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Breaking News on Global Pharmaceutical Technology & Manufacturing

Bluebird Bio reports positive early safety data from Ph I CAR-T trial

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.

Operator silence rings alarm bells during audits, say FDA and WHO experts

01-Dec-2016 - Full transparency and open conversation with operators will lead to more successful facility audits, say regulatory experts.

ROCKET TRIAL DEATHS

Juno deaths: Toxicity is therapy specific, not risk to whole CAR-T field, say 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.

ICH completes draft Q11 implementation Q&A; welcomes ANVISA and MFDS

29-Nov-2016 - The ICH has put together a draft Q&A document to clarify Q11 guidelines on drug active ingredient production.

Japan to share API plant inspection data with international regulators

28-Nov-2016 - European Union and Japanese regulators have announced they will share details of API manufacturing facility inspections.

US FDA clears Lupin to supply US with meds made in Goa

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.

US FDA finalises contract manufacturing quality agreement guidance

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.

Two more patients die in trial of Juno's JCAR015

23-Nov-2016 - Two more patients have died during a trial of Juno Therapeutics’ candidate white blood cell cancer therapy, JCAR015.

Experts warn pharma to take precautions against Thanksgiving thefts

23-Nov-2016 - Holiday drug and API thefts are becoming less frequent but pharmaceutical firms still need to take precautions this Thanksgiving say experts.

MHRA global role key to attracting drug manufacturers to UK says ATMT

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.

US FDA calls Wockhardt efforts to fix Wrexham plant 'inadequate'

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.

Cel-Sci responds to US FDA clinical hold on Multikine study

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.

Sanofi Pasteur confirms plant problems prompted TheraCys decision

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.

Pharma Integrates 2016

Ignore EMA Advice at own peril

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.

Live from PCT Europe:Trump, Brexit and drug trials mulled in Vienna

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.

Pharma prepping for US track and trace but concerns remain says standards group

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.

Pfenex: consistently high manufacturing quality key for biosimilar success

15-Nov-2016 - Manufacturing quality is key for biosimilar success says Pfenex, as the US FDA continues to increase its regulatory oversight.

DISPATCHES FROM AAPS 2016

Pfizer and FDA: Expedited regulatory pathways ignore manufacturing burdens

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.

Precision meds and I-Phone microscopes: AAPS 2016 lands in Denver

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.

Product recall after mechanism failure complaints

Teleflex recalls faulty nasal delivery devices used to administer opioid overdose meds

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".

US FDA clears Adaptimmune to start fat cancer cell therapy trial

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.

US vaccine programmes set for shake up if Trump sticks to his word

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.

Catalent: smaller firms set to struggle in capital intensive CMO space

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.

USP calls for industry feedback on proposed HPMC monograph

08-Nov-2016 - The USP has proposed monograph for hypromellose capsule shells used to make vegetarian friendly medicines.

EAG opens elemental impurities lab citing US FDA alignment efforts

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.

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