Recon: FDA Panel Votes Against Jardiance as Add-On to Insulin in Type 1 Diabetes; Congo Begins Rollout of J&J Ebola Vaccine

• FDA panel votes against Lilly-Boehringer Ingelheim's diabetes drug (Reuters) (Endpoints) (Pink Sheet-$) (Press)
• AstraZeneca, Merck win red carpet treatment at the FDA as a 3-time loser seeks speedy OK for rare tumors (Endpoints) (Press)
• Sarepta picks up a slate of preclinical gene therapy programs, seeding new StrideBio deal with $48M upfront (Endpoints)
• Antibiotic-resistant infections killing twice as many Americans as once thought (Reuters) (CDC 1, 2)
• Pelosi aide hopeful White House will support drug-pricing bill despite criticism (The Hill)
• New price transparency rules landing tomorrow (Politico)
• How Much Can Pharma Lose? (Westhealth)
• Dialysis Patients Panic As Financial ‘Life Raft’ Becomes Unmoored (KHN)
• Apple’s Reach Reshapes Medical Research (NYTimes) (Reuters)
• Apple Watch detects irregular heartbeats in US study (Reuters)

• Rollout of Johnson & Johnson Ebola vaccine begins in Congo (Reuters)
• As swine fever fries China vaccine sales, Boehringer rewrites prescription for recovery (Reuters)
• China says plague outbreak risk minimal after two new cases in Beijing (Reuters)
• WHO Seeks to Expand Access to Insulin With Prequalification Program (Focus) (NYTimes)
• UK pharmaceutical industry launches General Election manifesto (ABPI)
• Investors could emerge from Woodford debacle with £1B loss, internal analysis reveals (Endpoints)
• Bayer and Dewpoint Ink Deal for Drugs R&D at New Frontier of Biology (Xconomy) (Endpoints)
• NICE greenlights Consilient Health's Elmiron for bladder pain syndrome (Pharmafile)
• What does $62B buy you these days? A lot, says Takeda execs as the pharma player promises a blockbuster R&D future (Endpoints)
• Mosquito sterilization offers new opportunity to control chikungunya, dengue, and Zika (WHO)

• Sanofi reduces chemical, water use more than 90% with continuous manufacturing (BioPharmaDive)
• The Promise Of Precision Neuroscience And Launch Of Arkuda Therapeutics (LifeSciVC)
• Today’s insulin isn’t what Banting and Best developed. It’s far, far better (STAT)
• Biogen is criticized by the National Multiple Sclerosis Society over pricing for its new pill (STAT)
• FDA Policy on JIA Meds Slammed (Medpage)
• Researchers Call on FDA to Rethink Guidance Allowing Use of Surrogate Outcomes (Focus)
• Allergan enlists Exicure in search of hair loss drugs with $25M upfront, doubling down on area dear to AbbVie (Endpoints)
• Molecular Scissors Could Help Keep Some Viral Illnesses At Bay (NPR)
• Working with ICER, or around it, on cost-effectiveness estimates (STAT)
• On the “Take” as a Biomarker (NEJM)
• 10-Year Update on Study Results Submitted to ClinicalTrials.gov (NEJM)
• US FDA Oncology Leadership Shuffle Moves Patricia Keegan To OCE; Gootenberg Takes On Recruitment (Pink Sheet-$)
• ANDA Sponsors Urged To Ask DMF Holders About 'Hidden Facilities' (Pink Sheet-$)
• ATAI Life Sciences, Cyclica team up for mental health JV (Fierce)
• Stanford researchers pursue AnaptysBio's embattled IL-33 drug in peanut allergy (Fierce)
• Fujifilm adding $120M facility to its gene therapy operations in US (Fierce)
• Intercept aims to triple salesforce as it gears up for potential NASH launch (Fierce)
• In crowded MS market, Merck KGaA's Mavenclad now offsets Rebif decline (Fierce)
• Rubius delays first clinical readout, as crowded PKU field marches on (BioPharmaDive)
• Shorts galore: Muddy Waters sees slide for PeptiDream, tweets concerns about FibroGen's new data (Endpoints)
• FDA orders Cadila to clean up its act at sterile plant in India (Fierce)
• Skyhawk Therapeutics : Announces a Second Multi-Target Collaboration Agreement with Celgene to Discover and Develop Novel Small Molecules that Modulate RNA Splicing (Press)
• Little biotech’s stock flatlines as its followup attempt at a depression drug trial win ends in another defeat (Endpoints)
• Pincer movement: California biotech gets $35M to suffocate cancer in coordinated attack (Endpoints)
• The FDA must pull Makena off the market (STAT)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (FDA)

• Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox (NEJM)
• Aadi Bioscience Breakthrough Therapy nab-Sirolimus (ABI-009) Independent Reviewed Data Released from the AMPECT Registration Trial in Advanced PEComa (Press)
• VBI Vaccines and Brii Biosciences Initiate Phase 1b/2a Study of BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B Infection (Press)
• Deciphera Pharmaceuticals, Inc. to Present Data from DCC-3014 and Ripretinib Programs at the Connective Tissue Oncology Society (CTOS) 2019 Annual Meeting (Press)
• Oramed Pharmaceuticals to Discuss Positive Phase IIb Data at Investor Event and Conference Call on Monday, November 18^th (Press)
• ALX Oncology to Present ALX148 Clinical Data at the 61st American Society of Hematology Annual Meeting (ASH) (Press)
• VistaGen Reports Topline Phase 2 Results for AV-101 as an Adjunctive Treatment of Major Depressive Disorder (Press)

• FDA Finalizes Guidance on Handling Device Export Certificate Denials (Focus)
• Medtech venture investors wait longer for an exit (Evaluate)
• LASIK eye surgery should be taken off market, former FDA adviser says (CBS)
• Baxter delays quarterly report amid internal accounting investigation (MassDevice)
• FDA experts weigh evidence on patients' adverse reactions to common device metals (MedtechDive)
• Hologic wins FDA approval for AI-based breast imaging tech (MedtechDive)
• Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications (Press)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (FDA)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices (FDA)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation (FDA)

• Trump's International Pricing Proposal Being Revised To Adopt ‘Most Favored Nation’ Policy – Azar (Pink Sheet-$)
• Obamacare early sign-ups drop 20% as Trump-backed lawsuit challenges constitutionality (CNBC)
• ‘An Arm And A Leg’: Mom Vs. Texas In A Fight To Get Kids’ Hearing Aids Covered (KHN)
• Drugmakers Rip HHS At DC Circ. For Price-Disclosure Rule (Law360-$)
• GSK Says Boehringer Spreading Lies About Its Inhalers (Law360-$)
• A Possible USPTO Solution To PTAB Constitutionality Ruling (Law360-$)
• Spinal Implant Maker Files Ch. 11 Over Development Debt (Law360-$)
• HHS Beats Suit Over Radioactive Drugs In Medicaid Program (Law360-$)
• Women Sue Co. Over 'Exorbitantly Priced' Preterm Birth Drug (Law360-$)
• TwIqbal Is Still Rolling (Drug & Device Law)

• FDA Advisory Committee Calendar

• EFPIA stresses need for patient input in HTA (PharmaLetter-$)
• EU Regulatory Roundup: Health Group Raises Concerns About Delays to Clinical Trial Portal and Database (Focus)
• ViiV Seeks Speedy EMA Review For Last-Resort HIV Drug (Pink Sheet-$)
• NGOs Urge Italian Govt Not To Replace Head Of Drugs Agency (Pink Sheet-$)
• Sliding UK health service performance sparks pre-election war of words (Reuters)
• In France, it’s illegal for consumers to order a DNA spit kit. Activists are fighting over lifting the ban (STAT)

• China NMPA Approves Adalimumab Biosimilar (BigMoleculeWatch)
• Vaccine Maker Bankruptcy Shows Regulatory Perils Of Business In China (Pink Sheet-$)
• For endorsement at the 24th AHWP Meeting in Muscat - PROPOSED FINAL documents (AHWP)

• NPPA fixes retail prices of 75 formulations under DPCO 2013 (Pharmabiz)

• Complementary medicines advertisers: 14 November 2019 update (TGA)

• Genome Sequencing in Newborns Raises Ethical Issues (Reuters)