Regulatory Focus™ > News Articles > Regulatory Recon: NICE OKs Janssen's Imbruvica for Second-Line CLL; Merck Details US Pricing Practic

Regulatory Recon: NICE OKs Janssen's Imbruvica for Second-Line CLL Merck Details US Pricing Practices (27 January 2017)

Posted 27 January 2017 | By Michael Mezher 

Regulatory Recon: NICE OKs Janssen's Imbruvica for Second-Line CLL Merck Details US Pricing Practices (27 January 2017)

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

In Focus: US

  • Ensuring a Timely PDUFA Reauthorization (Morning Consult)
  • Big Drug Companies Should Secede From The Pharmaceutical Research And Manufacturers Of America (Forbes)
  • Merck Gives Details on US Drug-Pricing Practices (WSJ)
  • Is 'what the patient pays' the right barometer for pricing drugs? (BioWorld)
  • Trump planning more action on Obamacare (Politico)
  • Days Before a Deadline, Trump Team Cancels Ads for Obama Health Plan (NYTimes)
  • Tom Price Cracks the Drug-Price Negotiation Door (Bloomberg)
  • House lawmaker seeks more documents in FDA criminal office inquiry (Reuters)
  • A GOP Regulatory Game Changer (WSJ)
  • Calls for compassion, pleas for funding ring out as governors tackle opioid crisis (STAT)
  • Drug Distributors Penalized For Turning Blind Eye In Opioid Epidemic (ProPublica) (Drug Channels)
  • Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations (Focus)
  • FDA Explains How GDUFA II Will Help Small Businesses (Focus)
  • Pig-Human Organ Farming Doesn't Look Promising Yet (MIT Technology Review) (Cell) (NYTimes)
  • 3-D-Printed Skin Leads the Way Toward Artificial Organs (MIT Technology Review)
  • Physician survey shows broad opposition to wholesale Obamacare repeal (Reuters)
  • Teva's Barr Labs settles Cipro antitrust case for $225 million (Reuters)
  • Roche cancer drug taking bite out of Bristol's Opdivo (Reuters)
  • Bristol-Myers Squibb Cuts Guidance on Cancer Drug Problems (WSJ)
  • Endo cuts staff in restructuring effort (Drug Delivery) (PharmaLetter-$)
  • Trump's top choices for FDA could bolster the 'right-to-try' movement (STAT-$)
  • The future of genome editing and how it will be regulated (PhysOrg)
  • What the FDA doesn't know about alternative medicine—thanks to politics—could kill you (Quartz)
  • Why President Trump Is Wrong about Trans-Pacific Partnership Agreement (Patent Docs)
  • Medical supplies would be hit by Trump's proposed 20% tax on Mexican imports (Modern Healthcare)

In Focus: International

  • Singapore's biomedical manufacturing output leaps 45% in December (PharmaLetter-$)
  • Editorial: Mr. Trump's 'Gag Rule' Will Harm Global Health (NYTimes)
  • After FDA rejection, Novartis pulls Amgen biosim candidate from EMA (Fierce)
  • Do I Need an Import License for Medical Device and IVD Sales in India? (Emergo)
  • ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success (Focus)
  • NICE approves Imbruvica for second-line leukaemia treatment (Pharmafile) (PharmaTimes)
  • Google's life sciences business gains $800 million funding in pivot to Asia (Pharmafile) (Law360-$)
  • European Regulatory Roundup: UK to Seek 'Closest Possible Regulatory Equivalence' With EMA Post-Brexit (Focus) (Pink Sheet-$)
  • Theresa May will not find it easy to broker a US-UK trade deal (Financial Times)
  • Five most talked about mergers and acquisitions of 2016 (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • 505(b)(2) NDA and ANDA Amendments: Don't Forget to Meet the New Verification Requirement (FDA Law Blog)
  • What makes physicians consider patients suitable for biosimilar infliximab (GaBI)
  • Sandoz awaiting facility inspections before filing Humira biosimilar in US (BioPharmaReporter)
  • Stem cell secretions may protect against glaucoma (NIH)
  • Billions On The Line With Celgene's Partnered Pipeline (Scrip-$)
  • FDA Autism Meeting: Will It Stray From Symptoms And Treatments To Causation? (Pink Sheet-$)
  • Biogen lowers forecast after disappointing 4th-qtr results (PharmaLetter-$) (Fierce)
  • FDA Okays New Linaclotide (Linzess) Dose for Constipation (Medscape)
  • Cannabis Drug Company Zynerba Is Gearing Up For A Big Summer (Forbes)
  • It's official – oncology is king in the venture-backed world (EP Vantage)
  • The Case of Baxter's Moldy HEPA Filters(Pink Sheet-$)
  • Biopharma Companies Tackle Non-Communicable Diseases (BIO)
  • Why Baxter's GMP False Claims Settlement Was Smaller Than Those Of GSK, Ranbaxy (Pink Sheet-$)
  • Regulatory Twitter Goes '#Rogue' With AltFDA (Pink Sheet-$)
  • Advera Health Analytics Says Breast Cancer Drug Neratinib "will likely be approved" by FDA (PharmaLetter-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Upcoming events – Late-stage data from Trevena and Chimerix (EPVantage)
  • SpinalCyte, LLC Enrolls First Patient in Landmark Phase I Human Clinical Trial (Press)
  • ImmunoGen Announces First Patient Dosed in FORWARD I Phase 3 Study of Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer (Press)
  • BELMONT Phase 2 Clinical Data to be Presented at IMCAS World Congress 2017 (Press)
  • Acucela Initiates Phase 2a Study of Emixustat Hydrochloride Addressing Patients with Stargardt Disease (Press)
  • Aurinia Selects Worldwide Clinical Trials as its CRO for Phase 3 Lupus Nephritis Trial (Press)

US: Medical Devices

  • Class I Recall: bioMerieux NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents due to Potential Inaccurate Test Results (FDA)
  • No Final LDT Guidance, But FDA Provides Insight into What a Future Guidance Might Contain (FDA Law Blog)
  • Varian shares droop on Q1 miss (MassDevice)
  • Philips, Bon Secours Charity Health ink $180m, multi-year deal (MassDevice)
  • Avinger touts 2-year Pantheris study data (MassDevice)
  • Medtronic wins CMS coverage for Micra leadless pacer (MassDevice)
  • DePuy Synthes wins FDA nod for Viper, Expedium pedicle screw systems (MassDevice)
  • Trump and medtech: What people in the industry think (MassDevice)

US: Assorted & Government

  • The nation's top scientists can't get through to Trump — and they're alarmed (Washington Post)
  • American University names new president: Obama Cabinet member Sylvia Mathews Burwell (Washington Post)
  • PCSK9 Patent Fight: Amgen Opposes Doctor Efforts To Keep Praluent On Market (Pink Sheet-$)
  • Feds Tell High Court To Pass On Flanax Trademark Case (Law360-$)
  • Guest Post – Midnight Madness − The FDA Continues To Discount First Amendment Implications Of Restrictions On Off-Label Promotion (Drug and Device Law)

Upcoming Meetings & Events


  • Green light for UK men B teenage vaccination study (PharmaTimes)
  • New CFO for Diurnal (Pharmafile)
  • Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections (EMA)
  • German CDMO migrates 800 staff to newly opened €100m packaging site (OutsourcingPharma)
  • EU Antitrust Watchdog Unsure About Merger Alert Reforms (Law360-$)
  • Guideline on the conduct of efficacy studies for intramammary products for use in cattle (EMA)
  • Celgene Receives Positive CHMP Opinion to Expand REVLIMID® (Lenalidomide) Indication as Monotherapy for the Maintenance Treatment of Patients with Newly Diagnosed Multiple Myeloma (MM) after Autologous Stem Cell Transplantation (Press)
  • Pfizer Receives Positive CHMP Opinion in Europe for XELJANZ® (tofacitinib citrate) for the Treatment of Moderate to Severe Active Rheumatoid Arthritis (Press)


  • India is an important site to conduct clinical trials for computer vision syndrome: Dr Raghu Nagaraju (PharmaBiz)
  • IDMA urges central govt to eliminate bottlenecks in API sector, incentivise exports (PharmaBiz)

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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