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Round-up of ASMS 2016 news

ASMS 2016: Who launched what at the conference?

13-Jun-2016 - Industry gathered recently for the American Society of Mass Spectrometry conference (ASMS). We look at who launched what during the event.

DISPATCHES FROM BIO 2016

US FDA Commissioner Califf calls on industry to tackle supply chain quality issues

09-Jun-2016 - Risk algorithms and international agreements will help ensure imported API quality, says FDA Commissioner Robert Califf but industry must also take responsibility for its own supply chain.

Ko Da not at end of regulatory problems: US FDA says Taiwan firm should hire CFR 211 consultant

08-Jun-2016 - The US FDA says Ko Da Pharmaceutical facility in Taoyuan City, Taiwan will not be able to supply the US unless the firm corrects all GMP deviations identified during an inspection last May.

Teva confirms it halted production at Hungary injectables plant in January

08-Jun-2016 - Teva has confirmed it stopped making all but two sterile injectable drugs at its plant in Godollo, Hungary in January after a US FDA inspection.

GSK's real-world Relvar trial called for 'game changing' tech says North West e-Health

02-Jun-2016 - A real-world trial of GSK's Relvar has prompted the development of a ‘game-changing’ database linking and tracking tech according to North West e-Health.

Megafine must investigate data faking at banned API plant says US FDA

01-Jun-2016 - The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US last year.

Granules 483-hit API plant receives all clear from US FDA

31-May-2016 - A Granules API plant in Hyderabad which received a Form 483 with three observations has been given the all clear by the US FDA.

Safety board clears TxCell to restart Ovasave study that was halted last year

27-May-2016 - TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.

Xellia starts work on testing lab at Hungary API plant citing growing demand

26-May-2016 - Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.

CGT to test scaffold tech for commercial-scale T-cell production

25-May-2016 - The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.

Mock sheets and lack of stability data: US FDA hits two API makers with warnings

25-May-2016 - The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.

Croatia's Halmed finds GMP deficiencies at Dhanuka Labs' antibiotic API plant

25-May-2016 - An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.

Catalent launches new kit labeling system to reduce 'risk of human error'

24-May-2016 - Catalent Pharma Solutions has released a new clinical supply labeling tool in response to a "work-around" which could put patients' safety at risk.

IMA: Angina drug API firm JP Laboratories cannot keep Daund plant up to code

23-May-2016 - Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).

Italian regulator slams simvastatin-maker Krebs for GMP deviations

23-May-2016 - APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.

MPA withdraws Bend's Oregon plant GMP certificate citing deficiencies

17-May-2016 - Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”

Live from EDQM: Regulators say quality will drive generics availability

13-May-2016 - Working together could save regulators millions and increase availability of medicines for patients, delegates say at the EDQM's International Generic Drug Regulators Programme (IGDRP) in Strasbourg.

Glatt and Innopharma target India with integrated PAT offering

12-May-2016 - Innopharma has teamed up with Glatt to offer Indian drugmakers process analytical technology (PAT) tools it says can reduce costs and increase compliance.

News in brief

Packaging defect prompts VistaPharm oxy recall

12-May-2016 - VistaPharm has recalled thousands of cases of generic oxycodone as a result of a defect that allowed the powerful painkiller to leak out of the packaging.

ANSM says Medreich plan will bring non-compliant Bollaram plant up to code

11-May-2016 - A remediation plan by Medreich Limited is sufficient to bring its Andhra Pradesh antibiotics plant in to compliance with GMP according to French regulator ANSM.

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