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Feb. 11, 2012 |
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Biopharma
Sanofi Targets 18 Drug Launches From 2012 To 2015 / Management highlighted several near-term product launch opportunities during a year-end sales and earnings call in an attempt to assure investors business goes on after Plavix, Avapro patent expirations. / “The Pink Sheet” DAILY Feb. 8, 2012
Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft / FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance. / “The Pink Sheet” DAILY Feb. 8, 2012
Will Mirabegron Pass Muster In Overactive Bladder? /
Astellas aims to muscle in to a growing disease space dominated by muscarinic receptor agonists with its beta-3 agonist mirabegron (YM178) – but first it must get by an FDA advisory committee review. / “The Pink Sheet” DAILY Feb. 8, 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
Top Device Stories Of 2011: Living In A State Of Transition / EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry. / IN VIVO January 2012
Industry Sponsors Health Care Delivery Innovation Design Challenges / Johnson & Johnson, Allscripts and Kaiser Permanente are among the groups sponsoring contests to improve tools for managing cardiovascular disease, diabetes and Alzheimer’s, as well as to enhance overall health care delivery. / “The Gray Sheet” Feb. 6, 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
Biopharma
Biopharma
Sanofi Targets 18 Drug Launches From 2012 To 2015 / Management highlighted several near-term product launch opportunities during a year-end sales and earnings call in an attempt to assure investors business goes on after Plavix, Avapro patent expirations. / “The Pink Sheet” DAILY Feb. 8, 2012
Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft / FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance. / “The Pink Sheet” DAILY Feb. 8, 2012
Will Mirabegron Pass Muster In Overactive Bladder? /
Astellas aims to muscle in to a growing disease space dominated by muscarinic receptor agonists with its beta-3 agonist mirabegron (YM178) – but first it must get by an FDA advisory committee review. / “The Pink Sheet” DAILY Feb. 8, 2012
Xgeva Comes Up Short On Clinical Benefit, Has Too Much Risk, ODAC Tells FDA / The oncologic drugs panel rejects an expanded indication for Amgen’s denosumab, saying a 4.2-month delay in progression of bone metastasis in castrate-resistant prostate cancer patients does not offset the risk of osteonecrosis of the jaw. / “The Pink Sheet” DAILY Feb. 8, 2012
As Majority Of U.S. Patients Tested For JCV, Tysabri Sales Rise, Elan Says / The Irish company is still dealing with the after-effects of splitting apart its business in 2011, including its search for a new CEO. Meanwhile, Elan’s lead revenue driver, Tysabri continues to grow. / “The Pink Sheet” DAILY Feb. 8, 2012
GSK To Downplay Europe Because of Poor Innovation Support, Focuses On U.S. and Japan Instead / GSK CEO Andrew Witty is scathing about the lack of support in Europe for innovation, and the company will now prioritize the U.S., Japan and emerging markets for the development of new products / “The Pink Sheet” DAILY Feb. 7, 2012
To Fill Pipeline Gaps, Astellas Narrows Focus And Takeda Spreads A Wider Net: Japan Earnings Roundup / PharmAsia News takes a closer look at pipeline updates from Japan’s two largest pharma companies. / “The Pink Sheet” DAILY Feb. 7, 2012
Consumer
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
Speakers At IFRA Meeting Offer Solidarity, Advice For Embattled Industry / The International Fragrance Association’s choice of speakers for its 2012 business meeting reflects the preoccupations of an industry under increasing pressure from NGOs. / “The Rose Sheet” Jan. 23, 2012
Campaign For Safe Cosmetics To Keep Pushing For Product Reformulation In 2012 / Activist group the Campaign for Safe Cosmetics says its top accomplishment in 2011 was getting Johnson & Johnson to reformulate its baby-care products. In 2012, the NGO plans to increase its pressure on firms to reformulate products, removing ingredients it deems unsafe. / “The Rose Sheet” Jan. 23, 2012
Fair Trade USA Tightens Standards For Products With Certified Ingredients / Fair Trade USA has revised its proposed certification criteria following consultation with stakeholders, including discontented NGOs. Composite products – such as personal-care products – must contain at least 20% fair-trade-certified ingredients to carry the associated seal under the new draft standard. / “The Rose Sheet” Jan. 23, 2012
FDA Analysis Finds Plan B Safe For Children / FDA found only 13 reports of serious pediatric AERs following ingestion of original two-dose Plan B or one-dose Plan B One-Step. In a review released Jan. 27, Office of Surveillance and Epidemiology officials said the data do not causally link the majority of pediatric AERs definitively to the drug. / “The Tan Sheet” Jan. 30, 2012
California AG Slaps Brazilian Blowout With Fees, “CAUTION” Labels / In the latest instance of a state taking cosmetic oversight into its own hands, California settles a lawsuit against Brazilian Blowout parent company GIB LLC. The consent judgment requires the firm to adequately communicate risks to salon workers and consumers using Brazilian Blowout Acai Smoothing Solution and Brazilian Blowout Professional Smoothing Solution. / “The Rose Sheet” Feb. 6, 2012
Attorneys See FDA Rulemaking By Guidance In NDI Notification Draft / FDA’s use of sweeping guidance documents, such as the NDI notification draft, faces criticism from industry attorneys. The recent Franck’s Lab case, which FDA lost, could serve as a precedent for legal challenges of agency enforcement that tracks guidance. / “The Tan Sheet” Feb. 6, 2012
Medical Devices
Medical Devices
Top Device Stories Of 2011: Living In A State Of Transition / EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry. / IN VIVO January 2012
Industry Sponsors Health Care Delivery Innovation Design Challenges / Johnson & Johnson, Allscripts and Kaiser Permanente are among the groups sponsoring contests to improve tools for managing cardiovascular disease, diabetes and Alzheimer’s, as well as to enhance overall health care delivery. / “The Gray Sheet” Feb. 6, 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
AngioDynamics Doubles Vascular Access Biz With Navilyst Acquisition / Deal worth $372 million makes AngioDynamics the clear number-two competitor in the global vascular access market, second only to Bard. / “The Gray Sheet” Feb. 6, 2012
Device Industry Expects Quicker Path To Market In Exchange For Doubling Of User Fees / The tentative agreement of $595 million in user fees over five years is more than companies had wanted to spend. But industry negotiators insist it is a good deal, tied to performance goals and process improvements they say will ensure greater speed and predictability in reaching the U.S. market. / “The Gray Sheet” Feb. 6, 2012
Abiomed Touts Advantages Of New Symphony Partial-Support Cardiac Assist Device /
Since heart attacks most often damage the left ventricle, left ventricular assist devices (LVADs) have become the treatment of choice for end-stage heart failure (HF) patients in this country. But pure product prices for today’s LVADs, which had previously been relegated to use only in end-stage disease but now are moving towards the treatment of earlier-stage HF patients, run as high as $120,000 per unit. / Medtech Insight January 2012
A-List Investor Spotlight / Investors like Imperial Innovations and Jumpstart are stepping up to fill the gap in Series A investing. / START-UP January 2012
Nano Retina Inc. / Israel’s Nano Retina Inc. is developing an artificial retina that it hopes will provide a superior solution for restoring sight to patients with late-stage AMD and other degenerative ophthalmic diseases, who currently have no curative options. Its permanently implantable device is powered by an eye-safe laser that can be imbedded or attached to eyeglasses. / START-UP January 2012