Recon: FDA Places Partial Hold on Trials for AbbVie’s Venclexta

• FDA puts partial hold on clinical trials of AbbVie's cancer drug (Reuters) (Endpoints) (Press)
• A drug pricing mystery: Who’s behind all the outrage over rebates? (STAT)
• The astounding 19-year journey to a sea change for heart patients (STAT)
• Ohio accuses UnitedHealth's OptumRx of drug overcharges in lawsuit (Reuters)
• Efforts to import drugs from Canada advance at state level, with Florida latest to get in line (STAT)
• Vivek Ramaswamy’s Urovant claims a big win in PhIII — but questions linger about a cheap generic and their branded rival (Endpoints) (Press)
• Bristol-Myers and Starboard Value spar over $74B Celgene buyout as shareholder vote looms (Endpoints) (Press)
• Roche stacks up Tecentriq nods, following up breast cancer approval with small cell lung cancer (Endpoints) (Press) (FDA)
• FDA approves first paediatric treatment for intra-abdominal and urinary tract infections in over 10 years (Pharmafile) (Press)
• Gilead raises prices on top-selling HIV treatments (BioPharmaDive)
• Lilly's $7M tax abatement in Indianapolis draws bipartisan pushback: reports (Fierce) (IBJ)
• FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions (FDA)

• Is May’s Brexit deal sinking after Speaker's procedural torpedo? (PMLive)
• National Portrait Gallery turns down £1m grant from Sackler family (The Guardian)
• Japan poised to allow ‘reprogrammed’ stem-cell therapy for damaged corneas (Nature)
• Chile takes several ‘unorthodox’ steps to push back on drug prices, angering pharma (STAT)
• Think Drugs Are Expensive in the U.S.? Just Try China (Bloomberg)
• Daiichi Sankyo show positive results for atrial fibrillation treatment Lixiana (Pharmafile)
• AZ’ Farxiga shows CV benefit in diabetes patients (PharmaTimes)
• Italy Moves To Raise Biosimilar Use And Awareness (Pink Sheet-$)
• Who'll follow Sanofi CEO Olivier Brandicourt? The company's eyeing candidates now (Fierce)
• Shortage of cancer doctors puts NHS patients at risk (Pharmafile)
• Latin America Notebook: Advancing Adaptive Trial Designs, Translating ICH Guidelines, Sharing Confidential Information (Pink Sheet-$)

• Behind the Numbers: FDA Offers Budget Specifics, New Proposals (Focus)
• Skin regeneration company PolarityTE reveals SEC investigation, probing into its lead product, former CFO and current investors (Endpoints)
• Mylan and Hospira both recall injected drugs after particulate discovered in vials (Fierce) (FDA)
• Daily aspirin no longer recommended to prevent heart attacks for healthy, older adults (NBC) (NYTimes)
• Novo's Victoza won't face Teva copies until 2023. Can semaglutide fill the gap by then? (Fierce)
• One-third of uninsured can't afford to take drugs as prescribed, says government report (CNN)
• NC Gene Editing Co. Launches IPO That Could Raise $134M (Law360-$)
• Generics Firms Improved Chances Of Winning Pre-ANDA Meetings For Complex Drugs Last Year (Pink Sheet-$)
• Bayer animal health sale could rake in $8B and bids from private equity: report (Fierce)
• Drug shortages jeopardize the lives of children with cancer (STAT)
• Biogen-Nightstar deal sheds light on gene therapy feeding frenzy (Fierce)
• Seeking a place among giants in the oncolytics virus field, little Cold Genesys bags $22M Series C (Endpoints)

• Perrigo Announces Tentative FDA Approval For The Generic Version Of Finacea® Foam, 15% (Press)
• Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for HER2 (ERBB2) Mutant, Metastatic Cervical Cancer at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting (Press)
• Millendo Therapeutics Initiates Pivotal Phase 2b/3 Clinical Study of Livoletide for the Treatment of Prader-Willi Syndrome (Press)
• Endo Announces Publication Of Collagenase Clostridium Histolyticum (CCH) Phase 2 Data In Dermatologic Surgery (Press)
• Vaxart Announces Initiation of Bivalent Norovirus Vaccine Phase 1b Clinical Trial (Press)
• I-Mab Biopharma Announces Dosing of First Subject in Phase 1 Clinical Trial of Anti-GM-CSF Monoclonal Antibody TJM2 in the United States (Press)
• Innovent Announces First Patient Dosed in Phase I Clinical Trial of Anti-CD47 Monoclonal Antibody in the US (Press)
• NeuroVive Enrolls First Subject in its KL1333 Phase Ia/b Clinical Study (Press)

• CDRH to Review Materials Used in Medical Devices (Focus)
• Industry Calls to Eliminate Tiers in FDA’s Premarket Cybersecurity Guidance (Focus)
• A fertility app bills itself as contraception, raising questions about marketing and efficacy (STAT)
• Divestiture in medtech: Are you the natural owner of your businesses? (McKinsey)
• Alcon Powers Up Portfolio Ahead of Novartis Split (MDDI)
• Israel-based Theranica raises $35M in series B funding (mobihealthnews)
• Report: Smiths Medical parent co to announce separation plans Friday (MassDevice)
• Aptar Pharma touts FDA approval of nasal spray device (MassDevice) (Press)
• Zoll reveals data breach during email server migration (MassDevice)

• Class Action Lawsuit Filed Against AbbVie and Biosimilar Developers Alleges Collusion (Center for Biosimilars)
• Strategies Used by Adults Aged 18–64 to Reduce Their Prescription Drug Costs, 2017 (CDC)
• Hospitals push back on surprise billing proposal (Politico)
• Why The Promise Of Electronic Health Records Has Gone Unfulfilled (NPR)
• Novo Nordisk and Teva reach US patent settlement (PharmaLetter-$)
• Minnesota House aims to hit drug companies for opioid crisis (MYNorthwest)
• 3rd Circ. To Hear Class Cert. Appeal In Lamictal Case (Law360-$)
• Justices Consult SG On Treatment Patent Case Testing Mayo (Law360-$)
• Plaintiffs Get to Keep Windfall Damages (Drug & Device Law)
• A Doggone Shame for Vanda: DC District Court Grants FDA’s Remand Motion on Dog Study/IND Clinical Hold Challenge (FDA Law Blog)

• FDA Advisory Committee Calendar

• enFlow® IV fluid and blood warmer - risk of unsafe levels of aluminium leaching from the device – updated safety advice from manufacturer (MDA/2019/016) (MHRA)

• Australia Consults On Adopting EU Extrapolation Paper And Other Guidelines (Pink Sheet-$)
• Australian manufacturing licences and overseas GMP certification (TGA)
• Requesting variations to your manufacturing license (TGA)
• Suspending, revoking and TGA initiated variation of conditions of a manufacturing license (TGA)