Regulatory Recon: Celgene to Pay $280M to Settle Off-Label Promotion Suit GSK Calls for at Least Two-Years' Brexit Transition (26 July 2017)

Posted 26 July 2017 | By Michael Mezher 

Regulatory Recon: Celgene to Pay $280M to Settle Off-Label Promotion Suit GSK Calls for at Least Two-Years' Brexit Transition (26 July 2017)

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

In Focus: US

  • Celgene to Pay $280 Million to Settle Fraud Suit Over Cancer Drugs (NYTimes) (The Street) (WSJ)
  • Eli Lilly CEO expects a Trump executive order on drug pricing this year (CNBC)
  • Gottlieb: FDA Will Delay Sending Layoff Notices (Focus)
  • Pharma companies flock to new drug production approach that promises big savings (STAT)
  • A bid for HHS to override patents on pricey drugs is shot down (STAT)
  • Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline (Pink Sheet-$)
  • Amgen tops sales estimates, raises earnings guidance (Financial Times)
  • Canadian Pharma Goes Before FDA Panel Wednesday on Tamper Resistant Opioid (The Street)
  • Fitting New Scientific Advances Into an Old Regulatory Paradigm: Fusion Proteins and Orphan Drug "Sameness" (FDA Law Blog)
  • US CRISPR rights battle heats up as UC team launches appeal (Fierce) (Press)
  • McCain Returns to Cast Vote to Help the President Who Derided Him (NYTimes) (WSJ) (AP)
  • Senate Votes Down Broad Obamacare Repeal (NYTimes)
  • What's next for Obamacare repeal: Complications and no guarantees (Politico) (AP) (Bloomberg) (KHN) (NYTimes)
  • Senate Health Bill's Only Win May Be Tax Relief To Device Makers (Forbes)
  • Obamacare repeal battle back on the Senate floor (Reuters) (NYTimes)
  • For Trump's 'Victims' of Obamacare, Senate Bill May Be Worse (NYTimes)
  • Dynavax hepatitis B vaccine works; raises safety issues: FDA (Reuters) (Endpoints)
  • Tetraphase's antibiotic succeeds late-stage study, shares soar (Reuters) (Endpoints)

In Focus: International

  • Drugmaker GSK calls for at least two years' Brexit transition (Reuters) (Pharmafile)
  • GSK's new boss streamlines R&D, ditches non-core drugs (Reuters) (Endpoints) (Fierce) (Financial Times) (Bloomberg)
  • Biogen Says It's Under Investigation by Milan Prosecutor (Bloomberg)
  • Asia Regulatory Roundup: India Seeks Feedback on Medical Device Safety and Performance Principles (Focus)
  • Bayer drops checkpoint regulator from Compugen pact (Fierce)
  • US, EU filings for Eisai's lenvatinib in liver cancer (PharmaTimes)
  • Rare disease agency Cambridge Bio goes global with $35M buyout by Irish UDG (Fierce)
  • NICE Backs Roche Gazyvaro for Follicular Lymphoma (PharmaTimes) (Pharmafile)
  • EMA Reviewing Guide To Support New Genome Editing Technologies, CAR-T Cell Therapies (Pink Sheet-$)
  • BMS' Orencia Approved for Active Psoriatic Arthritis in EU (Press)
  • New Report Shows 64 Of 195 Countries Aren't Meeting A Basic Vaccination Target (NPR)
  • British billionaire Jim Mellon and high-profile partners roll the dice on an anti-aging upstart (Endpoints)

Pharmaceuticals & Biotechnology

  • Interview – Aiming for a new Angle on liquid biopsy (EP Vantage)
  • How did biotech become a Hollywood supervillain? (STAT)
  • FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee (FDA Voice) (Meeting Notice)
  • The Startling History Behind Merck's New Cancer Blockbuster (Forbes)
  • FDA Finalizes GDUFA Q&A Guidance (Focus)
  • Why Amazon invested in this cancer-testing startup founded by a Google exec (CNCB)
  • Oncolytics Biotech granted end-of-phase 2 meeting with FDA (Reuters)
  • Canaan unveils $800M fund for fresh wave of biotech bets (Fierce)
  • Kezar adds $50M to its funding tally for immunoproteasome drug (Fierce)
  • Cancer patients in chemo ward may influence each other's survival (Reuters)
  • The science of rapid start—From the when to the how of antiretroviral initiation (PLOS)
  • Onconova eyes 'RASopathy' diseases as new targets for its lead drug (BioPharmaReporter)
  • Most Pharmacovigilance Teams Reach the Peak of Regulatory Submission Activities During Phase 3 (Cutting Edge Info)
  • Effective Treatment Prevents HIV Transmission Among Gay Couples, Study Finds (NBC)
  • Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance (FDA)
  • Allergan backs push for fibroids awareness month ahead of Esmya approval filing (Fierce)
  • Sarepta Prices Upsized $325m Follow-On (BioCentury)
  • It's elementary, pharma. Periodic table twist on marketing lays out multichannel basics (Fierce)
  • Breakthrough gene therapy shows promise in Duchenne muscular dystrophy (Pharmafile)
  • The Expanded Access Navigator – Helping Patients In Need of Potentially Life-Saving Drug Treatments (FDAVoice)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • BioCardia Completes Roll-in Cohort in Pivotal Phase III CardiAMP Heart Failure Trial (Press)
  • Verona Pharma begins dosing RPL554 in Phase IIb COPD trial (PharmaTimes)
  • Pacira Sinks On Mixed Phase III Nerve Block Data (BioCentury)

Medical Devices

  • Cochlear unveils hearing implants that work directly with Apple's iPhone (Reuters)
  • An Interview with Maria Sainz on Her Career Risk-Taking Payoff (MDDI)
  • Takeda, BioSurfaces collab on GI drug-delivery devices (Drug Delivery)
  • Abbott to study blood thinners after treatment with Xience drug-eluting stent (MassDevice)
  • Baxter beats the Street despite plunging Q2 profits (MassDevice) (Press)
  • Vertera Spine wins 510(k) for Coalesce interbody fusion device (MassDevice)
  • FDA clears Invacare's Elyria, Ohio wheelchair manufacturing facility (MassDevice)

US: Assorted & Government

  • Pharmacist Pleads Guilty to Health Care Fraud Charges for Role in $192 Million Compounded Medication Scheme; Pharmacy Marketer Also Pleads Guilty (DoJ)
  • Philly judge reverses pelvic mesh win for Johnson & Johnson (MassDevice)
  • Guest Post – Causation or No Causation, That Is the Question (Drug & Device Law)

Upcoming Meetings & Events


  • Boots ends 130 years of manufacturing as it sells off factories (The Guardian)
  • Torbay Pharma opens plant with sterile injectables capacity in UK (InPharmaTechnologist)
  • Further evidence of NHS recruitment crisis as vacancies skyrocket (Pharmafile)
  • Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance (EMA)
  • Recommendations for use of aminoglycosides in animals to reduce risk of antimicrobial resistance (EMA)
  • Breast implants and Anaplastic Large Cell Lymphoma (ALCL) (MHRA)


  • Sanofi Pasteur Korea appoint new General Manager (Pharmafile)
  • Dong-A Faces Price Hit As Korea Ups Fight Against Illegal Rebates (SCRIP-$)


  • IPC Ghaziabad becomes WHO collaborative centre for PV in public health programmes (PharmaBiz)
  • Health ministry issues list of drug units whose more than 5 samples failed in National Drug Survey (PharmaBiz)
  • India approves Anika's Monovisc osteoarthritis treatment (MassDevice)

General Health & Other Interesting Articles

  • Sperm count falling sharply in developed world, researchers say (Reuters)
  • Patient Voices: AIDS and HIV (NYTimes)
  • Insulin resistance linked to lower bone density (Reuters)
  • Doctors view technology as largely problematic (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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