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August 1, 2019
by Michael Mezher

Recon: Oklahoma Makes Final Bid in J&J Opioid Trial; Life Sciences VC Vida Ventures Raises $600M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Oklahoma makes final bid to hold J&J responsible for opioid epidemic (Reuters) (Law360-$)
  • Life sciences VC firm Vida Ventures raises $600 million in second fund (STAT) (Endpoints)
  • Trump firms up plan to import medicines; pharma companies resist (Reuters)
  • Drug costs push some to extreme measures as Trump admin unveils plan to import medicines from Canada (NBC)
  • Senate Democrats to force vote on Trump health care moves (The Hill)
  • The latest CRISPR patent fight is on. So is the mudslinging (STAT)
  • Everything (or almost everything) you need to know about importing drugs from Canada (STAT)
  • Vertex expects more, perhaps bigger M&A to come (BioPharmaDive) (BioCentury)
  • Fresh delay for $4.3B Roche/Spark deal triggers analyst concerns about gene therapy M&A (Endpoints)
  • Amarin Asks Justices To Get ITC To Look Into False Ad Claims (Law360-$)
  • Drugmakers’ Alleged Price-Fixing Pushed a Needed Pill Out of Reach (Bloomberg)
In Focus: International
  • China's big data draws Big Pharma (Nikkei)
  • UK sets aside £2.1bn for more no-deal Brexit prep (PMLive)
  • Rwanda seals Congo border after third Ebola case in Goma (Reuters)
  • Bangladesh struggles with worst outbreak of dengue fever (Reuters)
  • Court Ruling A ‘Sea Change’ For EU Orphan Designation (Pink Sheet-$)
  • Vas Narasimhan of Novartis: ‘We Are Not at All Prepared for a Pandemic’ (NYTimes)
  • Still trailing far behind a blockbuster rival, Novartis gathers another round of positive survival data for Kisqali (Endpoints) (Fierce)
  • London Lab Advances Use of A.I. in Health Care, but Raises Privacy Concerns (NYTimes)
  • Bayer teams up with AI firm Sensyne Health to mine NHS data for its heart disease pipeline (Fierce)
  • News from Abroad -- Swiss-type Patent Claims in Australia (Patent Docs)
  • GSK completes transaction with Pfizer (PharamTimes) (Press)
Pharmaceuticals & Biotechnology
  • Blue-blooded crabs at heart of pharma dispute on drug testing (Reuters)
  • FDA-EMA Workshop Discusses Quality Challenges for PRIME, Breakthrough Therapies (Focus)
  • OPDP Issues Untitled Letter Over Birth Control Device TV Ad (Focus)
  • New FDA Guidances Target Women’s Health, Neonatal Care (Focus)
  • Why health companies are branding themselves as tech companies (STAT)
  • 'Huge Need' For Neurotoxicity Biomarkers In Drug Development, FDA's Woodcock Says (Pink Sheet-$)
  • Saving the Endangered Physician-Scientist — A Plan for Accelerating Medical Breakthroughs (NEJM)
  • Lilly boosted by survival data for key growth drug Verzenio (PMLive)
  • Novo, e-therapeutics extend Type 2 diabetes research pact to include new genomics tech (Fierce)
  • National Immunization Awareness Month Faces Uphill Battle In Wealthy Areas Of US (Forbes)
  • The Patient As Customer: How Biotech And Medicine Are Being Driven By Advocacy Groups (Forbes)
  • Pathology Peer Review in Toxicology Studies: FDA Offers Q&A (Focus)
  • Adrian Hayday refutes challenge on influential autoantibody paper by Karolinska scientists (Endpoints)
  • Amicus touts latest set of gene therapy data; Novo Nordisk expands discovery deal for diabetes (Endpoints) (Fierce)
  • Adaptimmune R&D chief Amado is out amid a top-level shakeup as new CEO tries to revive ebbing enthusiasm (Endpoints)
  • Jumping into growing queue of buyers, Vertex chief targets a slate of new and 'larger' deals ahead (Endpoints)
  • PD-L1, CD47 and now CD24? Star Stanford I/O scientist Irv Weissman points to a ‘major’ new cancer target (Endpoints)
  • Specialty Pharmacies and PBMs Hop On the 340B Money Train (Drug Channels)
  • Sanofi in manufacturing deal for cannabinoid overdose treatment (InPharmaTechnologist)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma (Press)
  • Modra Pharmaceuticals Announces First Patients Treated in Phase IIb Metastatic Prostate Cancer Trial (Press)
Medical Devices
  • Integra Lifesciences picks up Arkis Biosciences (MassDevice)
  • Masimo Q2 results exceed expectations (MassDevice)
  • Abiomed plunges on fiscal Q1 earnings miss, lowered outlook (MassDevice)
  • Teleflex ticks up on Q2 beats, raised outlook (MassDevice)
  • Agilent Companion Diagnostic Gains Expanded FDA Approval in Esophageal Squamous Cell Carcinoma (ESCC) (Press)
  • Adaptive Bio Receives NY State Approval for ClonoSeq in B Cell Cancers (GenomeWeb)
US: Assorted & Government
  • What we learned from the Democratic debates (Politico) (KHN)
  • Express Scripts Boosts Cigna As Employers Stick With Larger Insurer (Forbes)
  • California Court Of Appeal Affirms New Trial In Talc Case (Drug & Device Law)
  • PhRMA's New Attack On Calif. Drug Pricing Law Gets Traction (Law360-$)
  • Ex-J&J Doctor Testifies She Told Bosses About Mesh Issues (Law360-$)
  • Judge tosses 5,000 warming-device lawsuits filed against 3M (MassDevice)
  • After Fresenius deal collapse, Akorn inks $74M settlement with investors over data integrity woes (Fierce)
  • HHS/FDA Safe Importation Action Plan Proposes Two Pathways for Drug Importation (FDA Law Blog)
  • $2,733 To Treat Iron-Poor Blood? Iron Infusions For Anemia Under Scrutiny (NPR)
Upcoming Meetings & Events Europe
  • Names of liposomal medicines to be changed to avoid medication errors (EMA)
  • Sussex criminal sentenced for laundering proceeds from the sale of black-market medicines (MHRA)
  • Proposal to make Colourstart Test 65mcg Cutaneous Patch available from general sales outlets without prescription (MHRA)
  • First allergy test for hair dye to go on general sale (MHRA)
Asia
  • Thailand set to deliver first batch of medical marijuana (Reuters)
India
  • Dr Reddy's expects US FDA re-inspection of Srikakulam plant (Pharmabiz) (Fierce)
  • Reddys seek funds: ADIA, Mitsui, Itochu eye stake in Apollo Holdco (Economic Times)
Australia
  • Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling? (TGA)
  • Advertising health products: Understanding what ‘natural’ means on your medicine (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? Email us at [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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