Shire plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date. Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.
Swedish Orphan Biovitrum AB (publ) (Sobi), an international specialty healthcare company, announces that the first patients have been enrolled in the A-SURE study (NCT02976753). A-SURE is a 24-month real-world study evaluating the effectiveness of Elocta compared to conventional FVIII products in the prophylactic treatment of patients with haemophilia A in Europe.
Siemens Healthineers and Biogen announced that the companies plan to jointly develop magnetic resonance imaging (MRI) applications with the intent of quantifying key markers of multiple sclerosis (MS) disease activity and progression. Biogen is a leading biotechnology company with a deep focus on neurological and autoimmune conditions, which for two decades has been at the forefront of delivering therapies to MS patients. Siemens Healthineers aims to enable healthcare providers to meet their current challenges and excel in their respective environments. To execute this strategy in the field of neurology, Siemens Healthineers will cooperate with Biogen and contributes its strength in medical imaging.
Quest Diagnostics, the world's leading provider of diagnostic information services, has announced the launch of a new test service that helps physicians evaluate a patient's response to drug therapies used to treat infection with the hepatitis B virus (HBV). The first test of its kind available in the United States, the test is significant because it may help physicians tailor more effective treatments for the up to 2.2 million individuals infected with HBV.
Adamis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the Company’s New Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe (“PFS”) product candidate for the emergency treatment of anaphylaxis. Filed on December 15, 2016, the resubmission was intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (“CRL”). The FDA indicated that it considered the resubmission to be a complete response to the CRL.
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