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Recon: FDA Approves Gilead's 3 Drug HIV Combo

Posted 08 February 2018 | By Michael Mezher 

Recon: FDA Approves Gilead's 3 Drug HIV Combo

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

In Focus: US

  • FDA approves Gilead triple HIV drug, rival GSK files lawsuit (Reuters) (Endpoints) (Forbes)
  • Drugmaker GSK wins fresh Advair reprieve as Novartis copy delayed (Reuters) (Bloomberg)
  • Biosimilars: the cure for sky-high drug prices or a stake in the heart of innovation? (STAT)
  • This drug has been used to treat PTSD symptoms. What happens when it fails a trial? (STAT) (Reuters) (NEJM)
  • This new company wants to sequence your genome and let you share it on a blockchain (MIT Technology Review) (Endpoints)
  • Regeneron profit beats on higher sales (Reuters)
  • US attorney urged to re-open an investigation into an Allergan unit for alleged fraud (STAT)
  • The Potential Consequences Of The New FDA-Approved 'Digital Pill' (Forbes)
  • In latest blow to Teva, CGRP migraine med delayed while rivals race towards the finish line (Endpoints)
  • Senate budget deal puts drug makers on the hook for more costs (STAT) (CNBC) (KHN) (McConnell)
  • Trump Says He Will Focus On Opioid Law Enforcement, Not Treatment (NPR)
  • States need help to protect drug-affected infants (Reuters) (GAO)
  • FDA Wants to Work with Providers on Opioid Issue (Medpage)

In Focus: International

  • Reckitt, GSK balance risk-reward in high-stakes Pfizer fight (Reuters)
  • No more Mr Nice Guy: GlaxoSmithKline is coming out of its corner swinging (Endpoints)
  • GSK chief urges government to secure Brexit transition deal by April (The Guardian)
  • China FDA Two-track Medical Device Testing Policy May be Coming (Emergo)
  • Another Knockback For Roche And Novartis As CJEU Rules On Italian Competition Case (Pink Sheet-$)
  • Brazil Revises Stability Study Standards To Bring Companies More Certainty (Pink Sheet-$)
  • EMA's Revised ATMP Evaluation Procedure Gets Industry Thumbs Up (Pink Sheet-$)
  • EMA Rejection For Raxone Plunges UK Early Access Scheme Into Uncharted Territory (Pink Sheet-$)
  • Dr Reddy's hit by yet another recall, of 80,000+ bottles (Pharmafile) (Economic Times)
  • Astellas confirms Kenji Yasukawa as new President and CEO (Pharmafile)
  • Norovirus outbreak worsens though athletes unaffected (Reuters)
  • An Open Pharma Approach Targets a Terrible Disease (GlobalHealthNow)           

Pharmaceuticals & Biotechnology

  • FDA's Off-Label Delay Not Enough For Big Drugmakers (Law360-$)
  • Creative Minds: Building Better Computational Models of Common Disease (NIH)
  • Kratom and the FDA (In the Pipeline)
  • Examining Data Types Collected During Pharmaceutical Pricing Studies (Cutting Edge Info)
  • GV-backed startup Rani gets $53M from new investors for 'robotic pill' (Endpoints)
  • Denali Therapeutics and Lonza Pharma & Biotech Announce Exclusive Partnership to Develop and Produce Biologic Medicines (Press)
  • Roche purchases shares in tender offer for Ignyta, Inc. (Press)
  • Medicalizing biomarkers – the sure-fire road to commercial success | Drug Baron (DrugBaron)
  • Who's To Blame For The High Cost Of Cancer Care (The Federal Government Or Justin Bieber?) (Forbes)
  • He calls animal testing 'taxpayer-funded torture.' He got the FDA to listen (STAT)
  • Eight Clinical Trial Read-Outs To Look Out For In Early 2018 (SCRIP-$)
  • Pharma wades into the world of virtual reality marketing (BioPharmaDive)
  • Bringing The Human Element Full Circle Thru Adaptive Ski Coaching (LifeSciVC)
  • 60-Year-Old Drug May Hold Clues To Stopping Spread Of Breast Cancer (Forbes)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Astellas Announce Top-Line Results for Two Phase 3 Trials of Peficitinib in Rheumatoid Arthritis Patients with Inadequate Response to Existing Therapy (Press)
  • ZYTIGA (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer (Press)
  • Madrigal touts a mid-stage success in HeFH, cutting bad cholesterol in a competitive field (Endpoints)
  • Novartis receives FDA approval for Cosentyx label update to include moderate to severe scalp psoriasis (Press)
  • BioMarin Presents Interim Data of Phase 1/2 Study of BMN 250 for Treatment of Sanfilippo B Syndrome (MPS IIIB) at WORLDSymposium 2018 (Press)
  • Amicus therapy shows durable muscle function improvements in Pompe disease patients (STAT)
  • Phosplatin Therapeutics Announces First Cohort Enrolled in Phase I / II Trial of PT-112 in Relapsed / Refractory Multiple Myeloma, and Receipt of FDA Orphan Drug Designation (Press)
  • Acesion Pharma Receives Approval for Phase I Study in Atrial Fibrillation (Press)
  • Bonti Announces Dosing of the First Patient in the SHINE-1 Phase 2 Clinical Study Evaluating EB-001 for Scar Reduction (Press)

Medical Devices

  • Smith & Nephew looks to $160m cost-cutting as 2017 earnings top estimates (MassDevice)
  • Masimo wins CE Mark for Eve newborn CCHD screening app (MassDevice)
  • Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared (FDA)

US: Assorted & Government

  • CVS to hike wages, introduce paid parental leave with windfall from new tax law (CNBC)
  • Here's How Amazon Could Disrupt Healthcare (Forbes 1, 2, 3)
  • House, Senate Health Committee Leaders Release Discussion Draft of FDA Animal Drug User Fees Reauthorization (House E&C)
  • CMS makes amends with Modern Healthcare but questions remain (AHCJ)
  • Top Democrat Blasts GOP on Healthcare (Medpage)
  • AbbVie Filed Patent Suits To Delay Competition, Court Told (Law360-$)
  • Illinois Court Rejects Novel Claims Alleging Deficiencies In Post-Approval Studies (Drug & Device Law)
  • Appeals court upholds $19m Boston Scientific loss in pelvic mesh case (MassDevice)

Upcoming Meetings & Events


  • Bayer starts legal proceedings in Russia due to violation of IP rights (PharmaLetter-$)
  • Johnson & Johnson opens first European JLABS incubator (Fierce)
  • Proposed Regulation on HTA in Europe (EUnetHTA)


  • Incentives, Novel Tech Seen Driving Multiple Korean IPOs In 2018 (SCRIP-$)


  • Cipla to market Novartis, and J&J's products, while Alkem partners Dong A of South Korea (Economic Times)
  • India's medical device industry protests NPPA stent price caps (MassDevice)


  • Consultation: Proposal to change the current good manufacturing practice (GMP) fees and charges (TGA)
  • Upcoming changes to the Permissible Ingredients Determination (TGA)

General Health & Other Interesting Articles

  • Waiting to Treat the Cancer (NYTimes)
  • African-Americans disproportionately endangered by HIV/AIDS (Reuters)
  • Star-like cells may help the brain tune breathing rhythms (NIH)
  • Rheumatologist shortage looms amid surging patient demand (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

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

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