Apotex has announced that the FDA has accepted for filing the company's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta. The product has been jointly developed with Intas Pharmaceuticals. The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA).
Amgen announced that the FDA has approved a new indication for XGEVA (denosumab) for the...
The U.S. Food and Drug Administration has approved Blincyto (blinatumomab) to treat patients...
AstraZeneca and Amgen today announced that AMAGINE-3TM, a pivotal, multi-arm Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara® (ustekinumab) and placebo at week 12
Amgen said Monday that its earnings fell in the third quarter on charges from an ongoing restructuring effort, but the biotech drugmaker's adjusted results still surpassed Wall Street expectations.
A hedge fund run by a famed investor has taken a large stake in Amgen and now wants the biotech drugmaker to consider splitting up into two. In a letter to investors, Third Point, a hedge fund run by Daniel Loeb, said it has recently increased its stake by an unspecified amount, making it one of the drugmaker's top shareholders.
Amgen said Wednesday that its version of Humira, the best-selling drug in the world, worked as well as the original medication in a late-stage clinical trial.
The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. BiTE antibody constructs represent an innovative immunotherapy approach that helps the body's immune system target cancer cells.
Amgen announced that the FDA has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.
Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible ParticulatesAugust 14, 2014 9:05 am | News | Comments
Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.
Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival (PFS).
Amgen said it will lay off 12 to 15 percent of its worldwide workforce and close four sites, even as it reported stellar second-quarter results that trounced Wall Street expectations.
Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).
Five years after Congress passed a law allowing biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.
Amgen has announced the appointment of Steven K. Galson, M.D., M.P.H., to the position of senior vice president, Global Regulatory Affairs and Safety, effective May 19. Galson will report to Sean E. Harper, M.D., executive vice president, Research and Development, and will be responsible for all regulatory and patient safety functions across Amgen.
Amgen and AstraZeneca announced that the Phase 3 AMAGINE-1TM study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses.
Despite higher sales, Amgen's first-quarter profit fell 25 percent as production and research costs rose sharply. Last year's quarter also gained from a tax benefit. The company missed Wall Street's expectations for both earnings per share and revenue, sending down its shares.
A new class of experimental medicines can dramatically lower cholesterol, raising hopes of a fresh option for people who can't tolerate or don't get enough help from Lipitor and other statin drugs that have been in use for decades.
Some of the world's biggest drugmakers are playing a larger role in anti-doping efforts at this year's Winter Olympics: They're providing information on drugs that once would have been considered proprietary trade secrets.
Amgen Inc.'s fourth-quarter profit jumped 30 percent mainly due to a tax benefit from prior-year audits, an acquisition and higher sales for nearly all its drugs — much of it from price hikes. The world's biggest maker of biologic drugs said Tuesday that net income was $1.02 billion, or $1.33 per share, up from $788 million or $1.01 per share, a year earlier.
Biotech drugmaker Amgen and Illumina, a maker of genetic testing equipment, said Wednesday they are developing a test that will identify patients who might be helped by Amgen's colon cancer drug Vectibix.
Amgen said Thursday that Chief Financial Officer Jonathan Peacock is leaving the company to pursue other opportunities.
Amgen has announced that its third-quarter profit jumped 24 percent, trouncing analysts' expectations, as sales of more than a half-dozen of its drugs increased by double digits, one of them helped by a big government purchase.
Amgen today announced that it has entered into a definitive agreement with F. Hoffmann-La Roche to acquire Roche's rights to filgrastim and pegfilgrastim in approximately 100 markets, effective Jan. 1, 2014.
Amgen will focus on the integration and strategy behind its acquisition of Onyx Pharmaceuticals, which makes two cancer drugs and has others in testing, when it reports third-quarter results late Tuesday.
Amgen and ShanghaiTech University today announced the two organizations have entered into a memorandum of understanding (MOU) to form a strategic partnership for the advancement of biopharmaceutical discovery and translational research in China. This agreement includes plans for Amgen to open a China research and development (R&D) center at ShanghaiTech University.
Amgen will buy cancer drug maker Onyx Pharmaceuticals for about $10.4 billion in cash in a deal that will add several cancer drugs to Amgen's stable and add to its pipeline of new drugs. Amgen Inc. said Sunday it will acquire Onyx for $125 per share, and it expects to complete...
Amgen said Tuesday that its second-quarter profit dipped 1 percent as higher spending on research, production and other items offset rising sales of its medicines. However, the results from world's biggest biotech drugmaker soared above Wall Street expectations and it raised its profit forecast significantly.
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