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News headlines

US FDA warns CordenPharma about Italian antibiotic API and cancer injectables plant

30-May-2016 - The US FDA was warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year.

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.

Novo Nordisk and Sanofi diabetes combo drugs receive US recommendation

26-May-2016 - The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.

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.

Recipharm will serialize customers' drugs for free until US and EU rules come into force

24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.

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.

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Clinical Trials Day: focusing on awareness, the ‘war on talent,’ and an industry-wide commitment

19-May-2016 - Clinical Trials Day celebrates the first randomized clinical trial conducted in May 1747 and the clinical research professionals that work in the industry more than 265 years later.

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17-May-2016 - Swedish regulators have withdrawn a GMP certificate issued to Bend Research after deeming the firm’s plan to address deviations at its Oregon plant “partly unacceptable.”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

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.

Brexit bad for patients according to ABPI which says UK would lose regulatory influence

10-May-2016 - Brexit would add extra barriers to licensing medicines in the UK according to the Association of the British Pharmaceutical Industry (ABPI).

Concealed compliance info lands ex-Ranbaxy owners $385m costs

10-May-2016 - The former owners of Indian drugmaker Ranbaxy have been ordered to pay Daiichi Sankyo $385m for concealing quality problems across its manufacturing network before selling the business.

News in brief

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

09-May-2016 - 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.

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

09-May-2016 - Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).

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

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

update

EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients

03-May-2016 - Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.

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

02-May-2016 - 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.

French regulators lift manufacturing ban at Catalent softgel plant

02-May-2016 - 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.

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