Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
JERUSALEM--(BUSINESS WIRE)--Aug. 6, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved Granix (tbo-filgrastim) Injection for a new vial presentation and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 6, 2018 Category: Drugs & Pharmacology Source Type: news

Nivestym (Filgrastim-aafi Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 6, 2018 Category: Drugs & Pharmacology Source Type: news

Second Filgrastim Biosimilar Gets Thumbs Up From the FDA Second Filgrastim Biosimilar Gets Thumbs Up From the FDA
The FDA has granted approval to Nivestym, which has several clinical uses.FDA Approvals (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 20, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2018 Category: Drugs & Pharmacology Source Type: news

Neupogen (Filgrastim Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 11, 2018 Category: Drugs & Pharmacology Source Type: news

Mylan CEO: Neulasta biosimilar will offer "significant savings" for patients
It's been nearly two years since the pharmaceutical giant took tremendous heat for the rising cost of EpiPens (Source: Health News: CBSNews.com)
Source: Health News: CBSNews.com - June 12, 2018 Category: Consumer Health News Source Type: news

FDA OKs 1st Biosimilar to Prevent Chemo-Related Infections
TUESDAY, June 5, 2018 -- The first biosimilar drug to Neulasta has been approved by the U.S. Food and Drug Administration. Fulphila (pegfilgrastim) is approved for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy and... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - June 5, 2018 Category: Pharmaceuticals Source Type: news

1st'Biosimilar' To Neulasta, Fulphila (Pegfilgrastim), OK'd to Prevent Chemo-Related Infections
TUESDAY, June 5, 2018 -- The first " biosimilar " drug to Neulasta, designed to ward off infections related to chemotherapy, has been approved by the U.S. Food and Drug Administration. Fulphila (pegfilgrastim) is approved for people with symptoms of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - June 5, 2018 Category: General Medicine Source Type: news

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. (Source: World Pharma News)
Source: World Pharma News - June 5, 2018 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

Neulasta Biosimilar OK'd
(MedPage Today) -- First copycat for blockbuster white cell booster (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - June 4, 2018 Category: Primary Care Source Type: news

FDA approves Mylan drug as first biosimilar to Amgen's Neulasta
(Reuters) - Mylan NV on Monday beat a clutch of drugmakers racing to get a biosimilar version of Amgen Inc's drug, Neulasta, to market, with U.S. health regulators approving its version of the blockbuster infection-fighting treatment. (Source: Reuters: Health)
Source: Reuters: Health - June 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer. (Source: Food and Drug Administration)
Source: Food and Drug Administration - June 4, 2018 Category: American Health Source Type: news

U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 4, 2018 Category: Drugs & Pharmacology Source Type: news

EMA committee backs Amgen ’ s on-body injector for Neulasta
Amgen (NSDQ:AMGN) said today that a committee for the European Medicines Agency has recommended that the regulatory body approve a label variation for its Neulasta product to include the Onpro on-body injector delivery device. Neulasta’s Onpro kit includes a pre-filled syringe paired with a single-use on-body injector. The lightweight device is given to the patient on the same day as their chemotherapy regimen. Get the full story at our sister site, Drug Delivery Business News. The post EMA committee backs Amgen’s on-body injector for Neulasta appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 27, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Oncology Pharmaceuticals Regulatory/Compliance Wall Street Beat Amgen Source Type: news

Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta(R) (pegfilgrastim)
Innovative Neulasta® Onpro® Kit is Designed to Provide the Right Dose for Patients at the Right Time THOUSAND OAKS, Calif., Feb. 27, 2018 -- (Healthcare Sales & Marketing Network) -- Amgen (NASDAQ: AMGN) today announced that the Committee for M... Biopharmaceuticals, Drug Delivery, Regulatory Amgen, Neulasta, pegfilgrastim, Neulasta Onpro Kit, neutropenia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 27, 2018 Category: Pharmaceuticals Source Type: news

Amgen Receives Positive CHMP Opinion For Delivery System Of Neulasta ® (pegfilgrastim)
Innovative Neulasta® Onpro® Kit is Designed to Provide the Right Dose for Patients at the Right Time THOUSAND OAKS, Calif., Feb. 27, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label variation for Neulasta® (pegfilgrastim) to include the Neulasta® Onpro® Kit. The Neulasta Onpro Kit combines the efficacy of Neulasta with an innovative on-body injector (OBI) delivery system. Neulasta is indicated in the European Union (EU) for the re...
Source: Amgen News Release - February 27, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Kirin-Amgen Joint Venture To Become Wholly-Owned Subsidiary Of Amgen
$780 Million Payment to be Funded From Joint Venture's Existing Cash Holdings Kyowa Hakko Kirin to Continue as Licensee in Asia THOUSAND OAKS, Calif., Oct. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Amgen and Kirin Holdings (Kirin) have agreed that Kirin-Amgen, a joint venture between the two companies, will redeem Kirin's shares in the joint venture and, as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen. Kirin-Amgen was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of EPOGEN® (epoetin alfa). Over time, the sco...
Source: Amgen News Release - October 31, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Are Biobetters Better?
Biosimilars and biobetters are both variants of a biologic drug, however, while biosimilars are close copies of the originator, biobetters have been improved, for example, in terms of efficacy, safety, tolerability or dosing regimen.Regulators consider biobetters as new products and so afford them the same patent protection as any originator, however, this means they require the same clinical and non-clinical data packages. Conversely, a reduced clinical data package is an attractive element for the development of biosimilars.Given the cost of development and the time pressure to bring a biobetter to market before biosimil...
Source: EyeForPharma - July 3, 2017 Category: Pharmaceuticals Authors: James Wright Source Type: news

After FDA delay, Redwood City 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 28, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

After FDA delay, Redwood City 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 28, 2017 Category: American Health Authors: Ron Leuty Source Type: news

After FDA delay, Peninsula 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 28, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

After FDA delay, Peninsula 'biosimilar' company sheds third of workforce
Coherus BioSciences Inc., stopped earlier this month in its efforts to offer a lower-cost version of a drug for cancer chemotherapy patients, will lay off 30 percent of its workforce. The Redwood City company (NASDAQ: CHRS) said it cut 51 jobs after the Food and Drug Administration asked it to reanalyze some data from clinical trials and provide more information about manufacturing. Coherus leaders had hoped to win FDA approval this month of the drug, its version of Amgen Inc.' s Neulasta, and hit… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 28, 2017 Category: American Health Authors: Ron Leuty Source Type: news

Copycat 'biosimilars' win fast track, but FDA says this Bay Area company must slow down
Despite a Supreme Court decision shaving six months off the time it would take a maker of a so-called biosimilar to get to market, Coherus BioSciences Inc. lost nearly a quarter of its value Monday as regulators held off on approving its lower-cost biologic copycat version of a blockbuster brand-name drug. Redwood City-based Coherus (NASDAQ: CHRS) had asked the Food and Drug Administration to approve CHS-1701, its version of Amgen Inc.'s Neulasta. But the FDA said Monday that it needed Coherus to… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 12, 2017 Category: American Health Authors: Ron Leuty Source Type: news

Copycat 'biosimilars' win fast track, but FDA says this Bay Area company must slow down
Despite a Supreme Court decision shaving six months off the time it would take a maker of a so-called biosimilar to get to market, Coherus BioSciences Inc. lost nearly a quarter of its value Monday as regulators held off on approving its lower-cost biologic copycat version of a blockbuster brand-name drug. Redwood City-based Coherus (NASDAQ: CHRS) had asked the Food and Drug Administration to approve CHS-1701, its version of Amgen Inc.'s Neulasta. But the FDA said Monday that it needed Coherus to… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 12, 2017 Category: Biotechnology Authors: Ron Leuty Source Type: news

FDA rejects Coherus' biosimilar for Amgen's Neulasta
(Reuters) - Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration (FDA) denied the approval of its biosimilar for Amgen Inc's blockbuster treatment, Neulasta, which fights infections in cancer patients. (Source: Reuters: Health)
Source: Reuters: Health - June 12, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA rejects Coherus's biosimilar for Amgen's Neulasta
(Reuters) - Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration denied the approval of its biosimilar for Amgen Inc's Neulasta, which fights infections in cancer patients. (Source: Reuters: Health)
Source: Reuters: Health - June 12, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Amgen Launches Neulasta ® (pegfilgrastim) Onpro® NARRATIVES
Online News Resource Highlights Importance of Patient and Care Team Dialogue THOUSAND OAKS, Calif., April 18, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the launch of Neulasta® (pegfilgrastim) Onpro® NARRATIVES, an online media resource about the value of a cancer care team that provides comprehensive support for patients receiving strong chemotherapy. Intended to support conversations between cancer patients undergoing strong chemotherapy and their healthcare team about potential risk for infection due to a low white blood cell count, Neulasta Onpro NARRATIVES shares personal cancer stories ...
Source: Amgen News Release - April 18, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Zarxio (Filgrastim-sndz Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 2, 2017 Category: Drugs & Pharmacology Source Type: news

This Is What Obamacare's Critics Won't Admit Or Simply Don't Understand
THOUSAND OAKS, California ― Maryann Hammers is likely to die from ovarian cancer someday. But she hopes someday won’t come anytime soon. Hammers, 61, received the diagnosis in late 2013, and doctors told her that it was stage 3-C, which meant that she could live for many years with the right treatment and a little luck. So far, she’s had both. She’s in remission for the second time, and her last course of chemotherapy ended a year and a half ago. But recent blood tests detected elevated levels of a protein associated with tumors, she explained when we met a few weeks ago. “Maybe it’s a fluk...
Source: Healthy Living - The Huffington Post - February 18, 2017 Category: Consumer Health News Source Type: news

Granix (Tbo-filgrastim Injection, for Subcutaneous Use) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 16, 2017 Category: Drugs & Pharmacology Source Type: news

Analyst: Insulet ’ s drug-delivery biz a long-term growth driver
Insulet’s (NSDQ:PODD) drug-delivery business will be a long-term growth driver for the company by as much as 20% a year for the next few years, according to Leerink Partners analysts. Billerica, Mass.-based Insulet generates 86% of its revenue from its OmniPod insulin delivery device, according to Leerink. The OmniPod technology could be easily adapted to other drugs, according to the investment bank, which cited Insulet’s partnership with Amgen (NSDQ:AMGN) as a foundation for other wearable drug-delivery products. “There are a significant number of injectable drugs that are nearing patent expiration over...
Source: Mass Device - October 3, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Business/Financial News Drug-Device Combinations Amgen Insulet Corp. Leerink Partners Source Type: news

FDA Rejects Novartis Biosimilar App for Amgen Neulasta
The U.S. FDA has declined to approve Novartis' application for a biosimilar copy of Amgen's blockbuster, Neulasta. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 19, 2016 Category: Pharmaceuticals Source Type: news

FDA knocks back Novartis copy of Amgen's drug Neulasta
(Reuters) - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections in cancer patients, the Swiss drugmaker said on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - July 19, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

Cinfa Biotech reports positive top-line clinical trial results of B12019 to treat neutropenia
Spanish biosimilars company Cinfa Biotech has reported positive top-line clinical trial results of B12019, a biosimilar version of Neulasta (pegfilgrastim), to treat chemotherapy-induced neutropenia. (Source: Drug Development Technology)
Source: Drug Development Technology - July 4, 2016 Category: Pharmaceuticals Source Type: news

Neulasta (Pegfilgrastim) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 9, 2016 Category: Drugs & Pharmacology Source Type: news

Neupogen® (Filgrastim): General Information for Clinicians
Centers for Disease Control and Prevention, National Center for Environmental Health. 12/10/2015This resource provides information about Neupogen (Filgrastim), which was approved in March 2015 by the U.S. Food and Drug Administration (FDA) to treat people who have received high doses of radiation. Neupogen is a drug that has been used successfully for cancer patients to produce more white blood cells. The fact sheet discusses who can take Neupogen, how it is given, and its side effects. (Text) (Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - April 28, 2016 Category: Global & Universal Authors: The U.S. National Library of Medicine Source Type: news

Use and Side Effects of Neulasta During Breast...
How is neulasta used during breast cancer chemotherapy, and what are some of its side effects and risks? (Source: About.com Breast Cancer)
Source: About.com Breast Cancer - March 21, 2016 Category: Cancer & Oncology Authors: breastcancer.guide at about.com Tags: health Source Type: news

Zarxio (Filgrastim-sndz Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - March 16, 2016 Category: Drugs & Pharmacology Source Type: news

What is the Difference Between Neulasta and...
Neutropenia during chemotherapy is treated with Neulasta or Neupogen. What's the difference, why is each chosen and what are the costs? (Source: About.com Breast Cancer)
Source: About.com Breast Cancer - March 16, 2016 Category: Cancer & Oncology Authors: breastcancer.guide at about.com Tags: health Source Type: news

EU agency accepts Sandoz application for pegfilgrastim biosimilar
ZURICH (Reuters) - The European Medicines Agency (EMA) has accepted an application to review Sandoz's biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulating factor, Sandoz parent Novartis said on Thursday. (Source: Reuters: Health)
Source: Reuters: Health - February 11, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

Novartis: Study shows copycat works just as well as Amgen drug
ZURICH (Reuters) - Novartis's copycat version of Amgen's Neulasta worked just as well as the original drug in preventing a condition that can lead to infections among breast cancer sufferers, the Swiss company said in a statement on Monday. (Source: Reuters: Health)
Source: Reuters: Health - December 7, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

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...
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