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Regulatory Recon: First Biosimilar Cancer Treatment Approved in EU Allergan CEO Pushes for Trump to Lead Pricing Talks (23 February 2017)

Posted 23 February 2017 | By Michael Mezher 

Regulatory Recon: First Biosimilar Cancer Treatment Approved in EU Allergan CEO Pushes for Trump to Lead Pricing Talks (23 February 2017)

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

In Focus: US

  • Standing up for science in the era of Trump (The BMJ)
  • FDA Must Forge Ahead With Biosimilar Drug Review (Morning Consult)
  • Allergan CEO Pushes for Trump to Lead Drug Price Discussions (Bloomberg)
  • DHS official: Ransomware an increasing threat to medical device cybersecurity (MassDevice)
  • Pediatric Drug Development A Priority For US FDA's New Oncology Center Of Excellence (Pink Sheet-$)
  • Pfizer, Merck, Lilly execs urge tax code revamp in letter to Congress (Fierce) (Letter)
  • Thermo Fisher did not infringe genetic-testing patent, US top court says (Reuters)
  • Lawmakers urge US Army not to issue exclusive license to Sanofi for a Zika vaccine (STAT)
  • Novartis cancer drug Zykadia gets FDA priority review (Reuters) (PharmaTimes) (Pharmafile) (Press)
  • Bristol-Myers Squibb: grave dancing denied (Financial Times)
  • US FDA's Authority Over CRISPR Is Adequate, NASEM Finds, But Off-Label Challenge May Emerge (Pink Sheet-$)
  • Second Theranos Lab Has Blood-Testing License Revoked (WSJ) (Law360-$)
  • Boston Scientific recalls all Lotus Valve heart devices (Reuters)
  • Big Pharma Quietly Enlists Leading Professors to Justify $1,000-Per-Day Drugs (ProPublica)
  • Many pacemaker recipients can safely get non-chest MRIs (Reuters) (NEJM)
  • Pediatric Drug Formulations — Unintended Consequences of Legislation (NEJM)
  • Repeal of Health Law Faces Obstacles in House, Not Just in Senate (NYTimes)
  • Obamacare supporters confront Republicans (Politico)
  • The Anti-Vaccine Movement Gains a Friend in the White House (NYTimes)
  • Many US cancer patients struggle to afford life-saving medications (Reuters)

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In Focus: International

  • Celltrion's Truxima is First Biosimilar Cancer Treatment Approved in Europe (Pharmafile) (EPR) (BioCentury) (BioPharmaReporter)
  • Bayer boss blasts Brexit, protectionism and emotion-driven politics (PharmaLetter-$)
  • How EMA's Adaptive Pathways Fits Into The Complex Drug Pricing Puzzle (Pink Sheet-$)              
  • Russian Regulators Extend Deadline for Replacing "Old" Medical Device Licenses (Emergo)
  • Mundipharma to launch Mabthera biosimilar in EU markets (PharmaTimes)
  • Sprint To Find Zika Vaccine Could Hinge On Summer Outbreaks (KHN)
  • China updates key drug list in boost for Big Pharma (Reuters) (Pharmafile) (Bloomberg)
  • Novartis' Afinitor gets NICE green light for kidney cancer (PharmaTimes)
  • Quality Regulatory Updates In Brief: ICH, EMA, MHRA and FDA (Pink Sheet-$)
  • Bayer looks beyond Xarelto and Eylea (EP Vantage)
  • Essure problems cost Bayer $413 million last year alone (Modern Healthcare)
  • EMA Considers Using Big Data and Real-World Evidence in Approval Decisions (FDANews-$)

US: Pharmaceuticals & Biotechnology

  • Rare Disease Day at NIH event features advances in rare diseases research (NIH)
  • Sixteen Years of Overregulation: Time to Unburden Mifeprex (NEJM)
  • Quality by Design for generic products: opportunities and challenges (EPR)
  • Roche Pd-L1 Assay Not Concordant With Others (BioCentury)
  • PhRMA CEO Links Press Coverage of High Prices and the Need for Generic Competition (FDANews-$)
  • Harvard's Verdine Aims to Retire, Become Full-Time FogPharma CEO (Xconomy)

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

  • Tocagen Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Toca 511 & Toca FC in Recurrent High Grade Glioma (Press)
  • Cyclacel's leukemia drug for elderly patients fails in key study (Reuters) (Fierce) (Press)
  • FDA Expands Indication for REVLIMID® (lenalidomide) as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (auto-HSCT) (Press)
  • Resverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Phase 2a Kidney Dialysis Trial (Press)
  • ImmusanT's celiac disease immunotherapy passes first clinical test (Fierce) (Press)
  • Zymeworks Submits ZW25 Phase 1 Clinical Study Findings Abstract for ASCO 2017 (Press)

US: Medical Devices

  • Philips upbeat on prospects for new image-guided therapy platform (Reuters) (MassDevice)
  • HIMSS 2017: Social media posts trigger cyber concerns (Fierce)
  • Seventh Sense Biosystems wins FDA nod for blood collection device (MassDevice)
  • Takeda and Cognition Kit partner in study to pilot wearable software in patients with Major Depressive Disorder (MDD) (Press)
  • Merit Medical sees 52-week high on Q4, 2016 beats (MassDevice)
  • Penumbra: Stroke study shows aspiration system equal to stent retrievers (MassDevice)
  • Meril's bioresorbable, drug-eluting vascular scaffold (Drug Delivery)
  • FDA Approves Increase in Number of Clinical Sites for E-QURE's Pivotal Trial of BST Device for the Treatment of Chronic Wound Care (Press)

US: Assorted & Government

  • FDA raced to find cause of meningitis outbreak (The Tennessean)
  • Generic Industry Hit With Avalanche Of Price Fixing Suits (Pink Sheet-$)
  • DEA Administrative Decisions Update: (Un)official Notice Revisited (FDA Law Blog)
  • Life Technologies Corp. v. Promega Corp. (2017) (Patent Docs)
  • And Now – From the Same Court That Gave Us Engle… (Drug & Device Law)
  • Single-Payer Health Care Bill Introduced In California Senate (KHN)
  • Baxter, Hospira Call Saline Price-Fixing Claims Illogical (Law360-$)
  • Less FDA Review May Boost Medical Device Plaintiff Awards (Law360-$)
  • Mylan Can't Shield Docs In $100M Tax Fight Over Drug License (Law360-$)

Upcoming Meetings & Events


  • Amgen wins marketing authorization for Repatha single-dose delivery option (Drug Delivery)
  • EMA to review generic version of Sobi's Orfadin (PharmaLetter-$)
  • Belgian CAR-T biotech enrols first blood cancer patient in new trial (BioPharmaReporter)
  • The British Pharmacopoeia – in 2017 and beyond (EPR)
  • Switzerland breaks silence on drug security label plans (Securing Industry)
  • I walk away knowing that the team here has made a difference (Pharmaceutical Journal)


  • China issues five-year plans on food and drug safety (PharmaLetter-$)
  • Is Takeda's Consumer Unit 'Agile' Enough To Stretch Outside Japan? (Pink Sheet-$)
  • Joint Storage and Transportation of Pharmaceuticals in Hokkaido by Astellas, Takeda, Teva Takeda Pharma and Teva Takeda Yakuhin - Further ensure stable supplies of pharmaceuticals (Press)


  • Dr. Reddy's API plant stays on probation with an FDA Form 483 (Fierce) (InPharmaTechnologist)  (Dr Reddy's)
  • Delhi HC asks government if it approved Biocon's trastuzumab for three cancers (Economic Times)
  • Zydus gets USFDA nod for phase II trials of liver drug (Economic Times)
  • Aurobindo recalls 47,000 bottles of antidepressant capsules in US (Economic Times)
  • NPPA directs stent cos to issue revised price lists to ensure price compliance (PharmaBiz)


  • BrainStorm seeks early Health Canada nod for NurOwn treatment (Drug Delivery)
  • Alimera, Knight seek Canadian regulatory nod for Iluvien intravitreal implant (Drug Delivery)
  • Summary Safety Review - Colorectal Stents Used with AVASTIN (bevacizumab) - Assessing the potential increased risk of bowel rupture (intestinal perforation) (Health Canada)
  • Summary Safety Review - Tramadol-containing Products - Assessing the Potential Risk of Serious Breathing Problems (Respiratory Depression) in Children and Adolescents (Health Canada)


  • R&D instability affecting Australian biotech, says report (PharmaLetter-$)
  • Submissions received: Guidance on risk management plans for medicines and biologicals (TGA)

Other International

  • Sun Pharma inaugurates first Egypt production facility (Pharmafile)

General Health & Other Interesting Articles

  • NIH consortium takes aim at vascular disease-linked cognitive impairment and dementia (NIH)
  • In the Face of ALS, Simon Fitzmaurice Finds His Fire Inside (NYTimes)
  • Popular Charity Heart Screenings For Teens May Cause More Problems Than They Solve (KHN)

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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