Recon: Sanofi Exits Diabetes Research; South Korea Convicts Three Samsung Execs for Destroying Evidence

• Drug manufacturers have spent a record $342 billion on M&A in 2019 (Market Watch)
• Do large pharma companies provide drug development innovation? Our analysis says no (STAT)
• Venturing A Perspective On The Drug Pricing Debate (LifeSciVC)
• UnitedHealth Plans Bargain Bid for Diplomat Pharmacy (AP) (Star Tribune)
• Startup Zentalis Quietly Gathers $147.1 Million for Cancer Drugs (WSJ) (Xconomy) (Press)
• Scripps Research, AbbVie Expand Drug Discovery Deal Beyond Cancer (Xconomy) (Endpoints)
• Amgen rejigs Bay Area presence with deal for new R&D facility (Fierce) (Endpoints)
• For an 'acquisitive' Gilead, 2020 will be key test for CAR-T plans (BioPharmaDive)

• Pharma Companies Set to Raise $5 Billion in Hong Kong IPOs in 2019 (Bloomberg)
• Sanofi, Maker of World’s Top-Selling Insulin, to Exit Diabetes Research (WSJ) (Reuters) (Endpoints)
• Sanofi says Dupixent could be a $10 billion drug, aims to sell Cialis and Tamiflu over the counter (STAT)
• S. Korea jails three Samsung Electronics executives over evidence destroyed in probe of alleged fraud (Reuters) (Endpoints)
• Healx, Boehringer link for rare neurological disease therapy (PharmaTimes)
• NHS Patient data from GP surgeries sold to US companies (The Guardian)
• NHS gives Amazon free use of health data under Alexa advice deal (The Guardian)
• Cholera vaccination campaign launched to protect 635,000 people in Cox’s Bazar (WHO)
• EU Commissioner for Health: MDR’s May 2020 Deadline Won’t Change (Focus)

• Upcoming market catalysts in Q1 2020 (Nature)
• US Biosimilar Launches About to Turn a Corner (Focus)
• US biosimilars glass--half full or half empty? (BioCentury)
• Bristol-Myers CMO on cell therapies: ‘This is the best time to be in drug development’ (STAT)
• The Hype Problem (In the Pipeline)
• FDA Continues Stem Cell Enforcement With New Warning Letter, Safety Notification (Focus)
• In a play-by-play of the $9.7B MedCo buyout, Novartis admits it overpaid while offering a huge windfall to execs (Endpoints)
• Could FDA Warning Letters Be Final Agency Action? (Drug & Device Law)
• Biotech is beating health care by double this year—here’s how one investor would play it (CNBC)
• Fujifilm liposome plant ready to deliver (Fierce)
• Opinion: Why you should worry about drug companies’ reliance on Chinese ingredients (LA Times)
• Perceptive allies with Garabedian on $210M early-stage fund (Fierce) (Xconomy)
• Research using brains-in-a-dish forces a radical rethinking of Huntington’s disease (STAT)
• US FDA's Office Of New Drug Leaders Listen To Stakeholders (Pink Sheet-$)
• US FDA's Pediatric Experts, Not Review Division, Should Have Final Say On Pediatric Trials, Former Official Says (Pink Sheet-$)
• Biosimilar Sponsors Want Off-The-Record Labeling Discussions With US FDA (Pink Sheet-$)
• US kids not getting measles shots before international travel (Reuters)
• Is Fear Of The QALY Warranted? (Forbes)
• Serial Biotech Entrepreneur Kevin Ness Has Raised $260 Million To Get His Genome-Engineering Device Into The Hands Of Every Scientist Who Wants One (Forbes) (Endpoints)
• Recalled Basic Reset and Biogenyx products including drugs, dietary supplements and devices (FDA)

• Dermira Receives Fast Track Designation from FDA for Lebrikizumab for the Treatment of Atopic Dermatitis (Press)
• ASH: J&J's Darzalex cuts death risk by 40% in new myeloma patients (Fierce) (Press)
• Amgen Data From Phase 3 CANDOR Study Combining KYPROLIS® (carfilzomib) And DARZALEX® (daratumumab) To Be Presented During Late-Breaking Session At American Society Of Hematology Annual Meeting (Press)
• Sage Therapeutics Announces Planned Progression of SAGE-718 to Phase 2 in Huntington's Disease and Presentations at the 2019 Annual Meeting of the American College of Neuropsychopharmacology (ACNP) (Press)
• Bristol-Myers Squibb Presents Overall Survival and Safety Data From Pivotal CC-486 Study QUAZAR AML-001 (Press)
• bluebird bio and Bristol-Myers Squibb Present Updated Data from Ongoing Phase 1 Study of BCMA-Targeted CAR T Cell Therapy bb21217 in Relapsed/Refractory Multiple Myeloma at 61st ASH Annual Meeting and Exposition (Press)
• Astex Pharmaceuticals Presents Topline Data from the ASCERTAIN Phase 3 Study of its Novel, Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727) in MDS and CMML at the American Society of Hematology Meeting in Orlando, FL. (Press)
• Kite Presents Positive Results From Pivotal ZUMA-2 Trial in Relapsed or Refractory Mantle Cell Lymphoma (Press)
• Gamida Cell Announces Results from Phase 1 Study of GDA-201 and New Mechanism of Action Data at ASH 2019 Annual Meeting (Press)
• ASH: Sanofi eyes FDA filing as orphan blood drug hits late-phase goal (Fierce) (Press)
• ImmunoGen Presents Updated Findings from Phase 1 Study of IMGN632 at ASH Annual Meeting (Press)
• Amphivena Reports Data on Phase 1 Study of AMV564 at Ash Annual Meeting (Press)
• Aurinia Plans FDA Filing After Lupus Nephritis Drug Hits Phase 3 Goals (Xconomy)
• Reblozyl® (luspatercept-aamt) Studies Evaluating Treatment of Anemia in Rare Blood Diseases Presented at American Society of Hematology (ASH) Annual Meeting (Press)
• Dyve Biosciences Receives FDA Clearance to Begin Phase 2 Study of DYV-700 for Treatment of Acute Gout Pain (Press)
• GIOSTAR in Process of US FDA Approval for Type 2 Diabetes Clinical Trial (Press)

• Roche wins CE Mark for blood glucose reading smartphone app (MassDevice) (Press)
• Tips for a successful FDA Human Factors meeting, Part Two: Meeting attendance and follow-up (Emergo)
• US FDA issues details on framework for abbreviated 510(k) medical device review pathway (Emergo)
• Dexcom app outage highlights communication pitfalls for device makers (MedtechDive)
• Abbott warns of issues with HeartMate 3 cable, mobile power unit (MedtechDive)
• Shoulder Innovations Announces FDA 510(k) Clearance For InSet Plus™ Augmented Glenoids For Total Shoulder System (Press)

• Court Rules Against FDA’s Finding That a Device was a Drug (Focus)
• Senators Question FDA on OTC Hearing Aid Regulations (Focus)
• Yang pitches public manufacturing of generic drugs (The Hill)
• Is Congress Poised to Deal a Significant Blow to Hatch-Waxman and the Generic Drug Industry? (FDA Law Blog)
• White House Summons Feuding Health Officials for Counseling Session (NYTimes) (PBS)
• What’s real — and what’s illusion — in drug pricing legislation on Capitol Hill (STAT)
• Pelosi warns progressives against revolt on drug pricing bill (Politico)
• Allergan Aims To Sink Suit Over Generics Antitrust Claims (Law360-$)
• J&J CEO spurns US congressional hearing on carcinogens in talc products (Reuters)
• Navigating The Regulatory Environment For CBD Marketing (Law360-$)
• FDA Wants Vape Group's Suit Against E-Cig Deadline Axed (Law360-$)
• US Supreme Court Seems Poised To Allow Patent Holders More Judicial Review Options (Pink Sheet-$)

• FDA Advisory Committee Calendar
• Fourth International Workshop on Global Bioequivalence Harmonization Initiative (GBHI) FDA/AAPS/EUFEPS CO-SPONSORSHIP AGREEMENT – 12-13 December 2019
• Developing Novel Therapies for Stimulant Use Disorder – 16 December 2019

• New EU Commissioner Outlines Plans To Tackle Shortages (Pink Sheet-$)
• Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators (Pink Sheet-$)
• How will pharmacovigilance look in 2030? (EMA)
• E-learning modules: medicines (MHRA)
• Private clinic launches UK’s first MRIdian radiotherapy machine (PharmaTimes)
• Agenda of the 85th meeting of the Pharmaceutical Committee 17 December 2019 (European Commission)

• Bribe for doctors: Medical body seeks action against whistleblowers (Economic Times)
• Indian drugmakers lagging in vast vaccines market, but some progress being made (PharmaLetter-$)

• Update - Tocilizumab and hepatotoxicity (TGA)
• Medicinal cannabis manufacture (TGA)

• Pete Frates, Who Promoted the Ice Bucket Challenge, Dies at 34 (NYTimes)