NEWS

For our visitors who seek the latest industry news and updates to keep abreast with the goings-on of the business on a global scale, Pharmaceutical Industry portal grants a dynamic and diverse feed of news items.

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The USFDA has found significant violations of current good manufacturing practice (CGMP) norms at a plant in Philadelphia that was earlier owned by Sun Pharmaceutical and has issued a warning letter to its current owner, Frontida BioPharm. The Philadelphia plant is among the two facilities that Sun Pharma had sold…

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Recent clinical trial results are likely to lead doctors to treat more patients who have a common form of lung cancer with a Merck drug at the expense of a Bristol-Myers Squibb medication at least until more data emerges, oncologists and analysts say. The yet-to-be-published studies involve drugs in a…

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Issues related to violations of data and manufacturing practices is back in the spotlight for the Indian pharmaceutical industry. An August 15 warning letter from the US FDA to Frontida BioPharm, a company that acquired two manufacturing units from India's Sun Pharma two months ago, pointed to discrepancies in records…

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Hemispherx Biopharma Inc Received approval of its new drug application from anmat for commercial sale of rintatolimod in argentine republic. Product will be marketed by GP Pharm, Hemispherx's commercial partner in Latin America. Will continue to seek approval in additional Latin American countries.   Source : reuters.com

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The European Medicines Agency (EMA) has accepted for review Biocon and Mylan's Marketing Authorization Application (MAA) for a proposed biosimilar Trastuzumab, used to treat certain breast and gastric cancers. The companies--co-developors of this proposed biosimilar--anticipate that this may be the first MAA for a Trastuzumab biosimilar accepted by EMA for…

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Novartis AG NVS entered into a license agreement with privately held Cyon Therapeutics Inc. for its anti-PCSK9 antibody, LGT-209, as per a press release issued by the latter. Although financial details of the agreement were kept under wraps, the deal does cover regulatory and commercial milestones. Cyon licensed LGT-209 from…

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Evgen Pharma Plc - FDA granted company orphan drug designation for use of stabilised sulforaphane for treatment of subarachnoid haemorrhage.   Source : reuters.com

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Zhejiang CONBA Pharmaceutical Co., Ltd. Says it will acquire 12 percent stake in its Inner Mongolia pharmaceutical unit for 50 million yuan. Says it will hold 100 percent stake in target co after the transaction.   Source : reuters.com

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Democratic presidential candidate Hillary Clinton called on pharmaceutical company Mylan NV to voluntarily drop the price of its severe allergy treatment drug EpiPen, which has increased in price by more than 400 percent in the past decade. "That's outrageous - and it's just the latest troubling example of a company…

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Clovis Oncology Inc FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer. FDA assigns PDUFA date of February 23, 2017.   Source : reuters.com