Regulatory Recon: Amgen's Blincyto Wins Full FDA Approval; NICE Backs Three Drugs for Plaque Psoriasis in Children (13 July 2017)

Posted 13 July 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • Sessions to Unveil Health-Care Fraud Crackdown This Week, Sources Say (Bloomberg) (Reuters)
  • Feds identify prescribers doling out too many opioids to Part D beneficiaries (STAT)
  • Amgen's Blincyto wins full US approval (PharmaTimes)
  • FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy (Focus) (Endpoints) (Financial Times) (Reuters) (NYTimes)
  • House Passes Bill to Reauthorize FDA User Fee Programs (Focus)
  • House Appropriators Send FDA Funding Bill To Floor By Voice Vote (IHP-$)
  • Ex-GSK CEO Andrew Witty goes biotech, taking a board seat at G1 (Endpoints)
  • FDA Considers Label Changes for Keytruda, Opdivo and Yervoy (Focus)
  • Feuding US Senate Republicans to get revised healthcare bill (Reuters) (NYTimes) (NPR)
  • Whichever Way 'Repeal And Replace' Blows, Pharma Is Due For Windfall (KHN)
  • Medicaid could torpedo repeal effort (Politico)
  • FDA Deal Would Relax Rules on Reporting Medical Device Problems (NYTimes)
  • Will Money-Back Guarantees Mitigate Drug Costs? (Medpage)
  • Valeant Shaves Another Chunk From Its Crushing Debt Load, Shares Continue March Higher (The Street)
  • Zimmer Biomet's Dvorak Out As CEO, Successor Search Underway (Xconomy)
  • FDA Collaborates to Promote Safety, Quality in Clinical Trials Done in India (FDA Voice)
  • FDA Spotlights Commitments to Precision Medicine, Biomarkers (GEN) (BioPharmaDive) (FDA Voice)
  • Threats to Information Security — Public Health Implications (NEJM)
  • SubHealth Reviews Legislation Addressing Medical Product Manufacturer Communications (E&C)

In Focus: International

  • NICE backs Humira, Enbrel and Stelara for plaque psoriasis in children (PharmaTimes)
  • Israel's Pharma Giant Teva Makes CEO Offer to French-born Exec Pascal Soriot (Haaretz) (Endpoints) (The Street) (Pharmafile) (Fierce)
  • GlaxoSmithKline woos Pfizer medicinal sciences chief Tony Wood to high-level R&D job (Endpoints) (Fierce)
  • UK, EU medicines trade groups lobby Barnier, Davis for medicines alignment (Politico) (PharmaTimes) (PMLive) (Financial Times)  (Pharmafile) (Financial Times) (ABPI)
  • Irish Health Minister Speaks About EMA Relocation, Drug Pricing, and Boosting Biosimilars (Pink Sheet-$)
  • 'Not What We Expected,' R&D Industry Says Of 'Onerous' EU Paediatric Regulation (Pink Sheet-$)
  • We'll See You In Court: UK Pharma Challenges Extra NHS Price Hurdle (Pink Sheet-$)
  • UK Government boosts NHS cyber security with additional £21 million (Pharmafile)
  • Examining Japan's 'Device Lag'—Part 2 (MDDI, Part 1)
  • Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC) (EMA)
  • DNA Links Deadly Germs, Tainted Heart Surgery Devices To German Factory (KHN)
  • BASF unveils new mosquito net in battle against malaria (Reuters)
  • The Dutch bid for the European Medicines Agency (CBG-MEB)

Pharmaceuticals & Biotechnology

  • ICER Releases Draft Evidence Report Reviewing Olaparib, Rucaparib, and Niraparib for Ovarian Cancer (ICER)
  • FDA Releases Correspondence in Texas Death Penalty Drugs Case (FDA 1, 2, 3)
  • More People Are Making Mistakes With Medicines At Home (NPR)
  • Allergan CEO comes out against aesthetic treatments for teens in debate-sparking blog post (Fierce)
  • Is HIV/AIDS Progress Made By The Last 5 Presidents Being Undone By The Trump White House? (Forbes)
  • FDA Struggles with Sizing Up Abuse-Deterrent Opioids (Medpage)
  • 3 Takeaways From The FDA Head's New Opioid Rx Standards (Law360-$)
  • CRISPR 'kill-switch' wards off unwanted side effects (Fierce)
  • 10 Hospitals With 340B Contract Pharmacy Mega-Networks (Drug Channels)
  • First US all-cargo airline to earn CEIV certification (Pharmafile)
  • Antidepressants in pregnancy not tied to intellectual disability in kids (Reuters)
  • Biocon bounces back as FDA report hints at Herceptin biosimilar recommendation (PharmaLetter-$)
  • Fresenius Petitions FDA to Deny Second Indication for Keryx's Chronic Kidney Disease Drug (FDANews-$)
  • Catalent re-ups manufacturing deal for Pfizer Liqui-Gels (OutsourcingPharma)
  • Klick brings tiny, trash-talking wrestler to new Novartis disease awareness work (Fierce)
  • Hair Repigmentation During Immunotherapy Treatment With an Anti–Programmed Cell Death 1 and Anti–Programmed Cell Death Ligand 1 Agent for Lung Cancer (JAMA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • FDA Grants Orphan Drug Designation to Allena Pharmaceuticals' Investigational Therapy for the Treatment of Primary Hyperoxaluria (Press)
  • FDA Grants Fast Track Designation to VT-1598 for Treatment of Valley Fever (Press)
  • Pfizer Announces FDA Accepts Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis (Press)
  • Clearside Biomedical launches Phase II diabetic macular edema trial (Drug Delivery)

Medical Devices

  • Medtech venture funding total hits all-time high (EP Vantage)
  • House Report Asks FDA Not To Finalize Guidance On LDT Regulation (BioCentury)
  • Clinical Trial to Evaluate Medtronic Cryoablation as First-Line Treatment for Patients With Symptomatic Paroxysmal Atrial Fibrillation (Press)
  • Philips receives U.S. FDA 510(k) clearance to market its Philips BlueControl, a wearable light therapy device to treat mild psoriasis at home (Press)
  • VR play Saebo wins FDA nod for SaeboVR rehab system (MassDevice)

US: Assorted & Government

  • FDA Faces Budget Crunch In 2023 Under User Fee Legislation (Pink Sheet-$)
  • Q&A: Former Obama science adviser John Holdren on the White House science office and Trump's science policy (Science)
  • New CDC chief partnered with Coke in state obesity program (Washington Post) (Fierce)
  • Martin Shkreli's Ex-Mentor Testifies About His Bad Behavior (NYTimes)
  • Drug Companies Lose Challenge To Alliance Of Private Lawyers And State Officials (Forbes)
  • What You Will See On Personal Jurisdiction Following BMS (Drug & Device Law)
  • Mylan and staff are big donors to CEO's dad, U.S. Sen. Manchin, but he says he had no idea (Fierce)
  • Lilly Reaches Settlement Agreement in U.S. Cialis Patent Litigation (Press)
  • Pfizer Assails Janssen Suit Over Remicade Biosimilar (Law360-$)
  • Off-Label Drug Bills Get Little Traction On Capitol Hill (Law360-$)
  • Court reaffirms Stryker's $248m enhanced damages win in Zimmer Biomet patent spat (MassDevice)
  • Animal Drug "Compounding": Criminal Indictment Against Pharmacy and Veterinarian Withstands Federal District Court's Scrutiny (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • Two new biosimilars 'could save NHS millions' (Pharmaceutical Journal)
  • Marketing authorisations granted in June 2017 (MHRA)
  • Parallel import licenses granted in June 2017 (MHRA)

India

  • India's New GST Tax A Game Changer For Pharma But Challenges Ahead (SCRIP-$)
  • PvPI registers 2.70 lakh adverse drug reactions through AMCs spread across 250 centres (PharmaBiz)
  • Addressing points raised by USFDA: Vista Pharma (Economic Times)
  • Pharma industry in Pondicherry faces big drop in business on account of GST, total production reduces to 50% (PharmaBiz)

Asia

  • Altona Diagnostics Zika Test Approved for Korean Market (GenomeWeb)
  • Astellas alliance with Kyoto University will focus on biomarkers (PharmaLetter-$)
  • TissueGene Therapy Gets Korean Approval For OA (BioCentury)

Canada

  • Health Canada wants to update the Assisted Human Reproduction Act Public invited to comment on the proposed changes to the Act (Health Canada)

Other International

General Health & Other Interesting Articles

  • Scientists Used CRISPR to Put a GIF Inside a Living Organism's DNA (MIT Technology Review)
  • HIV hijacks surface molecule to invade cell (NIH)
  • Dark hair dye and chemical relaxers linked to breast cancer (Reuters)
  • Toxic bacteria often lurk in children's, dogs' sandboxes (Reuters)

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