Regulatory Recon: US Court Reverses Praluent Sales Ban; Study Finds Most New Cancer Drugs Approved by EMA Don't Improve Survival (5 October 2017)

Posted 05 October 2017 By Michael Mezher

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

In Focus: US

  • US court reverses ban on sales of Sanofi, Regeneron drug Praluent (Reuters) (Financial Times) (Big Molecule Watch)
  • Sanofi and Regeneron, seeking to shield Dupixent, lose first IPR try against Amgen (Fierce)
  • Insurers are slow to approve pricey new cholesterol drugs (Reuters)
  • Johnson & Johnson's diabetes care unit to exit insulin pump business (Reuters)
  • Challenges in the Design and Interpretation of Noninferiority Trials (NEJM)
  • Cigna to end OxyContin painkiller coverage, signs contract for alternative (Reuters)
  • Time to Change the Way We Price Drugs (Medpage)
  • Zika vaccine shows promise in early human trial (Reuters) (NEJM)
  • HHS Watchdog Wants Device Identifiers Added to Medicare Forms (Bloomberg)
  • The Critical Role of Biomedical Research in Pandemic Preparedness (JAMA)
  • Bluebird's gene therapy shows promise in keeping lethal Lorenzo's Oil disease in check (Endpoints) (Fierce) (Medpage) (NEJM)
  • Peter Thiel and Sean Parker are financing a secretive cancer-fighting start-up, source says (CNBC) (Endpoints)
  • GMO Mosquitoes Aren't 'Drugs,' Need EPA Oversight (NYTimes)
  • Acadia adopts a new PhIII game plan for 'breakthrough' med, dumps Alzheimer's PhII (Endpoints)

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In Focus: International

  • Over half of new cancer drugs 'show no benefits' for survival or wellbeing (The Guardian) (Medscape) (AP) (PharmaTimes) (Pharmafile) (Study) (Editorial)
  • Roche bladder cancer drug struggles as medics focus on survival (Reuters)
  • Vectura asthma inhaler makes "positive" regulatory progress in Europe (Reuters)
  • EMA takes yet another step in public engagement with its first public hearing (EMA)
  • European Commission Gives Sneak Preview Of Hotly-Awaited Pediatrics Report (Pink Sheet-$)
  • Gilead offers its newest HIV drug candidate to patent pool for low-cost production (Fierce) (Press)
  • Medicines For Europe To Join The ISPOR Issue Panel On Value Added Medicines (Medicines for Europe)
  • Korea's Biotech Roadmap Aims To Bridge Funding Gaps (Pink Sheet-$)
  • Tension Between Quality Regulatory Paradigm and Innovation/Acceleration/Harmonization in Spotlight (IPQ)
  • UK Consults on Opt-Out Organ Donation System (GOV.UK) (Pharmafile)
  • Why 'Plague Season' Is A Big Worry In Madagascar This Year (NPR)

Pharmaceuticals & Biotechnology

  • Sizzling Startup Outcome Health's Drug Marketing Shows Signs Of Struggle (Forbes)
  • Examining Global Launch Sequencing Trends and Strategies Among Pharmaceutical Companies (Cutting Edge Info)
  • Rhythm Pharma IPO goes over the top, snags $120M in latest sign the biotech window is wide open (Endpoints)
  • ANDA Submissions — Prior Approval Supplements Under GDUFA (FDA)
  • Completeness Assessments for Type II API DMFs Under GDUFA (FDA)
  • Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA (FDA)
  • Visterra adds $24M to series C to take flu drug to phase 2b (Forbes) (Endpoints)
  • Can Medtech Firm Locate Solve A Cell Therapy Conundrum? (SCRIP-$)
  • Startup Palleon has a sweet plan for cancer immunotherapy (Fierce)
  • Scientists reverse heart failure via newly discovered regeneration pathway (Fierce)
  • HDA Schools FDA On DSCSA (RxTrace)
  • FDA's Dr. Theresa Mullin Addresses BIO Patient and Health Advocacy Summit (BIO)
  • A drug with the startling power to mute defective genes raises hopes for a new class of therapies — but hurdles abound (STAT)
  • Strata Oncology, UCSF Partner to Offer $25M in Free Tumor Sequencing (Xconomy)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; KOVALTRY (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; TECFIDERA (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Syros Presents Biomarker Data from Its Ongoing Phase 2 Clinical Trial of SY-1425 in Genomically Defined AML and MDS Patients at ESH Conference on AML (Press)
  • Palladio Biosciences Receives Orphan Drug Designation from the U.S. FDA for Lixivaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (Press)
  • Biogen's SPINRAZA (nusinersen) Data Show Earlier Treatment Initiation May Lead to Improved Motor Function Across a Broad Population of People Living with Spinal Muscular Atrophy (Press)
  • Neurocrine Announces FDA Approval of 80 mg INGREZZA® (valbenazine) Capsules for the Treatment of Adults with Tardive Dyskinesia (TD) (Press)
  • ACADIA Pharmaceuticals Initiates Phase III Study of Pimavanserin in Dementia-Related Psychosis (Press)
  • Purdue Pharma L.P. and Geisinger Announce First Patient Enrollment in Clinical Trial Assessing Effect of Wearable Health Technology on Chronic Pain Patients (Press)
  • Chugai's Bispecific Antibody "ERY974" Results of Preclinical Study Published in Science Translational Medicine (Press)

Medical Devices

  • Interview – Philips goes from imaging to treatment (EP Vantage)
  • Eli Lilly's Humalog Junior KwikPen diabetes drug-device combo launches in US (MassDevice)
  • Pavmed to drop 510(k), pursue de novo pathway for PortIO infusion system (MassDevice)
  • Carrot gets FDA clearance for OTC breathalyzer for smokers, launches cessation app (mobihealthnews)
  • Adhezion Biomedical wins FDA nod for SecurePort IV cath adhesive (MassDevice)
  • FDA expands protocol for investigational ReCell burn injury device (MassDevice)
  • Winning With A Customer Focus In Medtech (Forbes)
  • Solta Medical Receives FDA 510(k) Clearance for Thermage FLX System, Newest Generation Skin Smoothing Technology (Press)
  • FDA Grants Marketing Clearance for the Peerbridge Cor Multi-channel Remote ECG Monitor (Press)
  • These Consumer Technologies Could Show Us What's Next in Medical Devices (MDDI)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; IMPELLA 2.5 SYSTEM (FDA)

US: Assorted & Government

  • Murray Presses Former HHS Sec. Tom Price to Honor Commitment to Repay Taxpayers for Luxury Travel (Murray)
  • Bill to Rescue Children's Health Program Hits Snag in House (NYTimes)
  • Better Medicare For Those With Chronic Disease (Forbes)
  • To Save Opioid Addicts, This Experimental Court Is Ditching The Delays (NPR)
  • Gilead Seeks Supreme Court Review of FCA Claims in Whistleblower Suit (FDA News-$)
  • AbbVie, Lilly Slam Discovery Bid In Testosterone MDL (Law360-$)
  • Drug Manufacturers Shed No Tears Over Ruling that State Law Claims Based on Eye Drop Dispensers are Preempted (FDA Law Blog)
  • Never Too Late to Celebrate Preemption (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Russia viewed as one of the fastest growing pharma markets (PharmaLetter-$)

Asia

  • Eisai enters license deals for Latin America and Japan (PharmaLetter-$)

India

  • Health ministry launches mobile app for patients, healthcare professionals to report ADR (PharmaBiz)
  • Goa FDA calls for regulation & technology upgradation of supply chain to curb counterfeiting (PharmaBiz)

Australia

  • Submissions received: Guidance on biovigilance responsibilities of sponsors of biologicals (TGA)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
  • Surflink Media and Surflink Media 2 (Models 200 and 210) - used with wireless hearing aids (TGA)
  • TGA presentation: International Society for Cellular Therapy (Australia and New Zealand region), 15 September 2017 (TGA)

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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