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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.

There has been a lot of talk lately that ‘Big Data’ is just BS. Peter Houston looks beyond the hype to reveal what companies should be focusing on.

The radical shift currently taking place in pharma marketing is all about partnering with patients rather than talking at them

“Leaning in” might be all the rage – but “hanging in” is just as important to make sure women gather momentum in the workplace. At a meeting of the Global Women in Business Advisory Council last week in Palm Springs, CA, members discussed ways to build critical mass for stronger female participation in the workplace.

Compared to other manufacturing and technology industries, the bio/pharmaceutical industry has one of the longest product development timelines.

Congress gave final approval this week to new legislation to strengthen Food and Drug Administration authority to oversee large pharmacy compounders of sterile injectibles and to require more comprehensive tracking of prescription drugs moving through the global supply chain.

The European Medicines Agency’s ambitions are huge - as befits a body with such huge responsibilities. But its capacities to achieve what it sets out to do are now falling ever shorter.

As digital becomes a greater part of the pharma marketing mainstream, can the sector attract the digital marketing talent it needs to succeed in the space? That’s a question pondered this week by Rich Meyer on his World of DTC Marketing blog.

Can big pharma solve its fixed cost problem by going virtual? Not entirely, but drug companies can get more out of their CRO partners by treating them less like avatars and more like equals, according to conference-goers at a CBI event in The Triangle.

Big Pharma is quietly stepping up to provide critical supplies of essential medicines, other health equipment, and skilled local personnel to areas of the Philippines devastated by Typhoon Haiyan this month. Although industry operations in the Philippines appear largely intact, most companies are working through global humanitarian aid organizations due to the logistical challenges created by the collapse of infrastructure on the ground.

Oncology-market access doesn’t “just happen” anymore. As competition in the U.S. health-care market only continues to intensify, oncology-drug companies will need a good corporate strategy to ensure physician uptake and payer coverage of therapies.

At last week’s Partnering for Cures conference held in New York City, several expert panels discussed new angles of approaching solutions to disease, encouraging investment and mitigating inefficiencies in the delivery of medicines within the current healthcare system.

The future of healthcare centers on scale, population health and the value of care rather than the volume of care, according to thought leaders speaking at a leadership briefing in November in Akron, Ohio. But the political atmosphere also adds layers of complexity, they say.