Regulatory Focus™ > News Articles > 2 > Recon: Japan Approves New Flu Drug; Form 483 for Sun Pharma Plant

Recon: Japan Approves New Flu Drug; Form 483 for Sun Pharma Plant

Posted 23 February 2018 | By Ana Mulero 

Recon: Japan Approves New Flu Drug; Form 483 for Sun Pharma Plant

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

In Focus: US
  • Rituxan Patent Survives Celltrion, Pfizer PTAB Challenges (Law360-$)
  • FDA Publishes Final Rule and Draft Guidance on Acceptance of Clinical Data to Support Medical Device Applications and Submissions (FDA Law Blog)
  • Judget asks to seize Shkreli assets (AP)
  • Teva shutters New York, D.C. offices and dismisses lobbyists as part of U.S. consolidation drive (Fierce)
  • Public Workshop - Patient Engagement in the National Evaluation System for health Technology (NEST): Lessons Learned and Best Practices Workshop Announcement, March 22, 2018 (FDA)
  • Gilead loses its head of commercial ops as it takes on daunting sales challenges (Fierce)
In Focus: International Pharmaceuticals & Biotechnology
  • Amazon has quietly launched an exclusive line of over-the-counter health products (CNBC)
  • Deal-hungry Takeda forges another R&D alliance (FierceBiotech)
  • Chutes & Ladders—Pfizer’s early clinical head lands as Magenta CMO (Fierce)
  • LYNPARZA Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer (Press)
  • Vertex Pharmaceuticals Launches Triple Combo Cystic Fibrosis Clinical Trial Earlier than Expected (BioSpace)
  • Snippet roundup: A Pacific use for Imfinzi but Crispr gets the Zinc finger (EP Vantage)
  • Pfizer might buy BMS for $130bn – but should it? (pharmaphorum)
  • Puma Biotechnology Receives Results of CHMP Formal Decision for Neratinib for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer (Press) (Reuters)
  • Horizon Pharma Fired Aegerion's FCA Whistleblower: Suit (Law360)
  • Novo Nordisk secures Ozempic formulary coverage from Express Scripts (FiercePharma)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Impact of target interactions on small-molecule drug disposition: an overlooked area (Nature Reviews Drugs Discover)
  • Mesoblast preps first filings for GVHD drug after phase 3 win (Fierce)
  • FDA Acceptance of Medicines360's Filing for supplemental New Drug Application for LILETTA 52 mg (Press)
  • Acorda Announces FDA Acceptance of New Drug Application for INBRIJA (Press)
  • GeneTx Biotherapeutics launches to take on Angelman syndrome (FierceBiotech)
  • IDx-DR Achieves Endpoints in Pivotal FDA Trial of AI-based Diabetic Retinopathy Diagnostic Solution (Press)
  • Bellicum Announces Update on Clinical Hold of U.S. BPX-501 Studies (Press)
Medical Devices
  • March 21-22, 2018: Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 4th Circ. Resurrects Medical Device Co. Investor Suit (Law360-$)
  • Apollo Endosurgery Announces MFDS Approval for the ORBERA Intragastric Balloon System in South Korea, a Non-Surgical Solution to Assist Patients with Weight Loss (Press)
  • Paragonix Technologies, Inc., Announces European Conformity for the SherpaPak Cardiac Transport System and SherpaPerfusionCardiac Transport System (Press)
  • Access Vascular Receives FDA Clearance For Its HydroPICC Catheter (Press)
  • Endomag’s Magseed Marker Receives FDA Clearance for Long-Term and Soft Tissue Implantation (Press)
  • GE Healthcare and Navicent Health Enter Relationship to Reduce Costs, Improve Patient Care and Target $150 Million in Savings over Six Years (Press)
  • Alfa Scientific Designs, Inc. Announces First US FDA 510(k) Clearance for Its Driven Flow Technology Product, the Instant-view-plus Immunochemical Fecal Occult Blood Test (Press)
  • Getinge announces U.S. Food and Drug Administration 510(k) clearance for PulsioFlex Monitoring System and PiCCO Module (Press)
  • VoCare Develops the World's First Mobile Professional Grade Medical Multi-Diagnostic Device, Which Provides a Revolutionary Integrated Mobile Point-of-Care Solution as Well as a Remote Patient Monitoring Solution (Press)
  • Cedars-Sinai and Emulate Advance Precision Medicine With Organs-on-Chips, Stem Cells (Press)
US: Assorted & Government
  • Department of Justice Announces Mary Daly as Opioid Coordinator (DOJ)
  • Former CMS Chiefs Debate Drug Prices (MedPage Today)
  • VA Partners With DeepMind to Build Machine Learning Tools to Identify Health Risks for Veterans (VA) (mobihealthnews)
  • Trump: New HHS chief has already lowered drug prices (Stat News)
Upcoming Meetings & Events Europe
  • Kyowa Kirin and Ultragenyx Announce Crysvita Receives Conditional Marketing Authorisation in Europe for the Treatment of X-Linked Hypophosphatemia in Children (Press)
  • NHS drug errors may be causing up to 22,000 deaths every year (The Telegraph)
  • ‘Exorbitant’ 2,000% margins drive India to mull further device price caps (FierceBiotech)
  • Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
  • Bod Australia gains approval to commence importing medicinal cannabis oil (Small Caps)
  • Health Canada Approves BAVENCIO for the Treatment of Metastatic Merkel Cell Carcinoma in Previously Treated Adult Patients Français (Press)
General Health & Other Interesting Articles
  • The Opioid Diaries (TIME)
  • Our Other Prescription Drug Problem (NEJM)
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, 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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