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Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media.

The UK National Institute for Health and Care Excellence’s (NICE) decision that relapsed non-small cell lung cancer patients should no longer have access to Roche’s cancer pill Tarceva (erlotinib) is a setback for lung cancer care in England and Wales.

The European Medicines Agency (EMA) is 20 years old this year - and it confronts many of the problems familiar to anyone at that age.

For the first time, the spotlight shines on Russia's potential in biotechnology and pharma products

It is nowadays fashionable to question everyone in authority, and there is no shortage of self-appointed watchdogs who aim to make sure that things that happen are happening as they should.

It is tempting to imagine the use of the patient’s own mobile computing platform for collection of patient reported outcomes.

New research from Frost & Sullivan reveals that the global biosimilars market earned revenue of about $1.2 billion in 2013 and could reach $24 billion in 2019.

The gastrointestinal (GI) therapeutics market for Irritable Bowel Syndrome (IBS), Ulcerative Colitis (UC) and Crohn’s Disease (CD) in the Asia-Pacific (APAC) region will increase in value from $564m in 2012 to $784m by 2019 (a CAGR of 4.8%).

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance.

The initial proposals for Value Based Pricing (VBP) in the UK have evolved into something very different. There is now a focus on Value Based Assessment (VBA).

To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over.

Staying on top of the marketing information stream can be difficult for your customers, but plans for a ‘holistic’ healthcare network could make relationships easier to manage.

FDA has reported that it notified Ranbaxy Laboratories, Ltd., on Jan. 23 that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products.

Pharm Exec’s EU correspondent, Reflector, looks at some of the European regulatory developments earmarked for 2014 and anticipates their effect on the industry.

Pharm Exec begins its 34th year with a feature on Russia's ambitious plans to build a homegrown biopharma business. Back in 1980, the biotech industry did not exst. Drugs were still classified as chemicals, developed from the random screening of many thoughts.

Back in 1980, the biotech industry did not exist.

Tom Norton outlines the Obamacare-related questions that are likely to be of concern to pharma companies in the U.S. this year.

The IMS Institute for Healthcare Informatics worked up a methodology for assessing the effectiveness of pharma’s social media efforts across Facebook, Twitter and YouTube.

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays.

Europe’s Innovation Medicines Initiative (IMI) has appointed experts from Portugal and Finland to chair the IMI Scientific Committee.

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action.

Pharma marketers have been clamoring for clear advice from the Food and Drug Administration on how to accommodate established rules governing drug promotion to today’s world of internet communications and social messaging.

As expected, the Food and Drug Administration (FDA) approved only 27 new molecular entities (NMEs) in 2013.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process, writes Sean Milmo.

The headlines have moved on for the English Cancer Drugs Fund (CDF). Replacing the positive press releases such as “thousands of patients to benefit” in 2013 are headlines shouting out that “thousands face being denied life-extending medication”.

Two weeks in and the New Year already seems old. Yet members of our Pharm Exec Editorial Advisory Board are still eager to share their top of line predictions on trends that will shape the industry’s business and reputational assets.

Change has never been the word most associated with pharma. Irrespective of a record-breaking number of newly approved drugs over the last two years, a new report just out warns that continued growth is not sustainable unless R&D efficacies at drug companies are addressed and new paradigms adopted.

By using digital signatures to eliminate paper from signature approval processes, pharmaceutical companies are achieving automated processes that are efficient and cost-effective without compromising security or compliance.

It is not only the specific issue of clinical trials rules that hangs in the balance as Europe shifts from 2013 to 2014.