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The FDA is seeking public input on its efforts to facilitate patient participation in the regulatory approval process and on ways to assess those patient engagement activities. Read More
Gilead Sciences could soon lose its dominance of the hepatitis C market, as payers hint they may abandon the company’s blockbuster Sovaldi in favor of lower-cost alternatives that are expected to launch in the coming months. Read More
The FDA has cleared new prescribing information for Sanofi Pasteur’s Fluzone High-Dose influenza vaccine, indicating it provides improved protection for adults 65 years and older. Read More
AstraZeneca has filed a patent infringement lawsuit against Actavis subsidiary Watson over a proposed generic version of AZ’s diabetes drug Kombiglyze XR. Read More
To make it easier for generics firms to create versions of complex drugs, the FDA is asking industry to identify drug products it would like to see bioequivalence testing guidances written for. Read More
The National Institutes of Health has launched a website that it says should help drugmakers plan and implement clinical research across the globe. Read More
FDA regulations have gotten more restrictive and lengthy, with new data showing a double-digit increase in the percentage of regulatory restrictions from 2000 to 2012. Read More
The UK’s health care costs regulator is recommending Boehringer Ingelheim’s anticoagulant Pradaxa as an option to treat and prevent recurrent and potentially fatal blood clots in the legs and lungs. Read More
Cipla has asked the Indian government to forcibly revoke five patents covering Novartis’s lung disease drug Onbrez to pave the way for generic versions in the country, a move the Indian manufacturer says is needed to address a significant unmet need for the therapy. Read More
Indian companies that export active pharmaceutical ingredients to the European Union can use six months of long-term stability data rather than 12 months, under a new rule that relaxes the time period requirement to show conformity with good manufacturing practices standards. Read More
FDA advisors have recommended approval of Daiichi Sankyo’s proposed blood thinner to treat certain patients with atrial fibrillation, putting the Japanese drugmaker one step closer to entering a fierce competition to replace the decades-old treatment warfarin. Read More