Regulatory Recon: FDA Accepts Spark's Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate Evenity (17 July 2017)

Posted 17 July 2017

placeholder+image

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

In Focus: US

  • FDA Accepts Spark's Gene Therapy BLA (Endpoints) (Press)
  • Big Pharma Buys Into Crowdsourcing For Drug Discovery (Wired)
  • Big Pharma Spends on Share Buybacks, but R&D? Not So Much (NYTimes)
  • Pascal Soriot to remain at AstraZeneca (Financial Times) (Endpoints)
  • FDA rejects Amgen's osteoporosis drug romo as rival Radius surprises with a new CEO (Endpoints) (Fierce) (PharmaTimes) (Press)
  • FDA keeps a firm grip on partial hold for troubled Repros Therapeutics, with big trial demand (Endpoints)
  • 'Incredibly Exciting': CAR T Cells as 'Living Drugs' (MedScape)
  • New NIH report finds low morale, continued patient safety concerns (Washington Post)
  • Cash-rich Gilead should consider Incyte takeover, but it won't come cheap (Fierce)
  • Verily Robot Will Raise 20 Million Sterile Mosquitoes for Release in California (MIT Technology Review)
  • McCain's Surgery Delays Healthcare Vote; Recovery May Be More Serious Than Thought, Experts Say (NYTimes)
  • US health insurers want Cruz proposal dropped from Senate bill (Reuters)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

In Focus: International

  • This Secretive Clan Wants to Beat the World's Biggest Drugmakers (Bloomberg)
  • Non-EU Regulator Participation IN EMA Committee Meetings Is Increasing (Pink Sheet-$)
  • Shire boss says share price at odds with drugs pipeline (Financial Times)
  • TGA Approves Roche's Ocrevus for Relapsing Primary Progressive MS (Press)
  • Government awards over £120 million for global health research (UK DoH)
  • Indian pharma firms need to increase R&D investment: Report (Economic Times)
  • Despite pricing pressure, Indian pharma exports to US may rise in FY18 (Business Standard)
  • Chinese Regulators Launching Medical Device Clinical Trial Inspection Program (Emergo)
  • Are WHO's Revised Norms Masking Safety Signals In Vaccines? (Pink Sheet-$)
  • Quebec Expects $1.2 Billion in Savings With New Drug-Price Deal (Bloomberg)
  • Brexit Talks Round Two: What Are the Key Issues? (Bloomberg)
  • What pharma should know about the European Unitary Patent in light of Brexit (Pharmafile)
  • The Sidewalk Pill Peddlers Of Port-Au-Prince (NPR)

Pharmaceuticals & Biotechnology

  • Grading FDA on Opioid Prescriber Education (Medpage)
  • I Got the Wrong Drug. And a $2,500 Band-Aid. (NYTimes)
  • With Cancer Screening, Better Safe Than Sorry? (NYTimes)
  • This Isn't the First US Opiate-Addiction Crisis (Bloomberg)
  • Can The FDA Climate Be Too Good? (Pink Sheet-$)
  • FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions (FDA Law Blog)
  • Back To Ipsen's Roots (BioCentury)
  • Why Alsonex Is Targeting The Complement System At C5A To Treat ALS (BioCentury)
  • CAR-T Therapies: Failure To Meet Release Specifications May Not Bar Patient Use (Pink Sheet-$)
  • Amid dustup over taxpayer-funded research, Sanofi executive says it never rejected a Zika vaccine fair pricing request (Fierce)
  • Novartis says Cosentyx safe and effective for five years (PharmaTimes)
  • Five Questions for … Austin Biotech Entrepreneur Laura Bosworth (Xconomy)
  • TherapeuticsMD submits CRL-related data to FDA (Seeking Alpha) (Press)
  • More fake Avastin found, this time in Cyprus (Securing Industry)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • CymaBay shares get a bounce on positive PBC PhII data (Endpoints)
  • Can-Fite's Phase II NAFLD/NASH Trial with Namodenoson Set to Commence Patient Enrollment Following Conclusion of Successful Clinical Investigator Meeting (Press)
  • Wave Life Sciences Initiates Two Phase 1b/2a Clinical Trials: PRECISION-HD1 and PRECISION-HD2 in Patients with Huntington's Disease (Press)
  • Alzheon Presents New Data for Lead Candidate ALZ-801 on Novel MOA and Long-Term Clinical Efficacy at the Alzheimer's Association International Conference (Press)
  • Merck Announces Presentations of Clinical and Real-World Data at The Alzheimer's Association International Conference (Press)
  • Symbiomix Therapeutics Announces Publication of Pivotal Data for Investigational Solosec™ for the Treatment of Bacterial Vaginosis (Press)
  • Perrigo Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel® Topical Gel, 1.62% Packets (Press)
  • Impax Announces FDA Approval of its AB Rated Generic Concerta® (Methylphenidate Hydrochloride) Extended-Release Tablets CII (Press)

Medical Devices

  • Vela HIV, Melanoma Assays Secure Regulatory Approvals (GenomeWeb)
  • Mobius Bionics touts 1st use of DEKA's LUKE bionic prosthetic arm (MassDevice)
  • Study: Cybersecurity attacks pose manipulation risk for medical, device data (MassDevice)
  • Five-Year Data Demonstrate InterStim(TM) Therapy Offers Sustained Long-Term Efficacy and Quality of Life Improvements for Overactive Bladder Patients (Press)

US: Assorted & Government

  • Biosimilars Payments In Medicare: CMS Signals Willingness To Change (Pink Sheet-$)
  • Anthem sues Insys over a 'creative' scheme to win reimbursement for its painkiller (STAT)
  • Governors From Both Parties Denounce Senate Obamacare Repeal Bill (NYTimes)
  • Senate's Latest Health Blueprint Cuts Costs At The Expense Of Chronically Ill (KHN)
  • Sidelined healthcare lobby stymies Republican healthcare effort (Reuters)
  • A Sometimes Overlooked Fact About Express Warranty (Drug & Device Law)
  • Calif. Hits Nerve By Singling Out Cardiac Surgeons With Higher Patient Death Rates (KHN)

Upcoming Meetings & Events

Europe

  • Gerresheimer licenses syringe safety solution from West (Reuters)
  • Top 'Brexit-Proofing' Tips For Dealing With Even The Hardest Of EU Exits (Forbes)
  • Pierre Fabre secures Italian distribution rights for Noventure's Aprotecol (Pharmafile)

India

  • Site for India's first device testing lab in Gujarat approved by health ministry (PharmaBiz)
  • Alembic Pharma opens Rs 300 crore anti-cancer drug unit in Gujarat (Economic Times)
  • Alkem Labs Plant clears USFDA inspection (Economic Times)
  • Pharma industry in south has great potential in production of drugs for chronic diseases: S V Veeramani (PharmaBiz)
  • Pharma sector a big beneficiary of GST as cold chain supplies become hassle-free: Dr Piyush Gupta (PharmaBiz)

General Health & Other Interesting Articles

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.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community