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APIs (active pharmaceutical ingredients)

News headlines

AstraZeneca API plant set to shut by 2017 as Patent Cliff strikes again

18-Dec-2014 - An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.

API supplier issues again cause FDA to reject Pozen drug candidates

18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.

News in brief

US FDA issues Form 483 to Hovione API facility in Portugal

18-Dec-2014 - The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations. 

Rouble trouble: Big Pharma exposure to Russian currency volatility limited

17-Dec-2014 - Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.

Compound interest? US FDA sets up compounding pharmacy advisory committee

17-Dec-2014 - The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.

AstraZeneca shutting asthma drug plant as pipeline shifts to biologics

12-Dec-2014 - AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.

Foreign investment in UK drugmaking down; ABPI tasks ex-GSK exec with reversing trend

10-Dec-2014 - An ex-GSK staffer charged with winning manufacturing investments for the UK says fostering innovation and “fiscal attractiveness” are vital.

Merck & Co set to be superbug-busting superstar despite US Cubicin ruling, analyst

10-Dec-2014 - Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.

From CPHI India

CPHI India: experts say ‘data fraud’ dragging down Indian manufacturing

09-Dec-2014 - Experts at CPHI India say companies failing manufacturing inspections need to be more honest with their data.

Axim to build Dutch facility for cannabinoid-based chewing gum drug

04-Dec-2014 - A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build a manufacturing facility in the Netherlands.

From CPHI India 2014

Do you manufacture these APIs? ‘We’re interested in you,’ says WHO

04-Dec-2014 - The World Health Organisation says its prequalification scheme gives free help to makers of selected APIs, drugs and vaccines who want to boost their standards and access international markets.

Spoil sport: Pfizer teams up with WADA to combat drug cheats

04-Dec-2014 - Pfizer scientists wont have to run track, just share data to help catch sports cheats who use candidate drugs to enhance performance according to the World Anti-Doping Authority (WADA).

German regulators hit Ranbaxy with another warning letter

03-Dec-2014 - Another warning letter has landed in the hands of Ranbaxy execs, this time from German regulators charging the company with failing to comply with GMP standards.

From CPHI India 2014

Indian manufacturing problems spur growth... for testing companies

03-Dec-2014 - SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.

Johnson Matthey acquires API capacity in Scotland

03-Dec-2014 - Johnson Matthey has completed its acquisition of API and pharmaceutical intermediate manufacturing capacity in Scotland. 

Live from CPhI India

02-Dec-2014 - [View the story "Live from CPHI India" on Storify]

Advanced aspirin aspirations ailing? Sanofi and Pozen terminate deal

02-Dec-2014 - Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the US Food and Drug Administration (FDA) decides whether to approve the new drug.

MHRA says it will review plans for new UK pharma plants free of charge

01-Dec-2014 - Expert advice was key to persuading AstraZeneca to build a £120m ($188m) manufacturing plant in the UK according to the MHRA, which says the same help is available to all drugmakers free of charge.

Dr Reddy's API plant receives USFDA 483 with nine observations

27-Nov-2014 - Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.

US, Chinese regulators forge closer ties as FDA looks to triple staff

24-Nov-2014 - As FDA commissioner Margaret Hamburg wraps up her trip in China it looks like the FDA is creating a stronger bond with its Chinese counterparts as the FDA looks to triple its staff there.

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