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With the Affordable Care Act [ACA] officially settling into the US’ political landscape, a pressing – but little noticed – issue is the provisions for increased compliance on industry promotion practices.

The abrupt departure of Europe’s health commissioner continues to resonate across the European Union – and to leave plans for new clinical trials legislation without a patron.

With the Presidential election decided and President Obama the clear winner, it’s time for Pharma to get down to business on the implementation of ObamaCare.

The pharmaceutical industry as of late has faced a growing movement against patent protection in favor of providing access to low cost medicines, specifically in developing countries.

Pharm Exec's 2013 Pipeline Report

Providers and patients fish for that delicate balance between access and abandonment.

Prix Galien celebrates a new round of next generation drug technologies.

Pharmaceutical industry leaders Novartis and Merck-among others-released second-quarter 2012 results showing global sales down in third-quarter 2012, with growth in key pharmaceutical products helping to offset losses due to patent expirations.

Global Launch in the IMS Health Era

The sudden departure of EC Health Commissioner John Dalli tops an already difficult year for the European pharma regulators, writes Reflector.

No doubt the November 6th election is going to be close, very close: close for the Presidency, close for the Senate, and possibly close for the House.

Just days before the reports that R&D investment in Spanish pharma had fallen to below EUR1 billion ($1.3 billion) in 2011 for the first time since 2007.

Grey Healthcare Group - Leveraging Your Brand’s Name to Achieve Post-Patent Success

Ethics is a matter of trust, which in the regulatory space requires transparency and openness among all stakeholders, including patients and industry.

Featured panelists at ExL’s annual Digital Pharma East conference this week included practicing physicians, vocal ePatients, social media gurus and digital marketing consultants with plenty of hours logged in big pharma boardrooms.

FDA’s head of neurology products told industry execs at the Prix Galien Forum that the agency is open to alternative clinical trial designs in Alzheimer’s disease, and would like to see more combination products in clinical testing.

In a New York Times op-ed this week, a trio of physicians from the Memorial Sloan Kettering Cancer Center in New York announced their decision to remove an expensive new cancer treatment from the hospital formulary, citing cost-benefit as their reason.

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

With Halloween candy flooding the shelves in pharmacies across the nation, it’s only appropriate that we turn the conversation toward an ever-growing drug market and therapeutic area: diabetes.

Lundbeck's Big Bet

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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

Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA).

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.