QA/QC

update

Keryx halts Auryxia production citing API related manufacturing problems

02-Aug-2016 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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.

update

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

15-Jul-2016 By Gareth Macdonald

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 By Gareth Macdonald

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 By Phil Taylor

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 By Dan Stanton

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 By Dan Stanton

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 By Phil Taylor

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 By Dan Stanton

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 By Gareth Macdonald

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.

AMRI licenses Teewinot's cannabinoid analytical standard production tech

22-Jun-2016 By Gareth Macdonald

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

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

22-Jun-2016 By Dan Stanton

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.

Scancell stops dosing in long-term trial of cancer vaccine SCIB1

21-Jun-2016 By Gareth Macdonald

Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.

Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection

20-Jun-2016 By Gareth Macdonald

The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.

Phalanx Labs banned from shipping APIs to US after refusing inspection

17-Jun-2016 By Gareth Macdonald

The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.

correction

The strife of Pii: UK MHRA finds GMP deviations at two facilities

15-Jun-2016 By Gareth Macdonald

The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).

Austin Biotechnology hit with US FDA warning at Taipei facility

15-Jun-2016 By Dan Stanton

The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.

Round-up of ASMS 2016 news

ASMS 2016: Who launched what at the conference?

13-Jun-2016 By Joseph James Whitworth

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

updated

MHRA says Akums' cannot prove progesterone made at Hardiwar plant is sterile

13-Jun-2016 By Gareth Macdonald

The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.

DISPATCHES FROM BIO 2016

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

09-Jun-2016 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Dan Stanton

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 By Gareth Macdonald

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 By Melissa Fassbender

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 By Gareth Macdonald

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 By Gareth Macdonald

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 By Gareth Macdonald

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.”

Glatt and Innopharma target India with integrated PAT offering

12-May-2016 By Dan Stanton

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

Packaging defect prompts VistaPharm oxy recall

12-May-2016 By Gareth Macdonald

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 By Gareth Macdonald

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.

Drug firms would prioritize EU over smaller UK market post Brexit warns ABPI

09-May-2016 By Gareth Macdonald

Drug companies will prioritize the EU over the UK in the event of Brexit according to the ABPI, which says members recognize the benefits of centralised licensing.

Catalent's oral biz hit by Beinheim suspension and low modified release demand

09-May-2016 By Dan Stanton

The manufacturing suspension at a French softgel plant and low demand for modified release tech stunted Catalent’s Q3 2016 results, the firm says.

Europe delays Merck & Co.'s HCV drug on back of CMO quality issues

09-May-2016 By Dan Stanton

Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).

Return to growth: Pfizer thanks Hospira and looks to biosimilars

04-May-2016 By Dan Stanton

Pfizer has attributed Hospira’s sterile injectables and biosimilar assets to its return to growth, offsetting 17 quarters of declining sales.

Xellia and US FDA agree to modified consent decree at ex-Ben Venue site

02-May-2016 By Dan Stanton

The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.

Cambrex: delayed API plant opening set for Q2 opening

02-May-2016 By Gareth Macdonald

An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.

French regulators lift manufacturing ban at Catalent softgel plant

02-May-2016 By Dan Stanton

Full production at Catalent’s Beinheim softgel plant has begun five months after the discovery of out-of-place capsules led to French regulators suspending operations.