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Recon: Sanofi, Translate Bio Partner on mRNA Vaccines

Posted 11 June 2018 | By Ana Mulero 

Recon: Sanofi, Translate Bio Partner on mRNA Vaccines

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • Pharma giants like Novartis, Pfizer, and Sanofi are getting serious about a cutting edge therapy that changes human genes (Business Insider)
  • Is new generic competition enough to lower drug costs? (PwC)
  • The 'Right To Try Act': Another Compliance Requirement For Pharma And Biotech Companies (Forbes)
  • Doctors are coming around to Teva's Austedo as TD drugs get more play: analyst (Fierce)
  • LabCorp makes another acquisition to expand its drug development services (Triad Business Journal-$) (Press)
  • Drug pricing advocates take aim at Democrats for supporting pharma (STAT-$)
  • AbbVie is reprimanded by the FDA for failing to properly probe death complaints (STAT-$)
  • What’s in a tweet? Sanofi's viral Roseanne retort draws kudos, followers and flak (Fierce)
  • Tumor Biology Study Suggests Promising New Route to Cancer Drug Development (GEN)
  • Amryt Pharma: Realizing Rare Disease Treatments (PharmExec)
  • US Maps Strategy to Reform Drug Pricing (PharmExec)
  • Argentum Pharma wins patent invalidation trial against Valeant's Jublia (Pharmabiz) (Press)
  • KLARITOS Develops Assurance-Based Managed Care Model to Address Critical Inefficiencies in Specialty Drug Spending (Press)
  • WuXi AppTec Leads Strategic Investment in Insilico Medicine to Accelerate Drug Discovery Using Next-Generation Artificial Intelligence (Press)
  • Court Issues Decision in Favor of Eagle Pharmaceuticals Granting Seven Year Orphan Drug Exclusivity for BENDEKA (bendamustine hydrochloride injection) (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • A serious new hurdle for CRISPR: Edited cells might cause cancer, find two studies (STAT)
  • Allergan oral migraine drug succeeds in study (Reuters)
  • Rise in U.S. suicides highlights need for new depression drugs (Reuters)
  • FDA clears Investigational New Drug applications for Arcus Biosciences’ advanced product candidates (News Medical) (Press)
  • FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS (carfilzomib) Label (Press)
  • Tetraphase Pharmaceuticals Announces Data from a Pooled Analysis of IGNITE1 and IGNITE4 Phase 3 Trials Evaluating Eravacycline in Complicated Intra-Abdominal Infections at the ASM Microbe 2018 Annual Meeting (Press)
Medical Devices
  • RSP raises $7.7M for its noninvasive laser glucose monitor (Fierce)
  • Brain-machine interface startup Paradromics raises cash to treat disabilities (Fierce)
  • The Apple Watch just got a lot better at tracking symptoms of Parkinson's Disease (CNBC)
  • Diabetes 'technological wave' has too much upside to ignore: JP Morgan (CNBC)
  • Noble aims to put patients at ease with auto-injector training devices (DDBN)
  • Glooko launches next-gen Diabetes web analytics platform (DDBN)
  • US FDA grants 510(k) clearance to Centinel Spine's of FLX Platform of 3D printed all-titanium interbody devices (Pharmabiz) (Press)
  • False-Negative Test Results Put Severe Influenza Patients at Serious Risk (GEN)
  • Blood Tests Developed That Identify Women at Risk of Preterm Birth (GEN)
  • Off-the-Shelf Genome Engineering (GEN)
  • Roche introduces first self-testing device for Warfarin monitoring with built in Bluetooth technology (Press)
  • Optovue Receives FDA Clearance for AngioAnalytics – the World’s First OCT Angiography Metric (Press)
  • OrthoSensor, Inc. Secures Additional 510(K) Clearance (Press)
US: Assorted & Government
  • FDA Narrows Interpretation of “Same Product as Another Product” under PDUFA VI; 505(b)(2) Applicants Will Primarily be Affected (FDA Law Blog)
  • KKR is buying Envision Healthcare in a nearly $10B deal (AP News)
  • US pulls 2 more from Cuba amid new potential health cases (AP News)
  • How moderate Republicans disappeared from health policy (Axios)
  • Fed up with rising costs, big U.S. firms dig into healthcare (Reuters)
  • CDC warns residents in eight U.S. states of cut-fruit Salmonella outbreak (Reuters)
  • How early retail health clinics set the stage for today’s mega-mergers (STAT)
  • Trump administration shifted positions in a lawsuit against Affordable Care Act. It wasn’t first legal about-face. (WSJ)
  • Lawmakers reach deal on bill to crack down on synthetic opioid imports (The Hill)
  • Trump’s latest health care move squeezes Republicans (Politico)
  • In the Trump Administration, Science Is Unwelcome. So Is Advice. (NYT)
  • Theranos Wants Investor Fraud Settlement, But Only on Its Terms (Bloomberg)
  • Amazon Could Still Disrupt The Prescription Drug Market (Forbes)
Upcoming Meetings & Events Europe
  • EMA moves forward with Amsterdam relocation (BioPharma Dive)
  • Wound care giant Acelity buys U.K.’s Crawford Healthcare for undisclosed price (Fierce)
  • Pharma industry seeks early EU-UK drugs agreement (Financial Times)
  • Huddersfield Uni launches pharma policy and practice research centre (PharmaTimes)
  • French emergency room tests virtual reality path to pain relief (Reuters)
  • Celgene Korea gets 3 more indications for Revlimid (Korea Biomedical Review)
  • AI team at Insilico gets some major league backing from China as Alex Zhavoronkov builds global network (Endpoints)
  • Corindus Vascular receives Japanese marketing approval for CorPath GRX System (Pharmabiz)
  • Why are Indian Pharma Companies and Medicines in High Demand in China (EurAsian Times)
  • China introduces sweeping reforms to crack down on academic misconduct (Nature)
  • LivaNova’s Perceval Sutureless Aortic Heart Valve Approved in Japan (Press)
  • Zecotek's Working Closely With European Healthcare OEM as It Prepares to Open Its LFS Crystal Manufacturing Facility (Press)
  • India shares rise as Sun Pharma paces gains among drug makers (Nikkei Asian Review)
  • Cipla targets $1-billion revenues from domestic market in FY19 (Economic Times)
  • Bankruptcy court admits lenders insolvency plea against Sterling Biotech (Economic Times)
  • How decline in new product launches is impacting Indian pharma industry (Business Today)
  • Pharmaceutical industry records double-digit growth after 17 months (Times of India)
  • India is making steady progress in healthcare, says UNICEF’s Yasmin Ali (Hindustan Times)
  • Australian scientists design sensors for wearable medical devices (Verdict Medical Devices)
  • Health minister 'appalled' at evidence against surgeon Emil Gayed (The Guardian)
  • Dying refugee on Nauru barred from coming to Australia for palliative care (The Guardian)
  • Medical Ethics' sheep pain control technology readied for use in humans (The Australian Financial Review)
  • Gilead Sciences’ Chief Scientific Officer John McHutchison Appointed Officer of the Order of Australia (Press)
  • Winners and losers in the plan to equalize access to medication (CBC News)
  • Bioness Announces First Canadian Implants of StimRouter Neuromodulation System at Women's College Hospital (Press)
General Health & Other Interesting Articles
  • Made-to-order molecules could nix nicotine cravings (Nature)
  • Doctors need patients to keep their appointments. Uber and Lyft want to help make that happen (CNBC)
  • Drones are helping researchers figure out what viruses live in whales. Some are similar to ones in humans (STAT)
  • Why Didn't My Drug-Affected Family Get Any Sympathy? (Politico)
  • After Celebrity Deaths, Suicide Hotline Calls Jump 25% (WSJ)
  • Month Six Of My DNA Diet Experiment With Arivale (Forbes)

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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