Recon: AstraZeneca to Pay Daiichi Sankyo up to $6.9B to Develop Breast Cancer Drug

• Bristol-Myers scores critical endorsements for its embattled Celgene merger (STAT) (Endpoints) (CNBC)
• Drug makers continue to clamor for FDA approval of orphan drugs (STAT)
• Coalition attacks Trump plan to end drug rebates, calling it a ‘big pharma bailout’ (STAT)
• Top 20 cancer drug deals: AstraZeneca just changed the global landscape for dealmaking in oncology (Endpoints)
• Shares in Galapagos jump 15 percent after arthritis drug results (Reuters) (Endpoints) (Press)
• Amarin takes application to expand Vascepa label to the FDA as M&A chatter heats up (Endpoints)
• Diabetes group nods to Vascepa, sending Amarin stock higher (BioPharmaDive)
• Doughnut Hole Is Gone, But Medicare’s Uncapped Drug Costs Still Bite Into Budgets (KHN)
• FDA approves treatment for patients with a type of inflammatory arthritis (FDA)
• Biosimilar Pathway Would Disappear If ACA Repealed, Gottlieb Says (Pink Sheet-$)
• Pain intensifies for AbbVie as it slashes 178 jobs from Stemcentrx (Fierce)

• AstraZeneca pays up to $6.9 billion in Daiichi Sankyo cancer deal (Reuters) (Bloomberg) (WSJ) (Endpoints) (Fierce) (Press)
• EMA panel recommends approval of Bluebird Bio's first gene therapy (Reuters) (STAT) (Endpoints)
• Takeda takes a cautious step into neurological gene therapy, inking preclinical deal with StrideBio (Endpoints)
• Japan Approvals Include World-First For Skyrizi, Kymriah As Asia's First CAR-T (Pink Sheet-$)
• China Lists 30 More Overseas Drugs Eligible For Priority Review (BioCentury)
• EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack (EMA)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) (EMA)
• ABPI calls for temporary export ban in effort to prevent shortages in case of no-deal Brexit (Pharmafile)
• Call for temporary medicines export ban if no-deal Brexit strikes (PMLive)
• Novo plunks down $100M to ready plant for new generation insulins (Fierce) (Press)
• Keytruda nabs key lung cancer nod in China. But are blockbuster sales really attainable? (Fierce)
• Cholera cases jump to 138 in Mozambique's Beira after cyclone (Reuters)

• Microbiome companies look beyond the gut for new therapies (STAT)
• Durable, safe and effective long-term kidney drug data from Tricida fuel blockbuster potential (Endpoints)
• BIO Targets Compulsory Licensing, Regulatory Reforms Across Various Countries (Focus)
• Gottlieb Seeks New Comparative Approval Standard for Opioids (Focus)
• Bristol-Myers Squibb taps Concerto HealthAI for real-world cancer data work and trial design (Fierce)
• Chutes & Ladders—Allergan taps Celgene vet Bob Hugin for M&A guidance (Fierce)
• Xcovery hires CEO, CMO to lead assault on ALK NSCLC market (Fierce)
• Viruses act as decoys, study finds, helping bacteria evade the immune system (STAT)
• A Lawyer’s Guide to CRISPR Gene Editing (The Privacy Report)
• FDA Again Proposes To Advance Outsourcing Sector With Center Of Excellence (Pink Sheet-$)
• No Nucynta Generics Until 2025, Fed. Circ. Affirms (Law360-$)
• Breaking Down FDA’s New Rare Disease Natural History Studies Guidance: Practical Considerations (FDA Law Blog)
• Big Pharma/antibiotics: bug bears (Financial Times)

• Luye Pharma's Rykindo Expected to Be the First Chinese Innovative Drug to Receive U.S. FDA Approval (Press)
• J&J submits sNDA for Invokana after premature end to clinical trial (PharmaTimes)
• Proteon tanks after kidney disease drug fails again in phase 3 (Fierce)
• Seattle Genetics Completes Enrollment in Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer (Press)
• Daiichi Sankyo Confirms Plans to Accelerate BLA Submission to U.S. FDA for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive Metastatic Breast Cancer Post T-DM1 (Press)
• CIMZIA® (certolizumab pegol) is Now the First and Only U.S. FDA-Approved Treatment for Non-Radiographic Axial Spondyloarthritis (Press)
• CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study (Press)
• Antibe Therapeutics Announces Commencement of Phase 2B Dose-Ranging, Efficacy Study for Lead Drug, ATB-346 (Press)

• FDA Drafts Guidance on Inspections of Medical Device Establishments (Focus)
• Can "Internet-of-Body" Thwart Cyber Attacks on Implanted Medical Devices? (IEEE)
• Class 1 Device Recall Cardiohelp Emergency Drive (FDA)
• AngioDynamics wins expanded FDA clearance for OARtrac radiation dose monitor (MassDevice)
• OARtrac® Radiation Dose Monitoring System Receives Expanded FDA Clearance for Electron Radiation Therapy (Press)
• First US Patient Treated with Cook Medical’s Recently Approved Zenith® Dissection Endovascular System (Press)
• Stryker To Bring On Johnson & Johnson Exec For CLO Spot (Law360-$)

• Most Americans take supplements, FDA should know something about them (The Hill)
• LivaNova to settle majority of U.S. 3T Heater-Cooler cases (MassDevice)
• Bayer loses bid to toss some claims in Essure class action suit (MassDevice)
• Federal Preemption KOs Economic Loss Claims in Biologics MDL (Drug & Device Law)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates (Focus)
• MHRA Offers More No-Deal Brexit Guidance on Conditional Marketing Authorizations (Focus)
• NICE backs PredictImmune's IBD prognosis test (PharmaTimes)
• Illumina and BGI Clash over Patent in German Court (MDDI)
• Fresenius 5008 & 5008S haemodialysis machines – low risk of inadequate fluid removal during treatment (MDA/2019/018) (MHRA)
• Orchard Plans EU Submission For GSK-Originated MLD Gene Therapy (Scrip-$)

• ECRI Institute to open international medtech testing lab in Malaysia (MassDevice)
• China’s WuXi Biologics seeks global expansion (PharmaLetter-$)

• Boosting presence in Chinese market remains an uphill task for Indian drug companies; Yunnan export proposal finds few takers (PharmaBiz)

• GMP clearance guidance update (TGA)
• TGA instructions for disinfectant testing (TGA)
• Submission of an updated RMP (TGA)