Transgene, BMS’s clinical research deal
Posted on28 Apr 2017
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Bristol-Myers Squibb Company and Transgene announced a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene’s investigational therapeutic... Read More
EpiVax licenses novel immune-modulating technology to a global pharmaceutical company (undisclosed)
EpiVax, a Providence-based biotechnology company, has licensed its novel immune-modulating technology to an undisclosed global pharmaceutical company, for use in autoimmune disease... Read More
Serum Institute acquiring Czech vaccine maker Nanotherapeutics Inc. for €72 million
Serum Institute of India Ltd, the world’s largest vaccine maker by number of doses produced and sold, has acquired a defunct unit... Read More
USFDA Approves Renflexis Biosimilar to Remicade
USFDA approved another alternative version of Remicade, an expensive injected drug widely used for rheumatoid arthritis and other immune system disorders. The... Read More
Cipla to acquire pharmaceuticals company Anmarate Pty Ltd
Drugmaker Cipla Ltd’s South African arm has agreed to acquire pharmaceuticals company Anmarate Pty Ltd for ZAR 26.25 million ($1.8 million) in... Read More
Takeda – Finch Therapeutics drug development & commercialization deal for IBD molecule
Takeda is paying Finch Therapeutics $10 million upfront for exclusive, global rights to develop and commercialize the latter’s inflammatory bowel disease (IBD)... Read More
What is the difference between OOS, OOE & OOT?
The terms OOS, OOE and OOT is very important from pharmaceutical Quality Assurance & Regulatory Affairs point of view. These deals with... Read More
USFDA warning letter for Jinan Jinda’s Zhangqiu City, China facility
Posted on04 Apr 2017
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On 24 February, FDA warned Jinan Jinda following a three-day inspection of the company’s Zhangqiu City, China facility where it manufactures active... Read More
USFDA warning letter: USV’s multiple manufacturing units
Posted on04 Apr 2017
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In a warning letter dated 10 March 2017, FDA cites USV for issues related to sterility testing for its products and data... Read More
USFDA warning letter: Indoco Remedies Ltd’s manufacturing plant in Goa for violation of good manufacturing practices.
Posted on04 Apr 2017
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US Food and Drug Administration (FDA) has issued a warning letter to Indoco Remedies Ltd’s manufacturing plant in Goa for violation of... Read More