Regulatory Recon: CRISPR Gene Editing Tested in First Person; Republicans Tell US Federal Agencies to Stop Work on Regulations Until Trump Takes Office (16 November 2016)

Posted 16 November 2016 By Zachary Brennan

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Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US                                          

  • CRISPR gene-editing tested in a person for the first time (Nature News) (ClinicalTrials.gov) (Letter)
  • Republicans Tell Agencies To Halt Work On Regs Until Trump Sworn In (InsideHealthPolicy-$) (Letter)
  • SEC Settles Insider Trading Suit Against Ex-FDA Official (Law360-$)
  • Physicians back steps toward value-based drug pricing (AMA) (Modern Healthcare)
  • Trump Used to Rail Against Drug Prices. Now Industry’s Allies Are Shaping His Agenda (LA Times)
  • Trump’s Health Policy, Legislative Team Taking Shape (BNA)
  • Reality must trump rhetoric after US election shock (Nature)
  • Tom Price Being Considered for HHS Secretary (Politico)
  • America’s Drug Problem (Nature Biotechnology)
  • If Design Govern in a Thing So Small (In the Pipeline)
  • Lowering the Bar: How PMDD Went from an Idea to a Diagnosis (MedPage Today)
  • The flip side of personal genomics: When a mutation doesn't spell disease (Nature News)
  • First Time Generic Approvals for FY 2016 – The Final Numbers (Lachman Consultants)
  • Amgen and Allergan Submit Avastin Biosimilar App to FDA (Biosimilar News) (Press)
  • Linnea requests FDA to withdraw vinpocetine notice (Nutra-Ingredients)
  • Excipient Database: All Systems go as FDA clears backlog (In-PharmaTechnologist)
  • Walgreens Claims Theranos Voided 11.3% of Test Reports (WSJ-$)
  • FDA Warns Japanese API Maker Over Data Integrity Issues (Focus)
  • FDA Approves New Labeling for Essure, Closes Trade Complaint Against Bayer (Focus)
  • FDA Calls on Pharma Companies to Join Manufacturing Inspection Program (Focus)
  • FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs (Focus) (FDA Law Blog)

In Focus: International

  • EMA Revises Guideline on First-in-Human Trials (Focus) (PharmaLetter-$)
  • NICE rejects Shire’s pancreatic cancer drug (PharmaTimes)
  • Suit Says Glaxo’s Conduct Led to Couple’s Imprisonment in China (WSJ-$)
  • Teva puts aside $520 million to resolve overseas bribery probes (Stat) (Fierce)
  • Israeli billionaire Nacht bets big money on another Teva in healthcare (Reuters)
  • France sets up fund for Sanofi epilepsy drug victims (Reuters)
  • New HPRA Innovation Office to support the development of novel health products and technologies (HPRA)
  • Experiment to raise the dead blocked in India (Science)
  • EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report (Focus)
  • Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (Focus)
  •  WHO condemns massive attacks on five hospitals in Syria (WHO)
  • Worldwide trends in blood pressure from 1975 to 2015: A pooled analysis of 1479 population-based measurement studies with 19·1 million participants (WHO)
  • WHO delivers lifesaving medicines and supplies to displaced people in Yei River State, South Sudan (WHO)

US: Pharmaceuticals and Biotechnology

  • Why Pharma Needs To Invest In Discovery (Forbes)
  • Two years into an R&D overhaul, GSK plans $250M lab project near Philly in final retooling of its US ops (Endpoints)
  • Stem Cell Transplant Startup With Harvard Tech, Magenta Therapeutics, Gets $48.5M (Forbes)
  • Merck's pharma unit faces tougher 2017 as fertility boost recedes (PMLive)
  • BMS, Enterome Launch Microbiome Immuno-Oncology Collaboration (GEN)
  • Novel Machine-Learning Tool Opens Door to Improved Cancer Therapies (GEN)
  • 2017 California Life Sciences Industry Report (San Diego Union Tribune) (Report)
  • BIO’s Amicus Brief for In re Aqua Products, Inc. (Patent Docs)
  • GSK vet Jason Gardner takes the helm of Magenta, emerging from stealth with a $48.5M round (Endpoints)
  • J&J awards $1.5 million to QuickFire Challenge winners (MedCity News)
  • Led by Former Lilly Exec, Apexian Out to Tackle Pancreatic Cancer (Xconomy)
  • Continuing progress and promise in pediatric drug development (PhRMA)
  • Pharma prepping for US track and trace (In-PharmaTechnologist)
  • Promising outlook for pediatric drug development, US study shows (PharmaLetter-$)

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

  • Generic heart failure drug costs too high for many uninsured: study (Reuters)
  • CSL heart attack drug hits on safety, misses efficacy in PhIIb (FierceBiotech)
  • Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients (JAMA)
  • With New Data, Medicines Co. Takes Long-Lasting Heart Drug to Phase 3 (Xconomy)
  • Past depression tied to worse breast cancer survival odds (Reuters)
  • Genexine Granted FDA Orphan Drug Designation for GX-H9 in Growth Hormone Deficiency (Press)
  • Updated Phase III Results Reinforce Safety and Efficacy of Praxbind (idarucizumab) in Urgent Situations (Press)

Medical Devices

  • Hospitals look for ways to limit role of medical device salespeople in the operating room (MedCity News)
  • Health Technology And Human Touch Need Not Be At Odds (Health Affairs)
  • Report: EU regulators poised to OK Abbott’s $25B St. Jude Medical acquisition (Mass Device)
  • Abbott, Alere Report Records Deal But Merger Issues Linger (Law360-$)
  • Antimicrobial Resistance Concerns Leach into FDA's Classification of Wound Dressings Containing Drugs (MDDI)
  • Zimmer Biomet touts preliminary data for stem cell therapy (Drug Delivery)
  • Zimmer Wants 142 Knee Cases Without Expert Reports Cut (Law360-$)
  • Handheld breathalyzer as noninvasive blood glucose monitor in development (Drug Delivery)
  • Mount Sinai raises surgical robotics game (MedCity News)
  • CellMax Life Announces Genetic Cancer Risk Test for 98 Genes, 24 Hereditary Cancers (Press)
  • Theranos CEO Elizabeth Holmes is a victim, venture capitalist Tim Draper says (CNBC)
  • Galeo Pro Coronary Guidewire Recall (Health Canada)

US: Assorted and Government

  • Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017 (CMS in Federal Register)
  • Trump’s path on health law intersects with lawsuit (AP)
  • Will “Repeal and Delay” be the next “Doc fix”? (Incidental Economist)
  • Expect Medicaid to Change but not Shrivel Under Trump (NY Times-$)
  • On Republicans’ Path to Health-Law Repeal, Questions Emerge (WSJ-$)
  • Republican ACA Repeal Bill Would Unravel the Market Even Before It Goes into Effect (Center for American Progress)
  • Why Republicans Must Repeal Obamacare’s ‘Pre-existing Conditions’ Provisions (National Review)
  • VA HCV Cures Skyrocket (MedPage Today)
  • HIMSS says federal government needs a national chief information security officer (Modern Healthcare)
  • House Passes Two Capps Bills (Press)
  • Fed. Circ. Says PTAB Wrongly Invalidated Surgical Patent (Law360-$)

Upcoming Meetings and Events               

Asia                                                                                              

  • Thailand finds 33 new cases of Zika, says health ministry (Reuters)
  • TGA stakeholder survey 2016 (TGA)
  • 4th Joint Conference of Taiwan and Japan on Medical Products Regulation (PMDA)

General Health and Other Interesting Articles

  • America’s Drug Problem (Nature)
  • One Employer Fights Against Prescription-Drug Abuse (WSJ-$)
  • The WHO has stumbled in its response to emergencies. Can this man get the next one right? (Stat)
  • DC lawmakers approve death-with-dignity measure (Reuters)
  • Across Texas, growing clusters of unvaccinated children (Kaiser Health News)
  • Expect more bird flu cases in Europe and in the U.S., OIE says (Reuters)
  • Public Health Officials See Flu Pandemic As Greatest Disease Threat (WSJ-$)

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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