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India has the potential to become a “global innovation hub” for the biopharma industry, but without greater investment and regulatory reforms the opportunity may not be fully realized.

A report by The Boston Consulting Group released last week says the country must encourage greater investment and activity in bioinformatics, applied research, and translational research to maximize opportunities for R&D in the life sciences. Read the rest of this entry »

The question of whether outside pharmaceutical sales reps should get overtime  made it to the U.S. Supreme Court last month. A ruling, which will affect the estimated 90,000 reps working in the U.S., is expected by the end of June. Two federal courts came to opposite conclusions on applying the Fair Standards Labor Act to the pharmaceutical industry. The FLSA exempts outside sales people from overtime requirements, so the issue before the Court is whether PSRs are covered. SHRM

Making its biggest acquisition in five years, AstraZeneca says it will buy Ardea Biosciences Inc. for $32 a share, a 54% premium over Ardea’s closing price Friday. Ardea is in the third phase of clinical testing lesinurad, its urea reducing drug for the treatment of gout. The San Diego-based Ardea also has cancer treatment drugs in mid-stage testing. For AstraZeneca, the acquisition, valued at $1.26 billion, may be the first of more this year. BusinessWeek

Amylin Pharmaceuticals, which rebuffed a takeover offer from Bristol-Myers Squibb, now has Carol Icahn to deal with. The billionaire investor filed suit against Amylin yesterday after the company refused to extend its deadline for nominating board members. And he says he’s ready with another suit if he doesn’t get copies of Amylin’s books and records by tomorrow. A 10% owner of Amylin, Icahn criticized the board of directors for turning down the $22 a share Bristol-Myers Squibb offered. Amylin, a former research organization, began commercializing its diabetes research in 2005 when it introduced two diabetes medicines. The Wall Street Journal

Pharmaceutical companies are missing an opportunity by focusing on generics, and branded generics when they do business in the world’s emerging markets. McKinsey & Company consultants say the second largest pharma market in the emerging world — Brazil –  is hungering for trustworthy, branded medicines and would pay a premium for them. To be sure, say the authors of a new report on opportunities in Brazil for Big Pharma, not everyone is a candidate for patented meds, but nearly half the country’s 120 million middle class citizens are. And that, says McKinsey, translates into “a large, profitable opportunity.” McKinsey Quarterly

Could be that the days of in-house R&D by the big pharmaceutical companies are waning, and outsourcing (in a sense) the development of new drugs is rising.

That’s more or less what Sanofi CEO Chris Viehbacher told journalists during the CED Life Sciences Conference last month. In a novel — for Big Pharma — deal, Sanofi partnered with a venture capital firm to launch a biotech firm. Warp Drive Bio will develop natural product drugs while Sanofi may handle the licensing and marketing. Read the rest of this entry »

Big pharma is going through so profound a marketplace change that alone in the life sciences industry the sector views the future with uncertainty, hesitant to take the plunge on training and performance management to achieve the customer-centric approach its leaders claim they want.

Hay Group consultants say that even after making deep cuts in their sales force the last few years, half of all pharmaceutical companies believe they are still overstaffed. Many report plans to make further reductions ranging from 6% to 15%.

A report in Pharm Exec by Hay Group practice leaders and authors of the 2011 Annual Study of Sales Force Effectiveness talks about the “dramatic structural change” in the pharmaceutical marketplace and Big Pharma’s response. Read the rest of this entry »

Just because you’re a reader of this blog, we have a special gift for you: An extra day next month to catch up on things.

OK, OK. Caught us. It’s leap year, so everyone will get that extra day. But hey, if you’d rather use it for fun, then stop doing stuff that only offers the illusion of working.

You know what we’re talking about. Things like checking your email every time that message icon pops up, or dropping what you’re doing to respond. Or actually reading every article on a Reply All list. Read the rest of this entry »

Are pharmaceutical sales representatives entitled to overtime? Like any question that involves laws and lawyers, the answer is “It depends.” In the west, at least that part covered by the 9th District of Appeals, the answer is no. In New York, Connecticut, and Vermont, where the 2nd District appeals court reigns, the answer is yes. The two courts applied the same Fair Labor Standards Act and came up with opposite results. The U.S. Supreme Court may have to step in to resolve the matter. Until then, read this then call your lawyer.

The co-chairs of next year’s Partnerships in Clinical Trials conference are calling for radical changes in the way trials and clinical research are conducted.

“The world has dramatically changed, yet this industry still more or less conducts clinical research exactly as it did 20 years ago,” said conference Co-Chair Deirdre BeVard, vice president of development operations at Endo Pharmaceuticals. “Sponsors and CROs together need to rethink our approach to clinical operations and partnering if we’re to keep up with all of the changes taking place around us.”

The program she and her co-chair, Pfizer SVP of Global Development Dr. John Hubbard, are finalizing emphasizes discussion on innovation and collaboration, in addition to education. Read the rest of this entry »