Regulatory Focus™ > News Articles > Regulatory Recon: FDA to Allow Biosimilar Sponsors to Select Suffixes for Non-Proprietary Names; WHO

Regulatory Recon: FDA to Allow Biosimilar Sponsors to Select Suffixes for Non-Proprietary Names WHO Says Hep C Drugs are 'Unaffordable' for Many (1 June 2016)

Posted 01 June 2016 | By Michael Mezher 

Regulatory Recon: FDA to Allow Biosimilar Sponsors to Select Suffixes for Non-Proprietary Names WHO Says Hep C Drugs are 'Unaffordable' for Many (1 June 2016)

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

  • BioMarin to Stop Developing Current Drugs for Duchenne Muscular Dystrophy (WSJ-$) (BioCentury) (SCRIP-$) (Press)
  • FDA Reverses Course on Random Suffixes for Biosimilar Names (Focus)
  • From $4.5 Billion To Nothing: Forbes Revises Estimated Net Worth Of Theranos Founder Elizabeth Holmes (Forbes)
  • We Desperately Need Bioethicists...To Get Out Of The Way Of Gene Therapy (Forbes)
  • CDRH Offers Peek Inside New Expedited Access Program for Breakthrough Devices (Focus) (FDA Voice)
  • StemCells to wind down operations after ending mid-stage study (Reuters) (Xconomy)
  • AC Immune files for US IPO to develop Alzheimer's drug (Reuters)
  • Girl With Zika-Related Microcephaly Is Born at a New Jersey Hospital (NYTimes)
  • Cancer doctors face next drug challenge (Financial Times)
  • DSHS Announces First Texas-Acquired Chikungunya Case (Texas DSHS)
  • It's Finally Here! FDA's VASCEPA Exclusivity Determination on Remand: NCE Exclusivity Granted! (FDA Law Blog)
  • Change Lessons From Pharma and Medtech (McKinsey&Co)
  • FDA Draft Guidance to Assist CMS With IDE Coverage Decisions (Focus)
  • FDA Warns CMO's Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies (Focus)

In Focus: International

  • NICE spurns Imbruvica, but opens door to CDF (BioCentury)
  • A new operating model for procedure management to improve support for evaluation procedures (EMA)
  • Valeant hands ex-chief more than $10m payout (Financial Times)
  • Daiichi Sankyo to not proceed with lung cancer study (Reuters)
  • Ukraine to de-regulate national pharmaceutical market (PharmaLetter-$)
  • Russian government to start limitation of drug imports (PharmaLetter-$)
  • MDSAP update: As pilot winds down, manufacturer buy-in still lacking, Part II (MassDevice, Part I)
  • HIV preventive treatment will not be offered in England (OnMedica)
  • WHO experts urge fairer pricing of 'unaffordable' hepatitis C cure (Reuters) (PLOS 1, 2) (The Guardian)
  • Dutch Project To Monitor Safety Of Biosimilar Switching (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Biopharmaceutical Industry Collaborating to Better Control Raw Material Quality Through Improved Supply Chain Communications (IPQ)
  • Making Transparency Work: why we need new efforts to make data usable (Harvard School of Public Health)
  • The Brave New World of Biosimilars (Medscape)
  • Gene Editing for HIV Therapies (Biotechr)
  • Nondisclosure of Financial Interest in Clinical Practice Guideline Development: An Intractable Problem? (PLOS, Study)
  • Generic Topical Patches: FDA Offers Draft Guidance on Adhesion Studies (Focus) (FDA)
  • Litigating the Accountability of Clinical Genomics Laboratories (Genomics Law Report)
  • How to Tell if Your Supplier's Quality System Is Failing (GxP Lifeline)
  • Four Ways To Make the Most of Patient Data (GeeksTalkClinical)
  • Blame the FDA for missing-in-action off-label guidelines? Nope, say two lawmakers. It's the HHS (Fierce)
  • Discovery Could Help Deliver Protein Drugs (Forbes)
  • Changing the Subject (Part 3): The "All-Cancer Trial" (RPM Report-$)
  • Big Pharma leads the charge in TV ad spending increases, analyst report finds (Fierce)
  • Everyone has EHRs, many are interoperable. Is anyone happy? (MedCityNews)
  • Spurious Relypsa Bear Report Built on Unreliable Safety Data (The Street)
  • How prevalent are diagnostic errors? Check out this infographic (MedCityNews)
  • Exclusion lists challenge drug developers (Outsourcing-Pharma)
  • Biogen's MS drug Zinbryta tied to more serious side effects than Avonex: Advera (Fierce)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; OTEZLA (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; OSPHENA (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; MEKINIST (FDA)

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

  • Priority Review for Lexicon's telotristat etiprate (BioCentury)
  • FDA approves Jentadueto XR from Boehringer Ingelheim, Lilly (DSN) (Press)
  • JUVÉDERM VOLBELLA XC Approved By U.S. FDA For Use In Lips And Perioral Rhytids (Press)
  • AbbVie and Eisai Subsidiary EA Pharma Commence Co-promotion of Fully Human Anti-TNF-α Monoclonal Antibody HUMIRA in the Field of Gastrointestinal Disease (Eisai)
  • Bayer Collaborates with U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP) to Investigate Stivarga (Regorafenib) Tablets as Additional Adjuvant Therapy in Colon Cancer (Press)
  • CEL-SCI Reports Monthly Patient Enrollment in May for Its Phase 3 Head and Neck Cancer Trial (Press)
  • GeNeuro Announces First Patients Treated in Phase 2b Study for Multiple Sclerosis (Press)
  • Transgene Announces Poster Presentation at ASCO Annual Meeting on the Phase 3 PHOCUS Clinical Trial with Pexa-Vec Oncolytic Immunotherapy (Press)
  • Syros Pharmaceuticals Announces FDA Acceptance of IND to Advance SY-1425 Into Phase 2 Clinical Trial (Press)

US: Medical Devices

  • Medtronic Revenue Continues to Grow on Acquisition (WSJ-$)
  • Medtronic reorganizes its restorative therapies segment (MassDevice)
  • MITA Signs HHS Interoperability Pledge (MITA)
  • An Ultrasonic Implant for Fighting Heart Failure (IEEE Spectrum)
  • Podcast: From FDA Inspections And Adverse Event Reports, To Medical Device Cybersecurity, Here's A 'Spring Cleaning' List (Gray Sheet-$)
  • FDA approves Bioventrix trial for Revivent TC heart failure device (MassDevice)
  • Clinical grade wearables market to reach $18.9bn by 2020 (Outsourcing-Pharma)
  • Intersect ENT Announces Completion of Enrollment in RESOLVE II Clinical Trial of New In-Office Implant for Recurrent Chronic Sinusitis (Press)

US: Assorted & Government

  • Ariosa Files Opposition to Sequenom's Cert Petition (Biologics Blog)
  • UnitedHealth to Exit Key ACA Market (WSJ-$) (Forbes) (KHN)
  • Valeant Faces RICO Suit In 'Secret' Pharmacy Network Row (Law360-$)
  • Sanders Calls for Support of California Drug Pricing Initiative (Policy and Medicine)

Upcoming Meetings & Events

Europe

  • Pixium wins UK nod for Iris II 'bionic eye' trial (MassDevice)
  • Adaptive Pathways: Earlier Access, But What About Data Exclusivity And SPCs? (SCRIP-$)
  • Cameron pledges to halve inappropriate prescribing of antibiotics (Pharmaceutical Journal-$)
  • French court rules woman can use dead husband's sperm (Reuters)
  • 6th meeting of the HTA Network (Brussels, 20 May 2016) (EC)
  • CEN/CENELEC Initiative To Address 'Turmoil' In Harmonizing Medtech Standards (SCRIP-$)
  • European Drug Report 2016 (EMCDDA)
  • Downstream test facility set to address scale-up issues and keep investment in UK (BioPharma-Reporter)

Asia

  • Link gets China rights to 4SC cancer candidate (BioCentury)
  • Taking Takeda global (BioCentury)
  • Japan PCSK9 Rivalry Builds As Praluent Edges Closer To Market (PharmasiaNews-$)
  • Anticancer Agent Halaven Approved In The Philippines For New Indication For Treatment Of Soft Tissue Sarcoma (Press)
  • Toyama's pneumonia drug phase II trials records success (BioSpectrum)

India

  • Time for India to be innovator nation in bio-pharma: Expert (Economic Times)
  • Aurobindo Pharma to keep focus on drug launches in US, costs in Europe (Economic Times)
  • Fy17 forecast: Sun Pharma expects 8-10 per cent sales growth (Economic Times)
  • Glenmark plans to raise up to $200 million via FCCBs (Economic Times)
  • More than 2,000 Indians contract HIV after transfusions (Economic Times)
  • Strides Shasun gets tentative nod from USFDA for Roflumilast tablets (Economic Times)
  • Gujarat FDCA shortlists 50 drug inspectors to get online training on GMP (PharmaBiz)

Zika

  • CDC releases interim guidance on Zika testing and interpretation of results (CDC)

Other International

  • Guinea declared free of active Ebola transmission: WHO (Reuters)
  • Autologous insulin developer Orgenesis forms Israeli cell therapy JV (BioPharma-Reporter)

General Health & Other Interesting Articles

  • American Death Rate Rises for First Time in a Decade (NYTimes)
  • Women with Migraine Face Increased CV Risk (CardioBrief)
  • Thomas Ehrlich On Colon Surgery (Forbes)

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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