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May 17, 2012 | Search All Articles »

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Biopharma

PDUFA Scrubbing: How The House User Fee Bill Got So Agreeably Clean / Profound reforms to FDA’s mission were set aside, but industry seems poised for several big wins, including (probably) additional antibiotic exclusivity and even a national track and trace standard. / “The Pink Sheet” May 14, 2012

Truvada PrEP REMS Needs More Work, FDA Panel Says / In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug. / “The Pink Sheet” May 14, 2012

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns / Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early. / “The Pink Sheet” May 14, 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

Biopharma

Biopharma

PDUFA Scrubbing: How The House User Fee Bill Got So Agreeably Clean / Profound reforms to FDA’s mission were set aside, but industry seems poised for several big wins, including (probably) additional antibiotic exclusivity and even a national track and trace standard. / “The Pink Sheet” May 14, 2012

Truvada PrEP REMS Needs More Work, FDA Panel Says / In a marathon meeting, the Antiviral Drugs Advisory Committee endorses use of Gilead’s emtricitabine/tenofovir fixed-dose combination for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection, but some committee members say Gilead’s REMS needs more “teeth,” including a linkage between a documented negative HIV test and access to the drug. / “The Pink Sheet” May 14, 2012

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns / Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early. / “The Pink Sheet” May 14, 2012

Another Arcalyst Trial May Be Regeneron’s Best Path To Approval In Gout / Recommending against approval, FDA’s Arthritis Advisory Committee says there is not enough data for Regeneron’s gout therapy and suggests that chronic and refractory populations should be studied. / “The Pink Sheet” May 14, 2012

Lorcaserin Makes It Past Panel On The Strength Of Effect In Some Patients / The Endocrinologic and Metabolic Drugs Advisory Committee votes 18-4, with one abstention, in favor of lorcaserin for long-term treatment of overweight and obese individuals. / “The Pink Sheet” May 14, 2012

Will Pharmacovigilance Be Enough To Address Questions About Pfizer’s Tofacitinib? / Definitive data on structural damage measurement can be collected post-market, FDA’s Arthritis Advisory Committee said in voting to support approval. But the panel and FDA were both troubled by uncertainties over the safety profile, especially because the rheumatoid arthritis therapy would be for chronic use. / “The Pink Sheet” May 14, 2012

Consumer

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

Provital Skin-Care Active Sensfeel Ups Male Pheromone For Sex Appeal / Provital‘s Sensfeel can help men increase their sexual attractiveness by increasing synthesis of their own pheromone androstadienone, the company claims. Intended for skin-care applications, the ingredient is composed of forskolin and theaflavines, which together help to double production of androstadienone. / “The Rose Sheet” May 14, 2012

J&J’s Path Forward – An Interview With Alex Gorsky / In a conversation shortly before taking the helm at Johnson & Johnson, CEO Gorsky discusses deal strategies, emerging markets, his experience overseeing both the device and pharma businesses and the value of J&J’s consumer health product portfolio. / “The Tan Sheet” May 14, 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