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A German regulator says European Medicines Agency plans for implementing its clinical trials database lets drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercial confidentiality. Read More
Sponsors spend upwards of 23 million hours complying with clinical trial requirements, from requests for INDs to submission of NDAs, the FDA says. Read More
A federal judge has sided with the FDA in its decision to strip Ranbaxy of generic approval and first-filer rights to Nexium and Valcyte, meaning company’s efforts to control the generic market for the two drugs could be over unless it appeals. Read More
The HHS Inspector General is urging the Centers for Medicare & Medicaid Services to expand price substitutions for Medicare Part B drugs, saying the move could save millions of dollars a year. Read More
The UK’s healthcare cost watchdog today gave a positive nod to Gilead Sciences’ hepatitis C combination therapy Harvoni for certain genotype 1 and 4 patients. Read More
Generics maker Natco Pharma has signed an authorized generic licensing deal with Gilead to produce its pricey blockbuster hepatitis C drug Sovaldi in India and 90 other developing countries. The agreement likely signals an end to Natco’s fight to have Sovaldi’s patent protection in India revoked. Read More
The FDA on Friday approved Actavis and Medicines 360’s Liletta, a drug-eluting intrauterine device that prevents pregnancy for up to three years. Read More
The FDA has updated its list of planned guidances for the calendar year to include one on evaluating the abuse-deterrent properties of generic solid oral opioid drugs. Read More
Australian drugmakers want the government to create fast-track approval pathways for new cancer drugs, as well as parallel review processes that simultaneously assess safety and efficacy and reimbursement eligibility for new drugs. Read More