Teva Announces FDA Grants Approval for Tbo-filgrastim for the Treatment of Chemotherapy-Induced Neutropenia

03-Sep-2012 - Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years. Tbo-filgrastim is a ...

Sandoz initiates two more Phase III biosimilar trials

20-Jan-2012 - Sandoz announced that it has initiated two milestone Phase III clinical trials - one for biosimilar filgrastim (Amgen's Neupogen®) in the US market, the other for its global pegfilgrastim development program (Amgen's Neulasta®).The filgrastim study is to evaluate the efficacy and safety of ...

BAC and Octapharma extend collaboration for G-CSF custom ligand for commercial scale manufacture

18-Aug-2010 - BAC BV announced that it has entered into a licence agreement with Octapharma. Under the terms of the license, Octapharma can use BAC’s G-CSF CaptureSelect® custom affinity ligand for the purification of recombinant human granulocyte-colony stimulating factor (G-CSF) from human (HEK293F) cell ...

Hospira Acquires Worldwide Rights to Biogeneric Version of Filgrastim and Manufacturing Facility From PLIVA

02-Oct-2009 - Hospira, Inc. announced the acquisition of worldwide rights to a biogeneric version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska d.o.o., a move that will help extend Hospira's reach and vertical integration in biogenerics. Financial terms of the agreement ...

Biosimilar market growth contingent on the US

23-Jun-2009 - As the Federal Trade Commission weighs into the biosimilars debate in the US, new research by independent market analyst Datamonitor forecasts that the success of the emerging biosimilars industry hinges on access to this market. With Japan poised to receive its first biosimilar and the US moving ...

Amgen Continues Manufacturing Expansion with Additional $1 Billion Investment in Puerto Rico

06-Feb-2006 - Amgen announced that it expects to invest $1 billion over the next four years to expand its manufacturing capacity in Puerto Rico to meet rising global demand for the company's products. Fabrizio Bonanni, senior vice president, Manufacturing, said the investment will include expansion of existing ...

Amgen to Make Significant Investment in Manufacturing, R&D and Commercial Operations Expansion

26-Jan-2006 - Amgenannounced that it anticipates significant investment in additional manufacturing and R&D operations in the United States and Europe and expansion of its commercial operations into new markets. In Cork, Ireland, Amgen intends to invest more than $1 billion in new process development, bulk ...

Amgen Announces FDA Licensure of Two New Manufacturing Facilities

Company Continues to Meet Increased Demand for Its Novel Therapeutics

08-Sep-2005 - Amgen announced the U.S. Food and Drug Administration (FDA) has approved the company's new manufacturing facilities in West Greenwich, Rhode Island, and Juncos, Puerto Rico for the production of Amgen's therapeutics. The new manufacturing plant at Amgen's Rhode Island facility has received FDA ...

SICOR Announces Approval of G-CSF in Lithuania

04-Sep-2003 - SICOR Inc. announced that its wholly owned subsidiary, SICOR Biotech UAB, has received final regulatory approval from the State Medicines Control Agency at the Ministry of Health in the Republic of Lithuania for the manufacture and marketing of recombinant human granulocyte colony stimulating ...

Amgen Reports Third Quarter 2001 Earnings Per Share Of 30 Cents

26-Oct-2001 - THOUSAND OAKS, Calif., October 25, 2001 -- Amgen reported that earnings per share for the third quarter of 2001 were 30 cents, compared with 33 cents per share for the third quarter of 2000. Earnings per share for the third quarter of 2000 included a legal award of 4 cents per share for certain ...