Pharma News

Allergan plc announced that two pivotal trials of the Oculeve Intranasal Tear Neurostimulator, OCUN-009 and OCUN-010, each met their primary and secondary efficacy endpoints. With these new results, a premarket submission for the device is on-track to be submitted to the Food and Drug Administration (FDA) in the second half of 2016. 

Biogen announced a broad collaboration and alliance with the University of Pennsylvania (“Penn”) to advance gene therapy and gene editing technologies.This collaboration with Penn reinforces Biogen’s commitment to gene therapy and rare diseases. Biogen will work with James Wilson, M.D., Ph.D., Professor of Medicine and Pediatrics, and Director of Penn’s Gene Therapy Program, and Jean Bennett, M.D., Ph.D., Professor of Ophthalmology and Cell and Developmental Biology and Director of the Center for Advanced Retinal and Ocular Therapeutics. Both are recognized leaders in gene therapy in the Perelman School of Medicine at the University of Pennsylvania.

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Eisai Pharmaceuticals India Pvt. Ltd  announced that Eisai Pharmatechnology and Manufacturing Pvt. Ltd. and Eisai Pharmaceuticals India Pvt. Ltd. two subsidiaries of Eisai Co. Ltd, have been amalgamated and the new entity shall be known as “Eisai Pharmaceuticals India Pvt. Ltd”. The amalgamation of the two subsidiaries was completed to leverage the capability of Eisai India’s state-of-the art integrated research and manufacturing operations with its specialized sales force to meet its business objectives in India. This also provides a more rationalized structure for better efficiency.

Neos Therapeutics, Inc. announced that Adzenys XR-ODT™ is in distribution channels and is now available to prescribe to patients with ADHD in the United States. Adzenys XR-ODT was approved by the U.S. Food and Drug Administration (FDA) in January for the treatment of ADHD in patients six years and older and is the first and only extended-release orally disintegrating tablet (XR-ODT) for the treatment of ADHD. Adzenys XR-ODT is bioequivalent to Adderall XR®, one of the most commonly prescribed medications for the treatment of ADHD.

Scientists have found that heating the chemotherapy drug mitomycin-C prior to using it for treating bladder cancer may radically improve its efficacy. The findings, published in the International Journal of Hyperthermia, are the result of a four-and-a-half-year study by medics based at Comarcal Hospital, Monforte, Spain.

A review of nine observational studies found evidence supporting an increased risk of heart attacks in patients taking antipsychotic drugs. The review expands previous knowledge by demonstrating an increased and more pronounced risk in short-term users of these medications.

Swedish Orphan Biovitrum AB (publ) (Sobi™) and Biogen announced that the European Commission (EC) has approved Alprolix® (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation. Alprolix is indicated for both on-demand and prophylaxis treatment of people with haemophilia B in all ages.

BGI and UW Medicine have signed a memorandum of understanding to collaborate on biomedical technology development.  The shared aim is to advance precision medicine for diagnosis, treatment and prevention of common and rare diseases.  BGI is headquartered in Shenzhen, Guangdong, China.

Chugai Pharmaceutical Co., Ltd. announced that Actemra subcutaneous injection (Actemra), the humanized antihuman IL-6 receptor monoclonal antibody, successfully met the primary endpoint in a dose interval reduction study (MRA231JP study) conducted in patients with rheumatoid arthritis who inadequately respond to the currently approved bi-weekly dosage regimen.

Novartis announced the New England Journal of Medicine publication of the head-to-head FLAME study comparing the efficacy of once-daily Ultibro Breezhaler (indacaterol/glycopyrronium bromide) 110/50 mcg to twice-daily Seretide (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing chronic obstructive pulmonary disease (COPD) exacerbations.