Regulatory Focus™ > News Articles > Regulatory Recon: Pfizer Mulls Sale or Spin-Off of Consumer Health Unit; NICE Backs Afinitor, Xalkor

Regulatory Recon: Pfizer Mulls Sale or Spin-Off of Consumer Health Unit NICE Backs Afinitor, Xalkori After Discounts (10 November 2016)

Posted 10 November 2016 | By Michael Mezher 

Regulatory Recon: Pfizer Mulls Sale or Spin-Off of Consumer Health Unit NICE Backs Afinitor, Xalkori After Discounts (10 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Exclusive: Pfizer weighs sale or spin-off of consumer health unit – sources (Reuters)
  • Bribery: a bitter pill (PharmaTimes)
  • AstraZeneca revenues dented by generic rivals (Financial Times)
  • FDA Mulls New Policy on Off-Label Promotion (Medpage) (Law360-$) (Public Citizen) (Policy and Medicine) (PhRMA) (BIO) (Pink Sheet-$)
  • FDA/CMS Collaboration: "Sleeper Group" Goes Public With Call For Real-World Evidence (Pink Sheet-$)
  • Trump's victory is a likely roadblock to medical 'cures' package (STAT)
  • Biopharma's Trump Party Is a Little Too Raucous (Bloomberg)
  • Election verdict: Pharma needs a new prescription (STAT)
  • What will President Trump mean for science? (Washington Post)
  • AstraZeneca sees big healthcare changes under Trump (Reuters)
  • Pharma is Ready And Waiting For A Tax Holiday Under Trump (Pink Sheet-$)
  • Alexion Drug Sale Practices Target of Internal Investigation (The Street)
  • MCCONNELL: Cures Remains Top Legislative Priority (E&C)
  • Day One And Beyond: What Trump's Election Means For The ACA (Health Affairs Blog) (Forbes) (KHN 1, 2) (Medpage)
  • J&J vaccine plus Gilead immune booster shows promise as HIV fighter (Reuters)
  • Theranos accuses Walgreens of 'mishandling' partnership after drug chain files lawsuit (Washington Post)
  • At the Frontline of the Opioid Epidemic, but Unable to Help (NYTimes)
  • Ballot Initiatives: Voters Reject Calif. Drug Pricing Measure; Colo. Single-Payer System (KHN)
  • After Colorado, 'Right To Die' Movement Eyes New Battlegrounds (KHN)
  • Florida Vote Spells Uncertain Fate for Genetically Engineered Mosquitoes (MIT Technology Review) (KHN)
  • Six Thoughts on President Trump and the Durability of the Biotech Stock Rally (The Street)
  • Mylan working to finalize EpiPen Medicaid settlement: CFO (Reuters)
  • Mylan Posts Loss, Hurt by Lower EpiPen Volumes, Charge Related to Settlement (WSJ)

In Focus: International

  • Bristol-Myers pens $100M NASH, fibrosis drug deal with Japan's Nitto (Fierce) (Press) (Reuters)
  • China Keeping Eye On Key Regulatory Dialog After Trump Win (Pink Sheet-$)
  • NICE reappraisals back Novartis' Afinitor and Pfizer's Xalkori (PharmaTimes) (Reuters) (PMLive) (NICE)
  • EMA Revises Guidance On Risk Management Plans To Address Industry 'Misunderstandings' (Pink Sheet-$)
  • Japan, EU, US Pharmacopoeial Meeting Report, October 2016 (PMDA)
  • Siemens plans public listing of healthcare business (Reuters)
  • Guidelines and Guidance Documents for the Registration of Biosimilars in Nigeria (Slides)
  • Patent denied, price of prostate cancer drug may go down (Times of India)
  • Malaysian Regulators Issue New Guidance on Combination Products (Emergo)
  • £13m Oxford partnership to accelerate drug innovations (PharmaTimes)
  • Pfizer wins EU's approval for Ibrance as Novartis readies rival drug (Reuters) (PharmaTimes)
  • Government served legal notice over decision to cut NPPA's powers (Economic Times)
  • Torn lab suit used in Canada Ebola experiment faces review (Reuters)
  • Advanced manufacturing to drive next-gene biomedical research in Australia (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • US vaccine programmes set for shake up if President-elect Trump sticks to his word (BioPharmaReporter)
  • A Funny Thing Happened On the Way to See the FDA Monthly Approval Report (Lachman Consultants)
  • FDA lifts clinical hold on Adaptimmune cancer trial (Fierce)
  • Sarepta and the Regulation of Hope (Morning Consult)
  • AstraZeneca drops early head and neck cancer drug plans (Reuters) (Fierce)
  • Cantrell Drug Company Gets FDA Form 483 (FDA, Amendment 1, 2)
  • Kite updates KTE-C19 timeline (BioCentury)
  • Amgen Is a Total Battleground (The Street)
  • Ocular Therapeutix plans FDA re-submission for Dextenza by end of year, earnings (Drug Delivery)
  • Trump presidency unlikely to 'materially' impact CROs (Outsourcing Pharma)
  • Nicox confident of allaying FDA concerns on key eye care products (PharmaLetter-$)
  • Novavax swings the ax after late-stage failure for its RSV F vax (Fierce)
  • Research on new, rapid screening test identifies potential therapies against drug-resistant bacteria (NIH)

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

  • Bristol-Myers scores fresh bragging rights with PhIII gastric cancer success for Opdivo (Endpoints) (Press)
  • Seattle Genetics Receives FDA Breakthrough Therapy Designation for ADCETRIS® (Brentuximab Vedotin) in Mycosis Fungoides and Primary Cutaneous Anaplastic Large Cell Lymphoma (Press)
  • Anthera Announces that the Blisibimod CHABLIS-SC1 Phase 3 Study Did Not Achieve the Primary Endpoint in Patients with Active Systemic Lupus Erythematosus (Press)

US: Medical Devices

  • What Might Trump's Win Mean for Medtech? (MDDI)
  • Brain implants allow paralysed monkeys to walk (Nature) (Study)
  • Draft Guidance: FDA Calls for Contraindication for Ultrasonic Surgical Aspirators (Focus)
  • Scientists develop new type of HIV test on a USB stick (Reuters)
  • Glaukos Completes Patient Enrollment in Initial Phase of U.S. IDE Clinical Trial for Standalone Version of iStent inject® (Press)
  • Class 1 Device Recall Pipeline Embolization Device (FDA)
  • Class 1 Device Recall Marathon Flow Directed Micro Catheter (FDA)
  • Class 1 Device Recall XCelerator Hydrophilic Exchange Guidewire (FDA)
  • Class 1 Device Recall Alligator Retrieval Device (FDA)
  • Class 1 Device Recall FindrWIRZ Guidewire System (FDA)

US: Assorted & Government

  • Conservatives Push for Short-Term CR To Avoid Lame Duck Deal (Roll Call)
  • Pfizer Slams Appeal In Off-Label FCA Case In 1st Circ. (Law360-$)
  • Expert Testimony in Sheep's Clothing is Still Expert Testimony, Says Georgia Supreme Court (Drug and Device Law)
  • FDA Updates Its Food Facility Registration Guidance (FDA Law Blog)
  • Court quashes American Medical Systems subpoenas in pelvic mesh case, to mull sanctions (MassDevice)

Upcoming Meetings & Events

Europe

  • Advertising investigations: October 2016 (MHRA)
  • Health Collaboration Summit 2016 - a summary of the first day (EFPIA)
  • Court of Appeal rules that the NHS can legally fund HIV-prevention drug PrEP (Pharmafile)
  • Senseonics launches in Norway, completes FDA premarket submission (mobihealthnews)

India

  • CDSCO Notice on D-Penicillamine Shortage (CDSCO)
  • New partnership with India to beat antibiotic resistance (MRC)

Asia

  • Chinese FDA releases "drug scanner" app (Pharmafile)
  • Merck expands Chinese business with 250 mn Euros investment (BioSpectrum)

Canada

  • Qualifying Notice – Opdivo (Health Canada)
  • Summary Safety Review - Rivastigmine (Exelon and generics) - Assessing the Potential Increased Risk of Death (Health Canada)
  • Summary Safety Review - Loratadine - Abnormal heart rhythm (QT interval prolongation) (Health Canada)

Australia

  • Medicines and vaccines post-market vigilance - statistics for 2015 (TGA)
  • MRA GMP clearance application processing timelines (TGA)

Other International

  • Haiti launches massive cholera vaccination drive but worries remain (Reuters)

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.

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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