09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.
08-Dec-2016 - AmerisourceBergan has warned of the dangers of reimportation a day after the Senate rejected Bernie Sanders’ “Trump proposal” to overturn the ban.
07-Dec-2016 - The US FDA has issued Sun Pharmaceutical Industries with a Form 483 citing problems identified at its plant in Halol.
06-Dec-2016 - The US FDA has asked Spanish API firm Interquim S.A. for more details of its plan to bring its Barcelona manufacturing plant up to code.
06-Dec-2016 - Fake erectile dysfunction drugs found in Serbian coaches entering Switzerland were made in India according to regulator Swissmedic.
06-Dec-2016 - Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).
05-Dec-2016 - Italian PM Matteo Renzi has quit after voters rejected his controversial plan for parliamentary reforms, setting the stage for political and economic turmoil.
02-Dec-2016 - A ‘no’ vote in the Italian constitutional referendum this weekend may hurt the country's API industry and impact European drug supply chains.
01-Dec-2016 - Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.
30-Nov-2016 - Dongying Tiandong Pharmaceutical Co., Ltd does not do enough to ensure the crude heparin it uses is free potentially lethal contaminant OSCS according to the US FDA.
30-Nov-2016 - The deaths in a trial of Juno Therapeutics’ JCAR015 are most likely product-specific says the CEO of French CAR-T developer TxCell, who rejected the idea that chemotherapy or the CD19 target played a part.
29-Nov-2016 - The ICH has put together a draft Q&A document to clarify Q11 guidelines on drug active ingredient production.
28-Nov-2016 - European Union and Japanese regulators have announced they will share details of API manufacturing facility inspections.
28-Nov-2016 - The US FDA has cleared Lupin to restart production of drugs for the US market at its plant in Goa after the Indian firm fixed problems observed by agency inspectors.
24-Nov-2016 - The US FDA still has doubts about Srikem Laboratories’ plan to fix data integrity problems at its API manufacturing facility Taloja, India.
24-Nov-2016 - A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
23-Nov-2016 - Two more patients have died during a trial of Juno Therapeutics’ candidate white blood cell cancer therapy, JCAR015.
23-Nov-2016 - Holiday drug and API thefts are becoming less frequent but pharmaceutical firms still need to take precautions this Thanksgiving say experts.
23-Nov-2016 - A plan to attract advanced medicinal therapy manufacturing to the UK has emphasised the importance of the MHRA having a leading role in development of global regulatory standards.
22-Nov-2016 - The US FDA has cleared Aduro Biotech to recruit for trials of its listeria-based immunotherapies after the firm modified protocols to reduce the risk of subjects developing listeriosis.
Review a new Colorcon Technical Paper offering a summary of key points presented in the recent US Center for Drug Evaluation and Resea...