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NICE, the UK’s healthcare costs watchdog, has positively appraised Boehringer Ingelheim’s (BI) non-small-cell lung cancer (NSCLC) treatment, Giotrif. Read More
The FDA wants sponsors submitting bioavailability (BA) and bioequivalency (BE) data in support of an orally administered new drug to conduct pharmacokinetic studies of their products. Read More
Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More
PhRMA is seeking substantial changes to the FDA’s proposed generic drug safety labeling rule, saying the agency should pre-approve all safety labeling changes for drugs with more than one manufacturer. Read More
UK regulators have created a pathway to speed life-saving drugs to patients under an early-access program, which officials liken to the FDA’s popular breakthrough therapy initiative. Read More
The UK’s healthcare costs watchdog has once more rejected Celgene’s blockbuster cancer drug Revlimid for a new indication. This time, the National Institute for Health and Care Excellence (NICE) says the drug failed to show clear efficacy and cost-effectiveness as a second-line treatment for multiple myeloma. Read More
A court battle is heating up between PhRMA and the Federal Trade Commission over the FTC’s new rule expanding antitrust reviews of post-merger patent transfers, and the fees associated with the expanded reviews. Read More
The FDA has rejected a diabetes drug co-developed by Boehringer Ingelheim and Eli Lilly due to unresolved quality issues at one of Boehringer’s plants. Read More