23-Mar-2017 - Reference material manufacturer Chiron AS has been cleared to make carfentanyl for opioid researchers working in Europe.
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 - Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.
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 - 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 - 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.
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.
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?
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.
13-Mar-2017 - The UK MHRA has suspended Bbc Pharmaceutical Services Limited’s distribution license.
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.
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.
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.
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.
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.
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.
07-Mar-2017 - Wockhardt says Irish regulators have recommended renewal of its Shendra, Aurangabad facility's GMP certificate.
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.
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.
06-Mar-2017 - The US FDA has warned Wockhardt Limited about operations at its US subsidiary Morton Grove Pharmaceuticals Inc.
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.
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.
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.
01-Mar-2017 - in-PharmaTechnologist presents this month's roundup of who is moving where in the Pharma industry.
27-Feb-2017 - Data is a core competence for Big Pharma that should not be outsourced, according to an industry statistics expert.