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Amgen Says Version of Humira Meets Study Goal

October 8, 2014 3:49 pm | News | Comments

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.                

Amgen Submits BLA for Investigational BiTE Immunotherapy Blinatumomab

September 22, 2014 2:20 pm | News | Comments

The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-...

FDA Grants Amgen Priority Review Designation for Ivabradine

August 27, 2014 11:53 am | News | Comments

Amgen announced that the FDA has granted priority review designation for ivabradine for the...

Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible Particulates

August 14, 2014 9:05 am | News | Comments

Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (...

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Amgen Announces Phase III Trial of Kyprolis Met Primary Endpoint

August 4, 2014 9:04 am | News | Comments

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 Laying Off at Least 2,400

July 30, 2014 7:56 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

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 and Onyx Pharmaceuticals’ Phase 3 Trial of NEXAVAR Misses Study Goals

July 25, 2014 8:26 am | News | Comments

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).

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FDA Reviewing What Could Be First Biosimilar Drug

July 24, 2014 3:51 pm | News | Comments

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 Names Senior Vice President, Global Regulatory Affairs And Safety

May 13, 2014 8:25 am | News | Comments

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 Announce Positive Results from Phase 3 Psoriasis Study

May 12, 2014 8:52 am | News | Comments

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.       

Amgen Misses First Quarter Goals as Higher Costs Cut Profit

April 23, 2014 8:10 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

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.

Studies Find New Drugs Greatly Lower Cholesterol

March 29, 2014 3:31 pm | by Marilynn Marchione - AP Chief Medical Writer - Associated Press | News | Comments

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.  

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Pharma Data Play Larger Role in Olympic Drug Tests

February 10, 2014 8:34 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

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 Fourth Quarter Profit Leaps 30% on Higher Sales

January 28, 2014 7:13 pm | by Linda A. Johnson - AP Business Writer - Associated Press | News | Comments

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.

Amgen, Illumina Team on Personalized Medicine Test

January 16, 2014 8:43 am | News | Comments

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 CFO Stepping Down

January 10, 2014 8:00 am | News | Comments

Amgen said Thursday that Chief Financial Officer Jonathan Peacock is leaving the company to pursue other opportunities.                      

Amgen 3Q Profit Jumps 24% on Stronger Sales

October 23, 2013 8:34 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

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.   

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Amgen Acquires Filgrastim Franchise Rights from Roche In 100 Markets

October 22, 2013 9:15 am | News | Comments

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.     

Earnings Preview: Amgen to Report 3Q Results

October 18, 2013 7:52 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

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 Announce Plans for Amgen China R&D Center

September 25, 2013 8:21 am | News | Comments

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 Buying Cancer Drug Maker Onyx for $10.4B

August 25, 2013 6:46 pm | by The Associated Press | News | Comments

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 Second Quarter Net Dips on Higher Research, Other Costs

July 31, 2013 8:09 am | by LINDA A. JOHNSON,AP Business Writer | News | Comments

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.

Earnings Preview: Amgen to Report on Research

July 26, 2013 6:15 pm | by LINDA A. JOHNSON - AP Business Writer - Associated Press | News | Comments

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 to Collaborate on Cardiovascular Products

July 10, 2013 8:23 am | News | Comments

Amgen and Servier have announced a new collaboration agreement leveraging each company's commitment to cardiovascular disease.                     

Onyx Confirms, Rejects Amgen's $120-Per-Share Bid

July 1, 2013 8:27 am | News | Comments

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.

FDA Backs New for Amgen Drug for Rare Bone Tumors

June 14, 2013 8:29 am | by The Associated Press | News | Comments

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.

Astellas, Amgen to Form Joint Venture in Japan

May 29, 2013 7:56 am | News | Comments

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.

Amgen and Novartis Join Atlas Venture Fund IX As Corporate Strategic Partners

May 17, 2013 8:16 am | News | Comments

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.

Earnings Preview: Amgen Reports 1Q results Tuesday

April 19, 2013 8:01 am | by LINDA A. JOHNSON,AP Business Writer | News | Comments

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

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