Regulatory Recon: FDA Approves Dynavax's Hep B Vaccine; BMS' Sprycel Approved for Pediatric Ph+ CML (10 November 2017)

Posted 10 November 2017 By Michael Mezher

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

In Focus: US

  • Dynavax's hepatitis B vaccine gets FDA nod on third try, shares up (Reuters) (Endpoints)
  • Deal would keep Pentagon out of product approvals (Axios)
  • Former FDA Commissioners To Congress: Don't Give Pentagon The Power To Approve Drugs (Politico)
  • Grading Gottlieb: How Attys View FDA Chief's First 6 Months (Law360-$)
  • Heron takes on Merck's Emend with FDA win for antinausea drug Cinvanti (Fierce) (Endpoints)
  • FDA Expands Indication for BMS' Sprycel to Pediatric Patients with Ph+ CML  (Press)
  • Eli Lilly counts up 2,300 early retirements in $500M cost-cutting drive (Fierce)
  • How to speed up drug and vaccine development during a public health crisis (STAT)
  • Carlyle explores sale or IPO of Ortho-Clinical Diagnostics: Sources (CNBC)
  • Johnson & Johnson CEO: Washington needs to work with us for 'smart tax policy' (CNBC)
  • DEA to toughen stance on illicit fentanyl analogues (Reuters) (DoJ)
  • Laws To Control Cancer Drug Costs Don't Help Patients With Highest Expenses (Forbes) (KHN)
  • Expensive specialty drugs are forcing seniors to make hard choices (Washington Post)
  • Pressure Builds To Cut Medicare Patients In On Prescription Deals (KHN)
  • Hospitals and PhRMA face off over drug prices and 340B program (Politico)
  • Vermont probes whether drug makers violated its gift ban (STAT)
  • Opioid abuse crisis takes heavy toll on US veterans (Reuters)
  • Consumers sign up for Obamacare 2018 individual plans despite uncertainty (Reuters)
  • 6 medical innovations that moved from the battlefield to mainstream medicine (STAT)

In Focus: International

  • Drug bingo: EU readies vote for London-based pharma agency (Reuters)
  • Drug sales in Russia steadily grow this year (PharmaLetter-$)
  • Yemen set to run out of fuel and vaccine in a month (Reuters) (WHO)
  • BeiGene Unveils New Cancer Drug Plant With Eye On Affordability (SCRIP-$)
  • NICE backs Merck's Mavenclad for MS (PharmaTimes)
  • Zydus gets regulatory nod to market Lipaglyn in Mexico (Economic Times)
  • NHS England, Roche come to agreement on Perjeta (PharmaTimes)
  • ABPI echoes calls for increased NHS funding (ABPI)

Pharmaceuticals & Biotechnology

  • Forendo Pharma: Tackling The Endometriosis Challenge (SCRIP-$)
  • Insight into 21st Century Cures Implementation (Policy & Medicine)
  • FDA Awards Funding to Support Pediatric Clinical Trials Research (FDA Voice)
  • Sangamo joins biotech migration to Oyster Point with new HQ (Endpoints)
  • BIO Submits Comments Re: USP Drug Classification System, Second Round of Public Comments (BIO)
  • Ex-Shire R&D chief takes charge of immuno-oncology firm (Fierce)
  • Grail vet Bajaj aims for some broad influence with Foresite bucks (Endpoints)
  • South Korea approves Samsung Bioepis' Herceptin biosimilar (Biosimilar News) (Korea Herald)
  • Roivant CEO: Yes, we failed in Alzheimer's, but we're not giving up (Fierce)
  • After months of searching, Immunomedics lines up Celgene vet Pehl as its new CEO (Fierce)
  • Prescription-strength steroid creams sold without prescription (Reuters)
  • Health insurer Anthem eases restrictions on Sarepta's Duchenne treatment (Reuters) (BioCentury)
  • Risk for breast cancer's return can linger for decades (CBS)
  • Drug Spending in 2017: The CEO of Prime Therapeutics Responds to Drug Channels (Press)
  • Alnylam Announces Successful Outcome Following FDA Type A Meeting to Discuss Fitusiran Program in Hemophilia (Press)
  • Aligning top trial sites with sponsors and CROs through performance data transparency (OutsourcingPharma)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Momenta and Mylan reported unexpected results for proposed Orencia biosimilar (Biosimilar News)
  • Bristol-Myers posts early checkpoint combination data on fast-advancing rival to Incyte's IDO1 inhibitor (Fierce) (Endpoints) (Press)
  • IRX Therapeutics Announces Presentation of IRX-2 Phase 1b Biomarker Data in Early Stage Breast Cancer (Press)
  • Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF) (Press)
  • Alexo Therapeutics Presents Preliminary Results from ALX148 Phase 1 Clinical Trial in Patients with Advanced Solid Tumors and Lymphoma (Press)
  • New Data on FORTEO® (teriparatide [rDNA origin] injection) Showed Reduced Risk for New Vertebral and Clinical Fractures in Postmenopausal Women with Severe Osteoporosis (Press)

Medical Devices

  • Interview – Medtronic aims for world's first transcatheter mitral valve approval (EP Vantage)
  • For Brain-Computer Interfaces to Be Useful, They'll Need to Be Wireless (MIT Technology Review)
  • Stryker wins FDA HDE nod or Neuroform Atlas wide-neck aneurysm stent (MassDevice)
  • Johnson & Johnson opens Center for Device Innovation at TMC (MassDevice)
  • Powerdot finally launches FDA-cleared, smartphone-connected e-stim device (MobiHealthNews)
  • Hologic shares steady on Q4, FY2017 earnings beat (MassDevice)
  • LENSAR® Receives FDA Clearance for IntelliAxis™-L - LENSAR Laser System's Novel Toric Intraocular Lens Alignment Guidance (Press)
  • Smart Devices to 'Revolutionize' Treatment, says CPhI Award Winner (MDDI)
  • Designing Connected Medical Devices: Overcoming Key RF Challenges (MDDI)

US: Assorted & Government

  • BIO Submits Comments Re: HHS Draft Strategic Plan FY 2018-2022 (BIO)
  • Endo Cert Bid Calls AGs' Use Of Private Attys Unconstitutional (Law360-$)
  • Bayer Pharma AG v. Watson Laboratories, Inc. (Fed. Cir. 2017) (Patent Docs)
  • No Voluntary Dismissal for Plaintiffs, and a Summary Judgment Win for Defendants, in Central District of California Risperdal Case (Drug & Device Law)
  • Just in time for Halloween, California Retailers Charged with Illegal Sale of Cosmetic Contact Lenses (FDA Law Blog)

Upcoming Meetings & Events

Europe

Asia

Canada

  • The Summary Safety Review - Non-prescription fluconazole - Assessing potential risks to pregnancy outcomes (Health Canada)

Australia

  • TGA presentation: RACGP (GP17) conference, 26-28 October 2017 (TGA)
  • TGA presentation: Notifications to prescription medicines, 10 November 2017 (TGA)

Other International

  • Pfizer, hemophilia society launch disease-awareness app game for boys in Qatar (MobiHealthNews)

General Health & Other Interesting Articles

  • Aaron Hernandez suffered from worst CTE seen in someone his age (CNN) (NPR)
  • Fidget Spinners May Contain High Levels Of Lead, Report Suggests (Forbes)

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 news@raps.org.

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

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