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For more than fifty years the basic European Union rules about medicines have been clear.

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency.

Happy New Year! We at PharmExec are looking forward to a busy and hopefully fortuitous 2014. For our colleagues in the Northeast bracing for yet another snow storm – and for those of you with better short-term environmental prospects – here are the 10 most-read stories published on PharmExec‘s blog during 2013, in case you missed them:

FDA’s new Breakthrough Therapies designation sped Pharmacyclics/J&J’s ibrutinib (brand name: Imbruvica) through regulatory review in four months, based on Phase 2 studies. Pricing and access issues, though, may not get resolved so quickly.

PEGD 2014 Media kit

European Union (EU) regulators today reached agreement on the much-vaunted Clinical Trials Regulation. The regulation harmonizes the rules for the conduct of clinical trials in the EU and the ‘acceptability’ of the resulting data, and places further safeguards on the safety of trial subjects.

Bristol-Myers Squibb has agreed to sell its global diabetes business that was part of its collaboration with AstraZeneca for $2.7 billion with potential regulatory- and sales-based milestone payments of up to $1.4 billion and will make royalty payments based on net sales through 2025.

The global Parkinson’s Disease market will decline from $3.4 billion in 2012 to $2.9 billion by 2019 (a negative Compound Annual Growth Rate of 2.3%), according to a new report by GBI Research (New York, NY).

FDA’s push for abuse-resistant opioid formulations will disrupt the pain market, say analysts Frost & Sullivan.

The number of drugs developed in Turku, Finland, and granted marketing authorizations this year now stands at three, with a fourth expected to follow.

In a bid to improve transparency in 2014, the European Medical Agency’s December Management Board Meeting cleared the way for the publication of the agendas and minutes of the Agency’s Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Advanced Therapies (CAT).

Amid the environment of a gradual economic recovery and continued consolidation of bio/pharmaceutical companies, scientists, technicians, and professionals involved in drug development expressed a mix of muted optimism and stagnant employment options.

GlaxoSmithKline (GSK) will invest £200 million ($327 million) to expand its manufacturing facilities in Ware, Hertfordshire and Worthing, Sussex in the United Kingdom and establish a new manufacturing innovation facility.

Despite a patent expiry in 2010, generic versions of Advair aren’t expected to appear on the market for two more years. It took FDA eight years to develop a blueprint for how generics manufacturers might establish an acceptable bioequivalence for Advair, GSK’s blockbuster fluticasone propionate/salmeterol xinafoate combo inhaler.

Collaboration seems to be ‘in’ thing and it’s set to continue in Europe with the European Medicines Agency (EMA) and EUnetHTA agreeing a three-year joint work plan.

The Patient-Centered Outcomes Research Institute (PCORI) has approved a two-year commitment to spend more than $1 billion in funding for comparative effectiveness research (CER) projects.

I find December a fairly schizophrenic month. Half of your head is thinking back to what you’ve achieved, half of your head is focussing forward to what you will do in the New Year. Looking back on 2013, I re-read Should CEOs use Social Media?, a post I wrote back in February encouraging pharma CEOs to show their faces on the social networks. Looking forward, I wonder if CEOs will actually do it in 2014?

At a time when burst bubbles have created uncertainty for investors in the biomedical realm, it’s smart for a drug company to make use of new legislation and emerging trends in venture capital. This is particularly true in spurring confidence in that translational area of drug development many deem the “Valley of Death”.

The pursuit of excelMedal_4mpix__MG_0199-150x150lence in biopharmaceutical innovation in Russia has never had a sponsor-until now. Prix Galien International, a global network of Nobel laureates in medicines, established its 18th country beachhead in Moscow earlier this year, culminating in a historic first: an October 24 awards dinner to recognize the best in new drug research as well as innovation in biotechnology and pharmaceutical products.

Dr. Jan Lundberg, EVP science and technology and president Lilly Research Labs, Lilly & Co., sits down to discuss the company?s new approach to drug development and its Phase III pipeline.

The European Commission mandated that all member states have a plan for rare diseases back in June 2009. With the EC deadline just weeks away, the UK has now finalized its own.

Why do some doctors prescribe more generic drugs than others?

For senior executives, meeting the requirements of a Consent Decree to the satisfaction of regulators is only half of the job.

New and emerging technologies are noteworthy not simply for the excellent science behind them but also for the way they expose those raw edges of the industry's business model.

So, we’ve experienced two months of Obamacare. How is the U.S. pharmaceutical industry doing with this new program? I spent two weeks getting the opinions of several Rx representatives on their experience with Obamacare, as well as their thoughts on how it is impacting their marketing, sales, and R&D planning for 2014 and beyond.

The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in US to prevent this deadly disease, when such a therapy is approved in Europe and Australia.

New and emerging technologies are noteworthy not simply for the excellent science behind them but also for the way they expose those raw edges of the industry’s business model. In biopharma today, disruptive changes to the model are being driven by two forces.

The annual worldwide antibiotic awareness event - celebrated in Europe on November 15 - generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers

The pharmaceutical sector needs to shape up to deal with the big uptake in bribery and corruption enforcement actions - and not just in the USA, write Toby Duthie and David Lawler.

Poorer people are being prescribed more expensive branded drugs. Is that bad? According to a new investigation it is. And it is costing the taxpayers a shovel-load of money. Furthermore, it’s unnecessary.