Mallinckrodt plc’s second major buy in two months – about $5.6 billion for Questcor Pharmaceuticals Inc. – created more noise than the February takeover of Cadence Pharmaceuticals Inc. for about $1.3 billion, and not just because of the larger price tag. Read More
Bristol-Myers Squibb Co., of New York, said it submitted new drug applications (NDAs) with the FDA for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. Read More
Basilea Pharmaceutica Ltd., of Basel, Switzerland, reported new data demonstrating the broad activity of its oncology drug candidate BAL101553 in preclinical models of human breast cancer, including models resistant to standard agents used for the treatment of breast cancer. Read More
Pacira Pharmaceuticals Inc. announced additional phase III data supporting the safety and efficacy of (bupivacaine liposome injectable suspension) to achieve a femoral nerve block in patients undergoing total knee arthroplasty. Read More
Genzyme Corp., of Cambridge, Mass., a Sanofi SA unit, said, following discussions with the FDA, the company plans to resubmit in the second quarter its supplemental biologics license application seeking to market Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. Read More
SAN DIEGO – The annual meeting of the American Association for Cancer Research (AACR) draws a broad mix of clinical and basic scientists, and so the gathering usually brings news of broad themes of cancer research – be they biomarkers, immunotherapies or clinical trial design – from both a theoretical and a practical standpoint. Biomarkers exemplified that dual strength this year. Read More
Oncothyreon Inc. said that Merck KGaA has started a phase III trial of its out-licensed cancer vaccine tecemotide in patients with unresectable, locally advanced stage III non-small-cell lung cancer (NSCLC). The new trial seeks to confirm an overall survival (OS) benefit for certain patients and, if successful, could magnify the potential for Merck to acquire Oncothyreon in the future. Read More
SAN DIEGO – Results presented at the of the American Association for Cancer Research (AACR) annual meeting on Sunday from the phase II PALOMA-1 trial of CDK inhibitor palbociclib (Pfizer Inc.) led to plenty of buzz that Pfizer Inc. might file for accelerated approval for the drug, despite the lack of an overall survival (OS) benefit to date. Read More
Deemed “fantastic” by a leukemia expert, phase I data presented by Agios Pharmaceuticals Inc. snagged the spotlight Sunday at the American Association for Cancer Research (AACR) meeting in San Diego, with isocitrate dehydrogenase-2 (IDH2)-targeting candidate AG-221 producing a complete remissions (CRs) in three of seven evaluable patients. Read More
LONDON – Work on a mouse model representing a rare inherited disease that affects the heart muscle suggests that gene therapy to replace a missing protein may one day be possible in the clinic, for some conditions at least. Read More
Epitherapeutics ApS, of Copenhagen, said it raised €10.68 (US$14.7 million) in a second closing of a series A round, bringing the total series A to €15.7 million. Read More
