The FDA has withdrawn the breakthrough therapy designation it previously granted to Tonix Pharmaceuticals' posttraumatic stress disorder drug Tonmya, or cyclobenzaprine HCl sublingual tablets. Interim data from a clinical study showed that at week 12, there was inadequate variation from placebo on the primary endpoint.
Pfizer subsidiary Hospira Healthcare India received a warning letter from the FDA after an inspection found growth on environmental monitoring media plates from aseptic processing lines, contrary to the firm's record of "no growth." The FDA said this calls into question the validity of all quality control laboratory results at the site.
The FDA warned health professionals, cancer researchers and patients that the use of AbbVie's multiple myeloma drug Venclexta, or venetoclax, could lead to higher mortality risk, according to data from a late-stage trial evaluating the treatment. However, the warning does not cover use of the drug by patients already taking it for three approved indications.
Biogen and Eisai are discontinuing two late-stage trials evaluating aducanumab in treating Alzheimer's disease after an interim analysis from an independent monitoring committee showed the drug's unlikely benefit for Alzheimer's patients. Eisai has begun late-stage trials assessing the experimental Alzheimer's drug BAN2401.
The Department of Homeland Security has issued an alert on two cybersecurity vulnerabilities found in Medtronic's standard implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. Medtronic is working on updates to address the vulnerabilities and recommends that doctors and patients keep the wireless communications of the devices switched on.
After receiving consumer complaints of finding metal bits in products, Tyson Foods recalled over 69,000 pounds of Tyson and Spare Time brands of frozen chicken strips that were sold in retail locations across the country and institutional locations in Washington and Michigan.
Final guidance issued by the FDA on stem cell therapy trial design included an assurance from the agency that it will be more flexible. The agency said it "recognizes that, for regenerative medicine therapies for rare diseases, certain aspects of drug development that are feasible for common diseases may not be feasible, and that development challenges can be greater with increasing rarity of the disease."
Celgene and Exscientia entered a three-year collaboration to advance Celgene's oncology and autoimmunity programs using Exscientia's artificial intelligence-driven Centaur Chemist drug discovery platform. Under the terms of the deal, Exscientia will get a $25 million upfront payment plus milestone payments and royalties.
Mayo Clinic experts have created a consensus statement that includes evidence-based recommendations pertinent to hematopoietic stem cell transplantation use in eligible patients with multiple myeloma. The recommendations were published in the journal Bone Marrow Transplantation.
Updated results from GlaxoSmithKline's Phase I clinical trial evaluating its candidate GSK2857916 for multiple myeloma showed a 60% overall response rate and a 15% complete response rate during the 12-month follow-up period, as reported in Blood Cancer Journal. Data also indicated that median progression-free survival rose from the previously reported 7.9 months to 12 months.
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