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 (...
Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim...
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.
Biotech drugmaker Amgen Inc. will review sales of key drugs and lots of recent research results, both for experimental drugs and one already on the market, when it reports second-quarter results after the stock market closes Tuesday. Amgen executives likely will note a new...
Amgen and Servier have announced a new collaboration agreement leveraging each company's commitment to cardiovascular disease.
Onyx Pharmaceuticals on Sunday confirmed that it received an unsolicited takeover bid from Amgen Inc. for $120 per share. But the drug developer says it rejected the offer, because it "significantly undervalued" the company. Onyx also said that other companies have expressed interest in a buyout.
Amgen Inc. said yesterday that the Food and Drug Administration has approved a new use for its bone drug Xgeva. The company, based in Thousand Oaks, Calif., said it now can market Xgeva for treating a rare condition, giant cell tumor of bone, when surgery isn't practical.
Tokyo-based Astellas Pharma Inc. said today it will form a joint venture with major U.S. biotechnology company Amgen Inc. to develop and market drugs in Japan. The new company will start business operations in October to develop five drugs, including for gastric cancer and osteoporosis, under a plan to launch drug sales in 2016.
Atlas Venture has entered into Corporate Strategic Partnership (CSP) agreements with both Amgen, through its venture capital fund, Amgen Ventures, and Novartis. The CSP agreements are in conjunction with the closing of Atlas IX in which Amgen Ventures and Novartis are new limited partners.
Biotech drugmaker Amgen Inc. will focus on recent results on a key experimental melanoma drug, testing of other drugs and revenue from its top-selling drugs when it reports first-quarter results after the stock market closes Tuesday. The world's biggest biotech company will discuss promising preliminary results in a late-stage study of its experimental drug for the deadly skin cancer melanoma
The U.S. Department of Justice said Tuesday that biotech drugmaker Amgen Inc. will pay $24.9 million to resolve claims it paid kickbacks to increase sales of its anemia drug Aranesp. The Justice Department said Amgen paid kickbacks to Omnicare Inc. and PharMerica Corp., which sell drugs to...
Amgen today announced top-line results from the Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).
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