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AbbVie’s hepatitis C drug combo Viekira Pak was 100 percent effective in patients with genotype 1b and liver cirrhosis without the additional use of the antiviral ribavirin, the company said Wednesday. Read More
A panel of experts in Australia is recommending that the government establish three new drug approval pathways to expedite listing on the Australian Register of Therapeutic Goods and speed novel treatments to patients. Read More
The UK’s healthcare costs regulator is asking Santen Pharmaceutical to provide more information on its Ikervis eye drops following a preliminary recommendation denying its use for the treatment of severe keratitis in adults with dry eye disease that didn’t improve with tear substitutes. Read More
The Canadian government plans to require mandatory reporting of drug shortages, in a move that will bring it in line with U.S. and European shortages policies. Read More
The amount of sodium contained as an excipient in drugs should be readily available in an understandable format on product labels and package leaflets, the European Medicines Agency says. Read More
The House Appropriations Committee is proposing $2.6 billion in new funding for the FDA, roughly $200 million less than President Barack Obama requested, but no changes to the administration’s proposed user fee levels for drugs and biologics — which total about $1.2 billion. Read More
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