Regulatory Recon: Patient Dies in Stemline Cancer Trial Price Nomination Heads to Full Senate Vote (2 February 2017)

Posted 02 February 2017 | By Michael Mezher 

Regulatory Recon: Patient Dies in Stemline Cancer Trial Price Nomination Heads to Full Senate Vote (2 February 2017)

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

In Focus: US

  • Dear President Trump: Don't destroy the FDA we know and respect (Endpoints)
  • Speed Up Drug Approvals? FDA Already Did (NBC)
  • Side Effect Kills Cancer Patient in Stemline Therapeutics Drug Trial (The Street)
  • AstraZeneca CEO: We want a 'strong, science-led FDA' (Fierce)
  • Speedy US drug reviews would make payers the new gatekeepers (EP Vantage)
  • FDA's New Commodity-Based Inspection Approach To Take Effect In May (Pink Sheet-$)
  • US FDA May Find Relief From Trump's Hiring Freeze (Pink Sheet-$)
  • Anthem CEO Says Obamacare Could Turn 2017 Profit, Uncertain About 2018 Participation (Reuters) (Forbes)
  • Immunotherapy Tops Cancer Advances Again (Medpage) (ASCO)
  • Market watch: Value of 2016 FDA drug approvals: reversion to the mean? (Nature)
  • Medical group urges protection for doctors, patients after US travel ban (Reuters)
  • Merck's sales miss as Keytruda, diabetes drugs lag estimates (Reuters) (Press)
  • Price HHS nomination heads for full Senate (BioCentury)
  • SCOTUS nominee Gorsuch would hear biosimilar suits (BioCentury)
  • ICER revising value assessment framework (BioCentury)
  • Biogen hematology spinout Bioverativ launches (BioCentury)
  • A Five-Point Prediction Of The GOP Plan For Replacing Obamacare (Forbes)
  • A Look Forward To Health Care In 2017: Top Five Trends (Health Affairs Blog)
  • The Lower Drug Costs Through Competition Act: Prioritized Review for Some ANDAs . . . and a Priority Review Voucher (FDA Law Blog)
  • If Trump's 'serious' on drug pricing, Sanders says he's willing to pitch in (Fierce)
  • AstraZeneca Falls After Cautious 2017 Outlook as Crestor Sales Slow (The Street) (Financial Times)
  • An Interview With John Jenkins (Nature)

In Focus: International

  • Turkey Aims to Bolster Local Drug Production, Minister Says (Reuters)
  • European Patent Office Invalidates BMS' Patent for Sprycel (BMS)
  • Pakistan drug regulatory body "a complete failure" according to officials (Pharmafile)
  • Pfizer resubmits US and EU application for withdrawn ADC Mylotarg (BioPharmaReporter)
  • Brexit 'an opportunity,' but EMA likely to leave London, says AstraZeneca (Fierce)
  • EU Generic Industry Group Looks At Radical Options To Simplify Pharmacovigilance Tasks (Pink Sheet-$)
  • Regulatory watch: Outcomes of early health technology assessment dialogues in medicinal product development (Nature)
  • Clinical data for two more medicines now available online (EMA)
  • 2016: A retrospective from the industry (Pharmafile)
  • 2016 EMA drug approval recommendations (Nature)
  • European Commission, FDA take different approaches to biosimilar education (BioPharmaDive)
  • Budget 2017 Proposals Receive Mixed Reaction From Indian Pharma Sector (Economic Times)
  • Takeda Raises Guidance, Eyes Emerging Market Acquisition (SCRIP-$)
  • Zika ebbing in Latin America but vigilance needed: WHO (Reuters)
  • Novo Nordisk warns of lower profits and sales for 2017 (PharmaLetter-$)
  • Malaria superbugs threaten global malaria control, scientists say (Reuters)
  • WHO Executive Board Enters Into Official Relations With 5 New Institutions, Including Gates Foundation, KEI (KaiserFoundation) (IP Watch)

US: Pharmaceuticals & Biotechnology

  • Women Fear Drug They Used To Halt Puberty Led To Health Problems (KHN)
  • Opana Safety Review Will Set Tone For Opioid Regulation Under Trump (Pink Sheet-$)
  • Cornerstones of CRISPR–Cas in drug discovery and therapy (Nature)
  • 2016 FDA drug approvals (Nature)
  • More Spring-Loaded Reagents (In the Pipeline)
  • Induced pluripotent stem cell technology: a decade of progress (Nature)
  • ANDA Guidance: Reference Listed Drug Vs. Reference Standard Explained (Pink Sheet-$)
  • UnitedHealth Group covering Spinraza (BioCentury)
  • Look Back at OPDP Enforcement in 2016 – Focus on Pre Approval Communications (Eye on FDA)
  • Stem cell transplants may induce long-term remission of multiple sclerosis (NIH)
  • Amgen upgraded by Bank of America a day after CEO meets Trump (CNBC)

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

  • Xoma up on broadly positive data, but questions remain (Fierce)
  • FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) (Press)
  • Zimmer Biomet Announces FDA Approval of Expanded 26-week Efficacy Claim for Gel-One Cross-Linked Hyaluronate for Treatment of Pain Associated with Knee Osteoarthritis (Press)
  • Lantheus Medical Imaging Announces FDA Approval of DEFINITY Label Update (Press)

US: Medical Devices

  • Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure (NEJM)
  • FDA Grants Abbott the First Commercial Authorization for a Molecular Test to Detect Zika Virus Using Whole Blood (Press)
  • Boston Scientific swings to black for Q4, 2016 (MassDevice)
  • Medtronic CardioInsight Mapping Solution Cleared by FDA (Press)
  • Becton Dickinson's Q1 sales, earnings top forecasts (MassDevice)
  • QoL Improvements After TAVR Better In Real World? (Medpage)
  • NIST's Draft Update to Cybersecurity Framework Focuses on Third-Party Vendors and the Cost-Effectiveness of Cybersecurity Programs (National Law Review)
  • Hologic, Grifols close $2B Procleix blood-screening biz sale (MassDevice)

US: Assorted & Government

  • US proposes 0.25 percent hike in Medicare Advantage payments (Reuters) (WSJ)
  • Biotech Co. Must Face Willful Infringement, Judge Says (Law360-$)

Upcoming Meetings & Events


  • Information - key to tackling medicines shortages (EFPIA)
  • BIAL sells allergic immunotherapy business to Roxall (PharmaLetter-$)
  • Novo Nordisk Foundation grants $17m for pharma fermentation pilot plant (InPharmaTechnologist)
  • Sandoz withdraws Neulasta biosimilar application after EMA questions GMP status (BioPharmaReporter)


  • Eisai Releases Consolidated Financial Report For the Third Quarter of Fiscal 2016 (Press)
  • 'Last-resort' antibiotic-resistant bacteria found along 4km of Chinese coastline (Pharmafile)
  • Need To Redefine Recipe For Success In Korean Biotech? (SCRIP-$)


  • NPPA issues revised internal guidelines on discontinuation of production of scheduled formulations under para 21 (2) of DPCO, 2013 (PharmaBiz)
  • Health ministry sets deadline on coming out with new rules on cosmetics, medical devices and clinical trials (PharmaBiz)


  • Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2016 (TGA)

Other International

  • Saudi CDMO's fill/finish plant to offer Big Biopharma access to local benefits (BioPharmaReporter)

General Health & Other Interesting Articles

  • Medical records don't always match what patients say (Reuters)
  • Toxic chemicals in one-third of fast food packaging (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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