Stephanie Sutton

The head of the Association of the British Pharmaceutical Industry has issued a stark warning about the state of the UK’s pharmaceutical industry.

The European Commission has issued final approval for Europe's first gene therapy-a treatment for a rare genetic disorder that currently has no other treatment options.

The end of October saw chaos in the Caribbean and then on the east coast of the US.

Experts share insight into extractables and leachables testing, including high-risk products, analytical testing, and regulatory requirements from FDA and EMA.

Patheon will acquire softgel-specialist company Banner Pharmacaps, based in North Carolina in the US, for $255 million

Dr Reddy's is planning to acquire the specialty injectable company OctoPlus for approximately EUR 27.4 million ($35.7 million) in cash to strengthen its technological capabilities in drug delivery.

Earlier this year in June, Roche’s name hit the headlines after a pharmacovigilance inspection discovered around 80000 safety reports that had not been evaluated by the company to determine whether they should be reported as adverse drug reactions.

GlaxoSmithKline has outlined the measures it is taking as part of a new open innovation approach to R&D, including opening up its tuberculosis compound library, investing in its open laboratory in Spain, and sharing detailed clinical trial data with researchers.

Recent years of low approvals of new blockbuster products have given rise to the perception that pharmaceutical drug development.

Last week, FDA deemed that a generic drug manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA was not therapeutically equivalent to its reference product.

Takeda's US subsidiary, Takeda America Holdings, has agreed to acquire the vaccine specialist company LigoCyte Pharmaceuticals for an upfront payment of $60 million in a move intended to bolster and expand the company's vaccine business.

A new report has forecast that the global biopharmaceutical market will be worth more than $320 billion by 2020, up from just $138 billion in 2011.

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry.

Sanofi is planning to shed approximately 900 jobs in France in the lead up to 2015 as it seeks to implement certain key strategic objectives.

The European Medicines Agency has abolished its Cell-based Product Working Party and Gene Therapy Working Party, with the aim of improving efficiencies and optimizing the use of available expertise.

Yesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015”.

This year's CPhI Worldwide event is set to take place at the Feria de Madrid in Spain, October 9-12, with expectations for more than 30000 visitors and 2200 exhibitors from 140 countries.

Johnson & Johnson has announced plans to open four innovation centers in California, Boston, London, and China, with the aim of accelerating early innovation and facilitating collaboration and investment opportunities.

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

The pharmaceutical industry still lags other industries in spending on outbound social media programs that engage customers directly.

Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicolored brain that appeared on the company's website for the diagnostic PET tracer, Amyvid.

Merck KGaA has announced plans to eliminate 1100 jobs in Germany by the end of 2015—almost 10% of the company's 10,900 German positions.

Generic-drug manufacturers are preparing to pay fees to FDA for the first time in the agency’s history.

It’s common knowledge in the pharmaceutical industry that medicines regulators do not conduct as many inspections of foreign drug-manufacturing facilities as they might like to.

The European Medicines Agency has launched a public consultation concerning its inventory of pediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

In most industries, businesses run the same way. You can either stick your head in the sand and pretend that everything is going fine, or you can stand up and take the feedback-whether positive or negative-and react to it.

The European Commission remains vigilant in monitoring potential pay-to-delay deals.

Following an inquiry in 2009 that suggested the launch of various generic drugs was being delayed by anticompetitive business practices, the European Commission (EC) has been closely monitoring deals for potential breaches of the EU's antitrust rules.