The prices of 20 top-selling branded drugs increased at 10 times the price of inflation from 2012 to 2017, according to a new report released by Sen. Claire McCaskill (D-Mo.).…
For the second time Ablynx’s anti-IL-6R Nanobody, vobarilizumab has failed to pass muster. This morning Belgium-based company said vobarilizumab did not meet primary endpoints in a Phase II dosing study…
Biohaven Pharmaceutical released positive top-line results from two Phase III clinical trials of rimegepant for migraine. Despite the positive data, shares were down more than 30 percent in early trading…
ImmunoGen, released positive efficacy and tolerability data from its FORWARD II trial of its mirvetuximab soravtansine in combination with Merck’s Keytruda in platinum-resistant epithelial ovarian cancer (EOC). Shares jumped almost…
Shares of Protagonist Therapeutics plunged more than 60 percent in pre-market trading after the company announced it will discontinue its Phase IIb ulcerative colitis treatment after a review from an…
Allecra Therapeutics released positive top-line data from its Phase II trial of AAI101, an antibiotic against gram-negative bacteria. Source: BioSpace
The FDA hit Kolmar Korea with a Form 483 over numerous violations — including negligent handling of documents, lack of employee training and failure to conduct process validation — after…
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six medicines, including an orphan drug, for approval at its March meeting, in addition to three recommendations for…
The FDA last week previewed an upcoming pilot project that offers initial reviews of protocols for clinical trials with highly complex, innovative designs. Source: Drug Industry Daily
In what Commissioner Scott Gottlieb called “a significant milestone” in the FDA’s new policy for oversight of drug compounding , the agency released draft guidance Friday on how it will…