Investors in India’s $15 billion pharmaceutical industry are favoring smaller firms with little or no exposure to the United States, where increasingly tight regulatory controls have burnt two of the country’s biggest drugmakers over the past month.   Heavyweight generics makers, led by Sun Pharma and Dr Reddy’s Laboratories, have long been seen as a […]

Shares in India’s largest drugmaker, Sun Pharmaceutical Industries Ltd, skidded more than 7 percent on Monday after U.S. regulators warned of standards violations at a key plant in the latest blow to India’s generic drug industry.   The warning comes barely a month after rival Dr Reddy’s Laboratories Ltd was reprimanded by the U.S. Food […]

The U.S. Food and Drug Administration is investigating complaints filed by two former employees of privately held laboratory operator Theranos Inc, the Wall Street Journal reported, citing people familiar with the matter. In September, a complaint filed by a former Theranos employee to the Centers for Medicare and Medicaid Services stated that the management instructed […]

A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging from epilepsy to diabetes and creating business opportunities estimated to be worth tens of billions of dollars. Unlike popular fitness-tracking devices, such as Fitbit Inc’s Fitbit and […]

Drug developer BioMarin Pharmaceutical Inc said the U.S. Food and Drug Administration told the company that it would not be able to decide on the marketing approval of its lead drug as scheduled, the second setback for the company. Shares of the company were little changed in premarket trading. They closed at $100.64 on Thursday […]

The U.S. Food and Drug Administration on Wednesday approved Eli Lilly & Co’s diabetes drug Basaglar, a cheaper version of Sanofi AG’s top-selling drug Lantus. The drug, an injection known also as insulin glargine, is a long-acting, man-made version of human insulin. It is the first insulin product approved through a shortened review process based […]

Drug developer Advaxis Inc said on Wednesday the U.S. Food and Drug Administration had lifted a clinical hold on three of its experimental cancer therapies, sending the company’s shares up as much as 38 percent. The U.S. health regulator had in October put on hold mid-stage trials of the company’s lead therapy, axalimogene filolisbac, after […]

Merck & Co Inc.’s drug to reverse the effects of muscle relaxants used during surgery has won U.S. approval. The Food and Drug Administration said on Tuesday it approved the drug, Bridion, to reverse the effects of deep paralysis caused by rocuronium and vecuronium, muscle relaxants used at the beginning of surgery to help doctors […]

The number of new drugs approved in the United States this year has already topped last year’s 18-year high, yet large pharmaceutical companies are still struggling to get a decent return on their research dollars.   In fact, returns on research and development (R&D) spending by the world’s top drugmakers have fallen to just 4.2 […]

Specialist medicine company BTG received a triple dose of good news on Monday as U.S. regulators approved two new treatments and a clinical trial of a novel lung device produced positive results. U.S. green lights for Vistogard and Lumi, for chemotherapy overdoses and tumors, and the success of PneumRx coils in severe emphysema may help […]