Recon: Sanofi to Lay Off 466 in France and Germany in Shift to Cancer, Gene Therapies

• Billions at Stake in Opioid Suits, But It's No Tobacco Windfall (Bloomberg)
• Boston drug-pricing watchdog group is ‘mouse that roared’ (Boston Globe)
• Cities, States Denied Committee Seats in Opioid Maker’s Bankruptcy (WSJ)
• Deadly Superbugs Win as Wall Street Flees Makers of Antibiotics (Bloomberg)
• FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones (Focus) (STAT)
• Amazon looking to work directly with health plans and employers to sell prescription drugs, court documents reveal (STAT)
• Who’s next in line to succeed Ken Frazier as CEO of Merck? (Endpoints) (Fierce)
• Grassley announces opposition to key Trump proposal to lower drug prices (The Hill)
• Investors pony up $476M for the latest round of biotech IPOs to hit the Street (Endpoints)
• Senate committee to vote on health package with ambitious plan to reduce drug prices (STAT)
• PwC: US companies to spend 6% more on employee healthcare next year as drug prices rise (CNBC)
• Is sexual desire a medical issue? An experimental drug for women revives an intense debate (STAT)

• Sanofi to ax 466 jobs, step up focus on cancer, gene therapy R&D  (Fierce) (BioPharmaDive) (Endpoints)
• GSK Kicks Off Sale of $1.2 Billion Consumer Health Drugs-Sources (Reuters) (Pharmafile)
• GSK offers concessions to address EU concerns over Pfizer deal (Reuters)
• UN Health Agency to Remove Controversial Opioid Guidelines (AP)
• AstraZeneca's COPD triplet Breztri, rival to GSK's Trelegy, nabs first nod from Japan (Fierce)
• NHS to fast-track ‘game changing’ cancer drugs (PharmaTimes)
• 4 pharma companies accused of anti-competitive conduct (PharmaTimes)
• Japan Approves 1st Avastin Biosimilar (PharmaJapan)
• France has no plans to legalize cannabis for recreational use: minister (Reuters)
• Northeast Congo insecurity hampers response to measles outbreak (Reuters)
• Teva faces potential cash crisis amid lawsuit risks, flatlining sales (BioPharmaDive)

• The Most Synthetically Complex Drug Candidate Ever (In The Pipeline)
• Stem Cell Company Persuades Employers To Steer Workers Toward Controversial Therapy (KHN)
• Drug Pricing Should Reflect Value, Not Recoupment Of Investment (Forbes)
• Drug Prices And Innovation (Forbes)
• Analyst call with Allergan execs stokes anticipation of a plan to split the company in ‘a month or two’ (Endpoints)
• NEJM appoints Eric Rubin to succeed Jeffrey Drazen as EIC; Amphastar prevails against Momenta/Sandoz in years-long lawsuit (Endpoints)
• Drugmakers Seek Tweaks to FDA Guidance on Bispecific Antibodies (Focus)
• FDA Updates on FMT Donor Screening Recommendations (Focus)
• 'Our legacy matters': Merck maps out Keytruda kingdom while spotlighting advances in vaccines, hospital care (Endpoints)
• You can’t pay for 21st century medicines with a 20th century payment system (STAT)
• Eli Casdin backs Codexis' platform tech with $50M equity buy (Endpoitns)
• DHL invests $150M to expand pharma, medical supply chain (SupplyChainDive)
• Oncolytics Bio Tacks On Cancer Combo Study with Merck KGaA, Pfizer (Xconomy)
• Pharmacquired: Is $11B enough to secure Sanofi's spot in hemophilia? (BioPharmaDive)
• Rotavirus Vaccine May Help Protect Against Type 1 Diabetes (NYTimes)
• Cures Act Hiring Authority Expansion Could Help Recruitment Woes, US FDA's Sharpless Says (Pink Sheet-$)
• Amgen's Elliott Levy On Adaptive Design And Real-World Evidence Strategies (Pink Sheet-$)
• FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease (FDA)
• Forrester steps down as CEO of Verastem (Fierce) (Endpoints)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Oncology Indications in Direct-to-Consumer Television Advertising (FDA)
• GSK’s Rappuoli and colleagues propose model for sustainable vaccine development (BioCentury)
• Study of multiethnic genomes identifies 27 genetic variants associated with disease (NIH)
• Progress Toward 3D Printed Human Organs (NIH)
• Parexel pens CluePoints collab for risk-based monitoring work (Fierce)
• Rethinking Inclusivity in Precision Medicine Research: The Disability Experience and Barriers to Participation (Harvard Bill of Health)
• Infusion Options Inc. Issues Voluntary Nationwide Recall of All Lots of All Sterile Products Due to Lack of Assurance of Sterility (FDA)
• RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (FDA)

• In starved antibiotic field, Melinta soars as FDA grants speedy drug review (Endpoints) (Press)
• U.S. FDA Accepts Supplemental Biologics License Application (sBLA) for ULTOMIRIS® (ravulizumab-cwvz) under Priority Review for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) (Press)
• OxThera Initiates Extension Part of a Phase 3 Study of Oxabact in Primary Hyperoxaluria (Press)
• Cancer Prevention Pharmaceuticals (CPP) Reports FAP Phase 3 Clinical Trial Results at Digestive Disease Week Conference (Press)
• Camurus Receives IND Acceptance From the FDA to Enter Phase 3 with CAM2029 for Treatment of Acromegaly (Press)
• Onxeo Expands its Pipeline with New Optimized Lead OX401 Entering Proof-of-Concept Preclinical Phase (Press)

• FDA Updates Regulations on Mammography (Medscape)
• PrinterPrezz gains QMS certification for medical devices (MassDevice)
• FDA Panel Faces ‘Conundrum’ with Mortality Assessments on Paclitaxel-Coated Devices (Focus)
• Zimmer Biomet taps medtech vet Upadhyay for CFO | Personnel Moves June 20 2019 (MassDevice)
• Inside Insulet’s pivotal year with CEO Shacey Petrovic (MassDevice)

• FTC to the Rescue Regarding High Drug Prices and Patents (Patent Docs)
• No evidence Medicaid work requirements boost work (Politico)
• Litigation Funder Indictment in Pelvic Mesh Litigation (Drug & Device Law)
• Criminal Convictions for Compounding Activities Overturned for “Legal Impossibility” (FDA Law Blog)
• Clovis Directors Plead Ignorance On Rules In Drug Trial Suit (Law360-$)
• Amphastar To Get $60M In Settlement With Rivals (Law360-$)
• BD sues NeuMoDx over patents for diagnostic device (MassDevice)

• FDA Advisory Committee Calendar

• Suppliers of antidepressants accused of illegal anti-competitive conduct (MHRA)
• EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays (Focus)
• EU Regulatory Roundup: EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit (Focus)
• Brexit Transfers Nearly Complete But EMA Staff & Resource Pressures Remain (Pink Sheet-$)
• New implant recommended by NICE for uveitis (PharmaTimes)
• Pfizer to invest £5M in paediatric medicines (PharmaTimes)
• UK NICE Review Needs To Be More Than A ‘Bureaucratic Exercise’ (Pink Sheet-$)
• ‘Impossible' To Prepare UK Supply Chain For October No-Deal Brexit (Pink Sheet-$)
• Medicines: terminated and cancelled manufacturing and wholesale dealer licences (MHRA)

• MHLW Orders Label Revisions for Metformin, Blanket Contraindication for Patients with Severe Kidney Impairment (PharmaJapan)

• Aurobindo Pharma to spend over Rs.1,000 crore on research and development for FY 2019-20 (PharmaBiz)
• Indian Pharma industry aspiring to grow to $120-130 billion by 2030: IPA (Economic Times)