Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 2017)

Posted 23 June 2017 | By Michael Mezher 

Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 2017)

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

In Focus: US

  • Unpacking The Senate's Take On ACA Repeal And Replace (Health Affairs Blog) (KHN) (Forbes) (NYTimes) (NYTimes) (Politico)
  • Senate Health Bill Would Repeal Device Tax (Focus)
  • How the Senate health bill compares to House, 'Obamacare' (AP)
  • US health sector hits record high on Senate bill, biotech rally (Reuters)
  • Health Bill Includes Opioid Funding, but May Not Satisfy Some GOP Senators (WSJ) (STAT)
  • Where Senators Stand on the Health Care Bill (NYTimes)
  • The Endpoints 100 CEO Survey: Execs offer a big thumbs up for Gottlieb and some suggestions for making the FDA a better agency (Endpoints)
  • Bluebird Bio's gene therapy for blood disorders yields some impressive results ― but also raises questions (STAT) (Xconomy) (Press)
  • FDA Approves CSL Behring's Self-Administered C1 Esterase Inhibitor HAE Prophylactic (GEN) (Endpoints) (Fierce) (PharmaTimes) (FDA) (Press)
  • FDA approves more convenient form of Roche blood cancer drug (Reuters) (Press)
  • FDA rejects Pfizer's Epogen biosimilar for the second time (Fierce) (Endpoints) (BioCentury) (Pharmafile) (Press)
  • Novartis' Tafinlar + Mekinist Combo Wins FDA Okay for BRAF V600E-Mutant NSCLC (GEN) (PharmaTimes) (Press)
  • Pharma's new justification for high drug prices, and other takeaways from #BI02017 (STAT)
  • Orphan drug market set to climb above $200B: Report (Fierce)
  • Mylan shareholders vote against executive pay, re-elect board (Reuters)
  • Blurred Lines: The Convergence of Med Device and Pharma in 2017 ( MDDI)

In Focus: International

  • German court rejects compensation claim over faulty breast implants (Reuters)
  • Small-cap focus: UK's booming biotech groups (Financial Times)
  • Samsung Is Poised to Sell More Drugs (The Street)
  • Chinese courts call for death penalty for researchers who commit fraud (STAT)
  • European Regulatory Roundup: EMA Tasks Working Groups With Redistributing Workloads in Run Up to Brexit (Focus)
  • NHS England re-opens innovation accelerator scheme (PharmaTimes)
  • NICE turnaround for AstraZeneca's COPD drug Daxas (PharmaTimes)
  • Drugmaker Astellas handed further ABPI suspension (Financial Times) (ABPI)
  • BIO Expands Cooperation with China-Based Pharma Group (BIO)
  • Canada Aims To Implement eCTD v4 By 2022 (Pink Sheet-$)
  • GSK's new CEO aims to divest sports nutrition brand: sources (Reuters)
  • Asia Executives To Watch: New FDA China Director Named Amid ICH Push (SCRIP-$)
  • Key Indian Panel Go-Ahead For Novartis' Kisqali (Pink Sheet-$)
  • Could Trump's NAFTA Renegotiation Hit Canadian Drug Price Controls? (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • 14 Years Old. Losing Muscle Every Day. (NYTimes)
  • The multiple sclerosis market (Nature)
  • Martin Shkreli, 'Pharma Bro,' Prepares for Trial: 'I'm So Innocent' (NYTimes)
  • Unleashing CAR-T Therapies on Solid Tumors: Are We There Yet? (BIO)
  • How to prepare for ICH E6 R2 implementation (OutsourcingPharma)
  • Seqirus first to reach large-scale manufacture of cell-based influenza vaccines (Fierce)
  • Rare cancers through the looking glass ( Pharmafile)
  • FDA's OPQ Emerging Tech Program Plans to Help Sponsors Avoid Manufacturing Quality Failure (FDA News-$)
  • Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance (FDA)
  • BIO Notebook, Day 4: Annual Convention Winds Down With Oncology In The Spotlight (SCRIP-$)
  • Patients may buy idea of injectable meds with a little manipulation (Reuters)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • PhIII-focused Cara sees shares spike on its new 'breakthrough' status at the FDA (Endpoints)
  • Presentation confirms Venclexta/Venclyxto monotherapy benefit in certain patients with high-risk chronic lymphocytic leukaemia and its potential in other hard-to-treat blood cancers (Press)
  • Roche presents new data from GALLIUM study reinforcing clinical benefit of Gazyva/Gazyvaro in people with previously untreated follicular lymphoma (Press)
  • New data at EAN show Roche's OCREVUS (ocrelizumab) significantly reduced multiple measures of disease progression in relapsing and primary progressive multiple sclerosis (Press)
  • Indivior presents Phase III data on sustained-release opioid addiction therapy (PharmaLetter-$)
  • Takeda Presents Data from Phase 1/2 Studies for NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma Patients and in the Maintenance Setting (Press)
  • Acceleron Provides Updated Results from Phase 2 Studies of Luspatercept in Beta-Thalassemia at the 22nd Congress of the European Hematology Association (Press)
  • Acceleron Provides Updated Results from Ongoing Phase 2 Study of Luspatercept in Myelodysplastic Syndromes at the 22nd Congress of the European Hematology Association (Press)
  • Alzheon says data backs potential of Alzheimer's candidate (PMLive)

Medical Devices

  • Was Bristol-Myers Squibb's assay to blame for Opdivo's first-line lung flop? (Fierce)
  • Aethlon looks fast-track FDA nod for Hemopurifier blood filter through EAP (MassDevice)
  • Bard wins FDA approval for LifeStream covered iliac stent (MassDevice)
  • FDA grants de novo clearance for Merit Medical's Embosphere (MassDevice)
  • Medtronic warns on button glitch with MiniMed 640G insulin pump (MassDevice)
  • Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee (FDA)
  • Philips picks up EEG dev Electrical Geodesics for $37m (MassDevice)
  • ClearFlow wins FDA 510(k) for FlowGlide (MassDevice)
  • FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies (Press)
  • Roche receives FDA approval for fourth-generation HIV combination antigen-antibody assay --allowing detection of infection with high sensitivity and specificity (Press)

US: Assorted & Government

  • U.S. sues to stop western hospital system from buying clinics (Reuters)
  • Humana out of individual market, with or without Obamacare repeal (Reuters)
  • AHRQ's potential move to the NIH could strengthen its work (Modern Healthcare)
  • IBM VP & Chief Health Informatics Officer Dr. Anil K. Jain Appointed to the Health Information Technology Advisory Committee (IBM)
  • Eastern District of Wisconsin Grants Summary Judgment on Hip Component Manufacturer's Negligence Claims But Denies Summary Judgment on Strict Liability Claims. (Drug & Device Law)
  • Another Request for a Stay and Reconsideration of the Final Nutrition Labeling Rule (FDA Law Blog)

Upcoming Meetings & Events


  • HIV cases in gay men fall for the first time in England (Pharmafile)
  • Vaccine Liability In Europe: A New Development (Harvard Bill of Health)
  • Ewopharma to commercialize Eisai drugs in Central Eastern Europe (PharmaLetter-$)
  • EuroBiotech: More Articles of Note (Fierce)
  • Swiss Kuros Biosciences wins CE Mark for NeuroSeal dural sealant (MassDevice)


  • DoP rejects Sun Pharma's review petition against ceiling price fixation of "Lithium 300 mg" (PharmaBiz)


  • Exactech wins Japanese nod for shoulder, knee, hip replacement systems (MassDevice)


  • Sommetrics wins Health Canada nod for non-invasive sleep apnea device (MassDevice)

General Health & Other Interesting Articles

  • United States rejects U.N. call for access to safe abortions (Reuters)
  • Humanitarian Aid Is 'Broken,' Says Former U.N. Official (NPR)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles