Recon: FDA Panel Split on Sanofi-Lexicon Diabetes Drug; Lilly's Latruvo Fails Confirmatory Study

• FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists (CNBC)
• Immunomedics' cancer treatment fails to win accelerated approval from the FDA (Reuters) (STAT) (Endpoints)
• Lilly’s approved cancer drug Lartruvo fails confirmatory study, setting the stage for withdrawal of regulatory endorsement (Endpoints) (Reuters) (Press)
• FDA advisory panel split over Sanofi-Lexicon diabetes drug (Reuters) (Endpoints) (NYTimes) (Press)
• Ending Pharmacy Dispute, Walmart Renews Contract With CVS Heath's PBM (Forbes) (Press)
• Medicare experiment could put more pressure on insurers to save money on prescription drugs (STAT)
• Tyme Technologies misleads with new data on pancreatic cancer drug (STAT)
• Diagnostic innovations are slowed by bureaucratic roadblocks (STAT)
• Once again, lawmakers introduce a bill to end tax breaks for consumer drug ads. Will it work this time? (STAT)
• Celgene inks first deals since Bristol-Myers announced $74B buyout — bets $80M on immunometabolism (Endpoints) (Fierce) (Press)
• Drugmakers Raise Prices Amid Shortages, Recalls (WSJ)
• Secretive ‘Rebate Trap’ Keeps Generic Drugs For Diabetes And Other Ills Out Of Reach (KHN)
• Apple Has Just Ushered In The Era Of Digital Health (Forbes)

• This small Canadian drug maker is taking on Allergan and its best-selling eye drop medicine (STAT)
• Novartis teams up with Oxford researchers to crunch big data into clinical insights (Endpoints) (Fierce)
• Abbvie's chronic lymphocytic leukaemia drug Venclytxo scores greenlight from NICE (Pharmafile)
• NICE OK for Bravtovi skin cancer drug (PharmaTimes)
• Financial Transparency Concerns Over Patient Groups Advising NICE (Scrip-$)
• Canada Health approves Novartis' CAR-T therapy Kymriah (Pharmafile)
• Pharmacists warn of shortages in England (Pharmafile)
• FT Health: Fighting humanity’s three biggest infectious diseases (Financial Times)
• Mexican Pharma Industry Joins Anti-Corruption Crackdown (Pink Sheet-$)
• Aurobindo acquires 7 oncology drugs from spectrum for $300 million (Economic Times) (MedCity)

• New drug shortages rose in 2018 after three years of relative stability (STAT)
• How to stop a lack of diversity undermining clinical trial data (Financial Times)
• M.C. Escher By Way of Generic Drug Pricing (FDA Law Blog)
• Hunger For New Drugs, Tech To Drive 2019 Pharma M&A (Law360-$)
• ICER’s ‘Unsupported Price Increase’ Report Due This Fall (Pink Sheet-$) (BioCentury) (PhRMA)
• Celgene’s top 20 upfront hits: Just how generous was Celgene in dealmaking? Let’s review the records (Endpoints)
• Scoop: Forma axes discovery biology team as part of a broader reorganization (Endpoints)
• Photoacoustic imaging enables scientists to step up war on cancer (Financial Times)
• New Coalition to Lobby Against Patent Misuse by Branded Companies (FDANews-$)
• Former Insmed CMO Streck resurfaces at Alder (Fierce)

• Servier and Taiho Oncology Present Latest LONSURF® (trifluridine/tipiracil) Data at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) (Press)
• Acorda Announces The Lancet Neurology Publication of Phase 3 Data for INBRIJA™ (levodopa inhalation powder) (Press)
• Five Prime Therapeutics Presents Data from Safety Lead-in to Phase 3 FIGHT Trial of Bemarituzumab at 2019 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium (Press)
• ImaginAb Enrolls First Patient in Phase II Clinical Trial (Press)

• Deaths With Paclitaxel-Coated Devices in PAD Draw FDA Scrutiny (Medpage)
• Philips touts new gantry design for Azurion (MassDevice)
• LivaNova touts studies of its sutureless aortic valve (Medical Design & Outsourcing)

• CMS wants to reduce Obamacare subsidies through formula change (Politico)
• Statute of Repose Bars Suit in Biomet Hip Implant MDL. (Drug & Device Law)
• PTAB Axes Fish Oil Patent In Post-Grant Review (Law360-$)
• Medical Device Co.'s Del. Suit Says Competitor 'Sabotaged' It (Law360-$)
• NYC Adds Sacklers, Drugstore Chains To Opioid Suit (Law360-$)

• FDA Advisory Committee Calendar

• EMA continues to be open to alternative clinical development strategies for biosimilars (GaBI)
• Clinical trials for medicines: authorisation assessment performance (MHRA)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019 (EMA)

• FiercePharmaAsia—Gilead’s clinical VP; Aurobindo buys Spectrum assets; Aslan’s lead drug (Fierce)
• Abbott inks deal to test blood donations in Japan (Medical Design & Outsoucing)

• Sun Pharma's shares hit six-year low after further whistleblower allegations emerge (Pharmafile)

• Consultation Notice: Health Canada Requests Feedback on Potential Impacts and Uses if Company Names were added to the Generic Submissions Under Review List (Health Canada)