Regulatory Focus™ > News Articles > Regulatory Recon: CMS Finalizes Biosimilars Payment Rule Despite Opposition (2 November 2015)

Regulatory Recon: CMS Finalizes Biosimilars Payment Rule Despite Opposition (2 November 2015)

Posted 02 November 2015 | By Michael Mezher 

Regulatory Recon: CMS Finalizes Biosimilars Payment Rule Despite Opposition (2 November 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Vertex Pharma receives subpoena from Department of Justice (Reuters)
  • CMS finalizes payment rule for biosimilars (BioCentury) (InsideHealthPolicy) (SCRIP-$)
  • No timeline on Sientra’s return to breast implant market (MassDevice)
  • Biosimilar User Fees Could Be Raised Significantly In Renewal Talks (Pink Sheet-$)
  • Amarin free speech settlement delayed (BioCentury)

In Focus: International

  • Improving the quality of medical devices (ISO)
  • Data Integrity Inspections Go Global For Pharma (SCRIP-$)
  • ICH issues norms on assessment of DNA reactive impurities in drugs to limit potential carcinogenic risk (PharmaBiz)
  • Harvard launches new global health centre in Dubai (The Lancet)
  • South Africa Asked to Allow Generics for AbbVie HIV Drug (Bloomberg)

Sponsored Content

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US: Pharmaceuticals and Biotechnology

  • FDA To Clarify Human Cell And Tissue Product Regulations (Pink Sheet-$)
  • PDUFA Negotiations Begin With FDA Seeking Review System Reform (Tan Sheet-$)
  • New Diabetes Study Shows How Big Data Might Drive Precision Medicine (Forbes)
  • Forbes Commentary on '60 Minutes' Coverage of Heroin Epidemic (Forbes) (Forbes)
  • The Churchillian Biotech IPO: This Is Not Even The Beginning Of The End (LifeSciVC)
  • Payers' Choice: Death Is Cheap; Drugs Add Costs (SCRIP-$)
  • Draft Guidance: Bioequivalence Recommendations for Progesterone (FDA)
  • Melanoma Approvals Break New Ground In Immunotherapy (Pink Sheet-$)
  • Malaria protein conjugate could deliver anti-cancer drugs, researcher (In-PharmaTechnologist)
  • Will Kanuma Bring Alexion A Second Priority Review Voucher? (Pink Sheet-$)
  • Researchers Shed Light on Protein-Related Diseases (DD&D)

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

  • Isis Pharmaceuticals initiates Phase 2 study of ISIS-FXI Rx in ESRD (EPR)
  • Merck Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for KEYTRUDA® (pembrolizumab) in Advanced Colorectal Cancer (Press)
  • Daiichi Sankyo’s tumor treatment gets Breakthrough Therapy Designation (BioSpectrum)
  • New Data Continue to Characterize the Safety and Efficacy of XELJANZ® (tofacitinib citrate) in the Treatment of Rheumatoid Arthritis (Pfizer)
  • Ironwood and Allergan Initiate Phase IIb Clinical Trial of Linaclotide Colonic Release in Adults with Irritable Bowel Syndrome with Constipation (Press)

US: Medical Devices                        

  • Draft Guidance: Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices (FDA)
  • Theranos Scrutiny Shows FDA's Murky Oversight Of Lab Tests (Law360-$)
  • Novel antibacterial glasses prevent the infections associated with surgical implants (MNT)
  • UTMB researchers help discover simple, affordable diagnostic kit for chikungunya (MNT)
  • FDA approves Novartis’ Utibron Neohaler (DSN)
  • Tryton Medical Files Pre-Market Approval Application with US FDA for Tryton Side Branch Stent (Press)
  • ACADIA Pharmaceuticals Announces FDA Priority Review of NUPLAZID™ (Pimavanserin) New Drug Application for Parkinson’s Disease Psychosis (Press)

US: Assorted and Government

  • Nearly 500 Hospitals Pay United States More Than $250 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices (DoJ)
  • Large Scale Miami Drug Supplier Pleads Guilty in Nationwide Prescription Drug Diversion Scheme (DoJ)
  • Budget deal could boost FDA, NIH, hurt 21st Century Cures (BioCentury)
  • Budget Approval Means FDA Will Stay Open (FDANews-$)
  • So … How Do We Help FDA Get a Fair Cut of the Extra $40 Billion? (Alliance for a Stronger FDA)
  • Theranos Battled in Courtroom Over Name of Its Chief Product (NYTimes)
  • Fresenius Beats FCA Suit Over Charging Free Excess Drugs (Law360-$)

Upcoming Meetings and Events              


  • Final NICE 'no' for pancreatic cancer drug (PharmaTimes)
  • Europe plans IP waiver for pharma manufacturing (In-PharmaTechnologist)
  • EC approves Eylea for myopic choroidal neovascularization (EPR)
  • HTA is high on the European agenda for action (EUnetHTA)
  • Stemline Therapeutics Announces SL-401 Receives EU Orphan Drug Designation for Treatment of BPDCN (Press)
  • New initiative to boost UK pathology research (PharmaTimes)
  • European Commission funds €23m project to develop HIV vaccine (Pharmafile)
  • New EU indication for Bayer/Regeneron's eye jab Eylea (PharmaTimes)


  • Medical Devices Safety Update, Volume 3, Number 6, November 2015 (TGA)
  • Mallinckrodt's pharmaceutical gas approved in Australia and Japan (BioSpectrum)


  • The State Of India’s Drug Regulatory System (24 Insight)
  • Indian drug manufacturing companies need to make continuous efforts to maintain quality: Dr Vadlamudi (Pharmabiz)
  • CDSCO to have Central Drugs Testing Lab in Indore, plans offices in all states: Dr K Bengaru Rajan (PharmaBiz)
  • Pharma pricing authority NPPA puts cap on 18 formulations packs’ prices (Economic Times)
  •  Health ministry issues revised H1N1 guidelines to state (Economic Times)
  • Sanofi bets on dengue vaccine, 5 other drugs to bolster India play (Economic Times)
  • India's disproportionately tiny health budget: A national security concern? (Economic Times)
  •  India-Africa Summit focus on generics and Indian investment in Africa (PharmaLetter-$)


  • Japan’s PMDA Clarifies India Plans Amid Asia Cooperation (PharmAsiaNews-$)
  • Eisai Presents Results From Phase III Trial of Antiepileptic Drug Perampanel as Adjunctive Therapy For Refractory Partial-Onset Seizures Conducted in Asia Including Japan (Press)

Ebola Outbreak

  • Scientists Demonstrate a Way to Reduce the Ability of Ebola Virus to Exit a Host Cell and Spread (ICT)
  • The FDA Learned Nothing from Ebola (The Weekly Standard)

Other International

  • Uganda Calls for Continued Drug Patent Exemption (VOA)
  • More Govt Help For Korean Stem Cell, Gene Therapy Bioventures (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • Health care workers at heightened risk of hepatitis C (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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