Regulatory Recon: Merck Pauses Two Keytruda Studies After Patient Deaths; Pfizer, Roche & Aspen Face South Africa Pricing Probe (13 June 2017)

Posted 13 June 2017 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval (Focus) (Reuters) (Patent Docs) (FDA Law Blog) (Bloomberg)
  • Merck to pause two late-stage studies testing Keytruda in myeloma (Reuters) (BioCentury) (Financial Times) (Xconomy)
  • Nassau County Sues Drugmakers Over Opioid Epidemic (WSJ)
  • Why are pharma megadeals a tough pill to swallow? (Financial Times)
  • Government negotiation of prescription drug prices isn't a panacea for lower costs (STAT)
  • It's time to make it legal for Americans to order prescription drugs from abroad (STAT)
  • J&J Drug Prevents Heart Attacks At Cost Of Amputated Toes (Forbes) (Reuters) (Fierce)
  • Bayer, J&J win second US trial over Xarelto bleeding risks (Reuters)
  • Pfizer investors slam new price increases as 'out of step' with its Big Pharma rivals (Fierce)
  • Former Pfizer Scientist Is Resurrecting Projects To Solve The Multidrug Resistant Bacteria Problem (Forbes)
  • Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same? (Focus) (Politico)
  • As bill looms, key GOP senators signal their doubts (Politico) (CNBC)
  • The Fertility Doctor Offering to Rejuvenate Eggs for $100,000 (MIT Technology Review)

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In Focus: International

  • Pfizer, Roche and Aspen face South Africa probe over cancer drug prices (Reuters) (BioPharmaReporter)
  • Resistance to last-ditch antibiotic has spread farther than anticipated (Nature)
  • Tesaro Stock Jumps on Sanofi, Gilead Takeover Interest (The Street) (Fierce)
  • New South African Medical Device Authority Established (Emergo)
  • Germany will apply to host Europe's EMA, EBA regulators after Brexit (Reuters)
  • Innovation The Big Winner As China Joins ICH (Pink Sheet-$)
  • Prescription costs vary wildly between high-income countries (Pharmafile)
  • EMA To Improve Early Pediatric Advice Initiative (Pink Sheet-$)
  • ICH Expands MedDRA's Uptake Globally (Focus)
  • French Introduce Time Limit For Drug Approval Applications After Compassionate-Use Award (Pink Sheet-$)
  • NICE backs Lartruvo for soft tissue sarcoma (PharmaTimes)
  • Four new medicines win nod for NHS Scotland (PharmaTimes) (Pharmafile)
  • Ingrid Schwarzenberger, new Chair of the IGBA Biosimilars Committee (IGBA)

Pharmaceuticals & Biotechnology

  • The ADA skinny, with hot head-to-head data from Sanofi, Novo, Pfizer, Merck and more (Fierce) (Drug Delivery)
  • Human Insulin for Type 2 Diabetes An Effective, Less-Expensive Option (JAMA)
  • Cancer Drug Gleevec Might Slow Type-1 Diabetes (NBC)
  • Cancer treatment: scaling up a vein-to-vein solution (Financial Times)
  • Ex-BMS Exec To Lead Immuno-Oncology Play Kleo (BioCentury)
  • Generic Savings: REMS Obstruction, Not ANDA Backlog, Is Main Hindrance, AAM Says (Pink Sheet-$)
  • Duchenne Development: Data Sharing May Enable Trials To Move Beyond Six-Minute Walk (Pink Sheet-$)
  • Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL (SCRIP-$)
  • Interview – German Merck doubles down on dual-acting cancer agents (EP Vantage)
  • Pfizer Combo Drug Gets New Exclusivity After Ferring Win (Law360-$)
  • Oncology trends: smaller indications and greater efficiency, says QuintilesIMS Institute (OutsourcingPharma)
  • Mylan Requests Review of Two Patents for Sanofi's Lantus Insulin (FDANews-$)
  • US FDA clears BioMarin to make $380,000-a year Vimizim in Ireland (InPharmaTechnologist) (Pharmafile)
  • Bristol-Myers Squibb to Announce Results for Second Quarter 2017 on July 27 (Press)
  • OSE, MSK ally to advance anti-CD127 NSCLC candidate (Fierce)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; Hetlioz (FDA)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures in Professional and Consumer Prescription Drug Promotion (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Pfizer and Lilly Receive FDA Fast Track Designation for Tanezumab (Press)
  • Acceleron's Dalantercept Fails In Phase II RCC Trial (BioCentury) (Fierce) (Press)
  • Drug reduces dyskinesia, 'off' times in Parkinson's patients (Reuters)
  • Novo's Tresiba matches Sanofi rival Lantus in CV safety study—and cuts down the rate of severe hypoglycemia (Fierce) (NEJM) (Press)
  • Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes (NEJM)

Medical Devices

  • Manufacturers May Want to Lease—Not Sell—Their Patented Medical Devices (MDDI)
  • FDA lifts warning letter on Zimmer Biomet plant in China (MassDevice)
  • 3 Considerations for an Effective Embolic Protection Device Trial (MDDI)
  • FDA Seeks Nominations for Device GMP Advisory Committee (FDA)
  • FDA Seeks Nominations for National Mammography Quality Assurance Advisory Committee  (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; Neuropace RNS System (FDA)
  • Hearing Aids at the Mall? Congress Could Make It Happen (NYTimes)
  • TECHLAB Receives FDA 510(k) Clearance To Market E. HISTOLYTICA QUIK CHEK To Aid Clinicians In The Diagnosis Of Amebiasis Caused By The E. Histolytica Parasite (Press)

US: Assorted & Government

  • Label Or Liability: GSK Faces $3M Verdict Over Product It Didn't Make (Forbes)
  • One In, Two Out Executive Order Will Likely Increase Use of Internal FDA Communications (FDANews-$)
  • Jury quirk in U.S. meningitis outbreak case could bring stiffer sentence (Reuters)
  • Infliction of Emotional Distress Not a Viable Claim in Medical Device Case (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Jeremy Hunt reappointed as UK health secretary (PharmaTimes)
  • Netherlands aims to ensure stable drug supply after shortage (PharmaLetter-$)

India

  • CDSCO recruits 100 drug inspectors last one year to enhance cGMP compliance (PharmaBiz)
  • BDC&DA upset on NPPA's notification on ceiling price, seek modification (PharmaBiz)
  • NPPA to notify ceiling prices of sch formulations exclusive of GST rates after GST rates are notified (PharmaBiz)
  • Prices of many essential drugs to rise up to 2.29% post-GST (Economic Times)
  • Sun Pharma receives USFDA nod for anti-cholesterol drug (Economic Times) (Pharmafile)
  • Zydus Cadila gets USFDA nod for ezetimibe tablets (Economic Times)

Canada

Australia

  • Medical devices and IVDs: Suspensions from the ARTG (TGA)
  • Submissions received: Designation of Australian conformity assessment bodies for medical devices (TGA)
  • Fees and charges: summary - from 1 July 2017 (TGA)

General Health & Other Interesting Articles

  • More Than 10 Percent of World's Population Is Obese, Study Finds (NYTimes)
  • NIAID scientists discover rare genetic susceptibility to common cold (NIH)

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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