Recon: DBV Withdraws Peanut Allergy BLA; Agenus, Gilead Partner on Immuno-Oncology

• Big Pharma returning to US price hikes in January after pause (Reuters)
• Why The US Remains The World’s Most Expensive Market For ‘Biologic’ Drugs (KHN)
• Agenus shares soar after cancer therapy deal with Gilead (Reuters) (Endpoints)
• DBV pulls peanut allergy filing after FDA faults data details (Fierce) (Endpoints)
• HHS recommends opioid overdose antidote to high-risk patients (Reuters) (AP)
• Judge Blocks New York From Enforcing Opioid Surcharge on Companies (Reuters) (Law360-$)
• Relay Therapeutics raises $400 million in venture capital funding (STAT) (Endpoints) (Press)
• The right way to address prescription drug costs (STAT)
• Trump administration report would preclude reclaiming patents as a way to lower drug prices (STAT)
• AZ, Merck's Lynparza plows ahead in ovarian cancer with $1B-plus approval, phase 3 data (Endpoints) (Fierce) (Press)
• Merck's Keytruda puts heat on Pfizer, Merck KGaA's Bavencio with new Merkel cell OK (Fierce) (Press)
• The da Vinci surgical robot: A medical breakthrough with risks for patients (NBC)
• The Apple Watch is giving patients control over their health, but some doctors say consumers are taking it too far (CNBC)

• A Year In, Novartis’ Boss Faces The World (Forbes)
• Brexit: European Commission presents 'no-deal' contingency plans (DW) (BBC) (Emergo) (Pink Sheet-$)
• Post-Brexit immigration policy has a critical missing piece (PMLive) (PharmaTimes)
• EU Servier Court Ruling 'Reduces Competition Law Risks For Pharma' (Pink Sheet-$)
• South Korean pharma laid low by global retreat and Samsung scandal (Nikkei Asian Review)
• Merck KGaA hands off its CAR-T R&D operations to Intrexon in $175M deal (Endpoints)
• AstraZeneca's ovarian cancer and anemia treatments meet goals in late-stage studies (Reuters)  (Endpoints) (AstraZeneca) (FibroGen)
• 140 jobs in jeopardy as Recipharm weighs the fate of money-losing plant (Fierce)
• Dengvaxia approved for dengue in EU (PharmaTimes)
• NICE publishes updated guidance with expanded recommendation for Oncotype DX (PharmaTimes)

• Sen. Warren’s Generic Drug Idea (In the Pipeline)
• Massachusetts is trying to make the Berkshires a biotech hub. Can it succeed where so many other cities have failed? (STAT)
• Top Cancer Doctor Resigns as Editor of Medical Journal (NYTimes)
• Supernus Pharma's ADHD drug meets main goal in study on adolescents (Reuters) (Endpoints)
• Gilead, Scholar Rock Sign $80M Up Front Deal for Fibrosis Drugs (Xconomy)
• FDA turns thumbs down on Spectrum’s ‘breakthrough’ pitch for cancer drug poziotinib and shares tumble (Endpoints)
• Lilly lays out sunny 2019 forecast driven by growth of new diabetes, psoriasis and cancer drugs (Fierce)
• US Enforcement 2019: Compounding, Opioids Top Priorities But Beware Of REMS Violations, Too (Pink Sheet-$)
• US FDA's Robert Temple And Signatory Authority: Teacher And Back-Up (Pink Sheet-$)
• As immuno-oncology heads into 2019, one thing is clear: It’s good to be Merck (Fierce)
• OTC Switch For Naloxone Finding Interest Among Sponsors (Pink Sheet-$)
• Cocaine Anesthetic Not FDA-Approved, Rival Drugmaker Says (Law360-$)
• The valsartan carcinogen mess taught pharma a surprise manufacturing lesson. Will 2019 bring more? (Fierce)
• Discovering translational biomarkers in neurodevelopmental disorders (Nature)
• Google’s GV enlists machine learning pro Rosana Kapeller in its drive to create a new breed of biotech (Endpoints)
• Real World Evidence at the FDA (The Incidental Economist)
• It’s Time to Reform the Orphan Drug Act (NEJM Catalyst)
• Biotech bound, Liz Barrett passes Novartis’ top oncology job to Susanne Schaffert (Endpoints)
• G1 tanks after placebo beats drug in cancer response rate test (Fierce)
• No peak in sight: Cancer marketing spreads across media landscape, from TV to digital (Fierce)

• Chugai gains FDA breakthrough status for rare CNS treatment (PMLive)
• Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer (Press)
• Omeros Establishes Independent Academic Leadership Committee for its OMS721 Phase 3 Clinical Program in IgA Nephropathy (Press)
• Deciphera Pharmaceuticals Initiates Pivotal Phase 3 Clinical Study of Ripretinib (DCC-2618) in Second-line Patients with Gastrointestinal Stromal Tumors (“INTRIGUE” Study) (Press)
• Kalytera Provides Update on Phase 2 Clinical Study Evaluating CBD in Prevention of Acute GVHD (Press)
• Da Volterra Announces Enrollment of First Patients in SHIELD, a Phase 2 Clinical Trial with DAV132, a Novel Microbiota Protective Therapy (Press)
• Cerus Announces First Patient Enrolled in the Phase 3 ReCePI Study (Press)
• European Medicines Agency Grants Orphan Drug Designation for Xeris’ Investigational Ready-to-Use Glucagon for the Treatment of Non-Insulinoma Pancreatogenous Hypoglycaemia Syndrome (NIPHS) (Press)
• Janssen Announces European Commission Approval of Darzalex (daratumumab) Split Dosing Regimen (Press)

• FDA CDx Class Labeling Draft Guidance May Ease Patient Access, Spur Competition Among Test Makers (GenomeWeb)
• Concepta Diagnostics launches new tool to track ovulation (mobihealthnews)
• Haemonetics relocates HQ to downtown Boston (MassDevice)
• FDA green-lights pediatric indication for Paragonix’s SherpaPak heart transport device (MassDevice)
• Cerus launches US pivotal, bids for CE Mark for Intercept red blood cell treatment (MassDevice)
• Kleresca cleared to enter Australian, Canadian markets (Medical Design & Outsourcing)

• J&J loses bid to have $4.7 billion talc verdict set aside, vows to appeal (Reuters)
• New Hatch-Waxman Integrity Act Brings Hope For Patients (Law360-$)
• Fresenius Gets Win In Suit Over Hospira Sedative Patents (Law360-$)
• Judge signals skepticism in Trump team's bid to block Obamacare suit (Reuters)
• Facing oversight, Trump's ACA defense strategy is taking shape (Politico)
• DOJ Wants It Both Ways: Case Satisfies Materiality Standard, but Still Merits Dismissal (FDA Law Blog)
• Sign-ups for 2019 Obamacare insurance fall to 8.5 million people (Reuters) (NYTimes)
• VA Was “Taken Advantage Of” by Paying Billions in Fees, Secretary Says (ProPublica)
• Cigna-Express Scripts Merger A Done Deal By Thursday (Forbes)
• Walgreens And Alphabet's Verily Partner To Cut Health Costs (Forbes)
• Former President Of Billionaire-Owned Hearing Aid Manufacturer Sentenced To 7 Years In Prison (Forbes)
• Embattled Rite Aid Gets Rare Win With New 10-Year McKesson Deal (Forbes)
• Judge dismisses lawsuit accusing Craig Venter of stealing trade secrets (STAT)
• Juul May Get Billions in Deal With One of World’s Largest Tobacco Companies (NYTimes)

• FDA Advisory Committee Calendar

• MHRA statement on Allergan (MHRA)
• Roche Secures EU Fast-Track Review For Anticancers (Pink Sheet-$)

• Ranbaxy to ruins: How the Singh brothers turned from business whizkids to fraud accused (Economic Times)

• Consultation: Medical device cyber security (TGA)

• Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality (Health Canada)

• Brazilian doctors fail to report for duty to replace Cubans (Reuters)

• Child death rates far higher in U.S. than in other developed countries (Reuters)