Recon: Amgen Takes 20.5% Stake in BeiGene; Novartis Cosentyx Fails to Top Humira in Head-to-Head Trial

• FDA is modernizing its technology to prepare for a new wave of therapies (Politico)
• Google takes on wearables giants with $2.1 billion Fitbit deal (Reuters) (WSJ)
• Realizing the Dream of Molecularly Targeted Therapies for Cystic Fibrosis (NEJM) (NIH) (NYTimes)
• AbbVie Earnings, Revenue Beat in Q3 (Yahoo) (Press)
• AbbVie says multiple parties vying for assets related to Allergan deal approval (Reuters)
• White House distances itself from Pelosi plan to lower drug prices (The Hill)
• Neglected Sickle Cell Patients Finally Get a Break and New Drugs (Bloomberg)
• US vaping-related deaths climb to 39, Illinois reports third death (Reuters)

• Amgen takes 20.5% stake in BeiGene to sell cancer drugs in China (Reuters) (STAT) (Endpoints)
• Novartis arthritis drug falls short in challenge to global bestseller (Reuters) (Endpoints) (Press)
• Novo dumps proposed Rybeslus successor for newer model (Endpoints)
• Novo Nordisk nudges up 2019 sales outlook as new drugs excel (Reuters) (PMLive) (Press)
• German pharma experiencing a ‘Brexit boost’; report (PMLive) (CPhI)
• Lupin looks to sell Japanese arm Kyowa for $600 million (Economic Times)
• Pfizer Licenses TB Drug Sutezolid To Medicines Patent Pool (Pink Sheet-$)
• First patient dosed with Chiesi’s Holoclar (PharmaTimes)
• European agency highlights blood clot risks from Pfizer's arthritis drug (Reuters)
• England's antibiotic use is down, but antibiotic-resistant infections spreading, report warns (Pharmafile) (GOV.UK)

• AI will revolutionize drug discovery — but only if experts are involved (STAT)
• Giving vouchers to pharma to develop antibiotics could be a costly move (STAT)
• Infection amnesia: Measles 'destroys immune system memory' (Reuters) (NYTimes)
• Why Developing New Antibiotics is a Losing Battle (Medpage)
• Sometimes Drug Prices Are Too Low (WSJ)
• FDA Revises Draft Guidance on Implementing GDUFA II (Focus)
• Opinion Split Over ICH Proposal To Limit Safety Data Collection (Pink Sheet-$)
• Chronic Hepatitis D: FDA Drafts Drug Development Guidance (Focus)
• Researchers Publish Results Of Biosimilar-Switching Studies (Big Molecule Watch)
• Vik Bajaj unveils Foresite's new incubator, looking to hatch future giants crossing tech and healthcare (Endpoints)
• Data suggest gene, cell therapy trial initiations in Europe lag behind North America — here's why (Endpoints)
• AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial? (Pink Sheet-$)
• Merck's Ebola Vaccine Will Get US FDA Decision Before March Review Deadline (Pink Sheet-$)
• US FDA Hoping To Solve Drug-Software Issues With Digital Health Working Group (Pink Sheet-$)
• Next Billion-Dollar Startups: Truepill’s Dose Of Digital Disruption To The $400 Billion Pharmacy Industry (Forbes)
• ImmunoGen Reports Recent Progress and Third Quarter 2019 Financial Results (Press)
• FDA to consider new evidence, risks behind fecal matter transplants for C. diff treatment (STAT)
• Patient Advocacy Groups – Pharma in Disguise? (Harvard Bill of Health)
• Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)
• Paratek's top antibiotic fails to clear a key competitive hurdle in head-to-head studies (Endpoints)
• Dogs help Eli Lilly scientists identify new osteoarthritis target (Fierce)
• Gilead's ex-investor relations chief takes CFO job at Sangamo; Former GE Healthcare exec takes the helm at Vectura Group (Endpoints)
• AstraZeneca spinout Entasis nabs Shire exec as CMO (Fierce)
• Stem Cell Agency Approves Funding for Clinical Trials Targeting Parkinson’s Disease and Blindness (CIRM)
• Determination That MEXITIL (Mexiletine Hydrochloride) Capsules, 150 Milligrams, 200 Milligrams, and 250 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
• Research Misconduct Finding: Erin N. Potts Kant (ORI)

• Phase 3 Results from Two Studies of TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Triple Combination Treatment for Cystic Fibrosis Concurrently Published in The New England Journal of Medicine and The Lancet (Press)
• New England Journal of Medicine Publishes Results from Astellas' Phase 3 ADMIRAL Trial of XOSPATA® (gilteritinib) in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia(1) (Press)
• Promentis Pharmaceuticals Announces Positive Results for Phase 2A Study of SXC-2023 Targeting Novel Glutamatergic Mechanism and Completion of Enrollment for Phase 2 Trichotillomania Study (Press)
• IDEAYA Biosciences Reports End‑of‑Phase 1 Meeting with FDA for IDE196 Confirms Acceptability of Single-Arm Trial Design for Potential Phase 2 Registration-Enabling Study in Metastatic Uveal Melanoma (Press)

• FDA clears Xact's hands-free, robotic needle surgery system (Fierce)
• Abiomed targets 'TAVR-like' adoption for protected PCI (MedtechDive)
• Internal probe finds major problems at Ra Medical (MassDevice)
• Endologix defends AFX stent grafts after FDA warning (MassDevice)

• Senate Committee Advances OTC Monograph Reform Bill (Focus)
• Elizabeth Warren Releases $20.5 Trillion Plan to Pay for ‘Medicare for All’ (NYTimes) (Reuters)
• Obamacare open enrollment begins with new lower rates and same legal uncertainty (CNBC)
• The Trump Administration Cracked Down on Medicaid. Kids Lost Insurance. (ProPublica)
• Altria confirms FTC investigation of Juul as agency scrutinizes role in executive shake-up at vaping company (CNBC)
• Arizona's Purdue Suit Violates Ch. 11 Law, High Court Told (Law360-$)
• Georgia seeks to remake insurance market (Politico)
• Research Misconduct Finding: Erin N. Potts Kant (ORI)
• Removed to Federal Court? Not So Fast, Unless You’re Faster! (Drug & Device Law)
• Federal Circuit Holds APJs Are Principal Officers (Patent Docs)

• FDA Advisory Committee Calendar
• Office of Minority Health and Health Equity Public Meeting on Strategies To Improve Health Equity Amidst the Opioid Crisis; Public Meeting – 21 November 2019

• Current drugs are "poisoning" elderly patients due to insufficient trial data, House of Lords committee hears (Pharmafile)
• Updated: Make a payment to MHRA (MHRA)

• China Effectively Bans Online Sales of E-Cigarettes (NYTimes)

• TB Alliance seeks clinical trial waiver for Pretomanid drug (Economic Times)

• Advertising guidance for providers of disease education activities (TGA)
• Advertising guidance for businesses involved with medicinal cannabis products (TGA)

• Cardiac rehab after heart valve surgery tied to better outcomes (Reuters)
• Minority cancer patients less often see 'culturally competent' doctors (Reuters)