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

• 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)

• French tech giant Dassault to buy Medidata in $5.8B deal (CNBC) (Reuters) (Financial Times)
• Genome sequencing 'revolution' in diagnosis of sick children (BBC)
• Sobi buys rare-disease drug emapalumab, zooms in on hematology and immunology (Reuters) (Fierce)
• With Vertex and NHS still deadlocked, British pharma lobby touts industry's cooperation on pricing (Fierce)
• An Interview With MHRA’s Outgoing Device Director: Biggest Regulatory Challenge is Software Safety (Focus)
• EMD Serono allies with ‘free sequencing’ firm Nebula (PMLive) (mobihealthnews)
• WHO emergency committee to meet on Ebola on Friday: statement (Reuters)
• Two more cases of Ebola confirmed in Uganda: WHO (Reuters)
• Congo declares measles epidemic after it kills more than Ebola (Reuters)
• Oral Novo Nordisk diabetes drug poses no more heart risk than placebo: study (Reuters)
• China’s NMPA reports major decrease in medical device approvals (Emergo)
• Canada Moves To Boost Biosimilar Market (Pink Sheet-$)

• ‘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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• A Prescription for Canada: Achieving Pharmacare for All (Health Canada)

• TGA assessed claim for assessed listed and registered complementary medicines (TGA)