Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Baxalta's Vonvendi to Treat Willebrand Disease (9 December 2015)

Regulatory Recon: FDA Approves Baxalta's Vonvendi to Treat Willebrand Disease (9 December 2015)

Posted 09 December 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Baxalta's Vonvendi to Treat Willebrand Disease (9 December 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA approves first recombinant von Willebrand factor to treat bleeding episodes (FDA) (Reuters)
  • Trial for Bayer's Xarelto under scrutiny over defective device (Reuters) (Focus)
  • More Concerns Raised About Possible Risks Of New Heart Failure Drug (CardioBrief)
  • USFDA issues import alert against medicines made by Pan Drugs (Economic Times)
  • How Pfizer Set the Cost of Its New Drug at $9,850 a Month (WSJ-$)
  • How an obscure law brought us nasal flu spray — and new conflicts of interest (STAT)

In Focus: International

  • New Requirements Impacting European Notified Bodies' Lead Times (Emergo)
  • China Issues Rules Banning Dishonesty in Science Publishing (DD&D)
  • India Looks to Increase Generic Drug Exports to Africa (VOA)
  • "Harmonization…but also Innovation" – 11th DIA MERC Biannual Meeting (Thomson Reuters)
  •  Dr Reddy's submits response to USFDA over warning letter (Economic Times)
  • Japan Shoots For 'Zero' Device Lag With Review Time Targets (Clinica-$)

US: Pharmaceuticals and Biotechnology

  • Tastes Like Chicken: Second "BioPharm" Animal Approved to Produce Biological to Treat Orphan Disease (FDA Law Blog)
  • Pre-ANDA Meeting Goals May Be Created In GDUFA II (Pink Sheet-$)
  • Resistance to last-resort antibiotic has now spread across globe (New Scientist)
  • Turing Lengthy Letter Harangues Express Scripts/Imprimis Deal (SCRIP-$)
  • Setting The Pace In The Race To Treat NASH (LifeSciVC)
  • Orphan Drugs Under Fire: Recent Reports Reject Call for Additive Exclusivity & Urge Orphan Drug Act Reforms (FDA Law Blog) (Focus)
  • FDA Committee: Is Novel Anti-IL-5 Safe in Asthma? (MedpageToday)
  • Pharmaceutical industry increases investment in neglected tropical diseases by 28% (PhRMA)
  • Venetoclax Is A Powerful New Kind of Cancer Drug (Forbes)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Sandoz sets out Neulasta biosim plan after Ph III data brings US approval a step closer (BioPharma-Reporter)
  • Galapagos' inflammation drug comes through in Crohn's with Phase III in sight (FierceBiotech) (Press)
  • MGB Biopharma completes Phase I trial of MGB-BP-3 (EPR)
  • Antidepressant with novel action appears safe and effective in phase 1b clinical trial (MNT)
  • Chi-Med starts Phase III NSCLC trial of fruquintinib (BioCentury)
  • Galapagos' filgotinib clears Phase II Crohn's hurdle (BioCentury)
  • New CLL data presented for Zydelig, venetoclax (BioCentury)
  • Pfizer Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for XALKORI (crizotinib) for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer (Press)
  • New Phase III study of nintedanib in people with systemic sclerosis and lung fibrosis (Press)
  • Lilly's Type 2 Diabetes Candidate Succeeds in Phase 3 Trial (DD&D)
  • ARMGO Pharma Receives FDA Orphan Drug Designation and Rare Pediatric Disease Designation for ARM210/S48168 for the Treatment of Duchenne Muscular Dystrophy (Press)
  • Ocular Therapeutix™ Announces FDA Acceptance of NDA Filing for DEXTENZA™ for the Treatment of Post-Surgical Ocular Pain (Press)

US: Medical Devices

  • FDA allows marketing of cooling cap to reduce hair loss during chemotherapy (FDA)
  • Top gynecologists oppose FDA advice on morcellators (The Inquirer)
  • Upstart wins CE mark for first swallowable weight-loss gastric balloon (FierceMedicalDevices)
  • FDA Extends Comment Period on Next Generation Sequencing Workshop (Federal Register)
  • Medtronic Announces FDA Approval for the Only Full-Body MR Conditional Deep Brain Stimulation Systems (Press)
  • DSM Receives FDA 510k Clearance for Dyneema Purity® Radiopaque Cerclage Cable for Use in Orthopedic Trauma (Press)
  • SciBase Submits Application for Pre-Market Approval to FDA (Press)
  • Stimwave Receives FDA Clearance and Launches Commercialization for World's Smallest Fully-Programmable, Eight-Electrode Wireless Pain Relief SCS System (Press)

US: Assorted and Government

  • Spiracur to pay $3m to settle VA kickbacks case (MassDevice)
  • A New Year Filled With Debate Over Drug Pricing, PwC Predicts (Pink Sheet-$)
  • Could Washington's 2016 Actions Mean Upheaval For Biopharma? (SCRIP-$)
  • Handling Drug Price Spikes: A Sad Place To Be (SCRIP-$)
  • Takeda, AstraZeneca Sue Apotex Over Generic COPD Drug (Law360-$)
  • US CDC replaces lab director after pathogen incidents (Reuters)
  • South Carolina State Senator Submits 'Right to Try' Bill (Tenth Amendment Center)

Upcoming Meetings and Events              


  • EMA grants Orphan Drug Designation for Debio 1143 (EPR)
  • Cancer and MS drugs approved in Scotland (Pharmafile)
  • Can EU Member States Solve the Affordability Crisis Together? (SCRIP-$)
  • EU Notified Body Association Seeks New Head (Clinica-$)
  • The challenges of marketing to Russia's doctors (PharmaPhorum)
  • Janssen submits Stelara for EU approval for Crohn' (Pharmafile)


  • Government looking into SME drug firms' request on barcoding (Economic Times)
  • Separate ministry for pharma in next one year (Economic Times)
  • Chennai floods hit small drug factories, blow to US exports (Economic Times)
  • Health ministry notifies 5 NIB scientists as government analysts (PharmaBiz)

Other International                   

  • Malaria deaths drop below half a million, Africa makes progress (Reuters) (WHO)

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? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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