Regulatory Recon: Alexion to Lay Off More Than 200; FDA Approves Novartis Breast Cancer Treatment (14 March 2017)

Posted 14 March 2017 By Zachary Brennan

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

In Focus: US                                      

  • FDA approves Novartis drug as first-line treatment for breast cancer (Reuters) (PMLive) (FiercePharma) (FDA)
  • Alexion to Eliminate 7% of Workforce (GEN) (FierceBiotech)
  • Senate Confirms Verma to Head CMS (MedPage Today) (Modern Healthcare)
  • FDA Considers New Office of Patient Affairs (Focus)
  • FDA Drafts List of Class II Devices to be Exempt From Premarket Notification (Focus)
  • FDA Extends Comment Period on Biosimilar Interchangeability Draft Guidance to May (Federal Register)
  • Can a Statistical Method Speed Drug Approvals? (MedPage Today)
  • No Magic in How G.O.P. Plan Lowers Premiums: It Penalizes Older People (NY Times-$) (NPR)
  • CBO: Full Repeal Would Cover More People than House GOP’s ObamaCare-Lite Bill (Cato Institute)
  • Medicaid cuts, more uninsured: 3 takeaways from new estimates of the GOP’s health plan (Stat)

In Focus: International

  • EU IVD Regulation: A New Scrutiny System For Diagnostics (MedTech Insight)
  • Sanofi’s dupilumab joins UK’s early access scheme (PharmaTimes) (MHRA)
  • England Says No to Drugs That Cost More Than Your Car (or Home) (Bloomberg)
  • Health Canada aims to release secret drug records (Toronto Star)
  • Canada to Require Drugmakers to Publicly Disclose Shortages (Focus)
  • In a remote West African village, a revolutionary genetic experiment is on its way — if residents agree to it (Stat)
  • $62m injection in Hungary is latest boost for GSK vaccine production (BioPharma-Reporter)
  • If not now, when? Time for the European Union to define a global health strategy (The Lancet)
  • EMA Picks Valproate For First Public Hearing On Safety Of Marketed Medicines (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology

  • Allergan signs deal with Editas for gene-editing-based eye treatments (Reuters) (Xconomy)
  • Vaccine Makers Ranked on Pricing and Research (NY Times-$)
  • AstraZeneca Gives Rejected Drugs a Second Life (WSJ-$)
  • Ackman Sells Valeant Stake After at Least $2.8 Billion Loss (Bloomberg) (Reuters) (WSJ-$)
  • Sanders' next price-fighting tactic? Get the debate on TV screens (FiercePharma)
  • FDA lifts block on Sun Pharma facility (Pharmafile)
  • Pfizer runs away with pharma brand ad-spending crown, Nielsen data shows (FiercePharma)
  • New drug for one in five breast cancers (BBC)
  • CRISPR & Bayer acquire license to cell engineering technology (PharmaLetter-$)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Review of the Drug Trials Snapshots Program of the US Food and Drug Administration (JAMA)
  • One and done: Reasons principal investigators conduct only one FDA-regulated drug trial (Study)
  • US FDA orders Scynexis not to start new trials of injectable antifungal (InPharma-Technologist)
  • ‘Stunning’ gap: Canadians with cystic fibrosis outlive Americans by a decade (Stat) (Reuters) (Study)
  • Hope For Nonaddictive Opioid Painkillers (In the Pipeline)
  • Keeping the Future in Mind: Alzheimer’s Treatments and Bacteria That Can Cure (Scientific American)
  • CV Comparisons Between New and Older Diabetes Drugs Needed (Medscape)
  • Hot and cold? Analysts unpack CRO market expectations (Outsourcing-Pharma)
  • Peloton Therapeutics Completes $22.2 Million Private Financing (Endpoints) (Press)
  • Aurinia Prices US$150.5 Million Public Offering of Common Shares (Press)
  • TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction (Press)

Medical Devices

  • U.S. medtech shares gain as investors seek shelter from drug price debate (Reuters)
  • Autonomic Technologies wins expanded CE Mark for migraine-treating microstim (Mass Device)
  • Vertiflex raises $25m (Mass Device)
  • Cartiva touts 5-year synthetic cartilage study data (Mass Device)
  • Researchers develop sweat-based glucose monitoring & maintenance device (Mass Device)
  • Minimally-invasive migraine treatment for adults works on kids, too (Mass Device)

US: Assorted and Government

  • Charles River Laboratories International Inc. Agrees to Pay US $1.8 Million to Settle False Claims Act Allegations (DOJ)
  • Pharma-Related Probes Could Be Impacted By Departure Of US Attorneys (Pink Sheet-$)
  • FDA Panel Weighs Safety Issues Of Endo Opioid Painkiller (Law360-$)
  • Judge Skeptical Of FDA Fraud In Meningitis Murder Trial (Law360-$)
  • It's a 'bad deal,' Sanders says of U.S. Army's planned Zika vax license to Sanofi (FiercePharma)
  • GAO Issues Report on Qualified Infectious Disease Products (FDA Law Blog)
  • Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Zika Virus (FDA)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Assurance Case (Federal Register)
  • Agency Information Collection Activities; Submission for OMB Review; Comment Request; Focus Groups About Drug Products as Used by the FDA (Federal Register)
  • Submission for OMB Review; Comment Request; Guidance for Industry on Special Protocol Assessment (Federal Register)
  • Submission for OMB Review; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics (Federal Register)
  • Submission for OMB Review; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Federal Register)
  • Submission for OMB Review; Comment Request; Recommended Glossary and Educational Outreach to Support use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use (Federal Register)
  • Submission for OMB Review; Comment Request; Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer from a Disease or Condition That a Device is Intended to Treat, Diagnose, or Cure (Federal Register)
  • Proposed Collection; Comment Request; FDA Safety Communication Readership Survey (Federal Register)
  • Submission for OMB Review; Comment Request; Testing Communications on Medical Devices and
  • Radiation-Emitting Products (Federal Register)
  • Gottlieb to Face User Fees, De-Regulation Pressures (BioPharm International) (Drug Channels) (Pink Sheet-$)
  • FDA Targets Infar over Testing, Records, Sanitation (FDANews-$)
  • Updated final guidance for Industry Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (FDA)

Upcoming Meetings and Events             

Asia

  • No shortage of coronary stents, Indian gov says (Economic Times)
  • Dr. Reddy’s Hit With Form 483 For Records, Testing Issues (FDANews-$)
  • 50% pharma industries still unprepared for second phase of US Drug Supply Chain Security Act (PharmaBiz)
  • BioVentrix launches Revivent TC in China (Mass Device)

General Health and Other Interesting Articles

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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