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The Lead

FDA Approves Eliquis For DVT And PE

August 21, 2014 3:39 pm | by Pfizer | News | Comments

Bristol-Myers Squibb Company and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. 

Bristol-Myers Squibb & Celgene Collaborate On Immunotherapy & Chemo Combination

August 20, 2014 9:59 am | by Associated Press | News | Comments

Bristol-Myers Squibb Company and Celgene Corporation announced the establishment...

Allied Minds and BMS Form Enterprise to Advance Discoveries of Biopharmaceutical Innovations

August 4, 2014 8:32 am | News | Comments

Allied Minds and Bristol-Myers Squibb Company today announced the formation of Allied-Bristol...

European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

July 29, 2014 8:38 am | News | Comments

Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for...

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BMS Second Quarter Net Drops on Lower Drug Sales, Charges

July 24, 2014 8:15 am | News | Comments

Bristol-Myers Squibb Co.'s exit from the diabetes business, plus higher taxes and research spending, combined to slash the drugmaker's second-quarter profit by 38 percent, but the company handily beat Wall Street's muted profit expectations.

Bristol-Myers Squibb Makes Plans to Submit Biologics License Application for Opdivo®

July 10, 2014 8:12 am | News | Comments

Bristol-Myers Squibb Company today announced that, following discussions with the FDA, the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo® (nivolumab) for previously treated advanced melanoma.

Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® and Sunvepra® Dual Regimen

July 7, 2014 8:19 am | News | Comments

Bristol-Myers Squibb Company has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor ( in vitro ), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options.

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BMS Issues Voluntary Nationwide Recall of COUMADIN® for Injection Due to Presence of Particulate Matter

June 30, 2014 1:40 pm | News | Comments

Bristol-Myers Squibb Company is voluntarily recalling six lots of COUMADIN® FOR INJECTION, 5 mg single-use vials in the U.S. This recall is a precautionary measure based on the company’s investigation of visible particulate matter found in a small number of COUMADIN FOR INJECTION unreleased samples.

Bristol-Myers Says Cancer Drug Met Goal in Study

June 24, 2014 7:28 pm | by The Associated Press | News | Comments

Bristol-Myers said Tuesday that its skin cancer drug nivolumab worked in a late-stage clinical trial, leading the drugmaker to end the study early. Bristol-Myers said patients treated with nivolumab lived longer than patients who received only chemotherapy.

U.S. Court of Appeals Denies Appeal in Baraclude Patent Case

June 13, 2014 7:47 am | News | Comments

Bristol-Myers Squibb Company has announced that the U.S. Court of Appeals for the Federal Circuit has denied the company’s appeal of a February 2013 ruling by the U.S. District Court for the District of Delaware that found the patent covering Baraclude (entecavir), U.S. patent 5,206,244 invalid.

Bristol-Myers Squibb and Syngene International Extend Research Collaboration

June 3, 2014 8:18 am | News | Comments

Bristol-Myers Squibb and Syngene International, India’s largest contract research organization, today announced a five-year extension of their drug discovery and development collaboration in India.         

Actavis Confirms Generic Onglyza Patent Challenge

May 28, 2014 9:05 am | News | Comments

Actavis has filed an Abbreviated New Drug Application with the FDA seeking approval to market Saxagliptin Hydrochloride Tablets, 2.5 mg and 5 mg. Actavis' ANDA product is a generic version of AstraZeneca and Bristol-Myers Squibb's Onglyza. 

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BMS and Incyte to Evaluate Combination Regimen of Two Novel Immunotherapies

May 27, 2014 8:12 am | News | Comments

Bristol-Myers Squibb Company and Incyte Corporation announced today the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.

Bristol-Myers Squibb and AbbVie Receive Breakthrough Therapy Designation for Elotuzumab

May 19, 2014 8:18 am | News | Comments

Bristol-Myers Squibb and AbbVie today announced that the FDA has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies

Bristol-Myers Slumps on Cancer Drug Study Data

May 15, 2014 1:26 pm | News | Comments

Shares of Bristol-Myers Squibb slumped Thursday after the drugmaker reported disappointing clinical trial data for an experimental cancer treatment.                 

BMS and Celldex Therapeutics to Evaluate the Combination of Investigational Immunotherapies Nivolumab and Varlilumab

May 14, 2014 8:46 am | News | Comments

Bristol-Myers Squib and Celldex Therapeutics have entered into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of nivolumab, Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex’s CD27 targeting investigational antibody in a Phase 1/2 study.

Bristol-Myers Squibb Announces Retirement of Brian Daniels

May 6, 2014 9:36 am | News | Comments

Bristol-Myers Squibb Company today announced that Brian Daniels, senior vice president, Global Development and Medical Affairs, will be retiring from the company, effective July 1, 2014.           

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Bristol-Myers Squibb Acquires iPierian, Inc.

April 29, 2014 8:12 am | News | Comments

Under the terms of the agreement, Bristol-Myers Squibb has acquired all of iPierian'€™s issued and outstanding shares of capital stock and all common stock equivalents in an all cash transaction for a purchase price of $175 million, with the potential for additional development and regulatory milestone payments totaling $550 million, along with future royalties on net sales.

Bristol-Myers Profit Up 54% on Cost Cuts, Sale

April 29, 2014 7:59 am | by The Associated Press | News | Comments

Bristol-Myers Squibb Co. reported a 54 percent jump in first-quarter profit, as cost cutting and a gain from selling most of its diabetes business outweighed a slight dip in sales.            

BMS Submits NDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for HIV-1

April 14, 2014 8:18 am | News | Comments

Bristol-Myers Squibb Company announced today the submission of a new drug application (NDA) on April 4, 2014 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective.

Five Prime Therapeutics and BMS to Collaborate on Novel Immuno-Oncology Therapies

March 17, 2014 8:17 am | News | Comments

Five Prime Therapeutics and Bristol-Myers Squibb have signed a collaboration agreement for the discovery, development and commercialization of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime's proprietary target discovery platform.

FDA Approves Eliquis® to Reduce The Risk Of Blood Clots Following Hip Or Knee Replacement Surgery

March 17, 2014 8:12 am | News | Comments

Bristol-Myers Squibb Company and Pfizer announced that the FDA approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

FDA Eases Concern About Certain Diabetes Drugs

February 27, 2014 8:04 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

People who take Januvia, Byetta or certain other widely prescribed medicines for diabetes can breathe a little easier — U.S. and European regulators have found no compelling evidence of a link between these drugs and pancreas problems or pancreatic cancer.

Bristol-Myers Rises Following Analyst Upgrade

February 10, 2014 5:14 pm | by The Associated Press | News | Comments

Shares of Bristol-Myers Squibb Co. rose Monday after a BMO Capital Markets analyst upgraded the stock, saying Bristol-Myers has a promising group of cancer drug.                     

Partners in New NIH-Industry Project to Find Meds

February 4, 2014 1:43 pm | by The Associated Press | News | Comments

Ten pharmaceutical companies, seven disease-related foundations, the drug industry's main trade group and two huge federal agencies have joined together in an unusual collaboration to share information and speed up creation and approval of new drugs needed by patients.

AstraZeneca Completes Acquisition of Bristol-Myers Squibb Share of Global Diabetes Alliance

February 3, 2014 8:22 am | News | Comments

AstraZeneca today announced that it has completed the acquisition of the entirety of Bristol-Myers Squibb’s interests in the companies’ diabetes alliance.               

Sales Up, Q4 Net Falls for Bristol-Myers

January 24, 2014 7:58 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Bristol-Myers Squibb Co. reported a 21.5 percent drop in its fourth-quarter profit despite higher drug sales, because the year-ago results had a $411 million tax benefit from writing off a failed experimental medicine.      

XIGDUO™ Approved in the European Union for Type 2 Diabetes

January 22, 2014 8:06 am | News | Comments

AstraZeneca and Bristol-Myers Squibb today announced that Xigduo™ (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorization by the European Commission for the treatment of type 2 diabetes in the European Union (EU).

FDA Approves Diabetes Drug with New Approach

January 8, 2014 12:50 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration has approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar. Farxiga is a once-a-day tablet designed to help diabetes patients eliminate excess sugar via their urine. That differs from older...

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