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 Sprinting to the Finish
Could it really happen this time? The Obama Administration is pushing health care reform forward with tremendous force and alacrity, such that we may know in the next couple months whether one of the fundamental goals of the Obama presidency is achieved or not. Obama has said he wants a House version of a bill passed before Congress's August recess--a stunning pace for reform that has been over 70 years in the making. But that's the point: Obama doesn't want anyone to debate this too long, doesn't want negative lobbying and campaigns to gain momentum, doesn't want red state (and other) legislators to spend too long getting an earful from constituents during recess.
While history would suggest that Obama faces long odds in getting any sort of reform passed (think of large-scale failures in the Clinton, Nixon, Truman, Eisenhower, and Roosevelt administrations), Obama may be enjoying a historical alignment of the stars that hasn't happened since Medicare and Medicaid were created under the Johnson Administration in 1965. Part of that is circumstance--Democratic majorities in both houses of Congress, a high level of dissatisfaction with the status quo, and a period where trillions are already flowing out of taxpayers' pockets--but part of it is also strategy. Obama is willing to let Congress iron out the details as long as they meet some broad principles, a far cry from the we-know-what's-best executive fiat that marked the effort of the Clinton Administration. More...
More By Karl Thiel
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"How can you mend...a broken heart?" the Bee Gees once asked. Well, not with Merck's rolofylline, apparently. The highly-touted acute heart failure drug, once considered to have blockbuster potential, failed to meet primary or secondary efficacy endpoints in an interim analysis from a phase 3 trial. And there was more heartbreak to go around this past month--at Osiris, Insmed, and Cephalon, certainly, with at least a couple stifled sobs among Exelixis shareholders (I'm one of them). As is so often the case, the encouraging news seems to be coming from earlier in the development cycle. But wait! Is that...good news from...from...Jazz Pharma?!
-KT
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PPD: Gain the competitive advantage by partnering with one provider for central lab and product development services. PPD is a leading global contract research organization (CRO) providing discovery, development, post-approval and central lab services. As a CRO that combines clinical and lab data in real-time, we increase efficiencies and achieve accurate results faster, accelerating your development timelines. To learn more about PPD's Global Central Labs and other services, click here.
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Aptuit is a pharmaceutical services company focused on streamlining and supporting the drug development process for biotech and pharma innovators. Aptuit has been engineering a better drug development process by amassing a staff of consummate professionals, breakthrough technologies, facilities and new ideas to offer its clients seamless and globally integrated services.
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Hollis-Eden has found a new leader, three months after founder Richard Hollis was terminated under somewhat mysterious circumstances. He was fired "for cause," but the exact reason was never disclosed. Certainly the company hadn't flourished under his leadership, and nor is it flourishing now, having recently reported poor data for its diabetes drug. Richard Hollis won't be alone in unemployment, of course--the French newspaper La Tribune reported that the combined Merck and Schering-Plough will employ about 15% fewer people than the two companies separately, a big uptick in what had been a slowing rate of big pharma layoffs.
-KT
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Crown Bioscience
is a US-based oncology service company committed to advancing anti-cancer therapeutics through the preclinical and drug development stages. Our multi-disciplinary team of experts, located in two research campuses in Beijing and Shanghai, provides an integrated service solution from your idea to an enabling IND, including: preclinical, translational and clinical capabilities. Visit www.crownbio.com or call us at 603-686-9330.
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Solvias: BioPharmaceutical Analysis. Our biopharmaceutical services begin with our capability to understand the composition of your drug product or substance. At the heart of our services are method development and validation of QC and stability-indicating methods under cGMP, according to ICH guidelines.
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GlaxoSmithKline--you know, the big pharma company that's not in the midst of a merger--has been busy lately on the dealmaking front--not just with Chroma and Concert (detailed below), but in generics and vaccines with Dr. Reddy's and Shenzhen Neptunus, respectively. While these newer deals aren't quite the option alliances Glaxo and other big pharmas have come to favor lately, they do appear to be in the "show-me" category: Relatively modest upfront investments with the big payments pushed out into the future. I say they appear that way because Chroma offers zero details on the terms. It's a vaguely defined "$1 billion" deal that's all about hyperbolic biobucks and nothing about what the company is actually likely to get. The disintegration of Glaxo's partnership with Synta this month, less than two years after it began, illustrates the point: That was another "billion dollar" deal, but Synta didn't actually get a whole lot beyond its $80 million upfront payment and $50 million in milestones it achieved until now. And that was a single-product deal a whole lot more likely to reach its full potential than multiple-product target deals counting on multiple approvals.
There's other excitement this month as well, including a rare Genentech partnership and some intra-pharma relationships, and more!
-KT
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• Biotech Bay (Burlingame, California)
Epitomics, Inc.
Vice President of In Vitro Diagnostics
The Vice President of In Vitro Diagnostics will have primary responsibilities for the growth and quality leadership of the Company in the area of diagnostics. He or she will be directly responsible for all aspects of the diagnostic businesses.
More...
• Pharm Country (Bridgewater, New Jersey)
Abraxis BioScience
Vice President, R&D Operations and Program Management
Work with functional departments and project teams to manage the annual budgeting process for the R&D organization. Work with senior management and Program leaders to facilitate the R&D operating goal process and ensure integration with project teams and corporate goals.
More...
• Biotech Beach (San Diego, California)
Amylin Pharmaceuticals, Inc.
Vice President, Medical Development
Lead cross-functional groups charged with executing the various aspects of Medical Development plans and operations to ensure continuity across the entire development cycle. Lead Medical Development teams to insure that all outputs needed to support the activities outlined in the approved work plan for the R&D Strategic Relations group are met.
More...
• BioMidwest (St. Louis, Missouri)
KV Pharmaceutical
Vice President, General Counsel and Secretary
Provide legal guidance to the CEO and to the Company's Executive Committee to assist in the development and execution of the Company's annual plans. Act as primary legal advisor to the Board and has an independent duty to them. In addition, serves as a member of the management team that works to advance management's agenda and proposals.
More...
Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center!
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BioSpace Career Fair at WBBA Summer Social Seattle
Thursday, July 16, 2009. This Life Science Career Fair is being held in conjunction with the WBBA Summer Social. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device companies and research institutes across the Northwest.
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BioSpace Career Fair at Drug Discovery & Development Week
Tuesday, August 4, 2009. BioSpace is pleased to present the BioSpace Career Fair at Drug Discovery & Development Week in Boston, MA -- a career event devoted to the biotechnology, pharmaceutical, medical device and diagnostics industries. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the northeast region.
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Arena Pharmaceuticals could count its quarters of remaining cash on the good fingers of Django Reinhardt's left hand... That is, until Deerfield Capital swept in, as it so often seems to for the huddled masses of undercapitalized biotechs. Companies that could only raise debt, not equity, in a world that has grown to hate debt, have been in a tough place over the past few months, but things appear to be improving slightly, with more equity deals and even (gasp) an kinda-sorta biotech IPO.
-KT
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Green Pharma Summit
Pharmaceutical companies are discovering that going green is not just for altruistic reasons, but that going green actually has benefits to the bottom line. The Green Pharma Summit offers cutting edge case studies from large & small Pharma, EPA, FDA, Academia and more. The premier event for pharmaceutical executives working to advance their corporate sustainability efforts through the application of environmentally sound initiatives throughout the entire product life cycle.
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qPCR Symposium USA. The 3rd qPCR Symposium USA features keynote speech, presentations by experts on latest developments in the industry, applications and academic perspectives from eminent scientists. The Symposium is also hosting exhibition, poster session and related courses. For more information, visit www.qpcrsymposium.com.
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One of the big sticking points in the debate over a biogeneric bill (ahem, I mean legislation for an abbreviated regulatory pathway for follow-on biologics) concerns the exclusivity period that innovator products should enjoy. While Henry Waxman originally proposed a five-year period, most subsequent bills have settled on a 12-to-14 year timeframe. Now the Federal Trade Commission has come back and said that's too long. They suggest that most biogenerics won't be discounted more than 10% to 30% from the brandname drug price, that innovators will likely maintain strong market share even after the launch of follow-on products, and that the lengthy exclusivity period will stifle innovation. That's going to spark a whole new debate and perhaps kill chances of any kind of biologics bill getting attached to the larger piece of health care reform legislation that the Obama Administration (rather incredibly) hopes to pass before the August recess. I'm not sure what the right number is here, but the FTC does raise some interesting points. -KT
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Medical Device Daily Executive Compensation Report 2009
This exclusive report offers a detailed snapshot of executive compensation package information at 95 publicly traded medical device companies. The new Medical Device Daily Executive Compensation Report 2009 provides you with a variety of perspectives on compensation issues by means of key statistics and graphic analyses.
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Pharmaceutical Company Outlook to 2013 -- SAVE 15%
Gain a true understanding of the threats facing the pharmaceutical industry's sales performance and which sectors will be most heavily impacted. Assess the effectiveness of cost-cutting programs on operating profit performance in a period of low sales growth. Evaluate the impact of M&A on companies' historical performance and see how low top-line sales growth could prompt a further wave of consolidation.
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It's hard to overstate jut how critical prasugrel is to Eli Lilly. Lilly loses patent protection on its top seller, Zyprexa, in 2011. Its number two brand, Cymbalta, goes off patent in 2013. It hasn't launched a new drug in the U.S. since Byetta in 2005. Yet blood-thinner prasugrel looks like it could challenge mega-blockbuster Plavix and buoy Lilly's fortunes. The company already has a European approval under its belt, and a unanimous thumbs-up from an FDA advisory panel. Phew!
You can imagine, then, how Lilly CEO John Lechleiter must have felt when Victor Serebruany, one of the inventors of prasugrel, wrote a letter to FDA criticizing the studies used to support the application and urging the agency not to approve the drug. To make his missive, Serebruany teamed up with industry gadfly Public Citizen, which has a pretty spotty track record in its apparent mission to gut most of the U.S. pharmacopeia. Nevertheless, whether or not FDA lends an ear to Serebruany's warnings, it hardly tees up a nice launch for the drug. Execs at Bristol-Myers Squibb must be rubbing their hands in glee.
-KT
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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.
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