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Feb. 5, 2012 |
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Biopharma
Pediatric Study Delays Could Draw Civil Penalties Under Proposal For PREA, BPCA Reauthorization / Civil penalties would be more flexible than FDA’s current authority to label a drug misbranded if sponsors fail to conduct pediatric studies, Commissioner Hamburg argues as the House Energy and Commerce Committee’s Health Subcommittee opens hearings on reauthorizing prescription drug user fees. / “The Pink Sheet” DAILY Feb. 1, 2012
A New Chapter, A New CEO For Dendreon / Former Savient and ImClone CEO Johnson will be responsible for driving commercial expansion of Provenge in the U.S. and Europe. Mitchell Gold steps down as CEO after successfully getting the prostate cancer drug to market following an arduous FDA review but struggling with commercial complexities. / “The Pink Sheet” DAILY Feb. 1, 2012
Gleevec Extends Post-Surgery GIST Survival Significantly; Wins Full Adjuvant Approval / Patients who took Novartis’ Gleevec for three years after surgery to remove gastrointestinal stromal tumors had a 54% reduction in risk of recurrence and a 55% reduction in risk of death compared to patients who took it for only one year. / “The Pink Sheet” DAILY Feb. 1, 2012
Consumer
CMP Therapeutics Readies EU Launch With An Eye On The U.S. / CMP Therapeutics talks with large and small pharmas about distributing its micronized nasal spray, branded as Atlantic Secret. EU regulatory approval came seven years after the firm’s launch, but CEO Neil Moray Mackenzie expects much less time before a U.S. launch. / “The Tan Sheet” Jan. 23, 2012
Valeant Includes OTCs In Bid For Dramatic Growth By 2013 / The Ontario-based firm has its sights set on becoming a top-15 pharma company with a $50 billion market capitalization by the end of 2013. Emerging markets and consumer health products, including the recent iNova and Fleming deals, play a big part in Valeant’s plans. / “The Tan Sheet” Jan. 23, 2012
FDA Will Take GMP Inspections To The Next Level / If supplement firms thought FDA inspectors were tough on GMP compliance last year – they ain’t seen nothing yet. FDA investigators are ready to delve into more complex and technical GMP areas after focusing primarily on “surface level areas of GMP compliance” to date, FDA officials warn. / “The Tan Sheet” Jan. 23, 2012
Medical Devices
Reverse Innovation: Is The US Losing Its Edge In Innovation? / Is US-style innovation in the medical device industry heading towards extinction? Gone are the days when companies believed they could build robust businesses by serving largely, if not exclusively, the US market. / IN VIVO January 2012
As TAVI Advances, Adjunctive Devices Multiply / As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need. As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need. / IN VIVO January 2012
Medicare Panel Looks To Upcoming Study To Fill Evidence Gaps For Carotid Artery Disease / There's a lot more to learn about which treatment to choose for carotid atherosclerosis patients, Medicare advisors said this week. A new trial in the works that would compare both surgery and stenting to standalone medical therapy presents a good opportunity to fill the gaps. / “The Gray Sheet” Jan. 30, 2012
Medical Devices
Medical Devices
Reverse Innovation: Is The US Losing Its Edge In Innovation? / Is US-style innovation in the medical device industry heading towards extinction? Gone are the days when companies believed they could build robust businesses by serving largely, if not exclusively, the US market. / IN VIVO January 2012
As TAVI Advances, Adjunctive Devices Multiply / As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need. As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need. / IN VIVO January 2012
Medicare Panel Looks To Upcoming Study To Fill Evidence Gaps For Carotid Artery Disease / There's a lot more to learn about which treatment to choose for carotid atherosclerosis patients, Medicare advisors said this week. A new trial in the works that would compare both surgery and stenting to standalone medical therapy presents a good opportunity to fill the gaps. / “The Gray Sheet” Jan. 30, 2012
FDA Urged To Issue New Draft Guidance On Mobile Medical Apps / The mHealth Regulatory Coalition wants FDA to release an updated proposed guidance as soon as possible on regulating mobile medical applications. / “The Gray Sheet” Jan. 30, 2012
Heart Failure Devices: Raising Roadblocks To Readmission / A new Medicare cost-control program aimed at reducing costly hospital readmissions has heart failure squarely in the cross-hairs, and the consequences could mean hundreds of thousands of dollars in lost Medicare revenue for hospitals that fail to meet the new readmission standards. As a result, providers are scrambling to implement programs to assess and reduce heart failure readmissions, and a growing number of device companies are touting a variety of technologies they believe could help them achieve that goal. / Medtech Insight January 2012
New Horizons In Medical Imaging: An Interview With Siemens’ Gregory Sorensen / Marketplace uncertainty and pressures to reduce costs have had a major impact on the market for medical imaging technologies. Medtech Insight interviews Gregory Sorensen, MD, Siemens Healthcare’s CEO for North America about what’s on the horizon for the industry. / Medtech Insight January 2012
In Warp Drive Deal, VCs Have A Potential Buyer – And Can Force A Sale / Third Rock launches a computation-heavy discovery firm aimed at natural products, with commitments worth up to $125 million in equity and other funding. / START-UP January 2012
Artificial Retinal Devices Help The Blind To See / Worldwide rates of all diseases that cause blindness are expected to double by 2020 due to the aging population, making this an area ripe for medical device innovation. A multibillion-dollar market has been built around the surgical correction of "front of the eye" age-related vision disorders such as presbyopia, but the technological evolution in ophthalmology has now reached the back of the eye. / START-UP January 2012