Regulatory Recon: AstraZeneca's Tagrisso Gets Full Approval in NSCLC; Emma Walmsley Takes the Reins at GSK (31 March 2017)

Posted 31 March 2017 By Michael Mezher

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

In Focus: US

  • AstraZeneca's Tagrisso Moves from Accelerated to Full Approval for NSCLC (Press)
  • 'The Trump Of Georgia' Goes To Washington (KHN)
  • The nominee to run America's drug regulator is a sound choice (The Economist)
  • FDA: Helping Small Businesses Get Big Results (FDAVoice)
  • Bracing for the biosimilar wave (Nature)
  • Industry Wants FDA to Hit the Brakes on Quality Metrics Program (Focus)
  • FDA Unveils Regulatory Science Progress Report (Focus)
  • Democrats Propose Wide-Ranging Bill to Lower Drug Costs (Focus) (Harvard Bill of Health)
  • Inspection Delays Remain For Novel Approvals By US FDA; Will Quality Office Help? (Pink Sheet-$)
  • Soon-Shiong's NantHealth reports $184 million loss for 2016 (STAT)
  • Caveat Subscriptor When Academia Touts A Breakthrough (LifeSciVC)
  • J&J declares Actelion tender offer a success, sees closing in second quarter (Reuters)
  • NIH research grants yield economic windfall (Nature) (Pink Sheet-$)
  • Paul Ryan Signals Support for Insurance Payments Under ACA (WSJ) (NYTimes)
  • Kansas governor vetoes Medicaid expansion bill (Reuters) (WSJ)
  • Bill Aimed at Planned Parenthood Funding Passes With Pence Tiebreaker Vote (WSJ)
  • Francis Collins: As far as I'm able to see, I'm NIH director (CNBC)
  • J&J pulls the plug on PhII study for NHL after Darzalex falls short (Endpoints) (BioCentury)
  • Merck KGaA disses Ocrevus-Rebif price comparison as 'misleading and oversimplified' (Fierce)
  • Incoming AdvaMed chairman Yared: We'll take medtech tax repeal 'in any form' (MassDevice)
  • Bringing Device Makers into the Hospital: Good Business or Ethical Risk? (Medpage)

In Focus: International

  • U.S.-UK alliance targets the world's deadliest superbugs (Reuters) (Washington Post)
  • GSK's Emma Walmsley steps into Andrew Witty's shoes (BBC) (WSJ) (MedCityNews)
  • FSS to probe Samsung BioLogics over accounting fraud (Korea Herald) (Drug Delivery)
  • EMA says CRO monitoring activity not location based (InPharmaTechnologist)
  • Changing levels of investment in UK drug discovery (Pharmafile)
  • NHS England unveils new NHS survival plan (PharmaTimes)
  • Brazil's ANVISA Extends Appeal Timeframes for Medical Device Market Applicants (Emergo)
  • Regulatory information - adjusted fees for applications to EMA from 1 April 2017 (EMA)
  • Merck, Avillion ink development deal for nanobody psoriasis treatment (Drug Delivery) (SCRIP-$)
  • European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (Focus)
  • Now What? Sanofi CEO Urges Incentives As China Embraces New Drugs (Pink Sheet-$)
  • Iranian sovereign fund targeting healthcare, high-tech (Reuters) (Fierce)
  • Lupin, Cipla, other top drugmakers in fray for Novartis' brands (Economic Times)
  • Hanmi, Innovent In Bispecific Antibody Deal (BioCentury)
  • Consultation: Options for the future regulation of 'low risk' products (TGA)
  • Open Invitation for ATMP-developers to help improve product development and its regulation (EFPIA)

US: Pharmaceuticals & Biotechnology

  • Payers Want Deep Discounts To Make Biosimilars Worth Their While (SCRIP-$)
  • OTC Monograph Reform, User Fee Legislation Coming 'Any Day' – CHPA (Pink Sheet-$)
  • US FDA Shows Relaxed Approach On Personalized Medicine In Zejula Approval (Pink Sheet-$)
  • This week's examples of a discipline approach to R&D (Plenge Gen)
  • LISTEN: One humble test that makes or breaks companies and careers (STAT)
  • FDA Updates List of eCTD Files for CDER and CBER (FDA 1, 2)
  • Halozyme dips after pancreatic cancer trial halted for futility (Fierce)
  • Embrace 'moonshot medicine' to make the leap to a new era of human health (STAT)
  • NIH's new embrace of preprints will be a boon to science (STAT)
  • Fragile X biotech Vencerx hires ex-Pfizer, Wyeth exec Robert Ring as CEO (Fierce)
  • US generic drug imports falling in the Trump era (PharmaLetter-$)
  • The 'Dash to NASH' drives innovation in the biopharmaceutical industry (PharmaLetter-$)
  • Meeting the drug pricing debate at the clinical trial site level (OutsourcingPharma )
  • Biogen CMO Notes iPhone's Potential For Early Detection of Alzheimer's (Pink Sheet-$)
  • Acorda plans NDA for inhaled Parkinson's drug after touting long-term safety data (Drug Delivery)
  • Incyte and Merck Provide Additional Details on Previously Announced Collaboration Investigating Epacadostat and KEYTRUDA (pembrolizumab) (Press)
  • Advancements to Monitor, Combat and Prevent Pathogen Outbreaks (BIO)
  • DTC and OPDP (Eye on FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Aura Biosciences wins fast track designation for light-activated nanoparticle therapy (DrugDelivery)
  • Progenics' Azedra Headed For NDA (BioCentury)
  • SRI International Receives U.S. FDA Clearance for Investigational New Drug Application Evaluating Novel Oral Treatment to Combat Radiation Exposure (Press)

US: Medical Devices

  • Not so fast: Utah's Hatch thinks medtech levy repeal could still be part of tax reform (MassDevice)
  • Is It Time for a Chief Access Officer? (MDDI)
  • The US transcatheter aortic valve market enters the endgame (EP Vantage)
  • Robotics and Social Media Move into the Mainstream at SAGES (MDDI)
  • Why regional reimbursement strategies could be right for medtech (MassDevice)
  • Medtronic Initiates Global Trial Evaluating Cryoablation to Treat Persistent Atrial Fibrillation (Press)
  • FDA clears Bodycad's personalized unicompartmental knee system (MassDevice)
  • RenovoRx Announces FDA Clearance for Expanded Labeling (Press)

US: Assorted & Government

  • The Future Of Off-Label Promotion And Product Liability (Law360-$)
  • How the Trump Administration Responds to Democrats' Demands for Information: It Doesn't. (ProPublica)
  • Past Time for Rule 11 in Louisiana (Drug & Device Law)
  • Boehringer Ruling Limits Treatment Method Patent Eligibility (Law360-$)
  • Pharma Cos. Made $1B Off Wasted Cancer Drug, Suit Says (Law360-$)
  • Device Maker Wins Toss Of Investors' Illegal Kickback Claims (Law360-$)
  • Help Wanted: Cost-Effectiveness Research For Health And Wellness (Health Affairs Blog)
  • Georgia Senate passes expansion of limited medical marijuana law (Reuters)
  • Interagency Food Safety Analytics Collaboration Issues New Strategic Plan (FDA Law Blog)

Upcoming Meetings & Events

Europe                                               

  • Hungarian experience with the use of biosimilar infliximab in IBD (GaBI)
  • Report cites pharma industry for not reporting cargo thefts (Securing Industry)
  • Couple sentenced for selling dangerous slimming pills online (MHRA)
  • Health and social care workforce should be Brexit priority (PharmaTimes)

Asia

  • Calypso deal with Japanese gastrointestinal specialist (PharmaLetter-$)
  • Takeda's Ricardo Marek moves to new position (PharmaLetter-$)
  • Daiichi Sankyo to expand diabetes deal with Mitsubishi Tanabe (PharmaLetter-$)

India

  • CDSCO Issues Notice of Strict Controls for Oxytocin Manufacturing (CDSCO)
  • Fosun On Course To Full Indian Clearance For Gland Buyout (SCRIP-$)
  • Poison in ayurvedic drugs (Economic Times)

Australia

  • Consultation: The Scheduling Policy Framework and Advertising of Pharmacist-only medicines (Schedule 3 substances) (TGA)

General Health & Other Interesting Articles

  • Firearm-related hospitalizations cost U.S. billions (Reuters)
  • Why Blaming Most Cancer On Bad Luck Is A Kind Of Lie (Forbes)
  • The Haves and Have-Nots of Cancer Care (NYTimes)
  • U.S. rates of double-mastectomies for breast cancer vary by state (Reuters)
  • Chemical disinfectants and sanitizers linked to thyroid cancer (Reuters)
  • Young cancer patients may lag peers in social functioning for years (Reuters)
  • Hepatitis Tied to Parkinson's Risk (NYTimes)
  • Prior exposure to dengue or West Nile could make Zika worse: report (Reuters)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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