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Regulatory Focus™ > News Articles > 3 > Recon: Sanofi and Regeneron Find Success in Major Cholesterol Trial

Recon: Sanofi and Regeneron Find Success in Major Cholesterol Trial

Posted 12 March 2018 | By Ana Mulero 

Recon: Sanofi and Regeneron Find Success in Major Cholesterol Trial

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

In Focus: US In Focus: International
  • WHO enlists “Disease X’’ among most dangerous epidemics (New Telegraph) (Fox News) (The Telegraph) (Newsweek) (New York Post)
  • Commencement of operational phase of the EU – US mutual recognition agreement on inspection of manufacturers of medicines (HPRA)
  • Anvisa and lack of medicines for rare diseases (ANVISA)
  • Capacita-Visa announces course calendar for 2018 (ANVISA)
  • Brexit: New delays at UK borders could endanger time-sensitive transplant operations, MPs and MEPs warn (The Independent)
  • How an inconspicuous slaughterhouse keeps the world’s premature babies alive (STAT)
  • Mexico reports two outbreaks of highly pathogenic H7N3 bird flu: OIE (Reuters)
  • Coalition calls on US and Korea Trade Negotiators to prioritize public health over pharma corporations in trade negotiations (KEI)
  • Swissmedic Journal (Swissmedic)
Pharmaceuticals & Biotechnology
  • A costly PBM trick: set lower copays for expensive brand-name drugs than for generics (STAT)
  • Busy Sanofi takes a pass on one of Alnylam’s rare disease drugs, FDA offers ‘breakthrough’ status for PhIII (Endpoints News) (Fierce)
  • Impax faces U.S. antitrust trial over generic acne drug's delay (Reuters)
  • OGD Dashboard Sheds Current Light on Workload (Lachman Consultants) (FDA)
  • The first target on drug prices: pharmacy benefit managers (Axios)
  • Cantrell Drug, FDA Reach Settlement (Arkansas Business)
  • Biotech CEOs talk a lot. Here’s how to spot the red flags in what they’re saying (STAT-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Balancing Safety and Innovation for Cell-Based Regenerative Medicine (NEJM)
  • J&J's CANVAS study positive, pitting Invokana against Jardiance (Biopharma Dive) (Fierce) (Press)
  • Lantheus Presents New Data on Novel Cardiac PET Imaging Agent LMI 1195 in Development for the Diagnostic Assessment of Ischemic Heart Failure Patients at Risk for Sudden Cardiac Death at ACC.18 (Press)
  • Sarepta Says FDA Welcomes Review Of New Muscular Dystrophy Drug (Forbes) (STAT) (Endpoints News) (Boston Business Journal-$)
  • Apixaban Has Edge Over Other NOACs in Large, Real-World Analysis (TCTMD) (Press)
  • Despite crowded I/O field, pharma, VCs still eager to invest (Biopharma Dive)
  • ACC: AstraZeneca unveils more SGLT2 heart benefits with latest batch of real-world data (Fierce)
  • ACC: AstraZeneca's clot-busting Brilinta matches Plavix safety in high-risk heart attack patients (Fierce)
  • Newer gout drug poses risk to heart patients (Reuters)
  • Savara abandons drug behind last year’s reverse merger with Mast (Fierce)
  • Realm scraps eye drug after midphase flop, sinking stock (Fierce) (Press)
  • Covance forms dedicated immunology and immunotoxicology team for biologics (Fierce) (Press)
  • Anthera to explore options after lead drug's trial failure (Reuters)
  • CRISPR helps find new genetic suspects behind ALS/FTD (NIH)
  • Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data (Journal of Clinical Epidemiology)
  • Increased reporting of fatal immune checkpoint inhibitor-associated myocarditis (The Lancet)
Medical Devices
  • Abbott Unit Covered By Patent Safe Harbor, Magistrate Says (Law360-$) (MassDevice)
  • New Heart Pump Cuts Stroke, Blood Clot Risk (Newsmax) (MassDevice)  (Press)
  • Canon Medical Systems Introduces New Version of its Aplio i900 Premium Cardiovascular Ultrasound (Press)
  • SightLife Surgical to acquire AcuFocus Kamra corneal inlay (MassDevice)
  • mSTOPS: Wearable Patch ECG Detects More AF Than Routine Care (Medscape) (Press)
  • Medtronic wins FDA nod for connected, predictive CGM system (Drug Delivery Business News) (Press)
  • Applications Now Open for the 2018 Medtronic Global Champions Team (Press)
  • Medtronic’s CoreValve TAVR shows improved outcomes in a pair of studies (Fierce) (Press)
  • VA Secretary Announces VA Open Application Programming Interface Pledge (Health Data Management)  (Press)
  • Neurovascular Embolization Coils and the Potential for Increased Image Artifact When Using Magnetic Resonance Angiography for Follow-Up - Letter to Health Care Providers (FDA)
  • Laborie Medical to pay $214m for Cogentix (MassDevice)
US: Assorted & Government
  • Proprietary Names for New Animal Drugs; Draft Guidance for Industry; Availability (FDA)
  • Insurers Gobble Doctor Practices To Bolster Medicare Advantage Plans (Forbes)
  • Updated 'right-to-try' bill teed up for House vote (Politico) (Focus) (WSJ) (The Hill)
  • Medicaid Expansion Via Ballot Measure Gains Momentum In Red States (Forbes)
  • PDX Aromatics Recalls Kratom Powder Because Of Possible Health Risk (FDA)
  • Civil Lawsuits as a Public Health Strategy: Can Cases Brought by Injured Plaintiffs have a Broader Effect? (The Niche)
  • America’s “NICE”? (Health Affairs)
  • Proposed Reforms To The 340B Drug Discount Program (Health Affairs)
  • Big Health-Care Players Are Turning Their Partners Into Prey (Bloomberg)
Upcoming Meetings & Events Europe
  • European Pharmacopoeia Reference Standards recently released (EDQM)
  • Llanelli vinyl vendor jailed for selling illegal cancer drugs across the EU (MHRA)
  • MRC secures £40million for new UK Dementia Research Institute (UK DRI) building (Medical Research Council)
  • EU industrial policy strategy: Council adopts conclusions (EC)
  • Top 8 Healthcare Predictions For Asia (Forbes)
  • Blockchain-Healthcare Start-Up Patientory Showcases In KIMES 2018 (Press)
  • Nova Pharma debuts on LEAP (Malaysian Reserve)
  • India to create new essential list to improve access to life-saving diagnostic tests (The Economic Times)
  • Fortis row: Regulator who said hospitals inflated drug prices transferred (Business Standard)
  • 'Rare diseases' remain common in India: Government must provide push for research and screening (Firstpost)
  • CSIR authorises private path lab for genetic tests (The Economic Times)
  • NPPA chief transfer not unusual after a two-year term: Junior minister (Hindustan Times)
  • Scientists at India’s government labs struggle to adjust to changing priorities (c&en)
Australia Canada
  • Government of Canada supporting innovative health research at the University of Regina (Press)
  • Health Canada Warns Women Not To Take Chipped Birth Control Pills (Huffpost)
  • Pivot Pharma Retains Cannabis Compliance to File Dealer’s License Application on Behalf of Agro-Biotech Inc. (Press)
General Health & Other Interesting Articles
  • In The War Against High Drug Prices, Some Patients Are Collateral Damage (Forbes)
  • Barbershop study trimmed black men’s hair and blood pressure (AP News)
  • Do Antidepressants Work? (NYT)
  • Five Years Ago, Fentanyl Was An Obscure Hospital Drug. Here’s How It Completely Took Over The US Illicit Drug Market. (BuzzFeed News)
  • Amazon, JPMorgan, Berkshire Hathaway have healthcare CEO in mind: Dr. Cosgrove (Fox News)
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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