SUBSCRIBE

Breaking News on Global Pharmaceutical Technology & Manufacturing

Regulations

News headlines

WHO commits to source drugs and vaccines from 'green' suppliers

09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.

US drug reimportation 'Trump proposal' risky and inefficient, AmerisourceBergen

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.

Troubled Halol plant earns Sun a US FDA Form 483

07-Dec-2016 - The US FDA has issued Sun Pharmaceutical Industries with a Form 483 citing problems identified at its plant in Halol.

US FDA says Interquim's API plant remediation plan is inadequate

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.

Indian-made fake erectile dysfunction meds seized in Switzerland en route from Serbia

06-Dec-2016 - Fake erectile dysfunction drugs found in Serbian coaches entering Switzerland were made in India according to regulator Swissmedic.

MULTIPLE MYELOMA

Takeda overturns negative EU CHMP opinion for oral drug Ninlaro in ‘face-to-face’ appeal

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).

Italian PM's resignation will hit API sector if anti-EU party takes power says expert

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.

Opinion

Ita-leave? Italian referendum may impact European API supply chain

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.

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.

US FDA slams Dongying Tiandong for poor raw heparin supplier oversight

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.

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.

update

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 says Srikem plan will not fix data integrity issues at Taloja plant

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.

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.

update

US FDA lifts clinical hold after Aduro modifies listeria-based therapy trials

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.

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...

Product Innovation