Having trouble viewing this email? View in Browser.
BioSpace BioPharm Exec
Wednesday, July 27, 2011
Facebook  |  Linked In  |  Twitter  |  RSS  |  Subscribe

FDA, Faster Than Ever?

At the recent BIO annual convention in Washington, D.C., Biotechnology Industry Organization president Jim Greenwood offered up a legislative blueprint to revamp the mission of FDA's (we previewed it briefly last month). Among the proposals were to make FDA an independent agency of government--rather than arm of the Department of Health and Human Services -- and to make promotion of innovation part of its mission. BIO is even seeking to change the agency's system of basing approval decision on two well-controlled clinical trials. The proposal would instead have approval hinge on the "weight of evidence."

All bold stuff, if unlikely to find much traction in Congress anytime soon. But BIO's bold reform initiative is at least in part an expression of industry frustration with the current state of FDA, which they say is approving too few drugs, too slowly, with too many strings attached. More...

More By Karl Thiel

ViiV Healthcare, the 85/15 HIV joint venture between GlaxoSmithKline and Pfizer, looks to have a winner with dolutegravir, a novel HIV integrase inhibitor. The only approved drug in this class is Merck's Isentress, but dolutegravir looks better so far. And it also looks potentially more potent than Gilead Sciences' elvitegravir, a part of the "Quad" pill that company is developing. With the vast majority of Gilead's revenue coming from HIV drugs and patent expirations coming in several years, you can bet the folks there are nervously watching the progress of ViiV. -KT

GlaxoSmithKline (GSK)-Pfizer Inc. (PFE) AIDS Pill May Dislodge Bristol-Myers Squibb Company (BMY)'s, Study Suggests
More...

Nabi Biopharmaceuticals (NABI) Shares Plunge After Smoke-Cessation Drug Shown Ineffective in Study
More...

Sanofi (France) (SASY.PA)/Regeneron Pharmaceuticals, Inc. (REGN)'s Sarilumab Shines for Rheumatoid Arthritis, Fails in Ankylosing Spondylitis in Phase 2b Trial
More...

Genentech (RHHBY) Drug Impresses in Phase III Trial; to Seek Approval by Year End
More...

Amylin Pharmaceuticals, Inc. (AMLN), Alkermes (ALKS) Shares Jump on Success in Bydureon Study
More...


More Bench To Clinic News
FDA is getting a little more hierarchical after a broad reorganization by Commissioner Margaret Hamburg that will channel reporting through a number of new directorates. Perhaps more significantly, Hamburg has created a new Deputy Commissioner for Medical Products and Tobacco and named Dartmouth University Medical School Dean Stephen Spielberg to the post. Spielberg will "provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products," although management will remain with the heads of each of the Centers.
-KT

Teva Pharmaceutical Industries Limited (TEVA) Axes 340 Jobs, to Close Plant in Mirabel, Quebec
More...

Forest Laboratories, Inc. (FRX) Pushes New Board Members in Fight Vs Carl Icahn
More...

FDA Restructures Upper Management
More...

Merck & Co., Inc. (MRK) Job Cuts to Pick Up Steam
More...

Merck Serono Reorganizes R&D, Attracts Former Bristol-Myers Squibb Company (BMY) Medical Head
More...


More Career Track News
Bristol-Myers Squibb has over the past several years restructured itself as a lean, mean, pure pharma R&D organization, and it is looking to keep the pipeline flowing with the acquisition of Amira. It isn't coming cheap though--the company is paying $325 million upfront...largely for AM152, a potential treatment for idiopathic pulmonary fibrosis and scleroderma that has only just completed phase 1 trials. It's putting far less up front in its oncology deal with Innate Pharma, although there are large potential payments down the road. The In Vivo Blog notes that the price tag on early stage (i.e. phase 1) partnerships has skyrocketed over the past few years in oncology; perhaps the same is becoming true in other therapeutic areas.
-KT

Bristol-Myers Squibb Company (BMY) to Pay Up to $475 Million for Amira Pharmaceuticals, Inc., Scoops Up Lung Drug
More...

Novartis AG Ends Pursuit of Gen-Probe Incorporated (GPRO)
More...

AMAG Pharmaceuticals, Inc. (AMAG), Allos Therapeutics, Inc. (ALTH) to Merge in $686 Million Deal
More...

Micromet Inks Cancer Drug Deal With Amgen (AMGN) Worth Up to $1.01 Billion
More...

Bristol-Myers Squibb Company (BMY), Innate Pharma (IPH.PA ) Announce $465 Million Deal for an Investigational Immuno-Oncology Biologic; Innate to Receive $35 Million Upfront, Shares Soar
More...


More Golden Handshakes News

Top Jobs
• BioCanada East (Toronto, Canada)

Ontario Institute for Cancer Research
Executive Positions
Two positions available: Chief Operating Officer and Head of Research Operations. Join an international leader at the forefront of discovery and innovation in cancer research.

• Biotech Bay (Anywhere in the U.S)

Cardica, Inc.
Vice President, Global Sales & Marketing
The Sales Executive is responsible for the development & execution of strategic and tactical sales & marketing plans to ensure commercial success of Cardica's product suite, while achieving global revenue and product sales objectives. Hire, train, develop and lead a high performance sales organization.

• Genetown (Lexington, Massachusetts)

Cubist Pharmaceuticals, Inc.
Sr. Director - Biometrics
Serve as the premier technical leader within biostatistics, liaise with product strategy teams, and communicate therapy area plans and strategy to colleagues in Biostatistics, Clinical Research, Regulatory, and other functions. Guide and monitor the selection of appropriate statistical methods for the analysis of clinical study data. Provide input to CDPs. Review protocols, statistical analysis plans, and case report forms, and regulatory statistical documents such as CSRs, as well as summary documents for rigor, consistency and clarity etc.

• Biotech Bay (Bay Area, California)

Setren, Smallberg & Associates, Inc.
Vice President, Clinical Affairs
The VP of Clinical Affairs will join a multidisciplinary research and commercialization team to direct the clinical evaluation of new drugs. The majority of the Companys research is focused in the area of metabolic diseases. This individual will have responsibility for primary clinical leadership experience for a number of internal medicine related therapeutics in late phase 2 and phase 3 stages.

Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center!

Most talk about stem cells relates to the wonderful things we hope to one day do with them. Verastem, on the other hand, wants to kill them. Or, more specifically, they want to kill cancer stem cells--the hard-to-kill, self-renewing cancer cells that are thought to drive metastasis. There are some heavy hitters among the founders, including Robert Weinberg of MIT's Whitehead Institute at Eric Lander of the Broad Institute of MIT and Harvard University.
-KT

SARcode Pulls in $44 Million Series B Financing
More...

Verastem, Inc. Nabs $32 Million Series B Financing
More...

DVS Sciences Raises $14.6 Million in Series A Financing to Advance Commercialization of Novel Single-Cell Analysis Technology
More...

Merrimack Pharmaceuticals Inc. Files $172.5 Million IPO
More...

Zafgen Secures $33 Million Series C Financing
More...


More Money Talk News

It wasn't the best month for Teva. The company has been enjoined from selling Neutroval in the U.S. until November 10, 2013, having acknowledged that the product infringes two Amgen patents. And before Teva management could breathe a sigh of relief that the issue is at least resolved, trouble reared its head again. The Feds are looking into Cephalon's alleged off-label promotion of Treanda, a treatment for chronic lymphocytic leukemia. The Department of Justice is looking into allegations that reps and company-sponsored speakers have been promoting the drug as first-line treatment of non-Hodgkin's lymphoma, for which it is not approved. Teva is in the midst of wrapping up its $6.2 billion acquisition of Cephalon and would probably prefer to avoid the distraction. As we've seen with some of the major pharma mergers, legal problems at an acquired company can be a headache of the parent for a long while after the ink is dry.
-KT
Johnson & Johnson (JNJ) Blames Staff Cuts, Pfizer Inc. (PFE) Deal for Tylenol Recall Flood
More...

Amgen (AMGN) Resolves G-CSF Patent Litigation With TEVA Pharmaceuticals USA (TEVA)
More...

Cephalon, Inc. (CEPH) Probed by Department of Justice for Treanda (CEPH)
More...

Gilead Sciences, Inc. (GILD) Kickstarts Patent Pool for AIDS Drugs, Agrees to Let Generic Companies like Mylan Inc. (MYL), Ranbaxy Laboratories (RANBAXY.BO) Make Them
More...

Pfizer Inc. (PFE) Sues Aurobindo Pharma for Patent Violation
More...


More Legal Briefs News
AstraZeneca won what one analyst called a "Pyrrhic victory" in gaining FDA approval for the blood-thinner Brilinta. While it is an alternative to the mega-blockbuster Plavix that proved superior in extending survival in some studies, its approval came with a series of strict warnings and limitations. Moreover, it got the green light only shortly before Plavix goes generic later this year. Once considered the most important drug in AstraZeneca's pipeline, most analysts now expect muted sales. AstraZeneca first submitted the drug for approval in 2009, but FDA asked for more data on U.S. patients.
-KT
FDA Approves AstraZeneca PLC (AZN) Heart Drug Brilinta
More...

FDA Panel Rejects AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Diabetes Pill
More...

National Institute for Clinical Excellence (NICE) Proposes to Disapprove the Use of the Drug Novartis AG's Lucentis; Diabetes Groups Outraged
More...

FDA Panel Backs Seattle Genetics, Inc. (SGEN) Lymphoma Drug Adcetris
More...

Roche (RHHBY) Loses UK Appeal Over Long-term Tarceva Use
More...


More Rockville Files News

Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.

You may contact Karl Thiel at Karl.thiel@biospace.com.

BioSpace, Inc.
6465 South Greenwood Plaza, Suite 400
Centennial, Colorado 80111 U.S.A.
Phone: 877-277-7585
Fax: 800-595-2929
BioSpace, Inc.
90 New Montgomery Street, Suite 414
San Francisco, California 94105 U.S.A.
Phone: 877-277-7585
Fax: 415-576-9217



If someone forwarded this news to you and you'd like to receive your own complimentary monthly copy, simply Subscribe here.

Safely unsubscribe from Biospace.com e-mail at any time by managing your account here.
BioSpace in an onTargetjobs company