FDA accepts Sandoz's BLA for biosimilar pegfilgrastim to treat non-myeloid cancer
The US Food and Drug Administration (FDA) has accepted Sandoz's biologics licence application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulat… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - November 19, 2015 Category: Pharmaceuticals Source Type: news
Novartis biosimilar takes aim at Amgen drug Neulasta
ZURICH (Reuters) - The U.S. Food and Drug Administration has accepted Novartis unit Sandoz's submission for approval of a biosimilar version of U.S.-based Amgen's Neulasta drug that fights infections in cancer patients, the Swiss group said on Wednesday. (Source: Reuters: Health)
Source: Reuters: Health - November 18, 2015 Category: Consumer Health News Tags: healthNews Source Type: news
NLM’s Radiation Emergency Medical Management (REMM) Site Redesigned
The National Library of Medicine’s Radiation Emergency Medical Management (REMM) site has been redesigned. REMM now includes a more modern banner, a refreshed color palette and font style, and a new navigation system.
There are six content groups and an easy-to-use navigational menu on the home page with sections for:
Interactive Clinical Tools,
Diagnosis and Treatment,
Reference and Data,
Overview of REMM, and
Links to downloading the REMM app for various mobile devices
Significant content updates have been added including:
New references and on most of the Emergencies Incidents pages
New references in the Key...
Source: Dragonfly - October 9, 2015 Category: Databases & Libraries Authors: Emily Glenn Tags: Emergency Preparedness News from NLM Technology Source Type: news
Sustained Rigors and Fever in Filgrastim HypersensitivitySustained Rigors and Fever in Filgrastim Hypersensitivity
Learn from this case study of a 36-year-old man who presented to an emergency room with fever, fatigue, and severe rectal pain. Oncology Nursing Forum (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 28, 2015 Category: Consumer Health News Tags: Nursing Journal Article Source Type: news
Intas Pharma expects US approval for Neulasta biosimilar this year
India's Intas Pharmaceuticals Ltd could get approval this year to launch a version of Amgen Inc's white blood cell boosting Neulasta drug in the United States. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 18, 2015 Category: Pharmaceuticals Source Type: news
Sandoz launches Zarxio (TM) (filgrastim-sndz), the first biosimilar in the United States
Launch follows March 6, 2015 FDA approval. Sandoz One SourceTM offers patient support services (Source: Pharmacy Europe)
Source: Pharmacy Europe - September 3, 2015 Category: Drugs & Pharmacology Authors: Annabel De Coster Tags: *** Editor's Pick Biosimilars Clinical trials Practical therapeutics Oncology fda approval filgrastim-sndz Latest News zarxio Source Type: news
Neupogen (Filgrastim Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 14, 2015 Category: Drugs & Pharmacology Source Type: news
Novartis's Sandoz cleared to launch generic version of Amgen’s Neupogen
Novartis's subsidiary Sandoz has been cleared to launch its biosimilar Zarxio (filgrastim) in September, after the US Court of Appeals for the Federal Circuit declined Amgen's claims. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - July 21, 2015 Category: Pharmaceuticals Source Type: news
Novartis Blocked From Selling Neupogen Copycat Until Sept. 2Novartis Blocked From Selling Neupogen Copycat Until Sept. 2
Novartis AG unit Sandoz must wait until Sept. 2 to sell Zarxio (filgrastim-sndz), the first biosimilar drug to be approved in the United States and a copycat version of Amgen Inc's $1.2 billion-a-year anti-infection drug Neupogen (filgrastim), a U.S. appeals court said on Tuesday. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 21, 2015 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news
Biosimilar Filgrastim vs Lenograstim in Autologous HSCTBiosimilar Filgrastim vs Lenograstim in Autologous HSCT
Find out how these biosimilars stack up for autologous HSCT in patients with hematological malignancies. Therapeutic Advances in Hematology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 2, 2015 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
Monthly News Roundup - March 2015
FDA Approves First Biosimilar Product Zarxio
On Friday, March 6th the U.S. Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim-sndz), the first U.S. approved biosimilar. Zarxio, the biosimilar for Amgen’s filgrastim... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - March 31, 2015 Category: Pharmaceuticals Source Type: news
Zarxio (Filgrastim-sndz Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 12, 2015 Category: Drugs & Pharmacology Source Type: news
Novartis's Sandoz receives FDA approval for biosimilar Zarxio
Novartis subsidiary Sandoz has received approval from the US Food and Drug Administration (FDA) for its Zarxio (filgrastim-sndz) for all indications included in the reference product's label. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - March 9, 2015 Category: Pharmaceuticals Source Type: news
FDA Approves First Biosimilar Product (FREE)
By Kristin J. Kelley
Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
The FDA has approved the first biosimilar product in the U.S. — filgrastim-sndz (marketed as Zarxio).A biosimilar is a … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - March 9, 2015 Category: Primary Care Source Type: news
First Biosimilar, a Filgrastim Copycat, Is Approved
(MedPage Today) -- Zarxio will compete against Amgen's Neupogen, but price impact still unclear. (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 6, 2015 Category: American Health Source Type: news
