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Covidien finalizes acquisition of Somanetics for $250M Sanofi-Aventis readies $18.7B bid for Genzyme Regeneron inks $295M discovery deal with Astellas Sanofi-Aventis & Merck Appoint New CEO
Beaker's Blog Biotechnology Devices & Diagnostics Pharmaceuticals   Most Recent Most Popular	Beaker's Blog presented by In biosimilars, Hospira fires the first round. The target? Amgen. Jeffrey Clark - Posted: 7/29/2010 With health reform now officially law, Hospira has jumped in to challenge Amgen’s product portfolio. Hospira said it will begin trials for a biosimilar, or a biogeneric, version of Amgen’s Epogen in patients with renal dysfunction who have anemia. Ho[...] Should FDA yield to EU-approved products? One group thinks so Jeffrey Clark - Posted: 7/28/2010 The Pacific Research Institute has issued a report arguing that American patients would benefit from an FDA that does not have a monopoly on regulation for health care treatments. Instead, the think tank argues that “allowing American patients to acc[...] One mistake creates a mess for DTC diagnostics companies Jeffrey Clark - Posted: 7/27/2010 Earlier this summer, Pathway Genomics made a PR splash by announcing their intent to sell a DNA testing kit through Walgreen’s & CVS pharmacies that could help consumer’s predict diseases to which they might be genetically predisposed.  The noise att[...] Pharmaplasia: The story of Big Pharmas fall from grace Jeffrey Clark - Posted: 7/26/2010 A new book to be released this week chronicles the recent history and potentially troubling future for the pharmaceutical industry. Pharmaplasia describes in detail how Big Pharma grew too fast, creating organizations that were too large to manage ef[...] Sequencing: Now the most hyper-competitive sector of life sciences? Jeffrey Clark - Posted: 7/23/2010 The life sciences industry has long been known for its fiery competitions in hyper-growth related markets.  Remember J&J and Boston Scientific vying for control of the drug-coated stent market?  How about the War of the Statins amongst all the Big Ph[...] After production & financial struggles, a much different Genzyme Jeffrey Clark - Posted: 7/22/2010 Genzyme continues to work through massive manufacturing and regulatory woes which have battered its financial performance and investor confidence.  And, now the company has announced what its future may hold. Financial projections released this week [...] The path forward for a new leader at PhRMA Jeffrey Clark - Posted: 7/21/2010 When Billy Tauzin stepped down as President & CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), he set one of the key storylines of the summer.   Just last week, PhRMA completed an efficient search for Tauzin’s successor, namin[...] Gel derived from Gilead Sciences HIV drug a game changer in Africa Jeffrey Clark - Posted: 7/20/2010 A gel containing a Gilead Sciences drug can sharply reduce HIV infections in women.  This is the first time such an approach has protected against sexual transmission of the virus.  The findings, presented at an international AIDS conference in Vienn[...] Heads of FDA & National Institute of Health discuss a path forward for the indus[...] Jeffrey Clark - Posted: 7/19/2010 It is not that often that the Director of the NIH and the FDA Commissioner open themselves up to the industry to answer questions about the path forward for the life sciences industry and healthcare research in the United States. Yet a recent meeting[...] Impressive group of leaders discusses ideas, challenges for the life sciences Jeffrey Clark - Posted: 7/14/2010 The most prominent thought leaders of the life sciences industry gathered last week in Kansas City to discuss the future of drug development in the country.  In attendance, were Dr. Margaret Hamburg (FDA Commissioner), Kathleen Sebelius (Secretary of[...] A new frontier (& an ethical dilemna) created by life science research Jeffrey Clark - Posted: 7/12/2010 The edge of the research envelope in our industry is fast-developing and the focus is synthetic biology industry.  The process includes modify bacteria and other organisms by altering their gene sequences for scientific benefit.  While the intentions[...] Gone Tomorrow?: A must read for life sciences professionals Jeffrey Clark - Posted: 7/11/2010 Until last week, I had never heard of the Council for American Medical Innovation (CAMI). Launched in 2009, the Council bring together leaders in research, medicine, public health, academia, and business, who are working to promote medical innovation[...] Medical imaging sector spending resumes Jeffrey Clark - Posted: 7/7/2010 After suffering through a period of weakened spending in the hospital sector, the medical imaging market is primed for a rebound, according to a report from Frost & Sullivan. The medical imaging sector includes all things related to CT, MRI, ultr[...] How manufacturing problems & a drug shortage could lead to longer lives? Jeffrey Clark - Posted: 7/6/2010 A worldwide shortage of a drug used in lethal-injection procedures could jeopardize executions.  Hospira, the sole U.S. manufacturer of thiopental sodium, is experiencing a ‘manufacturing issue’ and do not expect the product to be available agai[...] Device sector pushes for their own fast track with the FDA Jeffrey Clark - Posted: 6/30/2010 The National Venture Capital Association is in discussions with FDA officials about establishing a more efficient efficient approval process for novel medical devices.   The new pre-market review process would be limited to breakthrough tec[...] The lesser known device company competing with the big boys Jeffrey Clark - Posted: 6/28/2010 Singapore-based Biosensors International has launched its BioMatrix Flex drug-eluting stent system in major European markets and selected regions in the Middle East, Africa and Asia.  The stent is approved for a comprehensive range of indication[...] Advamed releases glowing jobs report for life sciences Jeffrey Clark - Posted: 6/25/2010 Advamed has released a study showing the contribution of the medical technology industry to the US economy.  Overall life sciences supports over 400,000 jobs & $25B in annual payroll in the US. While not immune to the recent global economic [...] Kinetic Concepts continues to expand in global wound care market Jeffrey Clark - Posted: 6/24/2010 Wound care is an interesting category within the life sciences industry.  Unlike pharmaceuticals, medical equipment or other medical device categories, it’s not an enormous global market, around $10B. In the past few years, two of the industry’s[...] Stoking the competitive fires in the cardiovascular device sector Jeffrey Clark - Posted: 6/23/2010 The medical device industry had its last War of the Roses just over five years ago.  The battle was a fierce competition within the cardiovascular stent market, driven by emerging drug eluting stent (DES) technology. J&J was first to market [...] FDA calls out drugmakersto do what is right. But is it? Jeffrey Clark - Posted: 6/21/2010 The FDA published a list yesterday of 235 approved medicines that may have benefit other rare disorders for which they are not currently approved, named the Rare Disease Repurposing Database (RDRD). FDA’s motive is to encourage drug makers to examine[...] Can Genzyme finally turning the corner? Jeffrey Clark - Posted: 6/17/2010 In what has been described as a humbled tone, Genzyme CEO Henri Termeer assured investors at this week’s meeting that the company would do everything possible to prevent more manufacturing problems. And, while the company has ‘settled’ a longstanding[...] Female Viagra comes up short Jeffrey Clark - Posted: 6/17/2010 According to FDA, the first pill designed to boost the female sex drive failed to make a significant impact on libido in two studies, though some women did report slightly more sexually satisfying experiences. The drug is Boehringer Ingelheims fliban[...] FDA Commissioner addresses DIA Annual Meeting in Washington DC Jeffrey Clark - Posted: 6/16/2010 DIA’s Annual Meeting is underway in Washington DC. DIA is one of the lesser known (but heavily populated) associations across the industry. Because of its general industry focus, it lacks the sizzle of other conventions (ASCO, Advamed, RAPS, etc.).&n[...] In China, a different kind of FDA Jeffrey Clark - Posted: 6/14/2010 More scandal & controversy has erupted within China’s equivalent of the FDA.  And the penalties could be severe. For those who do not recall, exactly three years ago the disgraced head of Chinas drug administration was sentenced to death and[...] The evolution of DTC: The first ever medical device commercial? Jeffrey Clark - Posted: 6/13/2010 I remember the first time I saw a non-pharmaceutical ad for a life sciences product. It was 4-5 years ago and GE Medical released a television commercial touting their newest MRI scanner. At the time, I was flabbergasted and confused. It wasnt like p[...]