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Regulatory Focus™ > News Articles > 2019 > 4 > Recon: Takeda to Adopt Value-Based Pricing in Europe for Cell Therapy Alofisel

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

Posted 29 April 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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 $36m (MassDevice)
  • US FDA premarket submission recommendations for medical devices with quantitative imaging features (Emergo)
US: Assorted & Government
  • Say No To Canadian Drug Imports (Forbes)
  • Inspector General Must Investigate NIH’s Obstruction of a Probe of Unethical, Reckless Sepsis Trial (Public Citizen)
  • FDA Must Act on Drugs That Cause Compulsive Gambling, Insatiable Binging, Public Citizen Lawsuit Says (Public Citizen)
  • 'Medicare for All' poised for its moment (Politico)
  • Anti-vaxxers are burdening the economy, NIH doctor says as measles outbreak spreads (CNBC)
  • Bayer Is Still Fighting 'Flanax,' More Than A Decade Later (Law360-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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-$)
Other International
  • GHTC statement on universal health coverage (GHTC)
General Health & Other Interesting Articles
  • When It's Time For A Mammogram, Should You Ask For 3D? (NPR)
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.
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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