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

Posted 10 December 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
 Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
Upcoming Meetings & Events Europe
  • New EU Commissioner Outlines Plans To Tackle Shortages (Pink Sheet-$)
  • 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)
General Health & Other Interesting Articles
  • Pete Frates, Who Promoted the Ice Bucket Challenge, Dies at 34 (NYTimes)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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