Regulatory Recon: Alexion Nabs Priority Review Voucher, FDA Approves Adynovate for Hemophelia A (16 November 2015)

Posted 16 November 2015 | By Michael Mezher 

Regulatory Recon: Alexion Nabs Priority Review Voucher, FDA Approves Adynovate for Hemophelia A (16 November 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 modified antihemophilic factor for hemophilia A (FDA)
  • Questions for President Obama’s Nominee to lead the FDA (NYTimes)
  • Lawmakers, Candidates Target High Drug Prices (WSJ-$)
  • Clovis slumps after FDA asks for more data on lung cancer drug (Reuters)
  • FDA Issues Priority Review Voucher for Alexion's Strensiq (FDA)
  • How to Decrease Prices for an Expensive Class of Drugs (NYTimes)
  • FDA Says It Is Changing Its Cybersecurity Culture, And Others Should Too (Gray Sheet-$)
  • Genetic Testing, Genome Sequencing, and the FDA (National Law Review)

In Focus: International

  • WHO warns of widespread misunderstanding of superbug threat (Reuters) (PharmaPhorum) (WHO)
  • Why Your NDA Does Not Work For China (Forbes)
  • Guinea Releases Last 68 From Ebola Quarantine, No Confirmed Cases in 17 Days (Reuters) (Bloomberg)
  • The Debate Is On: To Deworm Or Not To Deworm? (NPR)
  • Incepta Vaccine Ambitions Bridled By Bangladesh Regulatory Gap (SCRIP-$)

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US: Pharmaceuticals and Biotechnology

  • U.S. drug benefit managers clamp down on specialty pharmacies (Reuters)
  • PDUFA VI Might Adjust Establishment Fees; FDA Aims For Simplification (Tan Sheet-$)
  • Bacterial Molecules Transformed into Novel Potential Drugs (GEN)
  • Pfizer’s Xeljanz Squeezes Into ACR Treatment Guidelines For First Time (Pink Sheet-$)
  • Breakthrough Requests: FDA Adds Quick Screen To Pare Workload (Pink Sheet-$)
  • Broad Range Of Classes In Late-Stage Antibiotics Pipeline (Pink Sheet-$)
  • No new safety concerns found in Ofev, study reveals (PharmaLetter-$)
  • If You Think Approval Is Hard, Try Selling A New Antibiotic (Pink Sheet-$)
  • FDA Adverse Event Data Clouds Potential Fluoroquinolone Label Changes (Pink Sheet-$)
  • FDA Biosimilar Naming Proposal Pits Providers, Patients Against Insurers, Pharmacies (Pink Sheet-$) (Focus)
  • Clinical Trial Data Sharing: Central Public-Private Portal May Expand Access (Pink Sheet-$)
  • Pfizer Recalls Lot of Anxiety Drug (PharmPro)

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

  • Merck's massive cardio study keeps rolling as fallen rivals pile up (FierceBiotech) (SCRIP-$)
  • Auven Therapeutics pits rival PhIII dry eye drug against Allergan, Shire (FierceBiotech)
  • Gene therapy: A promising candidate for cystic fibrosis treatment (Press)
  • GENFIT Announces Pivotal Phase 3 Clinical Trial of Elafibranor in NASH Following Regulatory Input (Press)
  • Baxalta to Advance Care for Hemophilia A Patients with FDA Approval of ADYNOVATE, a Simple, Twice-weekly Treatment to Reduce Bleeds (Press)
  • Genfit could bring NASH liver disease treatment to market in 2019 (Reuters)
  • Imbruvica Phase III combination data submitted to the FDA (EPR)

US: Medical Devices

  • NYS DOH Approves Cancer Exome Sequencing Tests from Columbia U, Weill Cornell Medicine (GenomeWeb)
  • FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors (FDA) (Focus)
  • In-Person Ways to Avoid Form 483 Observations and Warning Letters (MDDI)
  • FDA: Class 1 recall of Hamilton Medical G5 Ventilators (MassDevice) (FDA)
  • Class 1 Device Recall RotaWire Elite and sireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy (FDA 1,2)
  • One-step test for hepatitis C virus infection developed by UC Irvine Health researchers (MNT)
  • AirXpanders seeks de novo FDA nod for AeroForm (MassDevice)
  • Philips Launches Wearable Diagnostic Device To Combat Children's Pneumonia  (MedDeviceOnline)
  • Spectranetics wins 510(k) clearance for laser atherectomy cath (MassDevice)
  • Infection-detecting dressing improves treatment of burns patients (OnMedica)

US: Assorted and Government

  • Letter to the Editor: Don’t Pit the Healthy Against the Sick (NYTimes)
  • Fed. Circ. Incentivizes Offshore Generic Drug Testing (Law360-$)
  • Pharmaceutical Pricing -- Let's Debate the Facts (DrugWonks)
  • Drug makers beat diabetes lawsuits with an unusual ruling (Pharmalot)
  • CAFC decision would allow Cubicin generics in 2016 (BioCentury)
  • FDA Rolls Out More FSMA Rules (FDA Law Blog)
  • FDA is Slow so We FOIA (RxViewBlog)
  • Privileged Docs In Adderall Pay-For-Delay Suit Still Off-Limits (Law360-$)
  • Wyeth Rejects Claim That It Promoted Off-Label Prescribing (Law360-$)

Upcoming Meetings and Events              


  • UK lawyers, medical device makers convene over metal-on-metal hip lawsuits (MassDevice)
  • C-Path’s Polycystic Kidney Disease Outcomes Consortium Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD (Press)
  • Antibiotic prescribing continues to spiral (OnMedica)
  • Swissmedic approves Xadago for use in Parkinson’s disease (PharmaLetter-$)


  • MP govt plans to permit Ayush doctors to prescribe allopathic medicines in rural areas (PharmaBiz)
  • Delhi Pharmacy Council may cancel registrations of 12,000 pharmacists for non-renewals (PharmaBiz)
  • Make in India boost: Government to incentivise companies to produce bulk drugs likely (Economic Times)
  • Pharma companies like Medtronic and Dr Reddy’s innovate with financing schemes for cheaper treatment (Economic Times)
  • Shasun Pharma gets US FDA nod to market Carisoprodol (Economic Times)


  • Taiho files for Japanese approval of TAC-202 (bilastine) (PharmaLetter-$)


  • Amendments to the regulatory framework for in vitro diagnostic medical devices (IVDs) (TGA)
  • Review of cardiovascular safety of non-steroidal anti-inflammatory drugs and Safety review of diclofenac (TGA)
  • OTC business process improvements (TGA)
  • Primordial goo used to improve implants (Press)

Other International

  • Building Defences Against Future Ebola Outbreaks (PharmaAfrica)
  • Baxalta Singapore Facility Receives FDA Approval, Strengthening Company Leadership in Providing Reliable Supply to Hemophilia Patients (Press)

General Health and Other Interesting Articles

  • Child with drug-resistant TB successfully treated at Johns Hopkins Children's Center (Press)

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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