Industry News

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).

Hutchison China MediTech Limited (Chi-Med), an innovative biopharmaceutical company, has initiated a phase II study of sulfatinib in second-line biliary tract cancer (BTC) patients in China. Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and colony-stimulating factor-1 receptor (CSF-1R), three key tyrosine kinase receptors involved in tumour angiogenesis and immune evasion.  The first drug dose was administered on January 9, 2017

Allergan Plc and Gedeon Richter Plc. announced positive results from Venus II, the second of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with abnormal bleeding due to uterine fibroids.  A new drug application filing for ulipristal acetate is planned for the second half of 2017.