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US NIH permanently halts drug production at site criticised by US FDA

04-Aug-2016 - The US National Institutes of Health (NIH) has permanently halted trial drug production at a site where cGMP violations were identified last year.

US FDA says Xiamen Origin Biotech lied to inspectors who visited API plant

03-Aug-2016 - The US FDA says Xiamen Origin Biotech Co. lied to investigators during an inspection of its API facility in Fujian in which significant deviations from cGMP were identified.

update

Keryx halts Auryxia production citing API related manufacturing problems

02-Aug-2016 - Keryx Biopharmaceutical's CMO has halted production of Auryxia (ferric citrate) as a results of manufacturing problems.

update

Spanish regulators: Jinan Jinda Pharmaceutical Chemi should not supply nitrofurantoin to EU

02-Aug-2016 - Jinan Jinda Pharmaceutical Chemi has not fixed GMP deficiencies at its Shandong plant say Spanish regulators calling for ban on nitrofurantoin shipments to the EU.

Dr Reddy’s Q1: warning letter ‘significantly impacted our earnings’

28-Jul-2016 - US FDA warnings and Venezuela's economic crisis have contributed to “a challenging quarter” for Dr Reddy’s, with its API business being particularly affected.

US FDA won't OK eye pain candidate until Ocular Therapeutix addresses production concerns

26-Jul-2016 - The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made. 

Micro Labs completes repeat studies and predicts drugs will be back on the market in autumn

Sandoz repeats tests and Teva pulls malaria pill as EMA calls for suspension of Semler trialled drugs

25-Jul-2016 - Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler Research Centre should be suspended.

GSK to expand recall of antibiotics made at Worthing API unit

21-Jul-2016 - GSK will recall more antibiotics made at a UK API unit that has been offline since the US FDA raised contamination concerns last year.

Constipation med linked to 46 B. cepacia cases in US recalled by PharmaTech

19-Jul-2016 - A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.

China's complex API regs fuelling US meth problem says congressional committee

19-Jul-2016 - Legal loopholes and poor enforcement let criminals in China divert APIs for illegal drug production according to a US congressional committee which says the country is fast becoming the major global supplier of crystal meth precursors.

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Juno trial restart positive, but CAR-T sector still on a learning curve says TxCell

15-Jul-2016 - The US FDA’s decision to let Juno Therapeutics restart its JCAR015 trial is positive, but the CAR-T sector must learn from safety and efficacy findings says French biotech TxCell.

EMA reviewing several drugs made by Pii in light of MHRA inspection

13-Jul-2016 - The EMA has started assessing some drugs made by Pharmaceutics International Inc (Pii). 

Shelf life issue halts trial of Scancell's cancer vaccine SCIB1

06-Jul-2016 - UK biopharma company Scancell was forced to halt trials of its flagship cancer immunotherapy SCIB1 because its supplies of the drug no longer meet quality specifications.

Advaxis: Manufacturing, safety and efficiency key to developing cancer drugs

30-Jun-2016 - In-house manufacturing investments have been key to the clinical development of Advaxis’ oncology candidates, the firm says.

US FDA slams two Chinese API makers for quality systems and data issues

29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.

Swissmedic ramps up ad hoc inspections in 2015

28-Jun-2016 - The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.

Serialisation regulations to impact all corners of pharma, says Recipharm

27-Jun-2016 - The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.

India to rewrite 75-year old drug laws with an eye on business, biologics and devices

23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.

Opko extended-release kidney disease drug approved after Catalent 483 delay

22-Jun-2016 - The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.

AMRI licenses Teewinot's cannabinoid analytical standard production tech

22-Jun-2016 - AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.

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