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May 26, 2012 |
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Biopharma
Epizyme Builds A Cancer Company At Mach Speed / Epizyme’s recent alliance with Celgene validates industry’s interest in histone methyltransferase inhibitors, a kinase-like class of epigenetic enzymes. Celgene’s willingness to cede US rights in return for access to preclinical assets belies HMTs’ novelty and helps to position Epizyme for potential success as a US-focused oncology company. / IN VIVO May 2012
Ikaria’s Hybrid Business Model Taps Big Pharma Trends / Although Ikaria focuses on a highly specialized segment of the hospital market, its integrated business model offers insights into continuum of care strategies that pharma companies are evaluating in a reimbursement-focused world. The company’s promising strategy could get a boost from key trial read-outs as soon as late 2012. / IN VIVO May 2012
The Hype And Hope Of Cancer Stem Cell Therapeutics / A wave of recent deals demonstrates a growing belief in the potential cancer stem cells might offer for more effective cancer therapies. Some say there’s more hope and hype than science behind the activity. / START-UP May 2012
Consumer
Perrigo Squares Off With Dr. Reddy’s In Lansoprazole Launch / FDA denied Perrigo’s petition that had sought to block Dr. Reddy’s ANDA for generic Prevacid 24HR because it used bioequivalence data for the proton pump inhibitor’s Rx version. / “The Tan Sheet” May 21, 2012
California GMO Labeling Initiative Threatens Supplements / A California ballot initiative to require labeling of genetically modified foods would be a “nightmare” for supplement manufacturers, says NAI CEO Mark LeDoux. CRN President Steve Mister advocates educating consumers about GMO. / “The Tan Sheet” May 21, 2012
Men Can Be Reached With “Right” Language – King Of Shaves Founder / Contrary to the hype, the men’s market is growing at only a “very average” rate, The King of Shaves founder Will King says. There is potential for an “awakening,” however, with the right message, the exec suggests. / “The Rose Sheet” May 21, 2012
Medical Devices
Cardionovum: As DEBs Heat Up, Who Needs The US Market? / German serial entrepreneur Michael Orlowski achieved a successful exit in his first cardiovascular device company, EuroCor, by selling not to a US-based giant, but to an Indian conglomerate, Opto Circuits. His new company, Cardionovum, has developed a next-generation drug-eluting balloon whose novelty rests on a different approach to the coating technology designed to produce better drug-elution. / IN VIVO May 2012
Orthofix Spin-Out Presents Another Opportunity For Private Equity / A handful of orthopedic companies are combating sluggish markets by sticking with what they know best – selling hip and knee implants. This has created a robust opportunity for private equity investors looking to build businesses in orthopedics peripheral markets. / IN VIVO May 2012
Stroke Devices: Innovation Drives Growth / Innovation is driving double-digit growth in the neurointerventional device market as an increasing number of medical device manufacturers develop newer, more effective devices for treating acute ischemic stroke. As new, stent-like retrieval systems and other next-generation neurothrombectomy devices hit the US market in the next few years, competition in this sector will also heat up as manufacturers try to differentiate their devices and jockey for a piece of the market, which is projected to reach almost $70 million by 2015. / START-UP May 2012
Medical Devices
Medical Devices
Cardionovum: As DEBs Heat Up, Who Needs The US Market? / German serial entrepreneur Michael Orlowski achieved a successful exit in his first cardiovascular device company, EuroCor, by selling not to a US-based giant, but to an Indian conglomerate, Opto Circuits. His new company, Cardionovum, has developed a next-generation drug-eluting balloon whose novelty rests on a different approach to the coating technology designed to produce better drug-elution. / IN VIVO May 2012
Orthofix Spin-Out Presents Another Opportunity For Private Equity / A handful of orthopedic companies are combating sluggish markets by sticking with what they know best – selling hip and knee implants. This has created a robust opportunity for private equity investors looking to build businesses in orthopedics peripheral markets. / IN VIVO May 2012
Stroke Devices: Innovation Drives Growth / Innovation is driving double-digit growth in the neurointerventional device market as an increasing number of medical device manufacturers develop newer, more effective devices for treating acute ischemic stroke. As new, stent-like retrieval systems and other next-generation neurothrombectomy devices hit the US market in the next few years, competition in this sector will also heat up as manufacturers try to differentiate their devices and jockey for a piece of the market, which is projected to reach almost $70 million by 2015. / START-UP May 2012
Transcatheter Technologies GMBH / A major limitation of existing transcatheter aortic heart valves is that they are unable to be repositioned once implanted. For these devices, the valve is mounted in a metal stent that contains a balloon, which is inflated once the valve is placed. / START-UP May 2012
Not So Special? FDA Proposal Would Damage Streamlined 510(k) Submissions Program, Firms Say / Agency’s proposed “special 510(k)” reforms, outlined in a recent draft guidance, will make the streamlined submissions program a lot less streamlined, and also less accessible to many device modifications, companies say. / “The Gray Sheet” May 21, 2012
Latest Senate FDA Reform Bill Would Delay Guidance On Mobile Health Apps / The Senate user fee reauthorization and FDA reform bill, formally introduced May 15, includes several new provisions, including a moratorium on FDA issuing final guidance on mobile medical apps. The bill should see action on the Senate floor this week. / “The Gray Sheet” May 21, 2012
Renal Denervation Sparks Device Market Gold Rush / With the recent success of Ardian’s Symplicity Renal Denervation System, drug-resistant hypertension has emerged as something of a device market “gold rush.” Some observers estimate there are now as many as 40 companies developing various device-based therapies for resistant hypertension, including most of the big names in the cardiovascular device arena – Medtronic, St. Jude Medical, Boston Scientific, Johnson & Johnson, and Covidien PLC – along with a number of start-ups, all of which are racing to stake a claim in this highly promising market. / Medtech Insight May 2012