Archive for March 2018
Sen. McCaskill: Prices for Top 20 Branded Drugs for Seniors Spiked 10 Times Faster Than Inflation
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.). Source: Drug Industry Daily
Read MoreAllecra Therapeutics New Antibiotic Shows Promise for Resistant Bacterial Infections
Allecra Therapeutics released positive top-line data from its Phase II trial of AAI101, an antibiotic against gram-negative bacteria. Source: BioSpace
Read MoreProtagonist Craters After Discontinuing Phase IIb Ulcerative Colitis Study
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 Independent Data Monitoring Committee (DMC). Source: BioSpace
Read MoreImmunoGen Stock Climbs on Positive Ovarian Cancer Data
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 12 percent in premarket trading. Source: BioSpace
Read MoreStock Plunges Despite Biohaven's Positive Migraine Data
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 this morning. Source: BioSpace
Read MoreAblynx Drug Fails Again in Mid-Stage Trial
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 for lupus patients. Source: BioSpace
Read MoreKolmar Korea Cited for Slew of Violations
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 a September inspection of its Sejong City, South Korea facility. Source: Drug Industry Daily
Read MoreCHMP Endorses Six Medicines for Approval at March Meeting
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 extensions of indications. Source: Drug Industry Daily
Read MoreFDA Previews Pilot Program to Provide Early Regulatory Review of Innovative Trial Designs
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
Read MoreFDA Issues Draft Guidance on ‘Clinical Need’ Test for Bulk Substances Used in Compounding
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 develop a list of bulk drug substances, known as the 503B list, that outsourcing facilities can use in compounded drugs. Source: Drug Industry Daily
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