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Headlines > November 2016

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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...

Arrowhead halts development of RNAi-based therapies that use its Ex1 delivery tech

30-Nov-2016 - Arrowhead has abandoned development of therapies which use its Ex1 delivery vehicle, axing multiple clinical trials and sacking staff.

West completes Mulhuddart expansion citing insulin as driver

30-Nov-2016 - Delivery device with West Pharmaceutical Services has completed the expansion of its plant in Mulhuddart, County Dublin.

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.

News in brief

AMRI signs second API supply deal with Shire

29-Nov-2016 - AMRI has signed a second deal with Shire plc under which it will supply an undisclosed active pharmaceutical ingredient (API).

update

Patheon buys Roche's Xeloda API plant and signs supply deal

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.

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.

Catalent adding OTC capsule maker Accucaps to global softgel network

28-Nov-2016 - Catalent will add two Canadian manufacturing facilities to its softgel network through the acquisition of Accucaps.

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.

News in brief

Nitika to build 4th excipients plant near emerging Indian export hub

28-Nov-2016 - Nitika Pharmaceutical Specialties Pvt Ltd has said it will build a fourth pharmaceutical excipients plant in Nagpur, India.

Pfizer axes parts of $425m Irish expansion after dropping PCSK9 inhibitor

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.

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.

Sun buys stake in Russian API and drug firm JSC Biosintez

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.

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.

Evonik to construct second Alabama facility for drug delivery polymers

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.

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.

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.

Swallowing Stars: MIT spin-out invents gastric device which solves problem of daily dosing

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.

US FDA asks Sekisui how it will fix API test data problems at Japan plant

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.

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