Recon: Pfizer Raises 2019 Guidance on Strong Cancer, Heart Drug Sales; Drugmakers Settle Medicaid Fraud Suit for $248M

• Pfizer raises 2019 forecast as sales of cancer drug, heart medicine surge (Reuters) (Financial Times) (WSJ) (Press)
• Mirati gives a first look at its KRAS-blocking cancer drug (STAT) (Endpoints) (Reuters) (Press)
• Will an FDA panel recommend a drug for preventing premature births remain available? (STAT)
• Drugmakers Ink $242M Settlement In Ill. Medicaid Fraud Case (Law360-$) (Fierce)
• Roche — surprise — delays $4.3B Spark buyout again as regulators hover (Endpoints) (Press)
• House unanimously clears PBM transparency bills (Politico)
• Pallone, Guthrie Introduce Legislation To Support Continuous Pharmaceutical Manufacturing (E&C)
• Pallone and Eshoo on House Passage of Five Health Bills  (E&C)
• Greg Walden to retire in latest sign of GOP doubts about retaking House (Politico) (E&C)
• Senate Democrats to vote this week to overturn Trump ObamaCare moves (The Hill)
• Is Crispr the Next Antibiotic? (NYTimes)

• GSK TB vaccine could prevent millions of deaths (PMLive) (Endpoints) (NYTimes) (AP) (NEJM)
• EU ‘yes’ for Bavencio (PharmaTimes)
• Eudamed reportedly delayed 2 years, IVDR gets 2nd notified body (MedtechDive)
• Morphosys shares fall after dermatitis treatment flops (Reuters) (Endpoints)
• Boehringer Ingelheim is joining the KRAS crowd as early success inspires rivals (Endpoints) (Press)
• Global Regulators Synergize Horizon Scanning Efforts (Pink Sheet-$)
• WTO Price Transparency Talks Face Resistance From Developed Countries (Pink Sheet-$)
• Counting down to the MDR date of application, and the legal stuff to get right before May 2020 (MedicalDevicesLegal)

• Realizing the promise of prescription digital therapeutics (STAT)
• Merck’s quarterly Keytruda sales soar past $3 billion, but analysts fret over future growth (Fierce)
• Pfizer kills off MacroGenics-partnered solid tumor bispecific (Fierce)
• Quarterly Inactive Ingredient Database (IID) Change Log (FDA)
• Generic Version of Xanax Is Recalled by FDA (NYTimes)
• How to communicate about antimicrobial resistance effectively (Wellcome Trust)
• Men With Breast Cancer Need More Treatment Options and Access to Genetic Counseling (FDA)
• People taking blood thinners may risk danger by mixing with OTC meds (Reuters)
• Agile's Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte. (Pink Sheet-$)
• Manufacturer Communications With Payers Easier Under US FDA Guidance, But Challenges Remain (Pink Sheet-$)
• Disc Medicine nabs cash, big backers and biopharma drug deal (Fierce)
• Early price setting, other market access planning is key for early-stage drug, device companies (STAT)
• Atlas, Novo-backed biotech reels in ex-Nimbus CEO Don Nicholson as exec chairman, hooks $50M to conquer anemia (Endpoints)

• TG Therapeutics touts safer PI3Kδ inhibitor as execs tout PhII data, hunt quick OK for a tough niche (Endpoints)
• Terns Pharmaceuticals Receives Fast Track Designation From the FDA for TERN-101, an FXR Agonist for the Treatment of NASH (Press)
• Navidea Biopharmaceuticals Announces Positive Results of First Interim Analysis of Ongoing Phase 2B Study in Rheumatoid Arthritis (Press)
• Themis Bioscience and CEPI Announce Initiation of Phase 1 Clinical Trial with Lassa Fever Vaccine (Press)
• Vapogenix Reports Encouraging Phase II Results of Topical Non-Opioid Pain Medication (Press)
• Novus Therapeutics Receives FDA Guidance on OP0201 Phase 2a Study in Patients with Chronic Otitis Media with Effusion (Press)

• FDA again warns of leak risk with Endologix AAA grafts (MedtechDive)
• Siemens Healthineers closes $1B Corindus Vascular Robotics buy (MassDevice)
• Abbott plans $38m Mitraclip plant in Indiana (MassDevice)
• Medtronic wins FDA breakthrough nod for fully implantable LVAD (MassDevice)
• Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System (FDA)
• The Surmodics Sundance Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status (Press)
• FDA clears HeartVista’s One Click AI-assisted cardiac MRI (MassDevice) (Press)

• Woman Wants New Trial In Sanofi Chemo Drug Bellwether (Law360-$) (Bloomberg)
• FTC Sends Warning Letters to Sellers of Cosmetic Contacts: All Contact Lens Purchases Require a Prescription from a Medical Professional (FTC)
• The hard choices facing 'Medicare for All' (Politico)
• Justice Department issues grand jury subpoenas in J&J opioid probe: filing (Reuters)
• Boston jury finds biotech CEO guilty of fleecing investors, obstruction of justice (Endpoints) (Law360-$)
• FTC Rips Gilead's 'Erroneous' Argument In HIV Drug Rumble (Law360-$)
• Takeda Hid 'Dangerously Defective' Gout Drug's Risks (Law360-$)
• Chinese Distributor Can't Pause US Co.'s Trade Secrets Suit (Law360-$)
• CBD Rules In Limbo As FDA Grapples With New Cannabis Era (Law360-$)
• Supreme Court Preemption Teaser (Drug & Device Law)
• FDA Does Away with the Compliance Policy Guide for Homeopathic Drug Products (FDA Law Blog)

• FDA Advisory Committee Calendar
• Regulatory Science to 2025 (stakeholders for human medicines) – 18-19 November 2019
• Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 13-14 November 2019

• Early access to medicines scheme applications: pending, refused, granted (MHRA)
• Regulatory update - EMA encourages companies to submit type I variations for 2019 by end of November 2019 (EMA)
• Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released (MDA/2019/038) (MHRA)
• France’s Servier aims to accelerate Russian expansion (PharmaLetter-$)
• Germany’s Stada Arz to transfer production of four drugs to Russia (PharmaLetter-$)

• Asia Deal Watch: Qpex Partners Its Experimental Antibiotics With Brii In Greater China (Scrip-$)

• Prices of cancer, cardiac drugs may be slashed (Economic Times)
• Niti Aayog proposes separate regulator for medical devices (Economic Times)

• Changes to propolis and royal jelly in listed medicine applications (TGA)
• TGA presentation: How to submit an effective good manufacturing practice clearance application (TGA)
• Advertisers of complementary medicines (TGA)
• Introduction to medicinal cannabis regulation in Australia (TGA)

• Kenyan team aim to stop fatal snake bites (Reuters)

• Medicinal cannabis not proven in mental health, study finds (Reuters)
• Fast DNA Sequencing Can Offer Diagnostic Clues When Newborns Need Intensive Care (NPR)