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The Congressional Budget Office is estimating that provisions in the proposed drug overhaul bill, if implemented by the FDA, would cost $872 million from 2016-2020, according to a report issued Tuesday. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
Canadian drugmaker Tekmira has stopped recruiting patients for its Phase 2 clinical trial of TKM-Ebola-Guinea, citing lack of overall therapeutic benefit in Ebola virus patients. Read More
More than a year after being rejected by the FDA, The Medicines Company’s intravenous antiplatelet drug Kengreal has received the go-ahead as a post-angioplasty anticlotting agent. Read More
An interim Phase 3 analysis of idarucizumab shows the drug reverses the anticlotting effect of Pradaxa within minutes in patients requiring urgent procedures or with serious bleeding complications, Boehringer Ingelheim reports. Read More
The International Conference on Harmonisation has released a Q&A guide aimed at clarifying requirements for quality management, documentation, equipment cleaning and more in its Q7 guideline on GMPs for active pharmaceutical ingredients. Read More
The National Institutes of Health is working quickly to correct major lapses in its drug compounding unit so officials will be able to ask the FDA to register it as a cGMP manufacturing facility subject to periodic regulatory inspections. Read More
Valeant Pharmaceuticals is recalling more than 93,000 bottles of nifedipine extended-release 90 mg tablets throughout the U.S. because they dissolve too quickly. Read More
India’s national drugs authority is planning to hire 147 inspectors this year to ensure adherence to good manufacturing practice standards, although proper training will prove essential for success, one observer says. Read More
Eisai has received FDA approval of an expanded indication for its antiepileptic drug Fycompa as an adjunctive treatment for primary generalized tonic-clonic seizures in epilepsy patients 12 and older. Read More