Regulatory Focus™ > News Articles > 12 > Recon: GSK to Buy Tesaro for $5.1B

Recon: GSK to Buy Tesaro for $5.1B

Posted 03 December 2018 | By Michael Mezher 

Recon: GSK to Buy Tesaro for $5.1B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Too Cheap to Fail: Big Pharma Deal Presents Enticing Value (WSJ)
  • The new Congress is already threatening to push forward on drug pricing, but BIO CEO Jim Greenwood isn’t changing tack (STAT)
  • Politicians' Narrow Focus On Prescription Drug Spending Is Myopic (Forbes)
  • GOP balks at Trump drug pricing plan (The Hill)
  • Medical device makers spend millions lobbying to loosen regs in DC (NBC)
  • Genetically Modified People Are Walking Among Us (NYTimes)
  • We need a temporary moratorium on using gene editing to create babies (STAT)
  • Unbowed by critics, Gilead’s cancer chief pushes ahead with growth plans (STAT)
  • Misfortune strikes a Bluebird patient, highlighting the safety risks involved with gene therapy (STAT) (Press)
  • Novartis SMA treatment could get FDA approval in May (Reuters) (Endpoints) (Press)
  • Global Blood, FDA agree on fast-filing plan for new sickle cell disease drug (STAT) (Endpoints)
  • ASH18: Trial successes back Celgene belief in luspatercept (BioPharmaDive) (Endpoints) (Press) (Press)
  • The benefit of a blood disease drug from Acceleron and Celgene debated by experts (STAT)
  • High-cost Gilead cell therapy proves durable for some lymphoma patients (Reuters) (Endpoints) (Press)
  • Finally satisfied with Ocular’s manufacturing setup, FDA approves eye drug/device Dextenza (Endpoints) (Press)
In Focus: International
  • GSK to boost cancer drugs pipeline with $5.1bn Tesaro purchase (Financial Times) (STAT) (Forbes) (CNBC) (Endpoints) (Bloomberg) (Press)
  • Dutch firm Argenx, J&J affiliate to collaborate on cancer therapy (Reuters) (Fierce) (Endpoints)
  • China-US Drug Deal Is a Palliative, Not a Cure (Bloomberg)
  • UK to unveil £1bn life sciences investment (Financial Times)
  • Medicines for Europe Welcomes Competitiveness Council Discussion To Stop Delocalisation Of Medicine Manufacturing. It Is Time To Effectively Position Europe As A Global Hub For The Production Of Medicines (Medicines for Europe)
  • All in: Novartis adds another drug to its fast-growing radiopharmaceuticals division (Endpoints)
  • Millions flock to free tests as Egypt seeks to eradicate hepatitis C (Reuters)
  • Pharma Valley, China’s equivalent of Kendall Square, is expanding rapidly (STAT)
  • RedHill Biopharma's antibiotic succeeds in late-stage study (Reuters) (Endpoints)
  • Measles threat looms in Philippines as trust in vaccines declines: health officials (Reuters)
  • Industrial strategy delivers new vaccines manufacturing centre to lead the fight against deadly disease (GOV.UK)
  • US, Mexico and Canada Sign Pact to Replace Nafta (WSJ)
  • Norway biotech Ultimovacs plans IPO to develop cancer drug (Reuters)
  • Vertex, NICE, NHS Miss Orkambi Deadline (BioCentury)
  • Ceci n’est pas une période de transition and first reaction to the Implant Files (MedicalDevicesLegal)
Pharmaceuticals & Biotechnology
  • Biosimilars Forum Announces Launch of Biosimilars Roundtable (Biosimilars Forum)
  • The Quest for a Weight-Loss Drug That Actually Works (Bloomberg)
  • Takeda Acquisition Of Shire May Bode Well For R&D Staff (Forbes)
  • Principia chalks up a win for its BTK autoimmune program (Fierce)
  • Health Industry Alert - The DQSA: Five Years In (Akin Gump)
  • FDA Authorized Cantrell Drug Company Offers Significant Cost Savings for Sterile Injectable Drugs (Press)
  • New drugs, decades in the making, are providing relief for migraines. (Washington Post)
  • An Insight Of AI's Penetration In Drug Development Market (Forbes)
  • Off-the-shelf cell therapy for cancer? Fate Therapeutics to make its case at ASH (Fierce)
  • Fresenius Kabi Receives FDA Drug Shortage Assistance Award (Press)
  • Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework (HHS)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Novartis unveils strong longer-term Kymriah data at ASH 2018 (Pharmafile) (Press)
  • Real-world data show Novartis drug Revolade® improves outcomes for ITP patients compared to other second-line therapies (Press)
  • Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program (Press)
  • Pfizer Presents Positive 26-Week Data For PF-05280586, A Potential Biosimilar To Rituximab, At The American Society Of Hematology Annual Meeting (Press)
  • Seattle Genetics Highlights Multiple Data Sets Evaluating the Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) at ASH Annual Meeting (Press)
  • Seattle Genetics Highlights Additional Analyses from ECHELON-1 Phase 3 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Advanced Hodgkin Lymphoma at ASH Annual Meeting (Press)
  • ASH18: Bluebird's follow-on CAR-T finds initial success, but durability will be key test (BioPharmaDive) (Endpoints) (Press)
  • #ASH18: Celgene offers up a stellar complete response rate for JCAR017. Will anyone notice? (Endpoints)
  • #ASH18: Regeneron’s bispecific REGN1979 offers eye-catching 80% CR rate in follicular lymphoma, spurring swift shift to pivotal study (Endpoints) (Fierce)
  • Celgene Corporation Announces Results of AUGMENT Evaluating REVLIMID® In Combination with Rituximab (R2) In Patients with Relapsed/Refractory Indolent Lymphoma At ASH 2018 (Press)
  • Celgene Corporation Announces Initial Phase 1/2 Liso-cel Data in Patients with Relapsed/Refractory CLL, Including Those with High-Risk Disease, Previously Treated with Ibrutinib, at ASH 2018 (Press)
  • AbbVie's Venclyxto combo beats standard of care in chronic lymphocytic leukaemia (Fierce) (Press)
  • Syros Announces Promising Clinical Data from Ongoing Phase 2 Trial of SY-1425 in Genomically Defined AML and MDS Patients at ASH Annual Meeting (Press)
  • Longer-term follow-up data demonstrate sustained benefit of polatuzumab vedotin-based treatment in relapsed or refractory diffuse large B-cell lymphoma (Press)
  • ASH: Takeda maintenance data set up Ninlaro for new myeloma nod (Fierce) (Press)
  • Autolus Therapeutics Presents Initial AUTO3 Clinical Data from Phase 1/2 Clinical Trials in B cell Malignancies at the 60th ASH Annual Meeting (Press)
  • X4 Pharmaceuticals Presents Additional Positive Phase 2 Results for X4P-001 in WHIM Syndrome, Continues on Path to Initiation of Phase 3 Trial (Press)
  • Magenta Therapeutics Presents New Data from Phase 2 Study of MGTA-456 Cell Therapy in Patients with Inherited Metabolic Disorders (Press)
  • Tolero Pharmaceuticals Presents Updated Clinical Data from Ongoing Phase 2 Zella 201 Study Evaluating Investigational Agent Alvocidib in Patients with MCL-1 Dependent Relapsed or Refractory AML at ASH 2018 (Press)
  • Gamida Cell Reports Immune Reconstitution Data from Completed Phase 1/2 Clinical Study of NiCord® Presented at ASH 2018 Annual Meeting (Press)
  • ArQule Announces Clinical Data from Ongoing Phase 1 Study of Reversible BTK Inhibitor, ARQ 531, in Patients with Relapsed/Refractory Hematologic Malignancies at the 2018 ASH Annual Meeting (Press)
  • LEO Pharma initiates phase 2b clinical studies of topical delgocitinib cream in adults for the treatment of both atopic dermatitis and chronic hand eczema (Press)
  • NewLink Genetics Presents Encouraging Updated Phase 1 Data with Indoximod Plus Chemotherapy in Frontline AML in an Oral Session at 2018 ASH Annual Meeting (Press)
  • Tiziana Completes Patient Enrollment in a Phase 2a Trial to Evaluate Tolerability and Anti-Tumor Activity of Milciclib in Hepatocellular Carcinoma (HCC) (Press)
  • MEI Pharma Presents Clinical Data from Ongoing Phase 1b Study of ME-401 in Patients with Indolent B-Cell Malignancies at the 2018 American Society of Hematology Annual Meeting (Press)
  • MaaT Pharma Presents Positive Phase 1b/2a Study Results in Acute Myeloid Leukemia Patients at the ASH 2018 Annual Meeting (Press)
  • Aprea Therapeutics Presents Results From Phase Ib/II Clinical Study of APR-246 and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego (Press)
  • Spectrum Pharmaceuticals Announces Positive Results from Phase 2 Trial Evaluating Use of Oral Leucovorin to Potentially Mitigate Mucositis in Patients Treated with FOLOTYN® (pralatrexate) (Press)
  • Amphivena Presents at ASH First-in-Human Phase 1 Clinical Data on AMV564 (Press)
  • Vybion Receives Orphan Drug Designation for INT41 in Huntington's Disease (Press)
Medical Devices
  • Person of the Year: Bakul Patel, FDA (MedTechDive)
  • Opinion: It’s time to permanently end the job-killing medical device tax (STAT)
  • FDA grants breakthrough device designation to artificial intelligence software for CTEPH pattern recognition from Bayer and MSD (Press)
  • FDA picks eight medical device firms to help battle opioid crisis (Reuters)
  • FDA approves Meridian Bioscience's test for herpes in newborns (Reuters) (FDA)
  • ResMed puts $225m on the table for Propeller Health (Drug Delivery)
  • Merit Medical wins FDA nod for EmboCube embolization gelatin (Medical Design & Outsourcing)
  • Medtronic Announces First Patient Treated in TERMINATE AF Clinical Trial (Press)
  • JenaValve Technology Receives FDA Approval for Expanded IDE Enrollment in the Treatment of Patients with Severe Aortic Stenosis and Severe Aortic Regurgitation (Press)
  • Notal Vision Announces FDA Grants Breakthrough Device Designation for Pioneering Patient-Operated Home Optical Coherence Tomography (OCT) System (Press)
  • Diabeloop wins CE Mark for hybrid closed-loop diabetes management system (Drug Delivery)
  • Class 1 Device Recall CARESCAPE R860 Inspiratory Safety Guard (FDA)
US: Assorted & Government
  • GOP gives up on Planned Parenthood defunding (Politico)
  • “The Best of Times” … “The Worst of Times” (Alliance for a Stronger FDA)
  • DOJ Will Nuke Gilead FCA Suit, Supreme Court Hears (Law360-$)
  • Becton Buyers' Antitrust Suit Killed Under Illinois Brick (Law360-$)
  • Boston Scientific sues Micro-Tech over endo clip patents (MassDevice)
  • Doc inventor wins $113m in royalties spat with Medtronic (MassDevice)
  • Medical Device Enforcement and Quality Report (FDA Law Blog)
  • The Demise of Drug Design Litigation: Death by Federal Preemption (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Russia approves rules for launch of new drugs in domestic market (PharmaLetter-$)
India
  • Report on faulty hip replacement implants ready: Centre to SC (Economic Times)
  • Whistle-blower complains to SEBI against Sun Pharma, alleges insider trading: Report(Economic Times)
  • CDSCO to amend law to regulate brand names to avoid confusion over LASA medications (PharmaBiz)
  • India needs antibiotic monitoring system to save these drugs from extinction: Experts (PharmaBiz)
Canada 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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