Regulatory Focus™ > News Articles > 2019 > 6 > Recon: France’s Dassault to Buy Medidata for $5.8B

Recon: France’s Dassault to Buy Medidata for $5.8B

Posted 12 June 2019 | By Michael Mezher 

Recon: France’s Dassault to Buy Medidata for $5.8B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Move Over, Martin Shkreli: This Pharma Exec Is Accused Of Fixing Prices On 107 Drugs (Forbes)
  • Daily HIV Prevention Pill Urged for Healthy People at Risk (AP) (CNBC)
  • J&J ‘Did Everything’ to Push Opioids, Oklahoma Witness Says (Bloomberg)
  • Judge holds up Teva's $85M opioid settlement, sinking shares back to pre-2000 levels (Fierce) (Law360-$)
  • Accidental court filing reveals Novartis' kickback settlement talks: report (Fierce)
  • Bain’s biotech team has created a $1B-plus fund — with an eye to more Big Pharma spinouts (Endpoints)
  • Next up for KRAS-blocking cancer drug fans: a hugely important data reveal from Mirati Therapeutics (STAT)
  • Intermountain, Amgen subsidiary to launch DNA study of 500,000 patients (STAT)
In Focus: International
  • French tech giant Dassault to buy Medidata in $5.8B deal (CNBC) (Reuters) (Financial Times)
  • Genome sequencing 'revolution' in diagnosis of sick children (BBC)
  • Sobi buys rare-disease drug emapalumab, zooms in on hematology and immunology (Reuters) (Fierce)
  • With Vertex and NHS still deadlocked, British pharma lobby touts industry's cooperation on pricing (Fierce)
  • An Interview With MHRA’s Outgoing Device Director: Biggest Regulatory Challenge is Software Safety (Focus)
  • EMD Serono allies with ‘free sequencing’ firm Nebula (PMLive) (mobihealthnews)
  • WHO emergency committee to meet on Ebola on Friday: statement (Reuters)
  • Two more cases of Ebola confirmed in Uganda: WHO (Reuters)
  • Congo declares measles epidemic after it kills more than Ebola (Reuters)
  • Oral Novo Nordisk diabetes drug poses no more heart risk than placebo: study (Reuters)
  • China’s NMPA reports major decrease in medical device approvals (Emergo)
  • Canada Moves To Boost Biosimilar Market (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • ‘Slower Than Expected’: FDA Tries to Prep Stem Cell Clinics for Upcoming Enforcement (Focus)
  • Hospitals Rely on FDA-Designated Outsourcing Facilities for Compounded Drugs, OIG Finds (Focus)
  • Prelude Therapeutics nabs $60M series B, gains biopharma veteran as CMO (Fierce) (Endpoints)
  • Look here, FDA: Eli Lilly touts Olumiant safety data for unapproved high dose (Fierce)
  • UMD Joins the Race to Create a Universal Flu Vaccine, with a Patented Innovative Delivery Technique (UMD)
  • Fresh analysis spotlights cardio benefit of J&J's Invokana in diabetes patients without history of CV disease (Endpoints)
  • UPDATED: ADC Therapeutics beefs up monster $200M round with fresh $76M haul (Endpoints)
  • USP Rivalry With US FDA Over Compendial Standards Provision Busts Into Open Legislative Fight (Pink Sheet-$)
  • FDA Warns Taiwan Drugmaker Over GMP Violations (Focus)
  • US FDA Makes Flexibility Look Routine In TB Drug Review, But Not Everyone Is Pleased (Pink Sheet-$)
  • A Tale Of Two Advisory Panels: The Divergent Fates Of Pretomanid And Plazomicin (Pink Sheet-$)
  • Roche Outlines Use Of Real-World Evidence In Entrectinib NDA (Pink Sheet-$)
  • FDA hammers yet another Aurobindo plant for flawed data integrity (Fierce)
  • Nanobody approval gives domain antibodies a boost (Nature)
  • Synlogic, Ginkgo expand synthetic biology research pact (Fierce) (Endpoints)
  • Cosentyx shows efficacy in key manifestations of psoriatic arthritis (PharmaTimes)
  • Boehringer, Lilly present positive Trajenta results at ADA (PharmaTimes)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Pfizer Announces Results from XELJANZ® XR (tofacitinib) ORAL Shift Study, The First Phase 3b/4 Study to Evaluate Methotrexate Withdrawal with a JAK Inhibitor (Press)
  • FDA Grants Priority Review to Genentech’s Rituxan (Rituximab) in Children with Two Rare Blood Vessel Disorders (Press)
  • Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug (Press)
  • New Phase 2 Clinical Trial Results Continue to Demonstrate Potential Clinical Benefit of IMV’s DPX-Survivac in Combination with Merck’s Keytruda in Patients with DLBCL (Press)
  • BioInvent Publishes First Clinical Data From BI-1206 Phase l/lla Trials (Press)
  • Epizyme Announces Conference Call to Discuss Phase 2 Tazemetostat Follicular Lymphoma Data (Press)
  • Concert Pharmaceuticals Reports Positive Results from Phase 1 Studies Evaluating CTP-692 in Healthy Volunteers (Press)
Medical Devices
  • Medtronic and IBM Release Sweet Insights on Sugar.IQ (MDDI)
  • Class 1 Device Recall IntraClude IntraAortic Occlusion Device (FDA)
  • Boston Scientific closes $465m Vertiflex buy (MassDevice)
  • Nuvectra seeks another FDA nod for spinal cord stimulation system (MassDevice)
  • HistoSonics touts first-in-human study results (MassDevice)
  • EmCyte Announces FDA 510(k) Clearance for its PureBMC® Supraphysiologic Concentrating System (Press)
  • Applied BioCode Obtains FDA Clearance of the Roche MagNA Pure 96 Extraction System for its Gastrointestinal Pathogen Panel (Press)
US: Assorted & Government
  • Senators want to know if HHS money went to Chinese genomics firms (STAT)
  • Attempt to repeal abortion funding ban struck down (Politico)
  • Medical Device Maker ACell Inc. Pleads Guilty and Will Pay $15 Million to Resolve Criminal Charges and Civil False Claims Allegations (DoJ)
  • Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys (FDA)
  • Lack Of Proof Dooms Bayer Contraceptive MDL, Judge Says (Law360-$)
  • J&J Unit Seeks Kirkland's Pfizer Docs In Antitrust Fight (Law360-$)
  • Missouri Federal Court Finds No Specific Jurisdiction over Kansas Knee Implant (Drug & Device Law)
Upcoming Meetings & Events Europe
  • EU MDR: Germany and Ireland Express Concerns (Focus)
  • EC Selects Four UDI Issuing Entities (Focus)
  • US-EU Mutual Recognition Pact Adds Luxembourg, Netherlands (Focus)
  • Roche’s Tecentriq added to UK early access scheme in SCLC (PharmaLetter-$)
  • Non-Executive Directors to join Agency (MHRA)
Canada
  • A Prescription for Canada: Achieving Pharmacare for All (Health Canada)
Australia
  • TGA assessed claim for assessed listed and registered complementary medicines (TGA)
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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