H. Lundbeck A/S has raised its guidance for revenue and earnings this year on the back of strong growth of new products in the first half year. A one-off fine from the European Commission however contributed to a loss for the second quarter.
A Phase 3 study of Afinitor (everolimus) in patients with metastatic liver cancer did not meet its primary endpoint of overall survival, Novartis announced on 7 August. The Swiss multinational said it won’t seek to register the drug for this indication.
Cytos Biotechnology Ltd of Switzerland said that top-line data from a Phase 2b clinical study of its lead product for allergic asthma should be available during the second quarter of 2014. The trial is taking place in eight countries.
The Medicines Company of the US has completed the acquisition of ProFibrix BV following the successful completion of a Phase 3 trial of the Dutch company’s hospital product – a sealant to stop bleeding during and after surgery.
Bayer Healthcare has announced a new oncology collaboration and licensing agreement with Compugen Ltd to research and develop antibody-based therapeutics in oncology against two novel targets. The deal is valued at more than $500 million.
With a successful initial public offering on the Nasdaq market behind it, GW Pharmaceuticals Plc is recruiting patients for two pivotal studies that will examine the efficacy of its cannabis medicine, Sativex, as a treatment for cancer pain.
Sanofi Pasteur has started a Phase 3 trial of a new vaccine for the prevention of Clostridium difficile infection, a potentially life-threatening bacterium that causes intestinal disease. The trial will enrol up to 15,000 adults in 17 countries.
Pharming Group NV said that it expects the US Food and Drug Administration to complete its review, or otherwise respond, to its biologics licence application for Ruconest (recombinant human C1 esterase inhibitor) by 16 April 2014.
Sanofi SA is forecasting a 7% to 10% decline in earnings per share this year at constant exchange rates as the expirations of patents on key products continue to weigh on results and provisions are made against inventory write-offs in Brazil.
AstraZeneca Plc said that its five therapeutic and geographical priorities showed growth in the second quarter, even as the financial outlook for the group as a whole will be negatively affected by the loss of exclusivity on key products.