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It’s been more than a year since analysts first said Valeant could sell off its Obagi Medical Products business to raise cash, but the Canadian drugmaker has finally found a taker. The investment fund has agreed to invest more than $ 190 million to develop business in the field of dermatology. The company will use…
Opioid makers may face a new task, which, in fact, is partly new only: the dissemination of information on the correct use of their drugs and serious risks. That’s an extension of the FDA’s current requirements. The agency obliges drugmakers to specify information about therapy without opioids, as well as alternative methods of treatment that…
The entire pharmaceutical industry with great interest watched at FDA’s Oncologic Drugs Advisory Committee meeting Wednesday, where Novartis received support for its lead CAR-T drug. By a 10-0 vote, FDA panel experts endorsed tisagenlecleucel-T to treat patients aged 3 to 25 with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The FDA doesn’t have to follow its…
In 2010, Pfizer decided to withdraw from the US market Mylotarg, its cancer drug against leukemia, which was ineffective. Withdraw was supported by the FDA. However, now the Food and Drug Administration has supported the recent approval of the drug use for the treatment of acute myelogenous leukemia (AML) after Pfizer presented new data that…
According to estimate by The Economist, last year there were 165000 health-related apps available for Apple or Android smartphones. Such apps were downloaded 1.7 billion times by 2017. Scott Gottlieb, a Head of US FDA recently published an announcement about FDA plans on medical apps on FDA Voice blog. FDA commissioner announced new FDA Digital…
Bringing a new oncology drug to market in the U.S. is expensive. However, cost-effectiveness can be achieved, especially if the drug has several indications. Although the majority (60%) of the 20 drugs in a new study by Best Practices fell short of their initial market sales projections on first indication launches, the research found that…