Regulatory Recon: Results From CRISPR Gene Editing of Embryos (10 March 2017)

Posted 10 March 2017 | By Zachary Brennan 

Regulatory Recon: Results From CRISPR Gene Editing of Embryos (10 March 2017)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                      

  • Lawmakers Revise Bill to Speed Generic Drug Approvals (Bloomberg)
  • AHIP Speakers: Soaring Drug Prices Reach Crisis Stage (MedPage Today)
  • The Winners And Losers In The Republican Health Care Plan (NPR) (WSJ-$) (Rep. Burgess Comment)
  • Former CMS Administrator: How to Fix the Health Care Mess (Politico)
  • Expect the CBO to estimate large coverage losses from the GOP health care plan (Brookings)
  • Millions of Americans Could Face a Premium Surcharge Through the ACA Repeal Bill’s “Continuous Coverage” Provision (Commonwealth Fund)
  • Republicans Should Take The Time To Improve The American Health Care Act (Health Affairs)
  • Secretary Price Committed to Greater Medicaid Flexibility for States (HHS)
  • Why Cato's Cannon Finds GOP Health Plan 'So Inadequate' (Bloomberg)
  • Trump is losing his ability to scare biotech (Bloomberg)
  • Deregulatory mood spices PDUFA reauthorization (EP Vantage)
  • Readout of President Donald J. Trump's Meeting with Congressman Elijah Cummings (White House)
  • WH privately supports earlier rollback of Medicaid expansion: report (The Hill)
  • House Republicans would let employers demand workers’ genetic test results (Stat)
  • Hospitals could bear the financial brunt of the American Health Care Act (Stat)
  • Tanning Industry, Taxed Under Obama, Cheers G.O.P. Health Bill (NY Times)
  • Drug, Device Makers Urge New Kickback Safe Harbors (Law360-$)
  • 505(b)(2) Approvals: More time than regular NDAs? (Focus)
  • A New Rulemaking Is Needed for the Intended Use Regulation (FDA Law Blog)
  • Ex-FDA Commissioner: We can improve and modernize the drug development process in the US (The Hill)

In Focus: International

  • First results of CRISPR gene editing of normal embryos released (New Scientist) (Study)
  • UK cancer experts urge reform of paediatric cancer trial rules (Pharma Times)
  • China pledges to speed up approvals of foreign drugs (FiercePharma)
  • EU Industry Groups Urge Caution on Biosimilar Switching (Focus)
  • EMA To Tackle Inconsistencies In Quality Data For Drug-Device Combinations (Scrip-$)
  • Closure of Scottish J&J plant threatens 400 staff (Pharmafile)
  • Cost of kidney dialysis poses ethical dilemma in sub-Saharan Africa (Reuters)
  • India Again Requests Trial Protocols from Combo Drug Manufacturers (FDANews-$)
  • Cambridge industry-academia collaboration initiative (Pharmafile)

US: Pharmaceuticals and Biotechnology

  • Interview: Novo Nordisk's new CEO turns to deals to help revive growth (Reuters)
  • Regeneron CEO Q&A on drug prices (Stat-$)
  • The new CEOs in biopharma are joining the big players at the billion-dollar chip table (Endpoints)
  • Pharma’s Bogus Case Against the CREATES Act (American Spectator)
  • Pfizer mulls NC gene therapy plant (BioPharma-Reporter)
  • Pfizer Takes Step Back With Avelumab, Step Forward On CAR-T (Scrip-$)
  • Barclays loses patience with Gilead, tells it to change up its strategy (FierceBiotech)
  • Q&A: Repurposing existing drugs for new uses in cancer — for no profit (Stat-$)
  • Drug, Pharma Benefit Cos. Sued Over Insulin Pricing (Law360-$)
  • Patent watch: Patent insight into polymer-free drug-eluting stents (Nature)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Servier cleared to start US trials CAR-T therapy (PMLive)
  • Dual therapy first weakens, then kills antibiotic-resistant pathogens (C&EN)
  • Marked for death: targeting epigenetic changes in cancer (Nature)
  • Designer Chromosomes Point to New Synthetic Life-Forms (MIT Technology Review) (Stat-$)
  • Genetic counselors, genetic interpreters, and conflicting interests (Harvard Bill of Health blog)

Medical Devices

  • AdvaMed on Top FDA Guidance Priorities (Focus)
  • Gore wins FDA nod, launches Viatorr Tips endoprosthesis in US (MassDevice)
  • How are ophthalmic medical devices regulated in Australia? (TGA)

US: Assorted and Government

  • New House bill to allow the personal importation of drugs from Canada (Bill)
  • FDA warns of contaminated organ preservation solution (MassDevice) (FDA)
  • CDC probes multistate listeria outbreak linked to contaminated cheese (Reuters)

Upcoming Meetings and Events             

General Health and Other Interesting Articles

  • U.S. doctors sound alarm on yellow fever outbreak (CBS)
  • U.S. Employers Added A Robust 235,000 Jobs In February (NPR)

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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