|« Previous month||Next month »|
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...
30-Nov-2016 - Arrowhead has abandoned development of therapies which use its Ex1 delivery vehicle, axing multiple clinical trials and sacking staff.
30-Nov-2016 - Delivery device with West Pharmaceutical Services has completed the expansion of its plant in Mulhuddart, County Dublin.
29-Nov-2016 - The ICH has put together a draft Q&A document to clarify Q11 guidelines on drug active ingredient production.
29-Nov-2016 - AMRI has signed a second deal with Shire plc under which it will supply an undisclosed active pharmaceutical ingredient (API).
29-Nov-2016 - Patheon has bought a US API facility from Roche in a deal that will also see the CMO supply the Swiss firm with drug ingredients.
28-Nov-2016 - European Union and Japanese regulators have announced they will share details of API manufacturing facility inspections.
28-Nov-2016 - Catalent will add two Canadian manufacturing facilities to its softgel network through the acquisition of Accucaps.
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.
28-Nov-2016 - Nitika Pharmaceutical Specialties Pvt Ltd has said it will build a fourth pharmaceutical excipients plant in Nagpur, India.
28-Nov-2016 - Plans to build a five-story biomanufacturing plant in Ireland could be shelved following the clinical failure of Pfizer's proposed cholesterol-lowering candidate bococizumab.
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 - Sun Pharma has announced it will buy a controlling interest in Russian drug and API manufacturer JSC Biosintez to access local market.
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.
23-Nov-2016 - Evonik has laid plans to expand a polymer facility in Alabama to cater for growing demand for sophisticated drug delivery and medical devices.
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.
22-Nov-2016 - Efforts by Wockhardt to fix violations at drug plant in Wrexham, Wales are inadequate according to the US FDA which detailed its concerns in a warning letter this week.
22-Nov-2016 - Cel-Sci has responded to the partial clinical hold imposed on a Phase III trial of its candidate head and neck cancer cell therapy Multikine in September.
22-Nov-2016 - Sanofi Pasteur has confirmed the decision to stop making the bladder cancer drug TheraCys was prompted by long running problems at the Toronto manufacturing plant where it is made.
22-Nov-2016 - Lyndra Inc. has developed a star shaped gastric device which claims to solve the problem of delivering drugs with short half-lives.
21-Nov-2016 - The US FDA has asked Sekisui Medical to specify how it will resolve data integrity issues uncovered during an inspection of its API plant in Hachimantai, Japan in June.
|« Previous month||Next month »|