Thursday, August 27, 2015
The FDA has approved an expanded use for Novartis’ Promacta (eltrombopag) to include children age 1 and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 and older and in 2008 for use in adult patients with the same condition.
Hybrigenics, a Paris-based biopharmaceutical company, has received Orphan Drug designation by the FDA for inecalcitol for the treatment of acute myeloid leukemia (AML) in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing.
Clinical Ink, a Winston-Salem, N.C.-based provider of eSource solutions for clinical trials, has updated CentrosHealth, a mobile patient engagement platform, to include streamlined connectivity for a wide range of medical devices. Medical device connectivity is powered by the 2net Mobile Platform from Qualcomm Life, a wholly owned subsidiary of Qualcomm Inc. This new platform was developed with cooperation from Novartis and PPD, which also are supporting a pilot clinical study before broad commercial use.
Zogenix, a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, has appointed Gail M. Farfel, Ph.D., executive vice president and chief development officer, and Thierry Darcis, M.D., M.B.A., executive vice president and general manager, Europe.
Novartis International has agreed to acquire Spinifex Pharmaceuticals, a company focused on the development of new drugs for the treatment of chronic pain based in Stamford, Conn., and Melbourne, Australia, for an upfront cash consideration of $200 million plus undisclosed clinical development and regulatory milestone payments.
Emerging therapeutic categories and a string of breakthrough drug approvals are powering key drug sales across the U.S. and Europe, fueling a projected 5% increase in global prescription sales over the next five years, according to the EvaluatePharma World Preview 2015, Outlook to 2020 report from life science market intelligence firm Evaluate. With the FDA approving an unprecedented 50 drugs in 2014, eight of which are forecast to have sales of more than $1 billion five years after launch, sustained R&D productivity may finally be within reach.
The antibiotics market is at risk of losing another decade to inadequate levels of research and innovation, according to international intellectual property firm Marks & Clerk’s new report From rare to routine—medicines for rare diseases, vaccines and antibiotics. Research highlights the striking difference between research levels into rare diseases, vaccines and antibiotics across the globe.