The FDA continues to fret over weight loss treatments.  A new weight loss treatment has not been approved in more than a decade.  In the past two years alone, the FDA as rejected pills from all of the three small drugmakers focused on obesity:  Arena Pharmaceuticals, Orexigen Therapeutics and Vivus.   And, all three continue to press the FDA on their decisions by  resubmitting their products.

Vivus is up next….again.  The CA-based company has an advisory panel decision next week and an April time frame for a final FDA decision.  This following its initial rejection in October 2010 over two safety concerns.

So how will it play out?  Doctors believe new weight-loss therapies are desperately needed.   Investors know that even a modestly effective drug could have blockbuster potential.  But none of the three medicines before the FDA represents a breakthrough in research.  For certain, the next two months will go a long way toward deciding the fate of these specialty pharmaceutical companies and whether the industry as a hole should consider weight loss a viable category moving forward.

MSNBC

While venture markets, drug approval and the overall economy are lagging, investor markets seem to be bullish on biotechnology in early 2012. Proof? The S&P biotech index is up 13% so far this year.

While at the BIO CEO Investor conference this week, CEO of Alkermes, Richard Pops, shares his opinion of what’s behind the surge.

Some of our team at Beaker had a chance to watch Chris Viehbacher, CEO of Sanofi, speak this week. He is wildly impressive but was also the 2nd place finisher in the race to lead GlaxoSmithkline following the retirement of JP Garnier. Viehbacher obviously lost to Andrew Witty but the two are remarkably similar in their leadership style, communication and strategy toward leading Sanofi and GSK.

In this interview, Witty breaks down GSK’s Q4 profit and prospects moving forward in 2012. So, who is the better Big Pharma CEO?

Gilead Sciences set the industry on fire just months ago and sparked a frenzy over potential hepatitis C therapies with its $11 billion purchase of Pharmasset.  Most saw the acquisition price as staggering if not irrational for a Phase II product from a company with less than 125 employees.  Now some bad news leaves Gilead in a vulnerable situation, after some patients relapsed after stopping therapy.

Among eight patients with the most common form of hepatitis C in the US, six had a viral relapse within a month of stopping treatment.  The other two are still under treatment but have not relapsed.

Gilead’s purchase of Pharmasset was a bet on the promise of a $20 billion market in hepatitis C.  And, the move immediately triggered other deals, including BMS acquisition of Inhibitex for $2.5B and Roche acquiring Anadys for $230 million.

Analysts are playing both side of the fence, depending upon who they follow.  Gilead supporters claim it’s a limited patient group and the most challenging form of the disease.  Competitors like Vertex are praising the strength of their own treatments in comparison.

This story sounds much like the disappointments suffered by Roche with Avastin following its acquisition of Genentech, even with differences in therapeutic category, purchase price and this being only early clinical feedback.  Regardless, Gilead now has $11B in chips on the table with the cards still yet to be dealt.

Pharmalot

In the past, the CEO’s of Amgen, Gilead, Genentech, Chiron, Immunex and others would attend the BIO International convention every year.  When the convention became overwhelming, they started attending this more exclusive CEO event.  Now they send Business Development executives on their behalf to source deals.  So where do CEO’s hang out?  Most are now wedded to only the biggest events of the year, led by major investment banks (re: JP Morgan Healthcare Conference).

The BIO CEO Investor conference just wrapped up in New York City.  The two-day conference, put on by BIO typically spotlights smaller companies seeking an audience in front of larger biotechnology companies, venture capitalists, and investment banks.

TheStreet.com was live blogging the event on Day 1 and Day 2 with summaries of the lead stories from the conference:

The 2.3% medical device levy is more of a tax issue than a health reform issue, and repealing it “is the first down payment on much-needed tax reform,” according to AdvaMed President and CEO Stephen Ubl.

In doing what its member companies expect, Advamed is pulling out all the stops to give legislators a reason to overturn the excise tax before its institution next year.  Lawmakers included it to help pay for Obamacare, but the industry has been positioning it as a penalty and a stifling threat to job creation and innovation within the US medical device industry.

The looming question is whether they can rally enough support to enact any reversal of the bill that has already been passed.  Early this week, a group of 75 legislators sent a letter to the House GOP leadership calling for a floor vote on the Protect Medical Innovation Act of 2011 aimed at repealing the tax.

DOTMed.com

MassDevice.com (Boston)

Severin Schwan, Roche CEO, discusses Roche’s offer for Illumina. CNBC’s Faber does a great job digging into the motivations of Roche in pursuing Illumina. He even quotes Craig Venter who himself questions the rationalization of the deal, in such a changing market for sequencing. As we’ve learned from Roche’s acquisitions of Ventana Medical Systems and Genentech, the company will be doggedly determined in its desire to complete the deal. If history is any indicator, it’s only a matter of time.

Based just outside Boston, Abiomed is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. The company’s products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart.

The company recently released record revenue and strong earnings performance for the past quarter. CEO Michael Minogue, discusses those results and future performance potential with Mad Money’s Jim Cramer.

FierceBiotech has released its 25 Most Influential People in Biopharma list.

These lists crop up once every few months from different sources.  Many of the names are consistently present; others offer a surprise. For us, its difficult to leave off the biomedical, medical device and diagnostics leaders who should be considered.  If you’re going to include Severin Schwann of Roche and Jim Greenwood of BIO, how can you not consider Bill Weldon from J&J or Stephen Ubl from Advamed?  Fierce also fails to put them in order.  So is Commissioner Hamburg less influential than any Wall Street analyst?

A handful of CEO’s, thought leaders and government bureaucrats headline this list, along with the interesting addition of 2-3 industry financial analysts.  Did your CEO make the list?

FierceBiotech

New Jersey Governor Chris Christie has lost his Chief of Staff to the pharmaceutical industry.  What else do expect in Big Pharma country?

Richard Bagger joined Celgene at the end of January in a newly created position with the pharmaceutical company.  Bagger serves as senior vice president, corporate affairs and strategic market access, with responsibility for all government and public affairs, strategic market access, communications and patient advocacy initiatives.

Prior to working for the governor, Bagger worked at Pfizer for more than 16 years until 2010, serving in several posts from government relations to public affairs.

MedCity News