Recon: GSK to Buy Tesaro for $5.1B

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• Russia approves rules for launch of new drugs in domestic market (PharmaLetter-$)

• 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)

• List of Drugs for an Urgent Public Health Need (Health Canada)