Sanofi's Pentacel, which protects children against 5 serious diseases, nabbed the No. 3 spot on the world's list of best-selling vaccines last year. Whether an investigational 6-in-1 combo from the French drugmaker and partner Merck can eventually match its success remains to be seen, but the pair is now one step closer to finding out.
The Office of Pharmaceutical Quality will finally open Jan. 1, and the FDA's Janet Woodcock will serve as its first acting director.
Dexcom won FDA approval for its next-generation mobile communications device for diabetes monitoring, chalking up another regulatory win and furthering the company's R&D push.
More than three dozen drugs and APIs that were originally banned by health regulators in Canada will be allowed into the country because they are medically necessary.
Observed glitches with Thermo Fisher's popular drug development software have led to concerns that data used to win approvals may have been faulty, and the company is working alongside regulators to figure out just how widespread the issue may be.
Provectus Biopharmaceuticals, a biotech that has been stung by regulatory setbacks, has recruited INC Research to audit its data on two drug candidates, tasking the CRO with poring over its documents as it moves into late-stage development.
Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the R117H mutation. But first, it'll have to get the FDA's OK, and new briefing documents suggest the agency still has some doubts.
Prime Minister Narendra Modi got an ear full from both constituents and the U.S. drug industry about India's approach to drug patents during his first visit to the U.S. last month. Three weeks later, there is evidence the government will take a considered approach to the contested issue.
Boston Scientific won CE-mark approval for a new suite of MRI-friendly pacemaker products, boosting its product offerings and furthering its plan of revitalizing sales for its sluggish cardiac unit.
After years of clinical and regulatory setbacks, Repros Therapeutics was finally on the path to submitting its testosterone treatment to the FDA, scheduling a prefiling meeting for November with hopes of handing the drug in by year's end. But the agency has had some second thoughts, changing the agenda for the meeting and indefinitely delaying Repros' plans.