Regulatory Focus™ > News Articles > 2019 > 8 > Recon: Edwards, Medtronic Valves Win Expanded Low-Risk TAVR Indication; FDA Approves AbbVie’s Rinvoq

Recon: Edwards, Medtronic Valves Win Expanded Low-Risk TAVR Indication; FDA Approves AbbVie’s Rinvoq

Posted 16 August 2019 | By Michael Mezher 

Recon: Edwards, Medtronic Valves Win Expanded Low-Risk TAVR Indication; FDA Approves AbbVie’s Rinvoq

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA approves Zimmer Biomet’s pediatric spinal tether for scoliosis (MassDevice) (FDA) (Press)
  • Edwards, Medtronic win expanded indications for low-risk TAVR patients (MedtechDive) (FDA) (Press) (Press)
  • FDA approves AbbVie's new rheumatoid arthritis drug (Reuters) (Press)
  • Trump health official: Controversial drug pricing move is 'top priority' (The Hill) (BioPharmaDive)
  • Roche personalized cancer treatment to cost about $204,560 a year (Reuters) (Endpoints) (STAT)
  • FDA Offers Accelerated Approval for 3rd Tissue-Agnostic Cancer Treatment (Focus) (STAT)
  • Nationwide Conspiracy Claims OK’d in Generic Drug Pricing Case (Bloomberg)
  • How Amgen plans to BiTE into CAR-T’s hype (STAT)
  • FDA approves Celgene's bone marrow cancer treatment (Reuters) (Endpoints) (FDA) (Press)
  • Another US FDA Approval Record: ANDAs Set A New Annual High Mark In Only 10 Months (Pink Sheet-$)
  • For a decade, Francis Collins has shielded NIH—while making waves of his own (Science)
  • Federal Circuit Will Not Halt Sales of Amgen’s MVASI (bevacizumab-awws) Before It Resolves Genentech’s Appeal (BigMoleculeWatch)
Sponsored Content: Hear from the first Notified Body designated to the new EU-MDR In Focus: International
  • First two Ebola cases confirmed in Congo's South Kivu: officials (Reuters)
  • EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing? (Focus)
  • The top 10 franchise drugs in biopharma history will earn a total of $1.4T (trillion) by 2024 — what does that tell us? (Endpoints) (Evaluate)
  • Germline Genome Editing Governance Weighed by International Commission (GenomeWeb)
  • Debt-laden Glenmark counts on assets sales, spinoffs to dig it out (Fierce)
  • Leo Pharma to market AstraZeneca’s brodalumab outside Europe (PMLive)
  • Investors angry about insulin woes sue Novo Nordisk in Denmark for $1.75B (Fierce)
  • Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices (Focus)
Pharmaceuticals & Biotechnology
  • ‘Lithium’ Review: A Mysterious Balm for Mania (WSJ)
  • Meet the protein responsible for nearly $100B in cancer drug deals (BioPharmaDive)
  • Drugmakers Seek US, EU Harmonization on NASH Drug Development Guidance (Focus)
  • Growing Numbers of Priority and Competitive ANDAs Under Review as Approvals Trickle In (Focus)
  • Caligan Partners Built 10% Stake in Amag Pharma (Bloomberg)
  • ICER blasts FDA, PTC and Sarepta for high prices on DMD drugs Emflaza, Exondys 51 (Endpoints)
  • Top US medical centers roll out DNA sequencing clinics for healthy (and often wealthy) clients (STAT)
  • Monopar files for $40M IPO to test chemo side effect drug (Fierce) (Endpoints)
  • Bausch may have shed the Valeant name, but it still leans on price hikes: analyst (Fierce)
  • The key dates for KRAS watchers through the end of the year — the trail is narrow and risks are extreme (Endpoints)
  • Alector, Prevail trade blows over alleged misuse of confidential information (Fierce)
  • Bain's Orly Mishan joins Pfizer's neuro spinout Cerevel; Oncolytic virus biotech taps SillaJen exec Helena Chaye as CEO (Endpoints)
  • Breast Cancer Gene Mutation Also Increases Risk Of A Type Of Childhood Cancer, Says New Study (Fobres)
  • Advancing the Adoption of Risk-Based Monitoring Strategies in Clinical Trials (ACRO)
  • New migraine drug offers unprecedented relief, but some insurance plans don’t cover it (NBC)
  • Compound medicine regulation is key to patient safety (The Hill)
  • Technology permeates the cold chain warehouse — but it has its limits (SupplyChainDive)
  • Machine learning brings cell imaging promises into focus (Nature)
Medical Devices
  • Nexxt Spine wins clearance for Matrixx stand-alone cervical implant (MassDevice)
  • Medtronic wins approval to begin pivotal trial for new extended-wear infusion set (MassDevice) (Press)
  • FDA Stepping Up Actions Against PGx Testing, Forcing Some Labs to Stop Reporting Drug Information (GenomeWeb)
  • Five-Year FDA IDE Trial Outcomes Show a Higher Safety Profile and Greater Effectiveness at Preserving Range of Motion for the activL Artificial Disc Compared to Previous Generation Lumbar Discs (Press)
US: Assorted & Government
  • Is Promoting a 361 HCT/P for Its Clinical Effects Compatible with a Homologous Intended Use? (FDA Law Blog)
  • 4th NY Doc Charged With Taking Insys Kickbacks Cops Plea (Law360-$)
  • NY AG Issues 33 Subpoenas In Purdue Pharma Opioid MDL (Law360-$)
Upcoming Meetings & Events Europe
  • EU Regulatory Roundup: UK Confirms US Sites Can Batch Test Drugs in Event of a No-Deal Brexit (Focus)
  • UK Firm Creates 'Operating System' To Handle Massive Genomic Patient Data Sets (Forbes)
  • NHS England Tackles Barriers To Use Of Cannabis-Based Medicines in UK (Pink Sheet-$)
  • Hundreds of patients turn to private cannabis clinics in UK (Pharmafile)
  • Korea’s Clinical Trial Road Map Eyes Faster Development, Patient Safety, Rare Diseases (Pink Sheet-$)
  • CDSCO issues draft notification to mandate QR code on API packaging (Pharmabiz)
  • TGA cracking down on non-compliant advertising of bioresonance and similar devices (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.
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