Regulatory Recon: Months After Approval, Gilead's Yescarta Has Treated Just Five Patients Teva to Cut 14,000 Jobs (14 December 2017)

Posted 14 December 2017 | By Michael Mezher 

Regulatory Recon: Months After Approval, Gilead's Yescarta Has Treated Just Five Patients Teva to Cut 14,000 Jobs (14 December 2017)

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

In Focus: US

  • Months After Approval, Breakthrough Cancer Drug Given to Just Five Patients (Bloomberg)
  • Pfizer's second biosimilar of J&J's Remicade wins FDA approval (Reuters) (Pharmafile) (Press)
  • FDA Panel Gives Thumbs Down to Spine Device (Medpage) (EP Vantage)
  • Drug Companies' Liability for the Opioid Epidemic (NEJM)
  • Pharma industry's return on R&D investment falls sharply (Financial Times) (Reuters)
  • Agenda 2020 – Report on the Future of Health and Pharma (Politico)
  • The 2018 biosimilar litigation landscape: a primer (BioPharmaDive)
  • The top 10 prospective blockbuster drug launches slated for 2018 — Evaluate (Endpoints)
  • We must share data to fight Alzheimer's (Financial Times)
  • BMS teams up with Opdivo maker Ono on new I/O programs (Endpoints) (Fierce) (Press)
  • Revance will wait to seek backing for Botox-rival (Reuters)
  • Andreessen drums up a $450M fund to back their vision for engineering biology (Endpoints) (Xconomy) (Forbes)
  • Ginkgo Bioworks Pulls In $275M as Synthetic Biology Funding Soars (Xconomy)
  • GW regains US rights to Sativex (PharmaTimes)
  • 2016 Drug Spending: The Shift from Employers to Government Payers—And Troubling Trends For Patients (Drug Channels)
  • 'Big black box called PBMs' draws attention from lawmakers trying to solve drug prices (STAT)
  • Hospital and pharma lobbyists spar over drug-discount program before time runs out (STAT)
  • With no deal on children's health plan, US states scramble for Plan B (Reuters)

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In Focus: International

  • Israel's Teva to cut 14,000 jobs, suspends dividend in major restructuring (Financial Times) (Endpoints) (WSJ) (NYTimes)
  • Fears of Israeli job cuts at Teva sparks call for general strike (Reuters) (Financial Times)
  • Novartis generics arm says may sell or end some products (Reuters)
  • Former Philippine President defends controversial dengue program (Reuters)
  • Novartis, Abbott targeted by Indian watchdog over allegations of price collusion (Pharmafile) (Economic Times)
  • Up to 650 000 people die of respiratory diseases linked to seasonal flu each year (WHO) (Reuters)
  • AMRC strikes deal to aid Russian antimicrobial research (Fierce)
  • Real world data back use of Eisai, Bial's Zebinix in epilepsy (PharmaTimes)
  • From the fewest polio cases to the greatest contraceptive use—2017 saw a range of health milestones (CNBC)
  • Licensing procedure for electronic cigarettes as medicines (MHRA)

Pharmaceuticals & Biotechnology

  • Do pharma's executive pay plans push up drug prices? Investors want to know (Fierce)
  • Those calculators for the true value of a drug? They could backfire, a new report warns (STAT)
  • With a month left to go, pharma's $3.2B TV ad spending has already topped 2016 (Fierce)
  • Informed decision making in cancer care: more myth than reality (STAT)
  • Gene Editing with CRISPR-Cas9: The Next Step in Human Evolution to be Worth 25 Billion by 2030 (Forbes)
  • Minimal Residual Disease 'Coming Soon' As An Approval Endpoint, Celgene Says (Pink Sheet-$)
  • Investors call on Sanderson, Denny's, McDonald's to cut antibiotics (Reuters)
  • Head and neck cancer survivors have long-lasting cognitive problems (Reuters)
  • HELP Committee Hears Testimony on Banning DTC Ads (CHC)
  • Aduro brushes off cancer vaccine stumble (EP Vantage)
  • Arrakis bolsters RNA-targeting tech with UPenn license (Fierce)
  • Interview: Actelion CEO Aims To Drive 'Small Big Company' To Greater Growth In J&J (SCRIP-$)
  • Faster Inspection Follow-Up, Global Workload, Draw CDER Compliance Office Attention as 2018 Approaches (IPQ)
  • Contracting Relationships and Quality Agreements Are High on FDA's Inspection Radar Screen (IPQ)
  • Atlas and OrbiMed back Boston's Kyn in $49M round to pursue immunometabolism therapies (Endpoints) (Xconomy)
  • New clues to boosting checkpoint inhibition in lung cancer (Fierce)
  • New Jersey Drugmaker Draws FDA Warning for Adulteration (FDANews-$)
  • Relay grabs $63M to pay for a drug discovery trip into the fourth dimension (Endpoints) (Xconomy)
  • Its underlying biology 'too complicated' for further investment, Atlas-seeded Raze signs off (Endpoints)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • A Bivalent Meningococcal B Vaccine in Adolescents and Young Adults (NEJM) (Press)
  • Sanofi, Regeneron ready to file cemiplimab (PharmaTimes)
  • Pfizer Initiates Phase 3 Program for PF-04965842, a JAK1 Inhibitor in Development for Moderate-to-Severe Atopic Dermatitis (Press)
  • U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review (Press)
  • Protagonist Therapeutics Announces Final Phase 1 Study Results with Novel Hepcidin Mimetic, PTG-300 (Press)
  • Prolong Pharmaceuticals Announces Completion of Enrollment in Phase II Study of SANGUINATE in the Treatment of Sickle Cell Disease Patients with Vaso-Occlusive Crisis in an Ambulatory Setting (Press)

Medical Devices

  • New Steps to Facilitate Beneficial Medical Device Innovation (FDAVoice)
  • Millar offloads telemetry product line to Kaha Sciences (Medical Design & Outsourcing)
  • PQ Bypass wins IDE nod for Detour percutaneous femoropopliteal bypass study (MassDevice)
  • gel-e receives US FDA clearance to expand its bandage product line for Rx and OTC use (Press)
  • Chemence Medical Receives FDA Clearance for Exofin Fusion Skin Closure System (Press)

US: Assorted & Government

  • R&D Tax Credit Salvaged, Lobbyists Say (BioCentury)
  • US appeals court vacates conviction of drug distributor over Botox (Reuters)
  • Partial Win Likely For Celgene In Mylan Antitrust Suit (Law360-$)
  • Obamacare sign-ups rise but overall enrollment set to fall (Reuters)
  • More on Venue -- Plexxikon v. Novartis Pharmaceutical Corp. (N.D. Cal. 2017) (Patent Docs)
  • FDA Publishes Two Guidance Documents on GRAS (FDA Law Blog)
  • Christmas Came Early on December 8 – Favorable Developments in Fosamax & Accutane Litigation (Drug & Device Law)
  • Massachusetts' Proposed Medicaid Reforms — Cheaper Drugs and Better Coverage? (NEJM)
  • Researchers Say Mass. Effort to Influence Opioid Prescribing Failed (Boston Globe)
  • The CVS/Aetna Deal: The Promise in Data Integration (Harvard Bill of Health)

Upcoming Meetings & Events


  • MHRA data: Quality systems most common GDP deficiency in 2016 (InPharma)
  • How a New European Medtech Fund Could Help Private Companies (MDDI)
  • Working Life: Dr Rav Seeruthun, Medical Director of Roche UK (Pharmafile)
  • EuroBiotech—More articles of note (Fierce)
  • Parallel import licenses granted in November 2017 (MHRA)
  • Marketing authorisations granted in November 2017 (MHRA)


  • Torrent Pharma completes acquisition of Unichem Laboratories Ltd (Economic Times)
  • Cadila gets USFDA nod for generic drug to treat Parkinson's (Economic Times)
  • Lupin gets USFDA nod for generic contraceptive tablets (Economic Times)
  • Maha FDA detects 6 cases of stent overpricing in hospitals across the state (PharmaBiz)

General Health

  • A 'Game Changer' for Patients With Irregular Heart Rhythm (NYTimes)
  • Diabetes and obesity both tied to higher risk of cancer (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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