Regulatory Focus™ > News Articles > Regulatory Recon: First Biosimilar Application Gets FDA Support (6 January 2015)

Regulatory Recon: First Biosimilar Application Gets FDA Support (6 January 2015)

Posted 06 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: First Biosimilar Application Gets FDA Support (6 January 2015)

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

In Focus: US

  • Extrapolation main focus of first biosimilar advisory committee meeting (BioCentury) (MM&M) (Tarius) (Fierce) (Pink Sheet-$) (Reuters) (SCRIP-$)
  • FDA Adds Temporary Expertise To ODAC For Filgrastim Biosimilar Meeting (Pink Sheet-$)
  • FDA Scrutinizing Laxatives as a Childhood Remedy for Constipation (NYTimes)
  • Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice Strategy (FDA Law Blog)
  • Are Medical Device Trial Approval Times Getting Shorter? (MDO)
  • FDA's UDI Database Goes Live This Month By Accepting Accounts (IHP-$)
  • House Staffers Concerned With State 'Right To Try' Laws, 10 More Expected (IHP-$)

In Focus: International

  • Latvian Presidency to support rapid access to innovative medical devices (Clinica-$)
  • Italian Medicines Agency withdraws GMP certificate from Indian manufacturer (In-Pharma)
  • European Medicines Agency seeks brand development consultancies (Design Week)
  • France, Ireland oppose Mysimba EU approval on safety/efficacy grounds (SCRIP-$)
  • India calls for post-marketing data on cancer drugs approved without local trials (Outsourcing Pharma)
  • After “Peculiar” Turns, Abbvie Loses Patent Claim For Humira In India (PharmAsia-$)
  • South Korea's medtech chief is new AHWP chair (Clinica-$) (AHWP)

US: Pharmaceuticals and Biotechnology

  • Extrapolation main focus of first biosimilar advisory committee meeting (BioCentury) (MM&M) (Tarius) (Fierce) (Pink Sheet-$) (Reuters) (SCRIP-$)
  • FDA Adds Temporary Expertise To ODAC For Filgrastim Biosimilar Meeting (Pink Sheet-$)
  • FDA Scrutinizing Laxatives as a Childhood Remedy for Constipation (NYTimes)
  • Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice Strategy (FDA Law Blog)
  • House Staffers Concerned With State 'Right To Try' Laws, 10 More Expected (IHP-$)
  • DARA BioSciences Granted Waiver of Product and Establishment Fees by the FDA (Press)
  • After Sales, FDA Priority Review Vouchers Raise Pharma Industry Interest (Bloomberg)
  • Drug Companies Push For Predictability In Naming System Over Reservations (IHP-$)
  • Some Doctors Push Distinct Biosimilar Names, Breaking From AMA Stance (IHP-$)
  • Vaccine failure more apparent as flu spreads (SCRIP-$)
  • Warning and NOV Letters Plummet in 2014 (Eye on FDA)
  • FDA approves first dermal filler to treat acne scarring (Reuters) (Press)
  • Senators Ask Agency Heads If They Need Help Limiting Animal Antibiotics (IHP-$)
  • Actavis Accuses NY AG Of Trying To Slow Injunction Appeal (Law 360-$)
  • FDA says patients had problems after being given IVs intended for training (Fierce)
  • FDA Says Generic Copies of Reyataz (Atazanavir Sulfate) Can Come to Market (FDA)
  • Overly conservative FDA label likely prevents use of metformin in many type 2 diabetics (Press)

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

  • LEO Pharma Announces New Drug Application Submission of the First Aerosol Foam for Plaque Psoriasis (Press)
  • Cytrx cancer drug shows promise in trial, shares rise (Reuters)
  • Gamida Cell's NiCord Receives FDA and EMA Orphan Drug Designation (Press)
  • Tonix Pharma Gets FDA Written Guidance On Phase 3 Program For TNX-102 SL (Press)

US: Pharmaceuticals and Biotechnology: General

  • CVS to cover Gilead hepatitis C treatment over AbbVie regimen (Reuters) (SCRIP-$)
  • Calif. County Drug Cleanup Law Is Illegal, High Court Told (Law 360-$)
  • Chuck Norris Attacks The Pharmaceutical Industry (Forbes)

US: Medical Devices

  • Are Medical Device Trial Approval Times Getting Shorter? (MDO)
  • FDA's UDI Database Goes Live This Month By Accepting Accounts (IHP-$)
  • FDA Petitioned to Add Black Box Warning to LASIK (FDA)
  • FDA Grants NeuroSigma Humanitarian Use Device (HUD) Designation (Press)
  • VasoPrep Surgical Announces De Novo Product Clearance by US Food and Drug Administration (Press)
  • Cohera Medical Receives PMA Approvable Letter from U.S. FDA for TissuGlu Surgical Adhesive (Press)
  • dBMEDx Announces FDA Clearance of the BBS Revolution Bladder Scanner (Press)

US: Dietary Supplements

  • Dietary Ingredient Identity Testing Exemptions Remain A Puzzle (Tan Sheet-$)

US: Assorted And Government

  • New Batch of FDA Warning Letters Posted (FDA)
  • FDA in Crosshairs of new Senate Health Chair, Lamar Alexander (Politico)

Upcoming Meetings

Ebola Outbreak

Europe

  • Latvian Presidency to support rapid access to innovative medical devices (Clinica-$)
  • Italian Medicines Agency withdraws GMP certificate from Indian manufacturer (In-Pharma)
  • European Medicines Agency seeks brand development consultancies (Design Week)
  • France, Ireland oppose Mysimba EU approval on safety/efficacy grounds (SCRIP-$)
  • MHRA Posts New Regulatory "Orange" and "Green" Guides (MHRA)
  • Recombinant FVIII Fc Under Review in Europe (HCPlive)
  • Report on Failed Devices in the UK (Daily Mail)
  • Kite Pharma Granted Orphan Drug Designation in the European Union for KTE-C19, Kite's Lead Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy (Press)

India

  • India calls for post-marketing data on cancer drugs approved without local trials (Outsourcing Pharma)
  • Health ministry releases draft Drugs and Cosmetics (Amendment) Bill, 2015 to amend D&C Act, 1940 (PharmaBiz) (DNA India)
  • After “Peculiar” Turns, Abbvie Loses Patent Claim For Humira In India (PharmAsia-$)
  • AIDCOC urges Centre to give fair chance to state drug regulators in int'l drug regulatory programmes (PharmaBiz)

Australia

  • Consultation: Regulation of autologous stem cell therapies: Discussion paper for consultation (TGA)

Other International

  • South Korea's medtech chief is new AHWP chair (Clinica-$) (AHWP)
  • Globalizing the Development of Generic Medicines (FDA Life)

Regulatory Reconnaissance #465 – 6 January 2015

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 @AlecGaffney 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.


Categories: Recon, Regulatory News

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