Industry News

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.

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”).

Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, announced its randomized, controlled phase 2/3 clinical trial, called Toca 5, is now enrolling patients in South Korea. The trial is ongoing in the United States, Canada and Israel. The study compares a cancer-selective virus, Toca 511 (vocimagene amiretrorepvec), in combination with Toca FC (extended-release 5-fluorocytosine), to standard of care in patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection.

SpineGuard  announced  it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new DSG™ (Dynamic Surgical Guidance) integration module to be used in combination with Zavation’s spinal fusion system to make its pedicle screws “smart.”

Eisai Co., Ltd.,a leading global research and development-based pharmaceutical company, and Chugai Pharmaceutical Co., Ltd. (Chugai) announced that Eisai’s acquisition of the rights for manufacturing active pharmaceutical ingredients (API) for Japan from F. Hoffman-La Roche Ltd. for the insomnia treatment/anaesthesia induction agent flunitrazepam (Eisai product name: Silece, Chugai product name: Rohypnol) as well as the marketing authorization held by Chugai for Rohypnol in Japan has been agreed upon by the three companies, and this contract has come into effect.

Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, has completed enrollment of all 172 patients in a multinational phase II trial of its PLX-PAD cells in the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). Enrollment took place at 30 clinical sites in the US, Germany, South Korea, and Israel. IC is characterized by leg cramps and pain while walking, caused by insufficient blood flow through arteries that are partially obstructed by atherosclerotic plaques.

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