Regulatory Recon: House Committee Schedules FDA Budget Hearing; Janssen Sues to Block Samsung Bioepis' Remicade Biosimilar (19 May 2017)

Posted 19 May 2017 By Michael Mezher

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

In Focus: US

  • Janssen files suit in U.S. to block sale of Samsung Bioepis' Remicade copy (Reuters) (Pharmafile)
  • Nearly 700 vacancies at CDC because of Trump administration's hiring freeze (Washington Post)
  • Jim Chanos slams Express Scripts and Mallinckrodt over high drug prices (Reuters)
  • Democratic attorneys general seek to intervene in Obamacare case (Reuters)
  • FDA Approves Keytruda for Advanced or Metastatic Urothelial Carcinoma (Press)
  • House Appropriations Committee to Hold FDA Budget Hearing on 25 May (Appropriations)
  • House Subcommittee Advances User Fee Reauthorizations (Focus)
  • Schrader Amendment to House UFA Package Creates New "Competitive Generic Therapy" Pathway and 180-Day Exclusivity (FDALawBlog) (Pink Sheet-$)
  • House committee adds pharma 'bad actor' provision to FDA user fee bill (Modern Healthcare)
  • FDA, Industry Look for Gaps in Cybersecurity (Focus) (Emergo)
  • How did Vertex win an FDA approval without running a clinical trial? (STAT)
  • Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance (Focus)
  • Petition to FDA Seeks to Modify Trial Regulations Following Deaths (Focus) (Endpoints)
  • Crispr Creator Jennifer Doudna on the Promises—and Pitfalls—of Easy Genetic Modification (Wired)
  • FDA, Under New Leadership, Seeks More Comments on Rules Affecting Off-Label Communications (FDALawBlog)
  • Toward A New Model For Promoting The Development Of Antimicrobial Drugs (HelathAffairsBlog)
  • How Democrats' health law improved health care (Politico)
  • That Time Trump Wanted to Cut Science and Got a Portrait Instead (Bloomberg)
  • New 510(k) Approach Would Leverage FDA Objective Criteria (AdvaMed)
  • 340B Purchases Were More Than Half of the Hospital Market in 2016 (Drug Channels)

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In Focus: International

  • PRIME: The First 12 Months (EMA)
  • Drugs Watchdog in London Courted With Spanish Lessons, Childcare (Bloomberg)
  • As hopes for polio eradication rise, the endgame gets complicated, and a vaccine runs short (STAT)
  • India's drug factories provide breeding ground for deadly viruses (EurActiv)
  • Astellas completes 800 million euro biotech acquisition (PharmaTimes)
  • Novartis' Swiss head of operations reveals job cuts (PMLive) (PharmaLetter-$)
  • Teva, ditching a penchant for Israeli execs, taps out-of-towner as lead CEO pick (Fierce)
  • European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (Focus)
  • Hopes -- And Questions -- Are Raised By Study Of French Biotech's ALS Drug (Forbes) (Fierce)
  • Roche builds case for T-cell bispecific-anti-PD-L1 combo (Fierce)
  • Major research funders and NGOs to implement WHO standards on reporting clinical trial results (PharmaLetter-$)
  • Merck Develops 'New And Improved' CRISPR (SCRIP-$)
  • High Rejection Rate of Proposed Brand Names On EMA Radar (Pink Sheet-$)
  • Russian government to lift restrictions on setting prices for low-priced drugs (PharmaLetter-$)
  • Pope tells geneticists that destroying embryos is unjustifiable (Reuters)
  • Suspected Ebola cases in Congo rise to 29: WHO (Reuters) (NYTimes)
  • WHO seeking to bring Merck Ebola vaccine to latest outbreak area (BioWorld)
  • For millions of Chinese with rare diseases, some relief in sight (Reuters)
  • Hikma cuts revenue forecasts after drug approval setback (Financial Times)

US: Pharmaceuticals & Biotechnology

  • Pharma's Identity Crisis: Four strategies for creating value in life sciences (Pharmafile)
  • Ex-Sarepta CEO Garabedian Returns to Run Bio Accelerator Xontogeny (Xconomy)
  • More Women Live Longer With Metastatic Breast Cancer, But Questions Remain (Forbes) (NIH)
  • User Fee Reauthorization: Just When You Thought It Was Safe to Go Back into the Ocean! (Lachman Consultants)
  • It's Not All About IO: Seven Drugs To Watch At ASCO (SCRIP-$)
  • A Consumer-Centered Framework For Quality: How Do We Get There From Here? (HealthAffairsBlog)
  • Drug Promotion: Exclusivity Warrants Narrow Exception From Free Speech Protections (Pink Sheet-$)
  • Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run (Pink Sheet-$)
  • Manufacturer Communications: Industry Seeks Single Evidentiary Standard (Pink Sheet-$)
  • Alzheimer's research seeing 'exceptionally high levels' of innovation (PharmaTimes)
  • Data Integrity Problems Remain FDA Investigators' Focus (Pink Sheet-$)
  • ASCO: Lilly's abemaciclib vs. Pfizer's Ibrance? Too early to make a call, analysts say (Fierce)
  • New study could boost vaccination argument for Merck's Gardasil (Fierce)
  • No causal link between Viagra use and melanoma, study finds (Pharmafile)
  • Stem Pharm Aims to Add to Madison's Stem Cell Past with Biomaterials (Xconomy)
  • Antibodies from Ebola survivor protect mice and ferrets against related viruses (NIH)
  • Researchers connect brain blood vessel lesions to intestinal bacteria (NIH)
  • Product-specific pharmacovigilance (GaBI)

US: Medical Devices

  • Navigating the regulatory and development pathways for drug-device products (MassDevice)
  • Report: New Apple Watch could include glucose monitor, other health tech (MassDevice)
  • FDA panel recommends approval for TransMedics lung transplant device (MassDevice)
  • Ambionics creates 3D printed prosthetic arm for infants (Medical Design & Outsourcing)
  • Accreditation Bodies: Who They Are and What They Do (FDA)
  • Keeping Glucose Stable at the Hospital Bedside (MDDI)
  • Class 1 Device Recall Philips V60 Ventilators (FDA)
  • Correspondence: Registry-Based Surveillance of Medical-Device Safety (NEJM)
  • Rotation Medical release initial results for 'bioinductive' shoulder implant (MassDevice)

US: Assorted & Government

  • 'An embarrassment': U.S. health care far from the top in global study (Washington Post)
  • 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (HHS)
  • Ex-NIH director warns mooted Trump funding cuts would 'disembowel' U.S. research institutions (Fierce)
  • That Heart Attack Is Going To Cost You (Forbes)
  • Is the Government Protecting Your Private Information? (Drug & Device Law)
  • PTAB Life Sciences Report -- Part II (Patent Docs)
  • California Bill Addresses Safety Concerns At Dialysis Clinics (KHN)

Upcoming Meetings & Events

Europe

  • Faulty defibrillator: users urged to check battery connection (MHRA)
  • Conservative Party manifesto: ABPI response (ABPI)
  • Scientists to test whether Zika can kill brain cancer cells (Reuters)
  • CE Mark suspended for GI Dynamics EndoBarrier (MassDevice)
  • Iterum bags $65M for phase 3 trial of ex-Pfizer antibiotic (Fierce)
  • Russia may face drugs shortages in future due to new labeling system (PharmaLetter-$)

Asia

  • Chinese Food and Drug Administration (CFDA) Proposes New Patent Linkage and Data Protection Regime (Lexology)
  • MSD submits application for approval of type-2 diabetes drug combining selective DPP-4 inhibitor and selective SGLT2 inhibitor (Astellas)

India

  • Strides Shasun inks JV pact with Vivimed Labs (Economic Times)
  • Indian pharma hiring landscape takes a new route to replace its sales team with healthcare professionals (PharmaBiz)
  • Maha FDA issues over 3.83 lakh manufacturing and sale licenses through its online platform (PharmaBiz)
  • IDMA urges commerce ministry not to abolish advance licensing scheme for pharma exporters (PharmaBiz)

Australia

  • Medicines Safety Update, Volume 8, Number 2, April-May 2017 (TGA)
  • Compounded medicines and good manufacturing practice (GMP) (TGA)

Other International

  • Cuba says Zika tally rises to nearly 1,900 cases (Reuters)
  • Yemen cholera cases could hit 300,000 within six months: WHO (Reuters)

General Health & Other Interesting Articles

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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