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Studies Boost Hopes for New Class of Cholesterol Medicines

March 16, 2015 8:02 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

New research boosts hope that a highly anticipated, experimental class of cholesterol drugs can greatly lower the risk for heart attacks, death and other heart-related problems. The government will decide this summer whether to allow two of these drugs on the market.

Amgen: Blood Cancer Drug Kyprolis Beats Rival's in Study

March 2, 2015 3:39 pm | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Amgen's blood cancer drug Kyprolis doubled the time it kept the disease from worsening, compared...

Amgen Tops Wall Street Fourth Quarter Forecasts

January 28, 2015 8:12 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The world's biggest biotech drugmaker by revenue said it's starting a cycle of several important...

FDA Panel Endorses Novartis' Biosimilar

January 8, 2015 8:34 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

A panel of Food and Drug Administration experts ruled that the Novartis' version of Neupogen is...

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FDA Accepts Apotex’ Filing of its Biosimilar Application for Pegfilgrastim

December 17, 2014 11:24 am | News | Comments

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).

FDA Approves Amgen's XGEVA

December 8, 2014 10:40 am | News | Comments

Amgen announced that the FDA has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA.  

FDA Approves Blincyto for Rare Form of Acute Lymphoblastic Leukemia

December 3, 2014 3:09 pm | News | Comments

The U.S. Food and Drug Administration has approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.      

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Amgen Ends Studies of Gastric Cancer Drug

November 24, 2014 2:45 pm | News | Comments

Amgen is ending late-stage trials of its gastric cancer treatment rilotumumab because patients who took the drug were more likely to die. Amgen said more patients died after treatment with rilotumumab and chemotherapy than with chemotherapy alone.

Amgen and AstraZeneca Announce Brodalumab Phase III Results

November 12, 2014 9:01 am | News | Comments

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 Beats Third Quarter Estimates While Shrinking Workforce

October 28, 2014 8:31 am | by MATTHEW PERRONE, AP Business Writer | News | Comments

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.         

Hedge Fund Third Point Urges Amgen to Consider Breakup

October 22, 2014 8:24 am | by The Associated Press | News | Comments

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 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.                

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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-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.

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 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 Particulates

August 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 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.           

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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).

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, 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 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.     

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.

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.

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