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

• 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• FDA Publishes Final Rule and Draft Guidance on Acceptance of Clinical Data to Support Medical Device Applications and Submissions (FDA Law Blog)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)

• Drug That Promises to Kill Flu in a Day Approved in Japan (The Wall Street Journal) (Endpoints)
• Zika’s Never Ending Emergency (Hopkins Bloomberg Public Health)
• Fujifilm to spend four billion yen on manufacturing facility (PharmaLetter-$)
• Sun Pharma gets 3 observations from US FDA for Halol plant (The Economic Times) (Fierce)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• The Opioid Diaries (TIME)
• Our Other Prescription Drug Problem (NEJM)