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29-Mar-2017 - Fresenius Kabi wants Wockhardt to change a BSE filing it says does not accurately reflect its role in the production of a Zosyn generic recently approved in the US.
28-Mar-2017 - Wockhardt claims the US has approved its version of the combination antibiotic Zosyn (piperacillin and tazobactam).
28-Mar-2017 - Private equity fund Permira has announced its intention to buy freeze drying firm Lyophilization Services of New England Inc (LSNE)
28-Mar-2017 - Mylan will close a manufacturing site in Decatur, Illinois that it gained when it bought Swedish drug maker Meda last year.
28-Mar-2017 - As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.
27-Mar-2017 - Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.
27-Mar-2017 - Alexion Pharmaceuticals will use the LNP delivery licensed from Arbutus Biopharma as part of its messenger RNA therapeutics development partnership with Moderna Therapeutics.
27-Mar-2017 - Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive disadvantage.
24-Mar-2017 - Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, Scotland.
23-Mar-2017 - Imprimis Pharmaceuticals says it is evaluating pursuing New Drug Application (NDA) status for some of its product reformulations through the US FDA 505(b)(2) development pathway.
23-Mar-2017 - Reference material manufacturer Chiron AS has been cleared to make carfentanyl for opioid researchers working in Europe.
23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.
22-Mar-2017 - The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.
22-Mar-2017 - Pulmatrix Inc has extended its IP portfolio with a European patent for its particle-based drug delivery technology.
22-Mar-2017 - Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.
22-Mar-2017 - Jinan Jinda Pharmaceutical Chemistry Co. Ltd has more to do to bring its drug ingredient plant in Shandong, China up to code according to the US FDA.
21-Mar-2017 - The US FDA has issued AstraZeneca with a second CRL for its hyperkalaemia candidate Zs-9 after finding problems at a Texas facility operated by subsidiary Zs Pharma.
21-Mar-2017 - Solvias has struck a deal with Germany’s Merck to supply a monocyte activation test (MAT) kit for detecting pyrogens in pharmaceutical raw ingredients.
21-Mar-2017 - The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.
20-Mar-2017 - Mylan subsidiary Meda has recalled a batch of EpiPens in Denmark after reports some have defective auto-injectors.
20-Mar-2017 - Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
20-Mar-2017 - Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.
16-Mar-2017 - Axim Biotech has enrolled patients in its Phase II trial for Canchew Plus chewing gum – a delivery method with a “cumulative effect,” says CEO.
16-Mar-2017 - The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.
16-Mar-2017 - President Donald Trump wants to generate over $2bn from drug company user fees to help fund the US FDA, according to his 2018 budget blueprint.
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