
New stories earlier this year (1) reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.

New stories earlier this year (1) reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.


Lundbeck's Big Bet


Developing a drug is still very much a game of chance: a round puzzle of soft edges, with pieces that rarely fit the hard rectangles of time and money. Solving the puzzle correctly-with a new product as the sum of its parts-depends on making that lengthy progression from basic science to registration as linear as possible.

PE Ad Dimensions

PE June 2012 BPA

The furore that burst across Brussels in late September over reported findings of tumors in rats fed with genetically modified maize may seem only tangentially related to the concerns.

The sessions focused heavily on the state of doing business in Brazil.

A recent decision by the Department of Health (DoH) to introduce a compliance regime for NICE (National Institute for Health and Clinical Excellence) technology.

Pharm Exec’s 2012 Industry Audit relies on 2011 data to compare performance against 2010.

Innovation Excellence is a unique application of lean kaizen methodologies and personal coaching. It frees up capacity for innovative research, fosters ownership and significantly enhances the output of your research and innovation teams.

The Access to Medicines Index is an attempt to measure and compare the corporate social responsibility of both innovator (20) and generics (7) companies based on a number of different (and often quixotic) indicators.

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

The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop.

Busting the Tape

Autumn is a good time to present our annual post on how well the industry is doing in harvesting value for shareholders. Our diverse list of 24 companies, drawn from Big Pharma to the established biotechs, presents a similarly mixed picture on returns: smaller firms with a distinct customer base and tight oversight of costs are by and large proving more adept at delivering the strong growth that investors still expect from this business.

"Payers have evolved to become powerful global contenders with pharma for increasingly limited funding of drug budgets."

It’s something of an enigma that most physicians are keen to learn about and use cutting edge medicines and devices for their patients.

In the American version of the Australian TV series Wilfred, the show’s title character declares that for him, human life begins at 10 years old.

Public policy activities should be a distinct, mission critical function for Big Pharma - our business depends increasingly on government as a key customer.

The European Union is at last groping its way towards some form of standardization in judging the value of medicines.

The European Union is at last groping its way towards some form of standardization in judging the value of medicines.

Global Launch in the Post-Blockbuster Era

Today’s big product story - the apparent end to a decade-long drought in the drug development pipeline - is the prep stage for tomorrow’s big policy question: are industry R&D priorities in synch with the changing burden of disease?

Forest Labs has had a tough time with regulators over the last two years. The company’s sales reps can’t seem to stop breaking the law.

Can’t get your sales rep into that academic medical center? Try sending a medical science liaison (MSL).

Piramal Pivots for Growth

This month's feature by Ben Comer highlights what's behind the new Corporate Integrity Agreement (CIA) imposed on GSK by theHHS Office of Inspector-General to compensate for a long list of marketing and pricing malfeasances

The decisions you make today about patents – what, when and where to file – could have implications tantamount to billions of dollars in R&D investment and sales over the next two decades.