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When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process for generic drugs, and combat the agency’s backlog of drug applications.

Swedish Orphan Biovitrum AB (Sobi) was last night presented with a EURORDIS Award for its commercial and development portfolio in the field of rare diseases.

Bioscience research in China is set to overtake the United States within the next five to ten years, according to data from search engine CiteAb.

Not long ago, I was privy to a discussion taking place in a large drug development services company.

Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.

The latest news on the growing cost of conducting clinical trials is becoming a major concern for company sponsors and trial co-operative groups.

In less than a decade, online video marketing has moved from a standing start to become an essential part of the digital marketing mix

This week (February 28), Europe will celebrate Rare Disease Day. This is an interesting example – one might almost say a rare example – of a successful attempt by a European interest group to capture public attention.

Any pricing or revenue management initiative is only as good as the information on which it is based.

In this short video, Brianna Cayo-Cotter, Change.org’s managing director of communications, talks to Pharm Exec about how advocacy organizations and individual patients are getting more involved in every facet of the healthcare system, from drug R&D, to federal and state policy, all fueled by the hour-to-hour passion of living with a disease.

Four class representatives have been added to a class-action gender-discrimination employment suit originally filed last May against Merck & Co. in New Jersey.

Cuts in healthcare costs due to post-recession austerity programs mean favorable Health Technology Assessments (HTAs) are becoming crucial to the successful market launch of pharmaceuticals in Europe.

America’s biopharmaceutical research companies are currently developing 180 new medicines to help the nearly 400 million people who have diabetes worldwide.

To mark its 25th year in recognizing female leadership in the tough competitive ranks of biopharma, the Healthcare Businesswomen’s Association (HBA) is opting for a breakout triple play.

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name.

As the United Kingdom debate about whether to stay in the European Union becomes more bitter and intense, an insight into how EU membership impacts on medicines and pharmaceuticals has appeared from a British politician who was until recently the UK Government Adviser on Life Sciences, George Freeman.

Accenture has launched the latest version of its annual study of the biopharmaceutical industry.

Thirty-five out of every 100 job applicants in the pharmaceutical or clinical trial space in India “are lying about their credentials”, says a report by Delhi-based employee screening firm AuthBridge.

New products in development for women distressed by a lack of sexual desire and satisfying sexual experiences are causing a stir, but not for the reasons one might expect.

The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013.

The European type 2 diabetes market earned revenues of €9.50 billion in 2009 and is estimated to reach €15.46 billion in 2017 (CAGR 3.8 percent), according to new research by Frost & Sullivan.

Approximately $12.7 billion has been invested in Latin America’s (LATAM’s) pharmaceutical market through mergers and acquisitions (M&As) in recent years.

The Patient-Centered Outcomes Research Institute (PCORI) is launching new programs that are expected to encourage more analysis of the effectiveness of specific drugs and medical products

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