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Breaking News on Global Pharmaceutical Technology & Manufacturing

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. 

update

EU and US agree to share API and drug plant inspection data

02-Mar-2017 - The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed this week.

US FDA clears Akorn's generic CellCept after Form 483 resolved

02-Mar-2017 - The US FDA has cleared Akorn Inc. to sell a generic version of the immunosuppressant CellCept made at its plant in Decatur, Illinois.

Cardboard and brown agglomerates: FDA slams Pfizer injectables plant

01-Mar-2017 - Particulate problems in sterile injectables and poor aseptic techniques landed Pfizer with a US FDA warning letter at a former Hospira facility in Kansas.

People on the Move

Hiring and Firing Feb '17

01-Mar-2017 - in-PharmaTechnologist presents this month's roundup of who is moving where in the Pharma industry.

Pharma Outsourcing & Partnership Global Congress 2017 Europe

Vital statistics? Big Pharma undervaluing commercial data, expert

27-Feb-2017 - Data is a core competence for Big Pharma that should not be outsourced, according to an industry statistics expert.

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