Catalyst Pharmaceuticals Inc’s (NASDAQ:CPRX): Catalyst Pharmaceuticals, Inc., a biopharmaceutical company, focuses on developing and commercializing therapies for people with rare debilitating, chronic neuromuscular, and neurological diseases. The US$318.1m market-cap postedRead More...
The FDA endorses the safety profile of the biotech's Parkinson's disease psychosis drug Nuplazid.
Chewable products that protect dogs and cats against fleas can cause neurological problems such as stumbling or seizures, and pet owners need more warning, the Food and Drug Administration said Thursday. The FDA issued an alert to owners and veterinarians and said it was requiring clearer labels on the products. The flea pills and chews all contain a pesticide called isoxazoline, the FDA said. They include products sold under the brand names Bravecto, Nexgard and Simparica. “Another product in this class, Credelio, recently received FDA approval. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations,” the FDA said
The US Food and Drug Administration (FDA) is proposing heavy fines for pharmaceutical companies that fail to report clinical trial results online. In a 20 September draft guidance statement, the FDA said that failure to register trials or submit results to the government database Clinicaltrials.gov could result in fines of up to US$10,000 per day. The agency would send a notification letter to the company warning of an infraction. The company would then have 30 days to comply before facing fines. The public has 60 days to submit comments on the proposed rule. Studies1 have found that about 20% of industry-funded trials and 50% of publicly-funded trials in the US do not report their results. A
One of Britain's biggest online pharmacies is stockpiling up to a million Viagra pills in preparation for a hard Brexit. London-based Zava is the largest digital healthcare company in Europe and specialises in prescribing sexual health treatments for patients who avoid visiting their GP for fear of embarrassment. The company, whose online pharmacy platform is used by Superdrug and which has a million active patients in the UK, usually keeps about two weeks of stock. But chief executive David Meinertz told The Mail on Sunday the firm aims to extend that to three or four months by the end of the year – or about a million Viagra pills. 'We've gone through the different medicines we typically prescribe
Teva Pharmaceutical Industries Ltd.'s (TEVA) American depository receipts jumped in morning trading on Monday, Sept. 17, following the news late Friday that the company had clinched the U.S. Food and Drug Administration's nod for its migraine drug. The FDA greenlit Ajovy (fremanezumab-vfrm) injection as a preventive treatment for migraine in adults. It is the second anti-calcitonin gene-related peptide (CGRP) drug approved by the agency to prevent migraines, after Amgen Inc. (AMGN) and Novartis AG's (NVS) Aimovig in May. CGRP is thought to play a key role in causing migraine headaches. Teva's ADRs gained 4.6% to $23.89 on Monday morning. They are up 26% year-to-date and have risen 32% over the
The West Coast Consortium for Technology and Innovation in Pediatrics (CTIP) was awarded $6.6 million over five years by the U.S. Food and Drug Administration (FDA) to continue its essential work of improving child health outcomes by advancing pediatric medical devices. CTIP, based at Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC), is one of only five centers across the country awarded this prestigious FDA Pediatric Device Consortium (PDC) grant, offered by the Office of Orphan Products Development (OOPD).
Consumers today have more food choices available than at any other time in human history. More options mean more information to consider, but the terms and labels that communicate differences in food production and preparation are all too often more confusing than helpful. The word “organic” is one of these. Many people believe that something labeled organic means the product is healthier than a non-organic version. That's the impression organic growers and manufacturers have tried to create. Yet the government considers it just another marketing claim. When the first federal organic food standards came out in 2000, President Clinton's secretary of agriculture, Dan Glickman, was unequivocal.
Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, today announced that the Food and Drug Administration (FDA) has accepted its request to meet to discuss proposed next steps for the OPC1 clinical development program. The Company’s Type B meeting request was made in accordance with the Regenerative Medicine Advanced Therapy (RMAT) designation under the 21st Century Cures Act. The Company is currently completing the ongoing SCiStar trial, an open-label, single-arm trial testing three sequential escalating doses of OPC1 administered at up to 20 million OPC1 cells in 25 subjects with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) spinal cord injuries (SCI).
BUFFALO GROVE, Ill., Sept. 20, 2018 /PRNewswire/ -- Leica Microsystems received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its augmented reality GLOW800 surgical fluorescence for vascular neurosurgery. This augmented reality solution provides the surgeon a complete view of anatomy and physiology to support crucial decisions and actions during vascular neurosurgery.
Recently, the U.S. National Institutes of Health (NIH) and Food and Drug Administration (FDA) called for the eliminating involvement of the Recombinant DNA Advisory Committee (RAC) in human gene therapy experiments, marking the end of an era of federal government oversight. While the RAC played an essential role in helping human gene therapy research evolve to where it is today, James M. Wilson, MD, PhD, Editor, Human Gene Therapy Clinical Development, believes this is the right moment for it to exit the stage, as he explains in his Editorial "The RAC Retires After a Job Well Done," Human Gene Therapy Clinical Development, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. Click