Recon: AbbVie Adds Parkinson’s Gene Therapy to Voyager Pact; Sanofi Says it Gave Payers $12B in Rebates in 2018

• AbbVie hands Voyager a mega-billions gene therapy deal, with $310M in near-term cash (Endpoints) (Xconomy)
• Drug Middlemen Took $123.5 Million in Hidden Fees, State Claims (Bloomberg)
• Sanofi handed payers nearly $12B in drug rebates last year (BioPharmaDive) (Scrip-$) (Sanofi)
• Sackler Embraced Plan to Conceal OxyContin’s Strength From Doctors, Sealed Testimony Shows (ProPublica)
• Sackler Testimony Appears to Conflict With Federal Investigation (NYTimes)
• What You Should Know About Richard Sackler’s Long-Sought Deposition (ProPublica)
• Senate Inquiry On Drug Prices Echoes Landmark Hearings Held 60 Years Ago (NPR)
• BioMarin prepares for haemophilia A gene therapy data readout, filing (PMLive) (Endpoints)
• Nonprofit Trying to Upend Drug Costs Will Work With Pharma, Not Against It (Bloomberg)
• Supplement Industry May Be Next in FDA’s Crosshairs (Bloomberg Law)
• Foreign governments want to boost their biotech industries — so they’re setting up shop in Boston (STAT)
• FDA official says ongoing blood pressure drug investigation will probably uncover more tainted pills (CNN)
• HHS's Multi-Pronged Approach To Lower Drug Prices: Will It Work? (Forbes)
• Google launches effort to fight opioid epidemic (The Hill) (Google)
• DNA Gets a New — and Bigger — Genetic Alphabet (NYTimes)
• Two years following US approval, Japan’s Shionogi wins EU green light for opioid constipation drug (Endpoints)
• US government joins lawsuit against Abbott companies (Modern Healthcare)
• Who’s in line for the next big mega-merger? Morningstar handicaps the odds among the top players (Endpoints)

• WHO issues recommendations on next season's flu vaccine composition (NBC)
• Japan Battles Worst Measles Outbreak in Years (NYTimes)
• Measles kills 900 in Madagascar, according to WHO report (NBC)
• Life-threatening, insect-borne diseases spike in Venezuela, report says (NBC) (Reuters)
• As Venezuela’s Politicians Fight Over Aid, Patients Die Without It (NYTimes)
• Could New Governments In Brazil, Mexico Derail International Regulatory Convergence? (Pink Sheet-$)
• Latin America Inches Towards Greater Regulatory Harmonization (Pink Sheet-$)
• NICE knocks back BioMarin’s Batten disease drug (PMLive) (PharmaTimes)
• MHRA issues drug safety warning for Neo-mercazole in pregnancy (PharmaTimes)
• China’s CRISPR twins might have had their brains inadvertently enhanced (MIT Technology Review)
• China Uses DNA to Track Its People, With the Help of American Expertise (NYTimes)
• How an Israeli start-up turned the cellphone into a testing lab for kidney disease (CNBC)
• UK’s SFO Drops Corruption Probes Into Rolls-Royce, GSK (Law360-$)

• FDA Defends its Efforts to Ensure Generic Drug Quality (Focus)
• A New Treatment Can Relieve Food Allergies, But Few Doctors Offer It (NPR)
• FDA Warns of Increased Risk of Death With Gout Medicine Uloric (Focus) (Medpage) (FDA)
• The U.S. shouldn’t use the ‘QALY’ in drug cost-effectiveness reviews (STAT)
• FDA Responds to Public Citizen Petition on Febuxostat (FDA)
• FDA Proposes New Rule for Sunscreen Products (Focus)
• Catalyst Defends $375,000 Price Tag for Previously Free Drug (Focus)
• FDA Offers Guidance on Nicotine Replacement Therapies (Focus)
• FDA releases 74 product specific guidances (FDA)
• So you just got a BTD for your top drug? Don’t be surprised to see the enthusiasm fizzle fast among investors (Endpoints)
• Doubling down on R&D, Daiichi makes exec changes across its US research unit (Fierce)
• Achieve climbs on data from smoking cessation clinical trial (Fierce)
• Opiant dumps bulimia nervosa program after phase 2 flop (Fierce) (Endpoints)
• Rare Disease Biotech Mereo BioPharma Pulls $70M US IPO (Law360-$)
• Chutes & Ladders—Enzyvant finds new CEO in former Alexion executive (Fierce)
• Mylan launches generic sublingual film for opioid dependence (Drug Delivery) (Press)
• Stem Cell Agency Invests in Chemotherapy-Free Approach to Rare But Deadly Childhood Disease (CIRM)
• Dr. Reddy's relaunches Suboxone generic after court victories (BioPharmaDive)
• AbbVie’s cancer drug Venclexta blocks diabetes in mice by targeting beta cell ‘senescence’ (Fierce)

• AIVITA Completes Treatment of First Patient in Phase 2 Ovarian Cancer Trial (Press)
• ARS Pharmaceuticals wins fast track status for epinephrine nasal spray (Drug Delivery)
• Alder BioPharmaceuticals files BLA for eptinezumab (PharmaLetter-$)
• Enzychem Lifesciences Completes Stage 1 Patient Enrollment in Phase 2 CRIOM Study (Press)
• Achieve Announces Final Data from Cytisinicline Phase I/II Multi-Dose, Pharmacokinetic and Pharmacodynamics (PK/PD) Clinical Study to be Presented at Society for Research on Nicotine & Tobacco Annual Meeting (Press)
• Imbrium Therapeutics Announces U.S. FDA Orphan Drug Designation for Etoposide Toniribate for the Treatment of Relapsed Refractory Biliary Tract Cancer (Press)
• Aradigm Announces Receipt of Final FDA Minutes for the Type B Meeting on January 25, 2019 (Press)

• Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect (Focus)
• Dexcom beats The Street with Q4, FY18 results (MassDevice)
• Abbott touts real-world data for FreeStyle Libre glucose monitor (MassDevice)
• Mauna Kea, Cook Medical terminate Cellvizio dev, distro deal (MassDevice)
• CorMatrix launches FDA IDE Cor Tricuspid ECM cardiac valve trial (MassDevice)
• Philips wins FDA nod for DigitalDiagnost C90 digital radiography system (MassDevice)
• Teleflex shares dip on Q4, 2018 earnings release, restructuring announcement (MassDevice)
• Axonics Modulation touts results of sacral neuromodulation study (MassDevice) (Press)
• Axilum Robotics Announces U.S. FDA 510(k) Clearance for TMS-Cobot (Press)
• ViewRay wins FDA nod for MRIdian system soft tissue visualization capabilities (MassDevice)

• How Utah's GOP leaders moved to rein in Medicaid expansion (Politico)
• On Health Care, 2020 Democrats Find Their First Real Fault Lines (NYTimes)
• FTC Approves Final Consent Order against Company and Owner Who Allegedly Made Unsupported Health Claims for Intravenously Injected Therapy Products (FTC)
• Vanda Has A Bone to Pick with FDA: Dog Studies (FDALawBlog)
• Manufacturer’s Responsibility for Medication Guides Stops When It Provides Them to Pharmacies (Drug & Device Law)
• Dr. Falk Pharma GmbH v. GeneriCo, LLC (Fed. Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar

• EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials (Focus)
• Swissmedic Begins Working With EudraGMDP Database (Focus)
• EU Regulatory Roundup: Germany Warns Brexit Could Cause the Suspension of 1,300 Clinical Trials (Focus)
• German Regulators: 1,300 Trials Imperiled By ‘Hard’ Brexit (FDANews-$)
• Overview of comments received on ICH guideline M9 on biopharmaceutics classification system based biowavers (EMA/CHMP/ICH/493213/2018) (EMA)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 February 2019 (EMA)

• Korea IND Filing Moves Alteogen's Eylea Biosimilar Forward (Scrip-$)
• China Approves Solasia's Oral Mucositis Product (Biocentury)
• LivaNova wins Japanese reimbursement for Perceval aortic valve (MassDevice)

• D G Shah founder of Indian Pharmaceutical Alliance dies at age 77 (Economic Times)

• Norman Orentreich, 96, Force Behind Hair Transplants, Dies (NYTimes)