Recon: Vertex CF Drugs Win Coverage in Wales; Merck Buys San Diego Biotech Calporta for up to $576M

• FDA still allowing secret reports on medical devices (Star Tribune)
• NY insurance regulator notifies opioid makers, distributors of enforcement action (Reuters)
• Google’s ‘Project Nightingale’ Triggers Federal Inquiry (WSJ) (STAT)
• Lawmakers Scold Google’s ‘Project Nightingale’ Over Health-Data Privacy (WSJ)
• ICER draws new gene therapy pricing framework (BioPharmaDive) (ICER)
• Poll: 1 in 5 US adults report trouble affording prescription drugs (The Hill) (STAT) (Gallup)
• Rx Price Watch: Brand Name Drug Prices Rose More than Twice as Fast as Inflation in 2018 (AARP)
• Merck buys Calporta for up to $576M for preclinical neurodegeneration assets (Fierce) (Endpoints)  (Press)
• Abbott CEO Plans Exit After Forging Device Maker Into a Giant (Bloomberg) (Forbes) (MassDevice)
• Trump officials making changes to signature drug pricing proposal, Azar says (The Hill)
• Seattle Genetics Submits Arbitration Demand vs Daiichi Sankyo (Bloomberg) (Press)
• US recorded 11 cases of measles over the past month (Reuters)

• Vertex deal with Wales expands cystic fibrosis treatment coverage to all of UK (Reuters)
• J&J's Remicade losing ground in Quebec health plan despite court victory (Reuters)
• EC Offers Further Clarity on Clinical Trial Regulation (Focus)
• German Report May Be Road Map For Future AI Regulation (Law360-$)
• GSK's asthma biologic Nucala scores in rare blood disorder study (Endpoints) (PMLive) (Press)
• NICE recommends Elmiron for bladder pain syndrome (PharmaTimes)
• Ahead of FDA decision on BTK drug, Amgen-partnered BeiGene scores China OK for PD-1 (Endpoints)
• Merck shutters French research site in a reorganization aimed at eliminating more than 200 jobs (Endpoints)
• When Countries get Wealthier, Kids can Lose Out on Vaccines (NPR)

• Microbiome drug development: a rapidly evolving field (STAT)
• Employer Pharmacy Benefits in 2019: High Deductibles and Greater Coinsurance Expose Even More Patients to Prescription List Prices (Drug Channels)
• Pfizer's Upjohn and Mylan will become Viatris. Wait, haven't we heard that name before? (Fierce) (Press)
• Who shrank the drug factory? Briefcase-sized labs could transform medicine (Nature)
• FDA’s Project Orbis May Expand to Singapore and Switzerland (Focus)
• FDA Warns Mylan’s Indian API Facility Over Contamination Concerns (Focus)
• ICER Seeks Public Input to Guide Selection of Non-Drug Assessment Topics for 2020 (ICER)
• Reata’s Kidney Drug Hits Goals of Key Study, Paves Way for FDA Filing (Xconomy)
• Avidity Bio Adds $100M to Advance R&D of Muscle Disorder Drugs (Xconomy) (Endpoints)
• Weill Family Foundation gifts $106M for public-private 'Neurohub' (Fierce)
• Patients just as satisfied when surgeons give fewer opioids for pain (Reuters)
• AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019 (Eye on FDA)
• Another Reason to Take Your Blood Pressure Drugs: Lower Dementia Risk (NYTimes)
• FDA slaps a hold on an AML trial as Marker scraps a failing ovarian cancer program, sinking shares (Endpoints)
• Takeda doubles down on Finch's microbiome insights, signing up for a second project in Crohn's disease (Endpoints)
• Kiadis abandons lead PhIII program, shifts focus to natural killer cells (Endpoints)
• Italian API Firm Cited for Host of Violations (FDANews-$)
• bluebird bio and Forty Seven Announce a Research Collaboration to Study an All Antibody Conditioning Regimen for Use in Combination with Autologous Lentiviral Vector Hematopoietic Stem Cell Gene Therapy (Press)
• Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity (FDA)

• Bicycle Therapeutics Announces First Patient Dosed in Phase I/II Trial of Bicycle® Toxin Conjugate BT5528 in Patients with Advanced Solid Tumors (Press)
• LifeMax Receives Orphan Drug Designation From the European Commission for LM-030 for the Treatment of Netherton Syndrome (Press)

• AdvaMed Unveils Certification Tools For Updated Code of Ethics (AdvaMed)
• In understanding patient responses to metal implants, 'our toolbox is limited,' FDA says (MedtechDive)
• FDA Panel: Workers a Key Factor in Dirty Duodenoscope Saga (Medpage)
• Becton Dickinson Submits HPV Assay for Expanded US Premarket Approval (GenomeWeb)
• Boston Scientific faces lower reimbursement despite White House lobbying bid (MedtechDive)
• FDA Clears NantHealth Tumor-Normal Whole-Exome Test (GenomeWeb)
• Hologic wins FDA approval for 3DQuorum AI imaging technology (MassDevice)
• Nascent digital therapeutics group defines best practices, ethics code (MedtechDive)
• Paige gets CE mark for prostate cancer detection technology (MedtechDive)
• Stryker Issues Safety Communication on STAR Total Ankle Replacements (Stryker)

• FDA's Special Treatment Of Big Tech Faces Mounting Scrutiny (Law360-$)
• DTC Drug Price Transparency: Ball’s in Congress’ Court (Forbes)
• House panel takes up tobacco, maternal health bills (Politico)
• Verma Attacks Critics Of Medicaid Work Requirement, Pushes For Tighter Eligibility (KHN)
• Gottlieb On Pursuing Legislative Reform: Start Small, Build Later (Pink Sheet-$)
• Recent Executive Orders Clamp Down on Agency Guidances (Drug & Device Law)

• FDA Advisory Committee Calendar
• Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making; Public Workshop – 6 December 2019

• EMA Officials: Regulatory, HTA Advice Sped Access to Bluebird’s Gene Therapy (Focus)
• Statement of the ERN Board of Member States on Integration of the European Reference Networks to the healthcare systems of Member States (EC)
• Jumping Before They Were Pushed – Kiadis And Aradigm Withdraw EU Filings (Pink Sheet-$)

• Asia Regulatory Roundup: Industry Questions TGA’s Ability to Enforce Proposed Software Rules (Focus)

• DCGI clarifies on implantable medical device for its effective regulation as per new MD Rules, 2017 (Pharmabiz)

• Therapeutic Goods Advertising Consultative Committee, 17 October 2019 (TGA)
• Impersonation of Commonwealth public officials (TGA)

• New Zealanders to vote in referendum on legalizing euthanasia (Reuters)