In August 2012, the FDA placed IDX184 on partial clinical hold and IDX19368 on clinical hold due to cardiac adverse events seen in the Phase II trial of New York-based Bristol-Myers Squibb Co.'s BMS-986094
BioCryst withdrew an investigational new drug application last fall on FDA concerns about the toxicity profile of the drug, based in part on the occurrence of serious adverse events in HCV clinical trials of a nucleotide prodrug from New York-based Bristol-Myers Squibb Co
Irritability was chosen as the endpoint for the Phase II study because Abilify (aripiprazole, Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd.) and Risperdal (risperidone, Janssen Pharmaceuticals Inc.) are approved for autism spectrum disorders on the basis of their effects on irritability, which made irritability the only endpoint with precedent
By Randy Osborne | BioWorld Today | Tuesday, January 29, 2013
Crescendo has raised £7.7 million (US$12.2 million) since it was spun out of the Babraham Institute in Cambridge, UK, in 2009 to commercialize the invention of the triple knockout mouse by Marianne Brüggemann, the scientist who developed the first transgenic human antibody mouse technology, subsequently applied by Medarex (acquired by Bristol-Myers Squibb Co.), Abgenix (acquired by Amgen Inc.) and other companies
By Nuala Moran | BioWorld International | Wednesday, January 23, 2013
Though the long-term value of 2012 acquisitions is yet to be determined, the strategic importance of partnerships in attracting a suitor was apparent from some of the year's blockbuster deals, including Bristol-Myers Squibb (BMS) Co.'s acquisition of Amylin Pharmaceuticals Inc., together with AstraZeneca, and its pick-up of Inhibitex Inc. (See BioWorld Today, Jan. 10, 2012, and July 3, 2012.) Deloitte Recap also cited the joint BMS/AstraZeneca buyout of Amylin as one of the year's most creative
By Marie Powers | BioWorld Today | Wednesday, January 23, 2013
Company (Location) Product Description Indication Status Date Alfa Wassermann SpA (Bologna, Italy) and Norgine BV (Amsterdam, the Netherlands) Xifaxan 550-mg (rifaximin-alpha)/Refero/Targaxan/Tixteller Hepatic encephalopathy Received European marketing authorization 12/10/12 Astellas Pharma Inc. (Tokyo) Tacrolimus Extended-release capsules Organ rejection in adult kidney transplant and adult male liver transplant FDA accepted for review its NDA 12/6/12 Bristol-Myers Squibb Co. (New York) and
cytarabine alone 12/11/12 Bristol-Myers Squibb Co. (New York) and Abbott (Abbott Park, Ill.) Elotuzumab Monoclonal antibody Multiple myeloma Phase II data of elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone showed that in the 10 mg/kg arm, median progression-free survival (PFS) was not reached after 20.8 months of follow-up (N = 36) and the objective response rate (ORR) was 92
Achillion Pharmaceuticals Inc., of New Haven, Conn., said it completed enrollment in a pilot Phase IIa trial evaluating ACH-3102, a second-generation pan-genotypic NS5A inhibitor, in combination with ribavirin in patients with chronic genotype 1b hepatitis C virus (HCV) infection. The initial cohort enrolled eight patients to receive 12 weeks of combination treatment. To date, five patients have completed four weeks of treatment, and ACH-3102 has been well tolerated, with no serious adverse
Tranzyme Pharma Inc., of Research Triangle Park, N.C., reported the successful completion of its chemistry-based drug discovery collaboration with New York-based Bristol-Myers Squibb Co., which will now further develop the transferred active macrocycles across multiple drug targets
Deal for Actavis Specialty Brands to acquire worldwide rights to Valeant's metronidazole 1.3% vaginal gel antibiotic to treat bacterial vaginosis The payment of $55M includes up-front and milestone payments, plus royalties Adaptive Biotechnologies Bristol-Myers Squibb Co...Bristol-Myers Squibb Co
Bristol-Myers Squibb Co., of New York, and Pfizer Inc., of New York, said the FDA approved Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nanvalvular atrial fibrillation
reported a 100 percent sustained virologic response at four weeks with its Ns5B polymerase inhibitor GS-7977 (now known as sofosbuvir) in combination with Bristol-Myers Squibb Co.'s NS5A inhibitor daclatasvir
By BioWorld Staff | BioWorld International | Wednesday, January 2, 2013
and Bristol-Myers Squibb Co. (both of New York) ND Agreement to test a candidate that could reverse the anticoagulant effects of Factor Xa inhibitors Pfizer and Bristol-Myers were partnered on Eliquis and agreed to collaborate with Portola on a proof-of-concept trial with PRT4445 11/5/12 Selecta Biosciences Inc. (Watertown, Mass.) Sanofi SA (Paris) $900 $900M deal to discover targeted, antigen-specific immunotherapies for food allergies
In August 2012, the FDA placed IDX184 on partial clinical hold and IDX19368 on clinical hold due to cardiac adverse events seen in the Phase II trial of New York-based Bristol-Myers Squibb Co.'s BMS-986094