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 reduction in the duration...
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 scope ...
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:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 12, 2017 Category: Biotechnology 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
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 as well as...
Source: Amgen News Release - April 18, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
