02-Dec-2016 - Bluebird Bio has reported encouraging efficacy and safety data from a Phase I trial of its CAR-T multiple myeloma therapy, bb2121.
01-Dec-2016 - Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.
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 - 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 - 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.
18-Nov-2016 - Seeking EMA advice can significantly increase both the likelihood of drug approval and of winning financial support according to experts at conferences in London, UK this week.
16-Nov-2016 - Trump, Brexit, patients and technology innovations dominate conversation on day one of Partnerships in Clinical Trials in Vienna, Austria. Check back for live updates.
15-Nov-2016 - Industry efforts to comply with new US track and trace rules are accelerating, but concerns remain about the quality of symbols used to mark products according to GS1 US.
15-Nov-2016 - Manufacturing quality is key for biosimilar success says Pfenex, as the US FDA continues to increase its regulatory oversight.
15-Nov-2016 - The flexibility of clinical development for products on designated accelerated pathways is leading to at-risk investments in commercial manufacturing, say Pfizer and the FDA.
14-Nov-2016 - AAPS 2016 kicked off yesterday with a focus on new technologies, new delivery modalities, accelerated drug development and precision medicines - oh and a microscope on an iPhone.
10-Nov-2016 - Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
10-Nov-2016 - The US FDA has cleared Adaptimmune to start a trial of its fat cancer cell therapy, lifting the clinical hold imposed in August when the agency asked for more manufacturing data.
09-Nov-2016 - US public health programmes will use lower dose vaccines administered over longer periods from 2017 if President elect Donald Trump adheres to a plan he outlined last year.
09-Nov-2016 - Increasing regulatory burdens are increasing costs and will create fewer, bigger, and better players in the CDMO space, according to Catalent’s CEO.
08-Nov-2016 - The USP has proposed monograph for hypromellose capsule shells used to make vegetarian friendly medicines.
08-Nov-2016 - EAG Laboratories has set up an elemental impurities lab in response to US FDA moves to align testing rules with ICH Q3D guidance and USP requirements.