Recon: Rigel wins first FDA approval; Abbott shares down as device sales grow

• Has biopharma over-invested in cancer R&D? (Novartis Institutes for Biomedical Research)
• GSK flags pharma M&A ambitions by poaching Roche deal-maker (Reuters) (Fierce) (Endpoints)
• Ultragenyx wins a blockbuster OK for its leading rare disease drug burosumab — priced at $200,000 (Endpoints) (Fierce) (FDA)
• Rigel bags first FDA approval (PharmaTimes) (The Pharma Letter)
• Solid Bio clears partial hold, but DMD gene therapy trial is still on hold (Fierce) (Endpoints)
• US regulators float ideas for boosting medical device safety (The Washington Post-$) (AdvaMed) (Focus)
• Abbott shares down as device sales grow (MassDevice) (Reuters)

• Industry fears disruption as EU excludes UK from drug approvals (Reuters)
• Brussels seeks emergency powers to prepare for hard Brexit (Financial Times-$)
• Chinese Money Floods U.S. Biotech as Beijing Chases New Cures (Bloomberg)
• Astrazeneca Pharma firms up after announcing investment in India (Business Standard) (Times of India) (pharmabiz)
• CADTH to Evaluate CAR T-Cell Therapies (CADTH)
• Canada seeks U.S. help to solve EpiPen shortage (Reuters)
• Novo Nordisk, Red Cross team up to tackle chronic diseases in conflict zones (Reuters)
• UK and India extend health partnership to deal with global health risks (MHRA)
• New WHO Public Inspection Reports (WHOPIRs) published (World Health Organization)

• Shire faces criticism on CEO pay policy as crunch week looms (Reuters)
• Coke Versus Pepsi of Drugmakers? Wall Street Doesn't Buy It (Bloomberg)
• For New Trump Drug Plan, a Cautionary Tale in Italy (WSJ) (Axios)
• White House reviewing drug-pricing plan (Axios)
• Science hinted that cancer patients could take less of a $148,000-a-year drug. Its maker tripled the price of a pill. (Washington Post-$)
• CR UK, AACR form international cancer alliance (PharmaTimes)
• Express Scripts' Steve Miller: New Orphan Drug Price Is 'Responsible' (Forbes)
• Pfizer, Ranbaxy Look To Dump State Claims In Lipitor MDL (Law360-$)
• Trade secrets battle between Alnylam, Dicerna is just one of many (The Boston Globe)
• OP company recalls male supplement for containing actual drugs (Kansas City Business Journal)
• FDA Commissioner, Gottheimer meet on ways to help biopharma industry (NJBIZ)
• Sangamo probes for fresh breaches of its digital security system after top exec’s email was hacked — exposing secrets (Endpoints)

• Blood test shows promise for spotting early cancers (Science Magazine)
• Resistance to PD-1 Inhibition Overcome With a Combination (Medscape) (Endpoints) (Fierce)
• Erenumab Reduces Migraine in Hard-to-Treat Patients (MedPage Today) (The Times) (The Independent) (Endpoints)
• FDA's Leah Christl Provides an Agency Perspective on the Biosimilars Landscape (Center for Biosimilars)
• It's Official! Curing Patients Is Bad for Business (MedPage Today)
• US expands use of Shire’s Vonvendi (PharmaTimes)
• Full US approval to Praxbind, specific reversal agent for Pradaxa (The Pharma Letter)
• New report shows over 500 neurological meds in development by US firms (The Pharma Letter-$)
• Merck pits its pneumococcal shot against Pfizer's mammoth Prevnar in head-to-head phase 3 (Fierce)
• St. Jude, Microsoft and DNAnexus launch pediatric cancer genomics platform for researchers (Fierce)
• ImmuPharma dives on late-stage lupus failure (BioPharma Dive)
• Grid Therapeutics raises $5M for complement-activating I-O drug (Fierce)
• J&J Restructure: Will Cost Cuts Affect Suppliers? (MedTech Intelligence)
• Drug Active in RET-Altered Tumors (MedPage Today)

• Mass. medical device industry sees growth in VC funding, PMA approvals (MassDevice)
• LimFlow bags $34M to trial limb-saving artery disease device (Fierce)
• Novocure plans FDA filing as anti-cancer device clears phase 2 (Fierce)
• Allergan To Pay $3.5M To Resolve Lap-Band FCA Allegations (Law360-$)
• FDA Guidance Looks to ‘Modernize’ 510(k) Premarket Clearance Program (AAMI)
• Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures (FDA)
• Google Unveils Prototype Cancer-Detecting Microscope (BioCentury)
• New medical devices help doctors with disabilities (Medical Xpress)
• Cantel Medical Receives FDA 510(k) Clearance to Market ADVANTAGE PLUS Pass-Thru Automated Endoscope Reprocessor (Press)
• NextPhase Medical Devices Launches New Business (Press)

• Is PTAC on the Right Track? Some Say 'No' (MedPage Today)
• DEA seeks to more strictly manage opioid manufacturing (BioPharma Dive) (Axios) (Reuters)
• Cancer hospitals push for Medicare CAR-T payments (Axios)
• VA Chief Nominee Won't Privatize Agency, Senator Says (Law360-$)
• Missouri Talc Decision Could Signal Mass Tort Sea Change (Law360-$)
• HHS secretary back in hospital for bowel condition (AP News)
• Four-hour drive for a colonoscopy? What VA privatization warnings ignore (USA Today)
• Amazon About-Face On Drug Sales Not Surprising To Walgreens And CVS (Forbes)
• Crackdown on e-cigarettes coming, FDA chief says (Washington Examiner)
• Kentucky accuses J&J of contributing to opioid epidemic (Reuters)
• Patrick Kennedy profits from opioid-addiction firms (Politico)
• How Safe is the Safe Harbor? (FDA Law Blog)
• Does FDA Need Statutorily Imposed Incentives for Regulatory Compliance Matters? (FDA Law Blog)
• Paragraph IV Certifications Last 4 Plus Years (Lachman Consultants)
• Sens. Alexander, Murray Introduce Bipartisan Legislation to Address “Urgent Opioid Crisis” (HELP Committee)
• Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice (FDA)

• FDA Advisory Committee Calendar

• Eudamed Nomenclature Requirements Published (Emergo Group)
• Stakeholders To Gather In London To Plan Biosimilar Market's Future (Biosimilar Development)
• Sanofi nears deal to sell EU generics unit for $2.4B (BioPharma Dive)
• Microsurgery devicemaker Medical Microinstruments captures $24.5M in series A funding (Fierce)
• Abbott to produce new infertility drug in Russia (The Pharma Letter-$)
• Shire scores new filing acceptance for lanadelumab (The Pharma Letter)
• Mylan Partners with Fujifilm Kyowa Kirin Biologics (Big Molecule Watch)
• Our view: Redistribution of UK’s portfolio of centrally authorised products (ABPI)
• DHPC – Information on leaking syringes of various GSK vaccines (Swissmedic)
• HPRA Industry Survey now published - Impact of Brexit on the Medtech sector in Ireland (HPRA)
• Medical Devices Information Day on 23 May 2018 and publication of the HPRA Impact of Brexit Survey (HPRA)
• EMA 2017 Public Engagement Report (EMA)
• EU Innovation Network Report (EMA)
• LivaNova Receives CE Mark for VNS Therapy SenTiva Generator and Next-Generation Programming System for Treatment of Epilepsy (Press)
• Canon Medical Systems strengthens partnership with Arcoma by entering into a reseller agreement (Press)
• Beckman Coulter Diagnostics Announces CE Mark of the DxH 520 Closed Tube, 5-part Differential Hematology Analyzer for Small-volume Labs (Press)

• Israeli Billionaire Seeks $500 Million for Health-Tech VC Fund (Bloomberg)
• Astellas sells certain Agensys research facilities to Kite (The Pharma Letter)
• MHLW Pharmaceuticals and Medical Devices Safety Information (FY2018) (PMDA)
• China's Fosun becomes fourth suitor for India's troubled Fortis (Reuters)

• What We Know About the Mysterious Flesh-Eating Bacteria Spreading in Australia (Fortune)
• A third of corporate Australia is feeling stressed, anxious and depressed (Business Insider)
• Conference participation by the TGA (TGA)

• Health Canada says it takes safety 'very seriously' in face of concerns about homeopathic remedy (CBC News)
• Huge Canadian health group calls for decriminalization of illicit drugs (NEWS 1130)
• Supervised injection site needed for drug users in Manitoba: Canadian Mental Health Association report (CBC News)
• Notice - Update on Health Canada’s efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR) and consultation on a proposed Pathogens of Interest List (Health Canada)
• Notice: Release of Proposed IMDRF Document: Definitions for Personalized Medical Devices (Health Canada)

• How Big Data Is Fueling This Company's Digital War on Diabetes (Fortune)
• Raising retirement age may hit least-educated workers hardest (Reuters)
• Drug Test Spurs Frank Talk Between Hypertension Patients And Doctors (KHN)