Pharma News

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.

A new mouse model of early Ebola virus (EBOV) infection has shown National Institutes of Health (NIH) scientists and colleagues how early responses of the immune system can affect development of EBOV disease. The model could help identify protective immune responses as targets for developing human EBOV therapeutics.

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Scientists have long puzzled over cholesterol. It's biologically necessary; it's observably harmful - and nobody knows what it's doing where it's most abundant in cells: in the cell membrane.

An enzyme identified in Saccharomyces cerevisiae, commonly known as brewer's or baker's yeast, has passed in vitro trials, demonstrating its capacity to kill acute lymphoblastic leukemia (ALL) cells.

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.

Hutchison China MediTech Limited announces that it has initiated a Phase II study of a combination therapy using fruquintinib and Iressa® in the first-line setting for patients with advanced or metastatic non-small cell lung cancer (“NSCLC”) in China. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”).