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The Institute of Medicine is calling on clinical trial sponsors and governments to develop plans for substantially greater sharing of clinical trial data. Read More
The UK’s health cost-benefit watchdog is recommending Gilead Sciences’ blockbuster hepatitis C cure, Sovaldi, be offered through the National Health Service to patients with three additional types of hepatitis C beginning in July. Read More
The FDA is asking drugmakers to evaluate all new psychoactive and other drugs for their potential to impair a patient’s driving ability and provide warning labelling if needed. Read More
In observance of Martin Luther King Day holiday, Drug Industry Daily will not be published Monday, Jan. 19. The next issue will be published Tuesday, Jan. 20. Read More
India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies, a continuation of the rebounding number of studies in the country. Read More
Global drug regulators have reduced drug approval times over the last 10 years, and while the FDA remains the fastest at approving new drugs, other regulators are closing the gap. Read More
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Drug companies will find more payers refusing to reimburse for cancer drugs if they don’t reduce their prices, pharmacy benefits manager Express Scripts says. Read More
Concerns over potential heart risks have prompted the UK’s Medicines and Healthcare products Regulatory Agency to reclassify the anti-inflammatory drug diclofenac from OTC to prescription-only in tablet form. Read More
The FDA has issued an import alert for an Australian manufacturing plant, barring it from shipping Eli Lilly’s erectile dysfunction drug Cialis into the U.S. Read More