Regulatory Focus™ > News Articles > 2 > Recon: Sangamo Lands $3B Gene Editing Deal with Gilead; CDC Advisers Say Nasal Flu Vaccine Can Come

Recon: Sangamo Lands $3B Gene Editing Deal with Gilead; CDC Advisers Say Nasal Flu Vaccine Can Come Back

Posted 22 February 2018 | By Ana Mulero 

Recon: Sangamo Lands $3B Gene Editing Deal with Gilead; CDC Advisers Say Nasal Flu Vaccine Can Come Back

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

In Focus: US
  • Sangamo in $3 billion gene-editing deal with Gilead (Reuters) (Xconomy) (Press)
  • Bristol-Myers axes 107 more staffers as it completes an R&D overhaul (Endpoints)
  • Pharma's $50 billion tax windfall for investors (Axios)
  • States Work to Curb Drug Spending (Pew)
  • Middlemen Play Gatekeeper in Battle to Curb Soaring Drug Costs (Bloomberg)
  • The myth of what’s driving the opioid crisis (Politico)
  • 3 Ways FDA can facilitate claims of biosimilar interchangeability (Avalere)
  • FDA clears Access Vascular’s HydroPICC catheter (MassDevice)
  • FluMist nasal flu vaccine can come back, advisers say (NBC News) (BioCentury) (Reuters)
  • FDA Rolling Out Updates to UDI Database in 2018 (Emergo)
In Focus: International
  • ‘It’s breathtaking’: A Chinese biotech CEO weighs in on policy changes remaking China’s FDA (STAT)
  • Australia legislates lower drug prices (BioCentury)
  • Letter of support for intermediate Age Related Macular Degeneration (AMD) biomarker and novel clinical endpoint development (EMA)
  • Statement on medicines and medical devices safety review (UK Parliament)
  • Aquilon Medical Nebulisers: people urged to stop use immediately (MHRA)
  • Richter Expects Esmya Sales To Drop 50% Following EU Restrictions Over Liver Concerns (Scrip-$)
  • EFPIA and ICHOM form a Strategic Alliance Partnership to Foster Commitment to Outcomes Measurement as a Means of Driving Value in Health Care (EFPIA)
Pharmaceuticals & Biotechnology
  • Novo Nordisk prepares to swallow its rivals for breakfast (EP Vantage) (CNBC)
  • Forecasts of genetic fate just got a lot more accurate (MIT Technology Review)
  • Takeda Catches Rising Tide Of Antisense Neuroscience R&D (Scrip-$)
  • Regeneron vision drug Eylea sees upward tick in unexplained side-effect cases (Fierce)
  • Rite Aid's PBM Becomes More Attractive Under Albertsons (Forbes)
  • AMBER Partners with Multi-National Healthcare Company to Create Global 3D Bioprinting Collaborative (Press)
  • Achillion Announces Restructuring to Advance Corporate Strategy; Announces 2017 Fourth Quarter and Full Year Financial Results (Press)
  •  ImmunoCellular Therapeutics Announces Review of Strategic Alternatives (Press)
  • WuXi STA and Regulus Announce microRNA Development and Manufacturing Collaboration (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Bluebird bio details plans to file three blockbusters (pharmaphorum)
  • AbbVie fibroids drug meets Phase 3 endpoint (BioPharma Dive)
  • Cannabis Company GW Pharmaceuticals’ Seizure Drug Flunks Phase II Trial (BioSpace) (EP Vantage)
  • Europe Approves JHL Biotech's Clinical Trial Application for Bevacizumab Biosimilar to Affordably Treat Colorectal, Lung, and Ovarian Cancers (Press)
  • Arrowhead Receives Regulatory Clearance to Begin Phase 1 Study of ARO-AAT for Treatment of Alpha-1 Liver Disease (Press)
  • Daiichi Sankyo Initiates Phase 1 Study of DS-1062 in Patients with Advanced Non-Small Cell Lung Cancer (Press)
  • Xencor Doses First Patient in Phase 1 Study of XmAb 18087 Bispecific Tumor Targeting Antibody for the Treatment of Neuroendocrine Tumors and Gastrointestinal Stromal Tumors (Press)
  • Apellis Pharmaceuticals Announces 18-Month Results of Phase 2 Study (FILLY) of APL-2 in Geographic Atrophy (Press)
Medical Devices
  • Cognoa Hits Major Milestone Towards First AI-Based Autism Diagnostic (Press)
  • FDA Clears GOKnee3D MRI Application from Siemens Healthineers (Press)
  • RenovaCare touts win in patent spat with Avita Medical (MassDevice)
  • B. Braun subsidiary completes acquisition of California firm (The Morning Call)
  • Leaked Nokia memo says no path forward for ‘struggling’ digital health business (The Verge)
  • MiMedx, Fast-Growing Developer of Tissue Graft Products, Didn’t Report Payments to Doctors (The Wall Street Journal)
  • Why you should be 3D printing your medical devices (PlasticsToday)
  • FDA removed 10% of medtech establishments from its registration database: Here’s why (Medical Design & Outsourcing)
US: Assorted & Government
  • US FDA Advisory Cmte. Review Of Charleston's Hydexor Exposes Flaws In Commercial Strategy (Scrip-$)
  • IPAB RIP (Health Affairs)
  • Lawmakers, government target actions, plan hearings to address opioids (S&P Global)
  • Idaho is ignoring Obamacare rules. That could set off a catastrophic chain reaction (Vox)
  • Pew, HIMSS press ONC to modify planned trusted exchange framework to ensure interoperability (HealthcareITNews)
  • Practice Fusion is scrapping free software model after agreeing to sell to Allscripts (CNBC)
  • Philips launches FocusPoint, an intuitive web-based application to help reduce costs and improve operational efficiencies (Press)
Upcoming Meetings & Events Europe
  • Review launched to respond to patient concerns about NHS treatments (UK Gov)
  • Sanofi taps clinical site network in UK partnership (Outsourcing-Pharma)
  • Brain cancer research to receive £45 million funding (UK Gov)
India
  • Health ministry constitutes DTAB sub-committee to re-examine banned 344 FDC drugs (PharmaBiz)
  • NPPA report underscores inadequacy of DPCO in tackling overcharging by hospitals (PharmaBiz)
Australia
  • Australia legislates lower drug prices (BioCentury)
Canada General Health & Other Interesting Articles
  • Benzodiazepines: our other prescription drug epidemic (Stat)
  • How Value-Based Medicare Payments Exacerbate Health Care Disparities (JAMA)
  • Cerner Implements Surescripts Prescription Price Transparency Functionality Within the EHR (Press)
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? Send an email to news@raps.org.
 

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