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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
UK regulators shut down a plant in Cambridgeshire that was producing an unapproved and unlicensed product used against diseases such as HIV and cancer. Read More
Five Industry groups are jointly launching a new data center, the European Medicines Verification Organization, to help eliminate counterfeit drugs from the drug supply chain. 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