Industry News

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.

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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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Jazz Pharmaceuticals plc announced that the first patient has been enrolled in a Phase 3 clinical trial comparing the efficacy and safety of defibrotide versus best supportive care (BSC) in the prevention of hepatic veno-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant (HSCT) who are at high risk or at very high risk of developing VOD.  The defibrotide clinical trial will be conducted across approximately 100 medical centers in the United States (U.S.), Canada, Asia Pacific and countries in the European Union (EU). 

Hikma Pharmaceuticals PLC (Hikma, the fast growing multinational pharmaceutical group, announces that its wholly owned US subsidiary, Roxane Laboratories, Inc. (Roxane), has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem®. 

Biogen has agreed to enter into a settlement and license agreement with Forward Pharma, subject to the approval of Forward Pharma’s shareholders and other customary conditions. The license agreement will provide Biogen an irrevocable license to all intellectual property owned by Forward Pharma.

AstraZeneca has recently provided an update on its Immuno-Oncology (IO) late-stage clinical development programme in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the phase III Mystic trial.

ONCURIOUS NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric tumors, today announces that the European Commission has confirmed the orphan drug designation for TB-403 for medulloblastoma. Today's decision by the EC follows the earlier positive opinion issued by the European Medicine Agency (EMA).