Axsome Therapeutics, Inc. received from the U.S. Food and Drug Administration (FDA) Fast Track designation for AXS-02 for the treatment of the pain of knee osteoarthritis (OA) associated with bone marrow lesions (BMLs). There is currently no product approved specifically for this indication.
Inovio Pharmaceuticals, Inc. announced that it has closed the transaction to acquire all of BioJect Medical Technologies Inc.s assets, including pioneering needle-free jet injection technology, devices, and intellectual property, which it first announced in a definitive agreement on March 14, 2016. Inovio acquired BioJect for USD 4.3 million in Inovio common stock and USD 1.2 million in cash.
Inovio is advancing multiple novel cancer and infectious disease immunotherapies and vaccines as well as delivery devices to optimally administer them. Since administration of Inovio’s products is a two-step process involving injection and electroporation delivery, it is also focused on enhancing ease and cost of administration to best serve clinical requirements. An integrated injection and electroporation device that eliminates needles and reduces disposable materials in an automated process would be a paradigm-changing step in vaccine administration in large populations.
Inovio has been developing needle-free electroporation technology that works on the surface of the skin. BioJect’s needle-free jet injection technology uses high pressure gas or springs to propel liquid medicine into skin. Its devices have demonstrated favorable utility, safety, and tolerability attributes in animals and humans. Under a prior research agreement Inovio tested the two separate technologies together and generated compelling antigen expression and immune responses in animals. Inovio will now be combining the two technologies into one highly optimized integrated delivery device.
Roche announced new results from 19 approved and investigational medicines will be presented during the American Society of Clinical Oncology (ASCO) Annual Meeting from 3rd – 7th June in Chicago, United States. More than 200 abstracts have been accepted across eight cancer types, including four “late breakers” and nearly 30 oral presentations.
RXi Pharmaceuticals Corporation (RXi) and privately-held Thera Neuropharma, Inc. (Thera) have entered into an exclusive license agreement for RXi's novel and proprietary sd-rxRNA platform to develop therapeutics for neurodegenerative diseases.
With an aim to augment the Government of India’s ‘Skill India’ flagship project and to create a robust and vibrant eco-system for quality skill development in the healthcare sector, PHD Chamber of Commerce and Industry (PHDCCI) and Public Health Foundation of India (PHFI) signed a 5 year memorandum of understanding for launching a joint program to organize capacity building initiatives in skilling healthcare professionals especially in the areas of chronic diseases and prevention of Non Communicable Diseases (NCDs).
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The nerve agent sarin causes a deadly overstimulation of the nervous system that can be stopped if treated with an antidote within minutes of poisoning. Today, a ground-breaking study has been published in PNAS, which in detail describes how such a drug works. Researchers at the Swedish Defence Research Agency, Umeå University and in Germany are behind the study.
Ibrutinib is a drug for the treatment of rare diseases. It has been approved for the treatment of adults with chronic lymphocytic leukaemia (CLL) or with relapsed or refractory mantle cell lymphoma (MCL) since 2014, and since 2015 also for the treatment of adults with Waldenström macroglobulinaemia. Regarding the treatment of patients with CLL or MCL, the Federal Joint Committee (G-BA) already conducted a benefit assessment and made a decision in 2015.
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.
Flamel Technologies announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.
Oncurious NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric cancers, announces it has initiated a Phase I/IIa study that will evaluate the safety and tolerability and explore the preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children.
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