Actelion Ltd said that it has received a complete response letter from the US Food and Drug Administration for its treatment for Niemann-Pick disease, Zavesca (miglustat). This means the agency cannot approve the application in its present form.
Ark Therapeutics Group Plc has dropped its appeal against a negative opinion from the European Medicines Agency for its gene therapy for brain cancer, Cerepro. It also announced that it is in talks about a possible takeover of the company. Ark disclosed the developments on 9 March 2010.
Genmab A/S said that its antibody for head and neck cancer, zalutumumab, has failed to show overall survival in a Phase 3 study in which the drug was being tested in combination with best supportive care versus best standard care alone.
AstraZeneca Plc said that its candidate drug, Recentin (cediranib), for patients with first-line metastatic colorectal cancer, failed to meet its primary endpoint of non-inferiority in progression-free survival in a Phase 2/3 trial.
The Roche Group and Biogen Idec of the US have suspended clinical trials of the humanized anti-CD20 monoclonal antibody, ocrelizumab, in four rheumatoid arthritis trials because of safety issues. The drug was in Phase 2 and 3 trials.
BioAlliance Pharma SA is looking ahead to three possibly transforming events in the second quarter of 2010 that could secure its standing as a recognised specialty pharmaceutical company in Europe.
An investigational drug for patients with Alzheimer’s disease, Dimebon (latrepirdine), has failed in a Phase 3 trial because it could not show statistically significant improvements in patients compared with placebo for cognition and global function.
Intercell AG expects to report data in 2010 on two late-stage vaccine candidates against hospital-acquired infections, conditions that have become serious in recent years because of bacterial resistance to marketed antibiotics.
UCB expects that three recently launched drugs will drive the company’s growth for the next decade following a period of extensive restructuring.
Merck KGaA of Germany has made an agreed bid for the US service provider, Millipore Corp, in a transaction valued at $7.2 billion, including net debt. The merged company is expected to have critical mass in bioresearch and bioprocessing.