Regulatory Recon: J&J Uses Priority Review Voucher to Speed Psoriasis Approval; DoJ Charges 412 in Healthcare, Opioid Schemes (14 July 2017)

Posted 14 July 2017 By Michael Mezher

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

In Focus: US

  • J&J gets a quick FDA OK for its blockbuster psoriasis contender guselkumab (Endpoints) (Pharmafile) (Fierce) (Press)
  • 'Extreme' Use of Painkillers and Doctor Shopping Plague Medicare, New Report Says (ProPublica)
  • Expert panel to FDA: time to hold opioids to a new standard (Science) (Medpage) (NASEM) (FDA)
  • US charges 412 people with healthcare fraud, opioid-related schemes (Reuters) (DoJ 1, 2)
  • FDA system for reporting side effects has its own side effect: incomplete data (STAT)
  • Novartis stocks drug cabinet with "Big-3" arthritis blockbusters (Reuters)
  • Medicare escapes mandatory cuts in 2017, trustees report (Reuters)
  • Senate Republicans Unveil New Health Bill, but Divisions Remain (NYTimes) (Reuters)
  • Repeal effort in jeopardy (Politico)
  • White House Slams Generic Exclusivity Provisions In User Fee Bill (Pink Sheet-$)
  • Anthem files lawsuit against Insys Therapeutics (Reuters)
  • Importing drugs from other countries undermines safety (STAT)
  • NIH fetal tissue research would be barred under House panel's spending plan (STAT)
  • AstraZeneca: mystique (Financial Times)
  • Will AstraZeneca's CEO Leave for Teva? Credit Suisse Doesn't Think So (The Street)
  • Amgen's battered Kyprolis nabs a survival win, slashing death risk in Revlimid-chemo combo (Fierce)
  • White House Doubles Down on Call to Fund FDA Entirely With Industry Fees (Focus)
  • FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars (Focus)
  • FDA: Lead Test Company May Have Violated Federal Law (Focus)
  • FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances (Focus)

In Focus: International

  • Disorderly Brexit could put patients at risk, drug industry warns (Reuters)
  • What Brexit means for drug regulation (Pharmafile)
  • Morphosys sees revenue boost from Janssen psoriasis drug (Reuters)
  • GSK will explore extending its meningitis vaccine to gonorrhea (STAT)
  • German Isentress Case Could Mean More Compulsory Licensing In Europe (Pink Sheet-$)
  • Roche Supply Decision Under Investigation In Turkey (SCRIP-$)
  • Gilead's new HIV therapy under EU review (PharmaTimes)
  • £86 million funding announced for new medicine and technology (UK DoH) (ABPI)
  • ABPI responds to the publication of 2016 animal research data (ABPI)
  • European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (Focus)
  • Cipla, Novartis explore marketing tie-up (Economic Times)

Pharmaceuticals & Biotechnology

  • 2017 IPOs In Review: US Biopharma Offerings Rise, Values Decline At Mid-Year (SCRIP-$)
  • There's An Amazing New Drug For Multiple Sclerosis. Should I Try It? (NPR)
  • Cancer-fighting PARP drugs from AstraZeneca, Clovis and Tesaro largely overpriced, watchdog says (Fierce)
  • Alkermes' Vivitrol marketing and lobbying put it under gun; pharma says not fair (Fierce)
  • A Tide of Opioid-Dependent Newborns Forces Doctors to Rethink Treatment (NYTimes)
  • Opportunities for therapeutic antibodies directed at G-protein-coupled receptors (Nature)
  • Shire focusing on biotechnology and R&D hubs in MA operations shake up (BioPharmaReporter)
  • Sanofi shells out $650m for non-egg based vaccine maker Protein Sciences (BioPharmaReporter)
  • ABEC breaks the 2,000L 'plastic ceiling' with 4,900L single-use bioreactor (BioPharmaReporter)
  • Sunovion divests asthma, allergy tech to Covis Pharma (Drug Delivery)
  • Alder prices $150M offering to fund migraine market scrap (Fierce)
  • One step closer to a Zika vaccine for pregnant women (Fierce)
  • Experimental Zika virus vaccines restrict in utero virus transmission in mice (NIH)
  • Cord blood inspires an alternative to CAR-T for treating blood cancers (Fierce)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Mallinckrodt wins orphan drug status for long-acting muscular dystrophy therapy (Drug Delivery)
  • Allena claims orphan status for 'devastating' rare disease therapy (Fierce)

Medical Devices

  • UL 2900 Cybersecurity Standards Set for FDA Adoption (Emergo)
  • FDA Favors Collaborative Approach to Medical Device Cybersecurity (MasterControl)
  • Following Pivotal FDA Approval for Keytruda, Promega to Seek Clearance for Mismatch Repair Deficiency Assay (GenomeWeb)
  • Cardiologs Cloud-Based Software FDA Cleared to Spot Arrhythmias in ECGs (medGadget)
  • Tyber Medical wins FDA nod for TyFix extremity joint fixation system (MassDevice)
  • Philips wins FDA nod for BlueControl psoriasis treatment device (MassDevice)
  • Great Basin Receives FDA Clearance for Stool Bacterial Pathogens Panel (GenomeWeb)
  • Avita to seek PMA for ReCell burn indication, considers making US operations hub (MassDevice)

US: Assorted & Government

  • House Committee Proposes $1.1B Increase in NIH Funding for Fiscal 2018 (GenomeWeb)
  • VA Health Care: Improvements Needed in Data and Monitoring of Clinical Productivity and Efficiency (GAO)
  • California Sued For Allegedly Substandard Medi-Cal Care (KHN)
  • Retrophin CEO calls Martin Shkreli 'Pied Piper ... he tells a story, sings a song' during testimony at fraud trial (CNBC)
  • Judge rules that Mylan can't move EpiPen antitrust suit (Drug Delivery)
  • Eighth Circuit Affirms Exclusion of Expert in Hip Implant Case (Drug & Device Law)
  • cGMP Problems Shrink the DepoCyt Chemotherapy Market (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • Meeting with Heads of Agencies/High-Level Representatives and Heads of European Pharmaceutical Companies (EUnetHTA)
  • Proposal to make Arthriex 750mg and 1500mg film-coated tablets available from Pharmacies (MHRA)    
  • Merck unveils EU plant cuts and consolidation plan citing Sigma's US strategy (InPharmaTechnologist)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 July 2017 (EMA)

India

  • Remedy post-GST medicine shortages, government tells pharma companies (Economic Times)
  • Gujarat govt in talks with Centre to come out with policy on bulk drugs & medical devices (PharmaBiz)
  • Drug trade clueless over invoice format, reimbursement of unsold drugs even after 2 weeks of GST (PharmaBiz)
  • Indian Pharma market posts 7.5% growth in June 2017 at Rs.9,463 cr (PharmaBiz)

Australia

  • Metal-on-metal hip replacement implants (TGA)
  • Automatic conditions for medical devices - legislative amendments (TGA              )

General Health & Other Interesting Articles

  • Malaria genome study reveals savvy, finely tuned parasite (Reuters)
  • How Did Crimean-Congo Hemorrhagic Fever Pop Up In Spain? (NPR)

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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