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

• 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)

• At BSI's full-day EU Medical Device Roadshow, learn the challenges in meeting European CE-marking regulatory and compliance expectations for the new MDR/IVDR requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the first notified body designated under the MDR (EU 2017/745).

• 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)

• ‘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)

• 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)

• 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-$)
• NY AG Issues 33 Subpoenas In Purdue Pharma Opioid MDL (Law360-$)

• FDA Advisory Committee Calendar
• Food and Drug Administration Science Forum 2019; Public Workshop – 11-12 September 2019
• Nonprescription Drugs Advisory Committee; Notice of Meeting – 18 September 2019

• 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)