Recon: FDA Rejects AZ's Combo for Smoker's Lung; Alphabet Hires Former FDA Chief Califf

• Alphabet taps former FDA commissioner to oversee health strategy and policy (CNBC)
• The biotech scorecard for the fourth quarter: 13 stock-moving events to watch (STAT)
• AstraZeneca's combo lung disease therapy fails to win FDA approval (Reuters) (Press)
• Rep. Chris Collins, Charged in Biotech Insider-Trading Case, Resigns (WSJ)
• An AI startup, led by 23andMe veteran Andy Page, tries to take better pictures of the heart (STAT)
• Drugmakers look to use Purdue Pharma's bankruptcy to settle U.S. opioid suits: WSJ (Reuters) (WSJ)
• Vertex takes on Huntington’s disease in deal with Ribometrix (STAT) (Endpoints)
• J&J's embattled Invokana gets a boost as FDA expands label (Endpoints) (Press)
• Novo Nordisk walks tightrope on moral mission (Financial Times)
• Three percent of NIH grants involved a direct financial conflict of interest, watchdog report finds (Science)
• House Progressive circulates letter seeking changes to Pelosi drug pricing bill (The Hill)
• Endo comes out on top in its fight with FDA and bulk compounder (Fierce) (Endo)
• Gene therapies are getting approved. But there are major challenges ahead. (PwC)
• Ex-FDA chief McClellan says ‘regulatory structures’ weren’t in place to identify vaping crisis earlier (CNBC)
• FDA and DEA Jointly Warn Illegal Online Opioid Networks (Focus) (Reuters) (FDA)

• AstraZeneca sells acid reflux drug rights to Germany's Cheplapharm (Reuters)
• Johnson pledges £200m cash injection into UK’s life sciences sector (PMLive)
• UK Insists No Brexit Impact On Clinical Trial Rates (Pink Sheet-$)
• French drugmaker Sanofi to cut about 200 jobs in Japan (Reuters) (Fierce)
• Roche spells out weak data from  Tecentriq Ph III for bladder cancer (Endpoints) (Press)
• AstraZeneca rounds out ESMO with a case for expanded biomarker in prostate cancer (Endpoints)
• Roche sets new deadline for Spark acquisition as divestiture speculation brews (Endpoints)
• EC Offers MDR Guidance on New Safety and Clinical Performance Summary (Focus)

• Engaging patients in medicines regulation: a tale of two agencies (Nature)
• FDA Panels Address Persistent Concerns About Montelukast Safety in Kids (Medscape)
• Biogen Announces Leadership Update (Biogen)
• NIH forms new collaborative influenza vaccine research network (NIH)
• FDA’s research guidance will help take guesswork out of drug dosing in newborns (STAT)
• Patient-Focused Drug Development: New FDA Draft Guidance Delves Into What’s Important (Focus)
• Sentinel: FDA Expands Initiative With Two New Centers (Focus)
• Fees for Redeeming Priority Review Vouchers Fall to All-Time Low in FY2020 (Focus)
• Acacia, twice foiled by manufacturing CRLs, gets 2020 PDUFA after bringing on new API maker (Fierce)
• Zantac Pulled From Shelves by Walgreens, Rite Aid and CVS Over Carcinogen Fears (NYTimes)
• Asthma 3-in-1 Therapy May Improve Lung Function, Study Shows (NYTimes)
• Sangamo Therapeutics bags Cytokinetics' exec as new chief medical officer (Fierce)
• Startup Dyne Therapeutics hires Kaleido exec as new chief (Fierce)
• Seattle Genetics makes case it can be more than Adcetris (BioPharmaDive)
• Will A US FDA Advisory Committee Be In Intercept's Future? (Pink Sheet-$)
• NASH Pipeline Includes Six Candidates That Have Reached Phase III (Pink Sheet-$)
• Black Box On Singulair Doubtful After US FDA Panel Offers Divided Opinion (Pink Sheet-$)
• Assessing effects of drugs in wastewater on aquatic wildlife (FDA)
• An AI-Generated Drug? (In The Pipeline)
• Across The Atlantic, Nationalized Health Care Is Failing Cancer Patients (Forbes)
• Pediatricians stand by meds for ADHD, but some say therapy should come first (NBC)
• Fruit fly trial unlocks clues for 'polypill' to beat aging (Reuters)
• Reeling from a hefty civil and criminal settlement, Avanir stumbles into PhIII Alzheimer's failure (Endpoints) (PMLive)
• ‘There are moments’: Sanofi’s new CEO is thinking through the R&D strategy — and oncology will be key (Endpoints)
• Failed NewLink goes dark in a reverse merger, as Lumos jumps on board for a ride to Wall Street (Endpoints)
• ESMO: Will Adaptimmune's SPEAR-T results in a rare sarcoma appease investors? (Fierce)
• Cellect Products Inc. and Oglethorpe Ltd. Issue Voluntary Worldwide Recall of Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder, Lot #041907 Due to Potential Unsafe Levels of Arsenic and Lead (FDA)

• Pivotal RESTORE-IMI 2 Phase 3 Study of Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) in Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Met Primary Endpoint (Press)
• Agios lines up solid PhIII data to back Tibsovo's use in bile duct cancer — ahead of planned sNDA (Endpoints)
• LYNPARZA (olaparib) More Than Doubled the Time Without Radiographic Disease Progression in Patients With BRCA1/2- or ATM-Mutated Metastatic Castration-Resistant Prostate Cancer (Press)
• Sanofi's Jevtana doubles progression-free survival in metastatic castration-resistant prostate cancer (Pharmafile) (Press)
• Catabasis Pharmaceuticals Announces the Phase 3 PolarisDMD Trial of Edasalonexent in Duchenne Muscular Dystrophy has Exceeded Target Enrollment (Press)
• Tarveda Therapeutics Presents Data from the Phase 1 Portion of a Phase 1/2a Study of PEN-866 at the European Society for Medical Oncology (ESMO) Congress 2019 (Press)
• Themis Bioscience and ZIKAVAX Consortium Announce Initiation of Phase 1 Zika Vaccine Trial (Press)
• Sosei Heptares Notes the Announcement of Positive Results from Phase III IRIDIUM Study of Inhaled Combination QVM149 in Patients with Uncontrolled Asthma (Press)
• Oragenics Presents Interim Data on The AG013 Phase 2 Clinical Trial at the European Society for Medical Oncology Congress 2019 (Press)
• Annexon Biosciences Reports Top-line Phase 1b Results for Novel C1q Inhibitor ANX005 in Guillain-Barré Syndrome (Press)
• Adlai Nortye Presents Encouraging Phase 1b Study Data of AN0025 (an Oral EP4 Antagonist) for Locally Advanced Rectal Cancer at ESMO 2019 (Press)
• ESMO: Eyeing Novartis and Pfizer, Chi-Med touts neuroendocrine cancer win (Fierce)
• Novartis chalks up another phase 3 asthma win as approval nears (Fierce)
• Opdivo (nivolumab) Demonstrates Statistically Significant Overall Survival Benefit Versus Chemotherapy in Patients with Advanced Esophageal Cancer (Press)

• FDA Issues a Second Draft Guidance for Clinical Decision Support Software (FDA Law Blog)
• Medtronic establishes $35m settlement fund for Synchromed pumps (MassDevice)
• FDA plans advisory panel on metal implants, dental alloys (MassDevice)
• LivaNova launches vagus nerve stim depression study (MassDevice)
• Cleaning contractor glitch prompts Zimmer Biomet recall (MassDevice)
• CivaDerm™ - CivaTech Oncology’s New Skin Cancer Therapy Product Receives FDA Clearance (Press)

• Summary Judgment for Defendant on All Counts in Absence of a Product Defect (Drug & Device Law)
• Walmart pushing for bigger health care role (Politico)
• FTC Taking A Closer Look At $63B AbbVie-Allergan Deal (Law360-$)
• “An Act Improving Medical Decision Making:” An Argument in Favor of MA House Bill 3388 and Senate Bill 843 (Harvard Bill of Health)
• New Round of Medicare Readmission Penalties Hits 2,583 Hospitals (KHN)
• Skin-Lightening Cream Put A Woman Into A Coma. It Could Happen Again. (KHN)

• FDA Advisory Committee Calendar

• Medtech Europe's Bisazza: How Expert Panel Delays Have Caused Uncertainty for Companies (Medtech Insight-$)
• Notify MHRA about a clinical investigation for a medical device (MHRA)
• Servier Denies Deceit As French Mediator Trial Begins (Pink Sheet-$)
• Events concerning medical devices with speakers (Swissmedic)

• Panel likely to study stent companies' demand on price cap (Economic Times)

• Health Canada Needs to Act on Laboratory-Developed Diagnostics (CMAJ)
• Canada Urged To Regulate CBD As Natural Health Supplement (Law360-$)