Merck's Gardasil follow-up is here, meaning blockbuster sales figures are likely on the way. But the bad news is that they'll come at the expense of the world's second-best-selling shot.
Ebola vaccine developers now have a little less to worry about thanks to a Tuesday announcement from the U.S. Department of Health and Human Services. HHS will provide liability protections for the companies scrambling to develop Ebola vaccines in response to the current outbreak in West Africa, it said.
Indian drugmakers are in a dogfight with Indian regulators who have proposed banning the use of PET plastic bottles for some drug packaging. If they have to move to glass, it will add up to 30% to their transportation cost per bottle, they have complained.
VertiFlex is facing a regulatory setback for its spine implant, as the FDA postponed a meeting slated to review the company's application for premarket approval of the device.
U.S. drugmaker Mylan, Germany's Stada, India's Dr. Reddy's Laboratories and Unichem Laboratories are among 16 drugmakers who have had dozens of generic meds sidelined by German regulators who raised questions about bioequivalence tests.
Insys Therapeutics, a combination drug developer and delivery specialist, won an orphan designation from the FDA for a gastric cancer treatment that delivers paclitaxel trapped in liposomes to make the common cancer drug more soluble and less toxic.
Epigenomics won marketing approval in China for its next-generation colorectal cancer test, moving the company forward on its path toward global commercialization for the product and helping it compete in an increasingly competitive playing field.
The U.S. arm of India's Zydus Cadila has initiated its second recall in the U.S. in the last 7 months, this time because tablets of a drug for high blood pressure were found to have brown spots.
Many FDA advisory committee members have financial links to devicemakers that they do not publicly disclose, which critics say rips into public trust of the agency.
The National Institute for Health and Care Excellence decided to reverse course on a new use for Johnson & Johnson's anti-inflammatory drug Stelara, thanks to a new discount offer.