Regulatory Focus™ > News Articles > Regulatory Reconnaissance: CHMP Recommends Six New Drugs (28 April 2014)

Regulatory Reconnaissance: CHMP Recommends Six New Drugs (28 April 2014)

Posted 28 April 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Howard Sklamberg on the Safety and Quality of Generic Drugs (BioCenturyTV)
  • Track And Trace: Stakeholders Beg FDA For Early Guidance (Pink Sheet-$)
  • 5 Pharma Ad Enforcement Trends To Watch (Law 360-$)
  • Inside the Private Umbilical Cord Blood Banking Business (WSJ-$)
  • Sanofi Says Dengue Vaccine Succeeds in Late-Stage Trial (NYTimes) (Bloomberg)
  • Sorin Group Receives FDA Approval for the Mitroflow Aortic Heart Valve with New Phospholipid Reduction Treatment (Press)
  • Hacking the hospital: medical devices have terrible default security (Boing Boing) (Mass Device)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Howard Sklamberg on the Safety and Quality of Generic Drugs (BioCenturyTV)
  • Track And Trace: Stakeholders Beg FDA For Early Guidance (Pink Sheet-$)
  • 5 Pharma Ad Enforcement Trends To Watch (Law 360-$)
  • Inside the Private Umbilical Cord Blood Banking Business (WSJ-$)
  • Pfizer's Unusual Contribution to the AfrezzaReview (RPM Report-$)
  • Antibacterial Soaps Reduce Risk Of Foodborne Illness - Industry Study (Tan Sheet-$)
  • States Raise Legal Issues With FDA's Compounding Info-Sharing Plan (IHP-$)
  • FDA Draws Regulatory Line Between Moxduo, HIV Combos (Pink Sheet-$)
  • QRxPharma Given Statistical Leeway WithMoxduo, To No Avail (Pink Sheet-$)
  • FDA "Combination Rule" Trips Up QRxPharma's Moxduo (Pink Sheet-$)
  • More on Randomization Under the DQSA (RxTrace)
  • Low T Business Is Booming, Despite Questions About Risks (KHN)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Sanofi Says Dengue Vaccine Succeeds in Late-Stage Trial (NYTimes) (Bloomberg)
  • POZEN'S PA8140/PA32540 Receives a Complete Response Letter From FDA Citing Issues at a Facility of a Third Party Supplier of an Active Ingredient (Press) (Pharma Letter-$)
  • US FDA grants Sativex fast track status for cancer pain (Pharma Letter-$) (Press)
  • Stem cell treatment for ALS gets clinical trial greenlight from FDA (Reuters)
  • Erdosteine Received Orphan Drug Status by the FDA (Press)
  • Novartis hopes new COPD study data will draw patients from Glaxo's Advair (Fierce)
  • How A Kidney Drug Almost Torpedoed Concert Pharma's IPO (Xconomy)

US: Pharmaceuticals and Biotechnology: General

  • Some top Medicare beneficiaries spend heavily to lobby (USA Today)
  • For Drugs That Save Lives, a Steep Cost (NYTimes)
  • Antibiotic Incentive Legislation: Can Reimbursement Horn In? (RPM Report)
  • Cholesterol drug users may use pills as a license to overeat (Reuters)
  • At $1,000 A Pill, Hepatitis C Drug Sovaldi Rattles Medicaid Programs (Forbes)

US: Medical Devices

  • Sorin Group Receives FDA Approval for the Mitroflow Aortic Heart Valve with New Phospholipid Reduction Treatment (Press)
  • Hacking the hospital: medical devices have terrible default security (Boing Boing) (Mass Device)
  • Security Requirements for Medical Devices--What's Really Needed? (Medical Design)
  • Siemens SOMATOM Force Dual Source CT Scanner FDA Cleared (MedGadget)
  • CrossBay Medical, Inc. announces FDA, Health Canada, and CE mark marketing authorizations for SonoSure SonoHysterography and Endometrial Sampling Device (Press)
  • GS Medical USA Announces FDA Clearance and Launch of AnyPlus T/PLIF Cage (Press)
  • Baxter Recalls its Sigma Spectrum Infusion Pump Over System Errors (FDA)

US: Dietary Supplements

  • FDA's Dietary Supplement Tips for Women (FDA)
  • FDA Issues Final Rule On Certain Nutrient Claims For Omega-3s (Food Product Design) (NI-USA)
  • Firms Need Supplement Industry-Led Compliance "Stewardship" - P&G Safety Chief (Tan Sheet-$)
    NAD Fills Regulatory "Void" In Setting Advertising Standards (Tan Sheet-$)

US: Assorted And Government

  • Judge: Guidance and Policies do not Make Someone Eligible for Whistleblower Protections (ProPublica)
  • Mini Sentinel System Starts Leveraging Its Databases to do Clinical Trials (MiniSentinel)
  • Opinion: The Compassionate Freedom of Choice Act: Ill-advised "right to try" goes federal (Science-Based Medicine)
  • Clinical Data Sharing Could Increase Research Costs, Industry Fears (Pink Sheet-$)
  • FDA Getting Ready for International Cosmetics Regulation Meeting, Seeks Input (FDA)
  • Ninety Years of Regulatory Evolution: FDA From 1924 to 2014 (Strengthen FDA)
  • US Capitol Capsule: Rare disease sector matures; FDA keeping pace? (SCRIP-$)
  • FDA: Beware of False or Misleading Claims for Treating Autism (FDA)
  • Opinion: America's Broken Health Care System: The Role of Drug, Device Manufacturers (Forbes)
  • FDA Appropriations season begins (The Hill)
  • HRI regulatory center weekly newsletter (PWC)

Europe

  • EMA recommends approval of Mekinist for the treatment of melanoma (EMA) (GSK) (Pink Sheet-$) (PMLive) (BioCentury) (Pharmafile)
  • EMA recommends extending use of Nexavar to include treatment of differentiated thyroid cancer (EMA) (PMLive)
  • Six big pharma product extensions get CHMP nod (SCRIP-$) (Pharma Letter-$)
  • NICE chair: pharma must show how it prices drugs (Pharmafile)
  • Europe approves J&J diabetes combo Vokanamet (Pharma Times) (Pharma letter-$)
  • Guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies (EMA)
  • Positive CHMP opinion for Pradaxa in treatment of deep vein thrombosis and pulmonary embolism and prevention of repeat blood clots (BI)
  • CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem (EMA)
  • EMA recommends revoking authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures (EMA)
  • CMDh confirms recommendations on restricting use of domperidone-containing medicines (EMA)
  • EMA recommendation on the use of Linoladiol N and Linoladiol HN estradiol-containing creams (EMA)

India

  • Analysts Say Regulatory Affairs Among Top Jobs in Demand in India in 2015 (PharmaBiz)
  • India Wants a Low-Cost Device Industry to Match its Generics Industry (PharmaBiz)
  • Maharashtra FDA seizes GSK's overpriced paracetamol brands worth over Rs.1 crore (PharmaBiz)
  • India unrelenting over alleged lax IPR; may drag the USA to the WTO (Pharma Letter-$)
  • Wockhardt Ltd says Himachal Pradesh regulator lifts drug ban (India Times)

Japan & China

  • Multinationals' China Trial Strategies Shift As Industry Adapts (Pink Sheet-$)

Other International

  • Vietnam bans drugs from 45 Indian pharma firms (BioSpectrum)

General Regulatory And Interesting Articles

  • Human skin grown in lab 'can replace animal testing' (BBC)
  • Drugs Aim to Help Elderly Rebuild Muscle (WSJ-$)

Regulatory Reconnaissance #306 - 28 April 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

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