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Headlines > March 2017

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Lonza confirms drug firm was biggest customer in 2016

31-Mar-2017 - Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013

Emisphere set to benefit as Novo Nordisk pushes oral diabetes pipeline

30-Mar-2017 - Novo Nordisk’s focus on developing oral versions of semaglutide and four other diabetes drugs could net drug delivery firm Emisphere over $200m.

update - US FDA declines to comment on potential investigation

EMA says CRO monitoring activity not location based

30-Mar-2017 - The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.

US FDA wants evidence Opto-Pharm's Tuas plant remediation effort has worked

30-Mar-2017 - The US FDA has criticised Opto-Pharm Pte for selling unlicensed "drugs" and not bringing its Singapore manufacturing plant up to code.

Fresenius Kabi wants Wockhardt to amend Zosyn approval BSE filing

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.

Wockhardt says US FDA has approved Fresenius Kabi-made generic Zosyn

28-Mar-2017 - Wockhardt claims the US has approved its version of the combination antibiotic Zosyn (piperacillin and tazobactam).

News in brief

Permira to buy Lyophilization Services of New England

28-Mar-2017 - Private equity fund Permira has announced its intention to buy freeze drying firm Lyophilization Services of New England Inc (LSNE) 

Mylan confirms plan to close Meda Soma plant in Illinois

28-Mar-2017 - Mylan will close a manufacturing site in Decatur, Illinois that it gained when it bought Swedish drug maker Meda last year.

Half of CMOs unprepared for serialisation requirements, says Tracelink

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.

EMA looks to suspend 331 drugs due to ‘misrepresentation of study data’ at Indian CRO

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.

Alexion licenses mRNA delivery tech from Arbutus in potential $82.5m deal

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.

Lilly: Tax reforms would release $150m to further support US manufacturing

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.

Eurofins pumping $5m into a UK biopharmaceutical testing site

24-Mar-2017 - Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, Scotland.

Compounding firm looks at NDA opportunity for reformulation of Mallinckrodt's H.P. Acthar

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.

Chiron AS cleared to make carfentanyl for opioid researchers

23-Mar-2017 - Reference material manufacturer Chiron AS has been cleared to make carfentanyl for opioid researchers working in Europe.

Divi's Labs' Vizag plant banned from shipping to US

23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

update with comment from FDA

US FDA criticizes Indian drug firm USV for problems at multiple sites

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.

Pulmatrix secures EU patent for dry powder delivery tech

22-Mar-2017 - Pulmatrix Inc has extended its IP portfolio with a European patent for its particle-based drug delivery technology.

Amgen targets Roche in Europe with Herceptin biosimilar submission

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.

US FDA says Jinan Jinda Pharma must do more make Shandong plant compliant

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.

update

AstraZeneca gets second CRL for Zs-9 after inspection at Zs Pharma Texas plant

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.

News in brief

German Merck taps up cell-based pyrogen detection kit

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.

EC says separate GMP for cell and gene therapies is necessary

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.

PIC/S raises concerns about EC plan for advanced therapy GMP

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.

update - Epipen manufacturer Meridian Medical Technologies completes investigation

Meda recalls EpiPen batch in Denmark after reports of defects

20-Mar-2017 - Mylan subsidiary Meda has recalled a batch of EpiPens in Denmark after reports some have defective auto-injectors.

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