When Marathon Pharmaceuticals announced in February it would market a drug for treating Duchenne muscular dystrophy for US$89,000 a year, the negative reaction was so intense that the company immediately suspended the rollout. ...
Mar 17, 2017
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Although randomised clinical trials (RCTs) remain the gold standard for evaluating the benefit/risk of cancer drugs, single-arm trials (SATs) can provide invaluable opportunities to speed up cancer drug development and approval, ...
Oct 11, 2016
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At the beginning of August, the European Medicines Agency (EMA) published a report on a pilot project of a new accelerated path for drug approval (adaptive pathways). In this approval procedure, for a highly restricted population ...
Aug 9, 2016
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A drug to treat severe postpartum depression showed positive results in a mid-stage study, sending shares developer Sage Therapeutics skyrocketing Tuesday.
Jul 12, 2016
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As the year comes to an end, a survey of the hottest pharma news stories from the past year illustrates industry trends from megadeals to drug approvals. A suite of stories in Chemical & Engineering News (C&EN), the weekly ...
Dec 9, 2015
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A federal appeals court has ruled that Novartis can begin selling its lower-cost copy of an Amgen Inc. drug in September, rejecting a bid to further delay the launch of the knock-off biotech medication.
Jul 21, 2015
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The Food and Drug Administration says it plans to crack down on unapproved prescription ear drops often given to young children suffering from ear infections.
Jul 1, 2015
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Bristol-Myers Squibb, one of the world's largest drugmakers, will team up with a Dutch biotechnology company whose first approved drug could cost more than $1 million.
Apr 6, 2015
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There is good news for those suffering from spinal cord injuries. The U.S. Food and Drug Administration gave its stamp of approval to ReWalkâthe exoskeleton that enables paraplegics to walk. While the device has sparked ...
Jul 2, 2014
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Nick Auden didn't live to see the legislation, but the case of the Colorado melanoma patient who died while seeking access to an experimental drug helped inspire a first-of-its kind law.
May 17, 2014
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