 14, 2019, that were shipped to distributors and restaurant locations across the country.
High-level disinfectant and sterilant solutions designed for use on medical devices were reclassified by Health Canada from drugs to Class II medical devices. The regulator, which plans to amend the Medical Device Regulations to allow reclassification of the products as Class III devices, has given manufacturers an 18-month transition period to secure quality management system certificates.
The Cardiac Device Coordinated Registry Network, which would connect existing government and professional society registries of cardiac device data, was proposed by the FDA to enable procedure-based long-term follow-up for the devices, but it has drawn concerns from manufacturers and cardiologists. "Industry has to take its hands off the wheel, the FDA will have to accept a different standard of evidence and [the] CMS may need to change its quality standards for reimbursement," said Larry Wood, corporate vice president of transcatheter heart valves at Edwards Lifesciences.
Health Canada has granted mammography and orthopedic imaging company Planmed clearance for its Planmed Clarity 2D and 3D digital mammography systems.
Prexton Therapeutics was purchased by H. Lundbeck in a deal that will give Prexton $122.9 million upfront and up to $989.1 million tied to achieving milestones. Under the deal, Lundbeck will add Prexton's midstage Parkinson's disease candidate to its pipeline of drugs for the treatment of neurological and psychiatric disorders.
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