News

FDA approves new HIV combination treatment

Country
United States

The US Food and Drug Administration has approved a new once-daily combination tablet for HIV-1 infection in treatment-naïve adults that contains two previously approved HIV drugs plus two new ones, providing a complete treatment regime.

Pascal Soriot appointed CEO at AstraZeneca

Country
United Kingdom

Pascal Soriot of Roche is to become the new chief executive of AstraZeneca Plc on 1 October following the retirement on 1 June of David Brennan. Simon Lowth, the acting CEO, will stay in this job until Mr Soriot joins, after which he will continue as CFO.

Lemtrada application turned back by FDA

Country
France

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.

Lilly to discuss solanezumab results with regulators

Country
United States

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 raises revenue guidance

Country
Denmark

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 outlines restructuring plans

Country
Germany

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).

Ablynx looks ahead to RA data

Country
Belgium

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 raises CHF4.7 million in placement

Country
Italy

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 mounts challenge to antibody-drug conjugates

Country
Norway

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.