Industry News

Lannett Company, Inc. received a notice from the U.S. Food and Drug Administration (FDA) that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. 

BTG plc, an international specialist healthcare company, announced that the first patient in Malaysia was treated with TheraSphere - a transarterial radioembolisation (TARE) therapy, which targets primary liver cancer and metastatic colorectal cancer with a powerful dose of radiation while minimising exposure to healthy tissue.

Lipocine Inc.  announced the completion of a Post Action meeting with the U.S. Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.  The purpose of the meeting was to review the Complete Response Letter ("CRL") and to determine actions needed to achieve approval of LPCN 1021.

Biotricity inc has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a key component of its solution. This clearance is another watershed moment in the company’s quest to market its remote cardiac monitoring solution comprised of the bioflux software and device. By developing medical remote monitoring solutions that help prevent and manage chronic diseases, biotricity seeks to revolutionize the health industry by bridging the gap in chronic care management.

Addex Therapeutics announced that the company will conduct a phase IIa Proof of Concept Study of dipraglurant in focal cervical dystonia (CD). Addex expects to initiate the trial in the fourth quarter of 2016. The study was developed with support from the Dystonia Medical Research Foundation and in collaboration with investigators from the Dystonia Coalition, an international network of experts devoted to advancing research in dystonia. Buz Jinnah, Director of the Dystonia Coalition and Professor of Neurology at Emory University, will serve as the lead investigator.

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Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

Vedanta Biosciences, pioneering the development of a novel class of therapies for immune and infectious diseases based on rationally designed consortia of bacteria derived from the human microbiome, announced that the European Patent Office (EPO) has issued European Patent EP2575835. The patent broadly covers pharmaceutical compositions of Clostridium live bacterial strains and further expands Vedanta Biosciences’ patent portfolio after the issuances of three U.S. patents in the previous months and earlier issuances in Japan. The patents are exclusively licensed to Vedanta Biosciences under an agreement with the University of Tokyo and provide coverage through at least 2031.