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May 19, 2012 |
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Biopharma
Antibiotic Exclusivity’s Latest Push: Distressing Resistance Data From The VA / A Pew-funded study found growing use of “last-stand” antibiotics in VA hospitals as resistant pathogens spread. Researchers say the pending GAIN Act will help address some of the economics of convincing drug makers to invest in development of new antibiotics, but other financial – as well as regulatory and scientific challenges – will remain. / “The Pink Sheet” DAILY May 16, 2012
Small Companies Turning To CDER Ombudsman For Help With Drug Approvals / While the CDER ombudsman dealt with far fewer complaints overall in 2011 than in 2010 due to administrative changes, smaller companies are increasingly asking for help in certain key areas of drug development. / “The Pink Sheet” DAILY May 16, 2012
Alzheimer’s Research To Be More Collaborative, Better Funded Under National Plan / Most of the additional money will help support two trials – one for insulin as a treatment and one for crenezumab as a preventative. The Obama administration formally launched its national Alzheimer’s plan in the midst of a two-day meeting that underscored how little researchers know about the disease. / “The Pink Sheet” DAILY May 15, 2012
Consumer
Pallone, Pitts Committed To Cosmetics Legislation In “This Congress” / During a markup of an FDA user-fee bill, legislators from both sides of the aisle affirmed their intent to tackle cosmetics regulation in a separate, stand-alone bill later this year. The user-fee bill omitted a section that was in place previously to implement cosmetics user fees. / “The Rose Sheet” May 14, 2012
Industry-Backed Cosmetics Bill Will “Not Be Easy To Pass” – Rep. Lance / At a May 7 press conference held at L’Oreal USA’s Research and Innovation Center, Rep. Leonard Lance, R-N.J., admitted having “a lot of work to do” to convince colleagues that the Safe Cosmetics Alliance-backed Cosmetic Safety Amendments Act “is the way forward.” / “The Rose Sheet” May 14, 2012
Perrigo Feels Ill Effects Of Mild Cold Season, Excess OTC Capacity / The private labeler lowered its full-year revenue guidance, noting weak cough/cold/flu OTC sales. Perrigo built up excess capacity to take advantage of recalled Johnson & Johnson OTCs, and now is shifting some capacity in response to a Novartis plant shutdown. / “The Tan Sheet” May 14, 2012
Medical Devices
Covidien Acquisitions Keeps Buying Spree Alive / Since its spin-out from Tyco, Covidien has spent close to $5 billion acquiring public and privately held device companies, with more than $1 billion of that being spent just over the past six months. The string of purchases bulked up every one of Covidien’s existing medical device businesses. / IN VIVO April 2012
J&J’s New Path Forward – An Interview With Alex Gorsky / In his last interview before becoming CEO of Johnson & Johnson, Alex Gorsky talks about the changes that J&J has made recently in its medical device business and discusses his upcoming promotion to head of all of J&J. / IN VIVO April 2012
Renal Denervation: Device Market’s Gold Rush / Three years ago, only Ardian was publicly working on renal denervation devices for hypertension, but at last month’s ACC meeting, some said there were now anywhere from 16 to 40 companies in the space. Fast followers don’t want to miss out on an IP land grab in today’s hottest medical device space. / START-UP April 2012
Medical Devices
Medical Devices
Covidien Acquisitions Keeps Buying Spree Alive / Since its spin-out from Tyco, Covidien has spent close to $5 billion acquiring public and privately held device companies, with more than $1 billion of that being spent just over the past six months. The string of purchases bulked up every one of Covidien’s existing medical device businesses. / IN VIVO April 2012
J&J’s New Path Forward – An Interview With Alex Gorsky / In his last interview before becoming CEO of Johnson & Johnson, Alex Gorsky talks about the changes that J&J has made recently in its medical device business and discusses his upcoming promotion to head of all of J&J. / IN VIVO April 2012
Renal Denervation: Device Market’s Gold Rush / Three years ago, only Ardian was publicly working on renal denervation devices for hypertension, but at last month’s ACC meeting, some said there were now anywhere from 16 to 40 companies in the space. Fast followers don’t want to miss out on an IP land grab in today’s hottest medical device space. / START-UP April 2012
Device Firms Seek More Exemptions, Pricing Flexibility For Oncoming Excise Tax / Written comments were due May 7 on the Internal Revenue Service’s proposed regulation to implement a 2.3% excise tax on device sales in the lead-up to a May 16 public hearing. / “The Gray Sheet” May 14, 2012
Obesity Device Makers Debate Merits Of CMS Gastric Sleeve Coverage Proposal / Allergan and Johnson & Johnson have differing responses to the Medicare agency’s proposal to require clinical trial participation in return for coverage of a laparoscopic sleeve gastrectomy procedure to treat obesity. / “The Gray Sheet” May 14, 2012
Fireworks Kept At Bay As Congress Pushes To Enact FDA Reforms By July 4 / Bipartisan FDA user fee reauthorization and reform legislation sailed unanimously through the House Energy and Commerce Committee May 10, with many similarities to a Senate version that has also passed out of committee. / “The Gray Sheet” May 14, 2012
Digital Health In Brief / FCC sets MBAN discussion date. CMMI awards telemedicine projects. / “The Gray Sheet” May 14, 2012
Women's Health: Promising Advances, But Challenges Persist / The field of women's health is one of the most progressive medical technology sectors in the US, driven by the aging population, diagnostic advances in deadly ovarian and colorectal cancer, and medical device innovations in gynecologic and urogynecologic disease management, including a shift toward minimally invasive surgery (MIS) techniques and robotics and the addition of a new field: bariatric gynecology. At the WH 2.0 Consensus Conference on Women's Health, held recently in Los Angeles, experts agreed that advances in medical technology are promising better detection and treatment of a hos... / Medtech Insight April 2012