Medtronic received a CE mark for two implantable defibrillators that can not only shock the heart to prevent irregular heart rhythms, but also detect atrial fibrillation, a warning sign of stroke. Afib increases patient risk of stroke by a factor of 5, and risk of heart failure by a factor of 3.
AstraZeneca's new gout therapy, acquired in a $1.3 billion buyout, might not be effective enough to outweigh its safety risks, according to FDA staff, casting doubts on the drug's future as it heads for a key panel vote.
China's BeiGene has announced plans to raise as much as $100 million on the Nasdaq in an initial public offering that follows a steady stream of venture capital to the oncology-focused biotech and expansion into manufacturing.
Chinese hackers linked to the mainland government attempted to gain entry into computer systems at 7 companies including two unnamed pharmaceutical companies, according to a U.S. cybersecurity researcher.
The FDA last week added Megafine Pharma's plant in Lakhamapur, Maharashtra, in India to its import alert list, banning all of its drug products from entering the U.S.
Patients at China's public hospitals may be on the hook for higher charges after the government removed a 15% markup on prescription drugs that hospitals were allowed to impose, according to a South China Morning Post report.
Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.
Surgical imaging company Lightpoint Medical snagged a CE mark for its molecular imaging device, charting a win as it dials up development for the product overseas and in the U.S.
On second thought, Pacira Pharmaceuticals, the FDA might just take it back. As Law360 reports, the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices.
Small and medium-sized Indian drugmakers are decrying a move by the government to impose new bar-code requirements and say the action shows the government is taking sides with big multinational players to elbow out smaller competition. The larger companies are saying the move is necessary to protect the country's reputation.