HHS Secretary Alex Azar today is set to deliver a speech addressing the administration's efforts to reduce drug prices, and sources say a rule requiring pharmaceutical firms to include drug pricing information in advertisements could be part of the plan. Drugmakers are opposed to the idea, saying it would deter patients from obtaining necessary care and raise legal issues.
A study published in JAMA Network Open found that from 2007 to 2016, the FDA identified 776 dietary supplements that contained pharmaceuticals, but only 46.4% were linked to a voluntary recall. The most common adulterated supplements were those for sexual enhancement, weight loss and muscle building.
Sutro Biopharma's STRO-001, being developed to treat patients with multiple myeloma, was granted orphan drug designation by the FDA.
AcelRx Pharmaceuticals' Dsuvia, or sufentanil sublingual tablet, gained the endorsement of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee to manage moderate to severe acute pain in adults that cannot be controlled with non-opioid treatments. The committee voted 10-3 in favor of the drug.
Rockwell Medical plans to submit a New Drug Application to the FDA by the fourth quarter of 2018 for the intravenous formulation of its drug Triferic, or ferric pyrophosphate citrate. Triferic is the sole product approved by the FDA for adults with chronic kidney disease who require iron replacement and hemoglobin maintenance in hemodialysis.
A three-peg glenoid implant has been unveiled by Catalyst OrthoScience for its Catalyst CSR Total Shoulder System, intended for use in shoulder arthroplasty. The implant promotes secure fixation through its backside anchoring element design, and reduces the impact of eccentric loading through the tapered walls on its bearing surface.
China-based HelloCig Electronic Technology received a warning letter from the FDA for selling vaping e-liquid products that contain sildenafil and tadalafil, both active ingredients in erectile dysfunction drugs Viagra and Cialis, respectively. The agency also cited that the company sold other e-liquid products with false FDA-approved marketing claims.
Tandem Diabetes Care has obtained approval from Health Canada for its t:slim X2 Insulin Pump, which is integrated with the Dexcom G5 Mobile continuous glucose monitor. The company will begin the province-by-province launch of the device this quarter.
Dova Pharmaceuticals' Doptelet, or avatrombopag, met the primary endpoints of a study evaluating the drug's use in patients with chronic liver disease and thrombocytopenia regardless of their body mass index, according to a poster presentation made at a meeting of the American College of Gastroenterology. "The lack of effect of BMI on avatrombopag’s efficacy is important because it speaks to consistency of effect in the chronic liver disease patient," said lead study author Dr. Stuart Gordon.
A Phase I trial is being planned to assess the efficacy of a new combination regimen for patients with relapsed or refractory multiple myeloma that consists of Oncolytics Biotech's investigational drug Reolysin, or pelareorep, Bristol-Myers Squibb's Opdivo, or nivolumab, plus standard of care. The trial will enroll an estimated 62 patients by late 2018.
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