Bigfoot, Abbott to Partner on Diabetes Management Systems July 18, 2017 As part of the deal, the companies will integrate Abbott’s FreeStyle Libre glucose sensing technology and Bigfoot’s insulin delivery system. Read More
NICE, Alexion Reach Agreement for NHS Access to Strensiq for Hypophosphatasia July 18, 2017 The drug is the first therapy that targets the underlying cause of hypophosphatasia. Read More
India Classifies 462 Devices, 250 IVDs Under New Regs July 17, 2017 India’s device regulations separate devices from drugs for the first time. Read More
EMA’s Safety Committee to Hold First Public Hearing in September July 17, 2017 Valproate has been used as a drug since 1962, and is on the World Health Organization’s list of essential medicines. Read More
FDA Clears Saebo’s Virtual Reality Rehab System July 17, 2017 The device can be personalized to alter coordination, timing, speed, endurance and range of motion. Read More
Sanofi Suit Against Novo Narrowed July 17, 2017 The judge ruled a Sanofi claims brought under a state law meant to protect consumers not competitors should be dismissed. Read More
Three Devicemakers Cited for CAPA, Other Deficiencies July 14, 2017 The FDA issued Form 483s to Full Range Rehab, Cirurgica and CarboFix Orthopedics. Read More
FDA Advisory Committee Sees Benefits of CAR-T Leukemia Therapy July 14, 2017 The expert group hailed the T-cell therapy as potentially game-changing. Read More
Taiwan FDA Drafts First Medical Devices Act, Separating Drugs From Devices July 13, 2017 Medical devices are currently regulated in Taiwan under the Pharmaceutical Affairs Act, which was enacted in 1993. Read More
States Call on Lawmakers for Help to Fight Opioid Crisis July 13, 2017 Members of the House Energy and Commerce oversight subcommittee said they support a comprehensive, data-driven response. Read More
Brazil Adds Ireland as MDSAP Accredited Auditor July 12, 2017 Regulators in MDSAP participating countries can share data so multiple GMP audits are not required. Read More
FDA Ad Comm Recommends New Mylotarg Dose for Combination AML Treatment July 12, 2017 Reviewers added it is not clear if the reduced dose would provide optimal safety and efficacy. Read More