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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  [14 journals]
  • Bayer, Glaxo Consumer Businesses Find Difficult Path Toward Better Margins
    • Abstract: Glaxo and Bayer report second-quarter growth in consumer segment sales driven largely by the new parts of the businesses. GSK’s earnings report is its first since taking the helm of a consumer product JV with Novartis AG; Bayer’s is its second with Merck & Co.’s former consumer products brands in its lineup.
      PubDate: Thu, 30 Jul 2015 00:00:37 -040
       
  • Pfizer Pulls Plug On Lipitor Switch; Actual Use
           Studies Miss Objectives
    • Abstract: A 1,200-subject actual use trial to simulate the OTC use of Lipitor 10 mg did not meet its primary objectives of demonstrating patient compliance with the direction to check low-density lipoprotein cholesterol level and after checking their LDL-C level take appropriate action based on test results.
      PubDate: Wed, 29 Jul 2015 00:05:00 -040
       
  • Industry Roundup: P&G CEO Change, SEC Fines MJN
    • Abstract: Lafley releases P&G reins again; and FCPA violations cost Mead Johnson $12M.
      PubDate: Wed, 29 Jul 2015 00:00:18 -040
       
  • Out Of Teva’s Shadow, Mylan Sets Shareholder Vote For Perrigo Offer
    • Abstract: Mylan learns it no longer is targeted by Teva in a $40 billion hostile takeover play and schedules a shareholder vote on acquiring all or part of Perrigo’s shares, while analysts expect the Rx generics firm will need to increase its offer to succeed.
      PubDate: Tue, 28 Jul 2015 00:00:04 -040
       
  • Industry Roundup: Capsugel Expands, NAD On Lactation Claims, FitLife
           Kaniwa Extraction
    • Abstract: Capsugel expands in Edinburgh; Motherlove lactation supplement claims unsupported; FitLife extracts kaniwa protein; and more news in brief.
      PubDate: Mon, 27 Jul 2015 00:05:23 -040
       
  • OTC Switch Launches Drive Growth For Brand Product Sales
    • Abstract: Flonase Allergy Relief, Nasacort Allergy 24HR and Rhinocort Allergy Spray drive branded cough/cold/allergy/sinus OTC sales ahead of private label. A Deutsche Bank report compares overall brand and private label OTC sales and notes category trends.
      PubDate: Mon, 27 Jul 2015 00:03:34 -040
       
  • FSMA Import Requirements Could Reach Port Before Many Firms Prepare
    • Abstract: Supplement importers should review their supply chains and records maintenance to ensure FSVP compliance, though those and other actions are necessary for ongoing supply chain integrity. Still, many small and medium-sized businesses are unprepared, says regulatory consultant David Acheson.
      PubDate: Mon, 27 Jul 2015 00:03:28 -040
       
  • Consumer Health New Products Roundup: Boost, Premama, Skin
           Essentials
    • Abstract: Boost in 4-ounce servings; Premama expands pregnancy supplement line; Skin Essentials launches; and more news in brief.
      PubDate: Mon, 27 Jul 2015 00:01:47 -040
       
  • Senate Bill Aims At Streamlining Combination Product Regulation
    • Abstract: A Senate bill would streamline device/drug combination registrations by letting FDA rely on prior PMAs and approved drug findings to help support new product approvals, among other reforms. It was introduced by Sen.
      PubDate: Mon, 27 Jul 2015 00:01:14 -040
       
  • Petition Challenges California Prop 65 Safe Harbor For Lead
    • Abstract: In parallel with a lawsuit brought by the Mateel Environmental Justice Foundation, which seeks to eliminate the safe-harbor level for lead under Proposition 65, the Center for Environmental Health has filed a petition with California OEHHA asking for repeal or amendment of lead's maximum allowable dose level.
      PubDate: Mon, 27 Jul 2015 00:01:05 -040
       
  • FDA Ponders Trimming PDUFA Programs
    • Abstract: Acting Commissioner Ostroff considers whether all aspects of the user fee program are delivering maximum added value.
      PubDate: Mon, 27 Jul 2015 00:00:48 -040
       
  • To Improve Adverse Event Tracking, FDA Could Google It
    • Abstract: Teleconference between Google and FDA signals the internet search giant could have a way to improve adverse event detection. The agency calls the talk “a high-level, general discussion” of Google’s capabilities.
      PubDate: Mon, 27 Jul 2015 00:00:24 -040
       
  • House Passes Voluntary GMO Labeling, Pre-empting State Laws
    • Abstract: In a defeat for advocates of GMO labeling, the House passes the Safe and Accurate Food Labeling Act. Opponents of the legislation are hopeful a majority in the Senate will favor requiring GMO labeling.
      PubDate: Fri, 24 Jul 2015 00:00:03 -040
       
  • Perrigo Fattens European Play, Remains Main Course On Mylan’s
           M&A Plate
    • Abstract: Acquiring Naturwohl Pharma likely will not put Perrigo out of Mylan’s reach. The generic Rx firm, a takeover target of Teva Pharmaceutical Industries Ltd., has made multiple offers Perrigo has turned down and will ask its shareholders in August to approve a hostile takeover bid.
      PubDate: Thu, 23 Jul 2015 09:00:00 -040
       
  • First FTC ‘Natural’ Test Looms From
           Gatorade Challenge To Aspire
           Sports Drink Claims
    • Abstract: In a review from a challenge by Gatorade firm Stokely-Van Camp, NAD says Aspire Beverage provided no evidence that all its ingredients – particularly vitamins and citric acid – are natural. Rejecting NAD’s decision, the firm’s claims could be the subject of FTC’s first natural claims test.
      PubDate: Wed, 22 Jul 2015 10:30:00 -040
       
  • Efficient OTC Pathway Needs NDA Flexibility, Monograph
           Scope – Sharfstein
    • Abstract: Former FDA deputy commissioner Joshua Sharfstein, noting public health advocates’ disappointment with results from Sunscreen Innovation Act requirements, proposes an OTC drug review pathway that combines elements of the NDA and monograph systems and would require legislation to create.
      PubDate: Tue, 21 Jul 2015 00:00:00 -040
       
  • Cardiovascular Warning Boosts Profile For OTC NSAID Label Changes
    • Abstract: FDA more commonly requires similar changes for prescription drug labels based on emerging science on potential risks, but for non-aspirin NSAID label changes CDER also will contact OTC firms and advise them of changes needed to cardiovascular risk warnings on their product labels. “It doesn’t happen on quite the scale that we’re dealing with here and with the nature of these products,” says attorney Frederick Stearns.
      PubDate: Mon, 20 Jul 2015 00:05:00 -040
       
  • Executive Decisions Roundup
    • Abstract: POM Wonderful pomegranate dietary supplement marketer The Wonderful Co. is represented in the Aspen Institute’s inaugural “Health Innovators” program; nutritional and sports supplement brands EXOS and MusclePharm and eye care brand EyePromise sign pro athletes; and more news in brief.
      PubDate: Mon, 20 Jul 2015 00:00:32 -040
       
  • Novel Nicotine Products’ Potential in Harm Reduction Gets
           Appropriators’ Nod
    • Abstract: In its report on the fiscal 2016 spending bill it approved for FDA and USDA, the Appropriation Committee says sustaining 2007 cut-off date is unfair to electronic cigarettes and other yet-regulated tobacco and nicotine products already available.
      PubDate: Mon, 20 Jul 2015 00:00:22 -040
       
  • Sanofi’s Revamped Business Structure Includes Three New Pharma Units
    • Abstract: The French pharma said it will operate with five global business units beginning in January 2016: General Medicines & Emerging Markets, Specialty Care, Diabetes & Cardiovascular, Sanofi Pasteur and Merial.
      PubDate: Mon, 20 Jul 2015 00:00:18 -040
       
  • China Ups Penalties For Quality Violators Under Tougher Regulation
    • Abstract: The China FDA has officially released a new regulation governing unannounced inspections for drug and device manufacturers, ranging from production to distribution to product use, with many expecting more frequent inspections and stricter enforcement. Although traditional medicine manufacturers are the main target for now, the scope of focus could be expanded.
      PubDate: Mon, 20 Jul 2015 00:00:12 -040
       
  • FDA Appropriation Bill Holds Key To Electronic Cigarette Marketing
    • Abstract: Subcommittee chairman Robert Aderholt’s authoring of the provision in FDA’s fiscal 2016 appropriation that delays the grandfather date for tobacco and nicotine products the agency has yet to add its oversight could drive support in the Senate.
      PubDate: Fri, 17 Jul 2015 00:00:02 -040
       
  • J&J Rides Consumer Health ‘Growth Annuity’ As Rx,
           Device Divisions Slow
    • Abstract: Johnson & Johnson’s second-quarter U.S. OTC sales jumped nearly 16% on the return of recalled brands and Worldwide Group Chairman Peterson says J&J expects the consumer business to grow “increasingly” more robust.
      PubDate: Wed, 15 Jul 2015 00:05:02 -040
       
  • AHPA, NPA Argue For Transparency In Prop 65 ‘Labor Code’
           Decisions
    • Abstract: The American Herbal Products Association and the Natural Products Association argue that Prop 65’s labor code mechanism for listing chemicals, including aloe vera whole leaf extract and goldenseal root powder – is based on decisions of a “quasi-government” international agency and overlooks important scientific criteria.
      PubDate: Tue, 14 Jul 2015 00:05:09 -040
       
  • Industry Roundup: Bee Pollen Supplements Spiked, NAD Endorsement Claim
           Sunk
    • Abstract: Drug ingredients sting bee pollen products and ‘PhytoZon’ NAD endorsement claim shut down.
      PubDate: Tue, 14 Jul 2015 00:02:11 -040
       
 
 
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