Regulatory Focus™ > News Articles > 4 > Recon: Rigel wins first FDA approval; Abbott shares down as device sales grow

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

Posted 18 April 2018 | By Ana Mulero 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • 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)
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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