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Breaking News on Global Pharmaceutical Technology & Manufacturing

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.

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).

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.

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.

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.

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.

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.

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.

US 2018 budget

Gottlieb or not, Trump budget threatens FDA says advocacy group

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.

Reader's poll

American-made biosimilars a differentiator in US market, Coherus

15-Mar-2017 - US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?

update - US FDA confirms lifting of import alert

Sun says US FDA poised to lift Mohali import alert

14-Mar-2017 - Sun Pharmaceutical Industries Ltd has said the US FDA plans to lift the import alert imposed on its manufacturing plant in Mohali, Punjab in India.

update

Bbc license suspended by UK drug regulator

13-Mar-2017 - The UK MHRA has suspended Bbc Pharmaceutical Services Limited’s distribution license. 

update

US FDA imposes partial hold on trials of IV formulation of Karyopharm's cancer candidate

13-Mar-2017 - The US FDA has placed a partial hold on trials of an injectable formulation of Karyopharm Therapeutics Inc.’s cancer candidate selinexor.

Denmark clears Europharma to sell drugs after reinspection

13-Mar-2017 - The Danish Medicines Agency (DKMA) has cleared Europharma DK ApS to resume drug sales and distribution after the firm appointed a new managing director.

News in brief

Alkem Labs hit with FDA 483 with three observations at Indian plant

13-Mar-2017 - The US FDA has issued a Form 483 with three observations to Alkem Laboratories after an inspection at its facility in Himachal Pradesh, India.

Re-inspection lands Dr Reddy’s Form 483 with 13 observations at Duvvada plant

09-Mar-2017 - Dr Reddy’s Laboratories says it is addressing the observations at its Duvvada plant which was hit with a warning letter in 2015.

update

Ireland's HPRA did not recommend GMP cert renewal for Wockhardt Shendra plant

08-Mar-2017 - The Health Products Regulatory Authority of Ireland (HPRA) has said it did not recommend renewal of the GMP certificate for Wockhardt’s site in Shendra, Aurangabad.

US FDA slams second Megafine facility in India with warning letter

08-Mar-2017 - A second Megafine Pharma plant has landed a US FDA warning letter for cGMP violations, including sourcing API intermediate materials from a facility on import alert.

update

Wockhardt says Ireland's HPRA has recommended GMP cert renewal for Shendra site

07-Mar-2017 - Wockhardt says Irish regulators have recommended renewal of its Shendra, Aurangabad facility's GMP certificate.

US FDA says Wockhardt's oversight of drug production inadequate

07-Mar-2017 - The US FDA has told Wockhardt its quality issues are company-wide, citing problems at subsidiary Morton Grove as an example in a warning letter published today.

US FDA lifts hold on Seattle Genetics' blood cancer ADC candidate

07-Mar-2017 - The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths. 

US Wockhardt subsidiary Morton Grove warned by US FDA

06-Mar-2017 - The US FDA has warned Wockhardt Limited about operations at its US subsidiary Morton Grove Pharmaceuticals Inc. 

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