Vaxart Inc., of South San Francisco, reported results from a phase II trial testing its H1 influenza oral tablet vaccine compared to an injectable quadrivalent influenza vaccine (QIV). In the challenge study, Vaxart's influenza oral tablet vaccine provided a 39 percent reduction in clinical disease relative to placebo, compared to a 27 percent reduction by QIV. Read More
Perrigo Co. plc, of Dublin, said it settled the Hatch-Waxman litigation relating to acne product Onexton Gel (clindamycin phosphate 1.2 percent and benzoyl peroxide 3.75 percent) brought by Valeant Pharmaceuticals North America LLC and Dow Pharmaceutical Sciences Inc. Read More
Adial Pharmaceuticals Inc., of Charlottesville, Va., has filed to raise $16 million in its IPO, offering 1.4 million shares of common stock in the price range of $9 to $11 each. Read More
CLEVELAND – Coming into the Cleveland Clinic's 15th annual Medical Innovation Summit, gene therapy had been making headlines, most recently the unanimous recommendation by the FDA's Cellular, Tissue and Gene Therapies Advisory Committee in favor of Spark Therapeutics Inc.'s Luxturna (voretigene neparvovec) in RPE65-mediated inherited retinal disease. But back in the early 2000s, when Casey Cunningham, of Sante Ventures, was working as a clinical investigator, the gene-based technologies weren't exactly hot property. Read More
Calling it a "human tragedy," a "terrible affliction" and a "national shame," President Donald Trump officially declared the U.S. opioid epidemic a national public health emergency Thursday. Read More
The volume of biopharmaceutical deals have steadily declined each quarter this year, with only 200 recorded in the third quarter, a 23 percent fall over the second-quarter deal total and a 28 percent drop over the first-quarter number. However, in terms of value, third-quarter deals represented a total value of $21.7 billion, in line with the first quarter, and double that generated in the second quarter. (See Biopharma Deals: 2017, page 2.) Read More
Shares of Celgene Corp. tanked on Thursday following the company's release of third-quarter financials, which included a slow growth for arthritis/psoriasis drug Otezla (apremilast) and lowered long-term targets. Meanwhile, Amgen Inc. reported $67 million in pre-tax expenses due to Hurricane Maria's toll on the company's Puerto Rico-based manufacturing facility. It also dropped development of its oral cholesterol ester transfer protein (CETP) inhibitor, resulting in a $116 million charge. Read More
In 2010, when Sanofi SA signed a potential $560 million deal to get its hands on JAK2 inhibitor fedratinib (then known as TG-101348) via the buyout of Targegen Inc., the latter's director of research, John Hood, had high hopes for patients with myelofibrosis (MF) and polycythemia vera (PV). Several years later, though, safety problems turned up at the phase III stage, the FDA put fedratinib on clinical hold, and Sanofi dropped fedratinib like a hot potato. Read More
The FDA released a draft guidance to help sponsors in the clinical development of drugs for the treatment of gastroesophageal reflux disease in pediatric patients. The draft discusses clinical presentation by age and disease, study populations, endpoints and pharmacometric issues affecting dosing, according to a notice slated for publication in Friday's Federal Register. Comments are due in 60 days. Read More
