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  The Tan Sheet
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   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1206
   Published by Informa plc Homepage  [13 journals]
  • Bumper Crop Of Consumer Health Deals Expected As Large Firms Prune
           Portfolios
    • Abstract: The surge of M&A transactions in 2014 and early 2015 likely will result in brand spin-offs as big firms focus on core elements of their portfolios, consumer health market experts say. Fragmentation in the market, low interest rates and participation by private equity will drive more, though likely smaller deals.
      PubDate: Wed, 25 Mar 2015 00:10:02 -040
       
  • Homeopathics Regulation Under Spotlight In FDA Public Hearing
    • Abstract: The public hearing announcement comes a week after FDA alerted consumers to the prevalence of homeopathics with violative indications for treating asthma and could signal the start of the separate review of homeopathic regulations the agency said it would undertake when the OTC drug review began in 1972.
      PubDate: Tue, 24 Mar 2015 13:35:01 -040
       
  • Pre-emption Stifles One A Day Class Action, Not In Play In Bayer-FTC Tilt
    • Abstract: A federal judge in California says FDA supplement labeling regs pre-empt challenges to structure/function claims in a class action suit against One A Day claims, but litigation in New Jersey against Phillips’ Colon Health claims is by the Federal Trade Commission, eliminating pre-emption from Bayer’s defense options.
      PubDate: Tue, 24 Mar 2015 00:00:04 -040
       
  • Hamburg Says EMA Could Be Model For Global Regulatory Coalition
    • Abstract: The FDA commissioner urges authorities to move away “from an outdated paradigm of only working in our own jurisdiction” in speech at European Medicines Agency’s 20th anniversary meeting.
      PubDate: Mon, 23 Mar 2015 00:03:02 -040
       
  • Weekly Trademark Review March 17, 2015
    • Abstract: OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.
      PubDate: Mon, 23 Mar 2015 00:02:42 -040
       
  • Consumer Health New Products Roundup
    • Abstract: Skin & Sun Care Research debuts six products under its NO-AD, Bullfrog and Ocean Potion sun care brands; MegaFood introduces nutrient powders for consumers 40 and up; MusclePharm goes HardCore; and more new products in brief
      PubDate: Mon, 23 Mar 2015 00:02:35 -040
       
  • Homeopathic Claims Cloud Asthma Category In Consumer Health Market
    • Abstract: FDA officials identify “at least 23” asthma products marketed for asthma and labeled as homeopathic even though the indication is not approved for homeopathics. The consumer health care market for asthma products is made murky also by the status of OTC drugs labeled with the indication.
      PubDate: Mon, 23 Mar 2015 00:02:26 -040
       
  • Industry Roundup: Keep Extra-Strength Acetaminophen OTC –
           McNeil-Backed Survey
    • Abstract: Keep extra-strength acetaminophen OTC – McNeil-backed survey; direct sellers Jenuesse, MonaVie combine; Four Elements makes drug claims; and more news in brief.
      PubDate: Mon, 23 Mar 2015 00:02:15 -040
       
  • Bayer Satisfies DoJ ‘Need To Know’ About Probiotic Claim
           Studies
    • Abstract: A judge also grants Bayer’s request to depose an FTC attorney about the agency’s investigation that led to a contempt charge linked to allegedly violating a 2007 consent decree by making a drug claim for the Phillips’ Colon Health three-bacteria-strain formula.
      PubDate: Mon, 23 Mar 2015 00:02:02 -040
       
  • Cosmeceutical Pioneer Strivectin’s ‘Anti-Aging
           Solutions’ Draw Drug Claim Warning
    • Abstract: FDA cites Strivectin’s Potent Wrinkle Reducing Treatment and TL Advanced Tightening Neck Cream as unapproved drugs based on claims touting elastin-stimulating effects, skin-firming action and other structure/function benefits.
      PubDate: Mon, 23 Mar 2015 00:00:35 -040
       
  • Vitamin D Use Shines Light On Seasonal Affective Disorder
    • Abstract: Vitamin D3 levels and depressive symptoms among 185 women generally were negatively correlated in five-week studies conducted during the fall, winter and spring terms at Oregon State University.
      PubDate: Mon, 23 Mar 2015 00:00:25 -040
       
  • P&G’s Potential Personal Care Brands Divestment Sparks
           Analyst Support
    • Abstract: P&G could divest, at one fell swoop, prestige fragrances, makeup brands Cover Girl and Max Factor, and salon and small retail hair-care brands, analysts speculate, following reports that the firm is exploring a possible sale or IPO of personal care and beauty brands en masse.
      PubDate: Mon, 23 Mar 2015 00:00:12 -040
       
  • BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Separate Parts
    • Abstract: The firm’s representatives maintain a “weight-of-evidence” approach comprising repeated dose toxicity, photo-genotoxicity, dermal carcinogenicity and photo-carcinogenicity studies is adequate to establish safety. FDA officials consider BASF’s questions in a public meeting required by the Sunscreen Innovation Act.
      PubDate: Fri, 20 Mar 2015 00:00:00 -040
       
  • FDA Confirms Senators’ Doubts About N.Y. Herbal Product Tests
    • Abstract: “At this time, FDA does not use DNA sequencing by itself to analyze an herbal extract for phytochemicals,” FDA Associate Commissioner for Legislation Thomas Kraus tells Sens. Orrin Hatch and Martin Heinrich.
      PubDate: Thu, 19 Mar 2015 10:50:01 -040
       
  • Omega Marks The Alpha Of Perrigo’s OTC Brand Play
    • Abstract: The deal expands Perrigo’s distribution footprint from less than 10 to more than 40 countries, but also points toward marketing branded OTCs in some of Omega’s European markets. But another growth driver is in its generic OTC wheelhouse – retailers offering more store brand products, says Perrigo CEO Joseph Papa.
      PubDate: Thu, 19 Mar 2015 00:00:02 -040
       
  • Potential Patchwork Of Local Drug Take-Back Rules Spurs CHPA Program
    • Abstract: CHPA backs litigation challenging drug take-back requirements to help stave off a patchwork of similar programs. Consumer education requires “a long-term commitment and won't be cheap,” but the OTC industry “can push back against more onerous mandates, says CHPA chief Scott Melville.
      PubDate: Wed, 18 Mar 2015 00:00:03 -040
       
  • McNeil Chooses Litigation To Challenge Glaxo’s OTC
           Flonase Ad Claims
    • Abstract: The J&J consumer products subsidiary, which markets the Zyrtec and Benadryl OTC allergy lines, foregoes industry self-regulation channels to hasten a decision in its challenge of Glaxo’s recently launched Flonase Allergy Relief.
      PubDate: Tue, 17 Mar 2015 00:40:04 -040
       
  • Rx Statin Critic Predicts Safer Use In Lower-Dose Switch OTCs
    • Abstract: Duane Graveline says drug firms “are going to realize” they will not “get any support from people who understand” the full range of statin adverse effects. “Tens of thousands of statin users” report weakness, instability, easy fatigue, muscle aches and pains, depression, personality change and faulty memory, he says.
      PubDate: Mon, 16 Mar 2015 00:10:00 -040
       
  • Glaxo To Open Expanded Asian Headquarters In Singapore
    • Abstract: GSK bids to strengthen its presence in Singapore and consolidate functions in the business-friendly city-state with an expanded Asian headquarters there.
      PubDate: Mon, 16 Mar 2015 00:02:20 -040
       
  • Weekly Trademark Review March 10, 2015
    • Abstract: OTC drug, personal care product and nutritional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.
      PubDate: Mon, 16 Mar 2015 00:02:11 -040
       
  • Bittersweet Decision For Prestige In Little Remedies
           Honey Claims Review
    • Abstract: Robitussin pediatric OTCs marketer Pfizer contends in a NAD review that the brand Little Remedies is a “therapeutic effectiveness” claim because “remedy” is a “medicine, application, or treatment that relieves or cures a disease.” NAD takes a narrower view of the brand’s use of the term.
      PubDate: Mon, 16 Mar 2015 00:01:53 -040
       
  • Regulatory News Roundup: Two Customs Strikes Against MyNicNaxs, U.K. Ad
           Enforcement
    • Abstract: Two Customs strikes against MyNicNaxs; drug claims and GMP problems; curcumin bioavailability claim nixed; and U.K. ad enforcement news.
      PubDate: Mon, 16 Mar 2015 00:01:48 -040
       
  • Industry Roundup: Restoring Access To Medications In Both Chambers, Wahl
           Joins AHPA
    • Abstract: Restoring Access to Medication Act introduced; Wahl joins AHPA; NutraScience grows footprint; WANU is core health; SDC appoints CFO; NeuEnergy gets impulse placement; and more news in brief.
      PubDate: Mon, 16 Mar 2015 00:00:27 -040
       
  • Hamburg Departure Hinged On Filling FDA Leadership Roster
    • Abstract: Susan Mayne brings “new strength and focus to CFSAN and medical countermeasures expert Luciana Borio moves to chief scientist role. Hamburg offers previews on leadership approaches of Stephen Ostroff and Robert Califf.
      PubDate: Mon, 16 Mar 2015 00:00:06 -040
       
  • ‘Emotional’ NDACs Stymie OTC Switches – Former Chairman
           Wood
    • Abstract: OTC industry stakeholders must prepare better for FDA Nonprescription Drug Advisory Committee meetings and argue against members’ “emotional” objections to switches based on retail price or loss of doctor-patient visits, says former NDAC chair Alistair Wood.
      PubDate: Fri, 13 Mar 2015 00:00:02 -040
       
 
 
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