The US Food and Drug Administration has told Genzyme (Sanofi SA) to re-do its marketing authorization application for Lemtrada (alemtuzumab) for MS to change the presentation of the data. No additional data is being requested, Sanofi said.
Eli Lilly and Company is to seek advice from regulators about the possible next step for its investigative Alzheimer’s treatment, solanezumab, following the failure of two Phase 3 trials in patients with mild-to-moderate forms of the disease.
Zealand Pharma A/S has raised its revenue forecast and is predicting a higher profit for 2012 as its clinical programmes, especially in diabetes, continued to generate healthy milestone payments. Payments in the first half alone amounted to €25 million.
Agennix AG has announced plans to reduce its staff by 55% in order to conserve cash following the failure of a Phase 3 trial of its lead product for non-small cell lung cancer, talactoferrin alfa (talactoferrin).
SkyePharma Plc, which specialises in measured delivery of inhaled and oral drugs, announced a major debt refinancing on 23 August 2012 along with its half-year results.
Ablynx NV expects to publish early clinical data for a second potential rheumatoid arthritis treatment this year: a compound that targets the interleukin-6 receptor. The company issued the clinical update with the publication of its 2012 first-half results.
Newron Pharmaceuticals SpA of Italy has raised CHF4.7 million (€3.91 million) in a private placement of its shares ahead of the planned registration in 2013 of its lead compound for Parkinson’s disease, safinamide.
Algeta ASA is accelerating its bid to produce an alternative platform to the antibody-drug conjugate with the launch of a new programme of radionuclides linked to monoclonal antibodies. The latest programme is directed at haematological cancers.
UK scientists have reported new findings on the role of heat shock proteins in the development of prostate cancer which suggest that the p23 protein may act independently to activate the androgen hormones that fuel the cancer’s growth.
Pharmaceutical companies everywhere have been shrinking their research budgets, but Elan Corporation Plc has gone one step further. It is spinning out its research department to shareholders. This will put the Ireland-incorporated company immediately into profit. Moreover, profits will be sheltered from tax in future years by a large tax loss carried forward from previous years.