Recon: Takeda to Adopt Value-Based Pricing in Europe for Cell Therapy Alofisel

• FDA approves expanded label for Regeneron/Sanofi's cholesterol drug (Reuters) (Endpoints) (Press)
• uBiome, the health start-up just raided by the FBI, had been double billing insurers (CNBC) (STAT)
• Seattle Genetics' Adcetris sales fall short yet again (BioPharmaDive)
• Alexion gets off to the races with key Ultomiris, Soliris launches (Fierce)
• Jury Is Still Out In Case Involving Opioid Maker (NPR) (Bloomberg)
• US has recorded 704 cases of measles this year, a 25-year-high: health officials (Reuters)
• US measles outbreak raises questions about immunity in adults (Reuters)
• The obscure advisory committees at the heart of the US drug pricing debate (Reuters)
• FDA Approves 19th Biosimilar, 2nd for Enbrel (Focus) (Press)
• FDA approves first treatment for pediatric patients with lupus (FDA)
• AbbVie wins hep C contract with Washington state in latest 'Netflix' deal (BioPharmaDive)
• FDA approves device to help increase access to more lungs for transplant (FDA) (MassDevice)
• The entrepreneur behind the cancer immunotherapy revolution (STAT)
• Faster Drug Approvals Possible as AI Speeds FDA Reviews (Bloomberg)

• Where was differential pricing at the WHO Fair Pricing Forum? (STAT)
• Drugmaker Takeda to introduce value-based pricing in Europe (Nikkei Asian Review)
• Cancer-Drug Giant Roche Loses Edge as Rivals Grow (WSJ)
• Eisai to open a dementia-focused incubator in Cambridge (STAT)
• UK online pharmacies accused of 'aggressive' tactics to sell opiates (The Guardian)
• 'I could get 500 tablets a month': the ease of buying opiates online (The Guardian)
• Opioids to be labelled with addiction warning in UK (Pharmafile)
• India hits back at claims they are leading source of counterfeit drugs (Pharmafile)
• Allergan adds 63 jobs to Irish site as it finishes €140M biologics plant (Fierce)
• EU GMP Annex 1 Revisions Will Require Stronger Visual Inspection Programs (Pink Sheet-$)
• Bicycle files for $86M IPO to fund trials of novel drug conjugates (Fierce)
• A new Sun Pharma policy on insider trading raises questions of double standards (STAT)
• Azerbaijan joins the collaborative registration procedure (WHO)

• How Smart Pharma Can Stop Making Bad R&D Choices (Forbes)
• Y Combinator to fund more academic spinouts developing small-molecule drugs (STAT)
• New FDA Website Launching This Weekend (Focus)
• Scope of FDA Draft Guidance on Nonbinding Feedback is Too Restrictive, Industry Argues (Focus)
• Three biotechs reveal some secrets about themselves as they gun for $271M-plus in IPOs (Endpoints)
• FDA expands blood pressure drug recall for fifth time this year (NBC)
• Novo seeks Victoza label expansion with fresh pediatric trial results (BioPharmaDive)
• FDA's Risk Evaluation Guidance Brings Clarity, Not Solutions (Law360-$)
• Rise of the independents, biotechs go to market (BioCentury)
• U.S. trust in pharma ticks upward, but consumers still distrust the industry: survey (Fierce)
• Fired for code of conduct violations, Ian Smith still grabbed a multimillion-dollar stock package at Vertex — but the cash bonus was axed (Endpoints)
• Eyeing RNAi potential in cancer and fibrosis, trans-Pacific biotech Sirnaomics lines up $47M Series C (Endpoints)
• Regeneron bags Calixar tech to support antibody discovery effort (Fierce)
• After promising M&A and buybacks to revive long-term prospects, Biogen refreshes board with three appointments to enthuse investors (Endpoints)
• Roiled by C-suite turmoil and a CRL, Immunomedics salutes CMO Rob Iannone as he makes a quick exit (Endpoints) (Fierce)
• Sanofi's Eloctate, a Bioverativ buyout centerpiece, suffers on Roche's Hemlibra launch (Fierce)
• Financial Strategies and Accounting for Bioscience Companies (Drug Channels)
• BeiGene CEO Oyler nabs a $15M thank-you bonus, pushing 2018 pay to $27.9M (Fierce)
• New Roche data at the 2019 AAN Annual Meeting showcase breadth and promise of neuroscience portfolio (Press)
• Determination of Regulatory Review Period for Purposes of Patent Extension (FDA)

• FDA tags Bayer’s prostate cancer drug for priority review as drugmaker gears up against rivals (Endpoints) (Press)
• Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV (Press)
• AVROBIO, Inc. Announces FDA Clearance of Investigational New Drug Application for AVR-RD-01 Gene Therapy for the Treatment of Fabry Disease (Press)
• Finch Therapeutics Receives Fast Track Designation for the Investigation of Full-Spectrum Microbiota as a Treatment for Children with Autism Spectrum Disorder (Press)
• United Therapeutics Announces FDA Approval Of XPS™ And Steen Solution™ Used To Perform Centralized Ex-Vivo Lung Perfusion Services (Press)
• OMEICOS Therapeutics Announces First-Dosing in Phase 2 Clinical Study Evaluating its Lead Program OMT-28 in Patients with Persistent Atrial Fibrillation (Press)
• Sesen Bio to Host Conference Call to Review First Quarter 2019 Financial Results and Updated Preliminary Data from Phase 3 VISTA Trial (Press)
• New Data from Phase 3 Teprotumumab Trial (OPTIC) Shows Dramatic Reduction in Proptosis, or Eye Bulging, the Main Cause of Morbidity in Active Thyroid Eye Disease (TED) (Press)

• FDA: Edward’s select recall of Miller, Fogarty atrioseptostomy caths is Class I (MassDevice)
• Acutus Medical wins expanded CE Mark, FDA nod for AcQMap revisions (MassDevice)
• Philips sells Mass.-based U.S. healthcare HQ for $36m (MassDevice)
• US FDA premarket submission recommendations for medical devices with quantitative imaging features (Emergo)

• Say No To Canadian Drug Imports (Forbes)
• Inspector General Must Investigate NIH’s Obstruction of a Probe of Unethical, Reckless Sepsis Trial (Public Citizen)
• FDA Must Act on Drugs That Cause Compulsive Gambling, Insatiable Binging, Public Citizen Lawsuit Says (Public Citizen)
• 'Medicare for All' poised for its moment (Politico)
• Anti-vaxxers are burdening the economy, NIH doctor says as measles outbreak spreads (CNBC)
• Bayer Is Still Fighting 'Flanax,' More Than A Decade Later (Law360-$)
• Soriot sees progress in U.S.-China IP debate (BioCentury)
• DOJ Asks 7th Circ. To Revive Becton Price-Fixing Suit (Law360-$)
• Another U.S. Patent Issued for CRISPR (Patent Docs)
• Errata Sheet Errors (Drug & Device Law)
• D.C. Superior Court Holds That Challenge to Advertising Claim for Meat Product is Preempted Because USDA Approved Same Claim on Label (FDA Law Blog)
• Novartis Settles Short-Lived Suit Over Janssen's Psoriasis Drug Promo (Pink Sheet-$)
• In Washington, Juul Vows to Curb Youth Vaping. Its Lobbying in States Runs Counter to That Pledge. (NYTimes)

• FDA Advisory Committee Calendar
• Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee – 11 June 2019

• EMA Calls for Cancer Drug Withdrawal Following Negative Trial Results (Focus)
• European Medicines Agency closed 1 May 2019 (EMA)
• European Commission Survey on Attitudes Towards Vaccination (EC)
• Medicines and Healthcare products Regulatory Agency Business Plan 2019 to 20 (MHRA)
• Field Safety Notice: 23 to 26 April 2019 (MHRA)

• Indian Guide Offers Consolidated Advice On New Clinical Trial Requirements (Pink Sheet-$)

• GHTC statement on universal health coverage (GHTC)

• When It's Time For A Mammogram, Should You Ask For 3D? (NPR)