Guido Rasi, the new executive director of the European Medicines Agency, said the agency needs to take a fresh look at how patients gain access to the medicines that it regulates. This means further strengthening the network of European drug regulators and taking account of the role that government payers play in making it possible for patients to gain access to new drugs.
Galapagos NV has become the latest company to report positive clinical data for an oral Janus kinase (JAK) inhibitor in rheumatoid arthritis, an autoimmune disease that is estimated to affect about 1% of the world’s population. Current treatments include non-steroidal anti-inflammatory drugs; methotrexate, and biologic medicines.
UCB SA of Belgium has acquired, for an undisclosed sum, research assets from venture-capital backed Lectus Therapeutics Ltd of the UK as well as rights to the company’s technology platform for ion channel discovery.
The European Medicines Agency’s main scientific committee, the CHMP, has recommended that Caprelsa (vandetanib), a treatment for aggressive and symptomatic medullary thyroid cancer, be granted a conditional marketing authorisation.
The US Food and Drug Administration has approved a new treatment for acute lymphoblastic leukaemia (ALL), the most common form of childhood cancer. The drug, Erwinaze (asparaginase Erwinia chrysanthemi), is from EUSA Pharma Inc.
Gilead Sciences Inc said it has reached an agreement to acquire the Princeton, New Jersey-based Pharmasset Inc in order to accelerate the development of an all-oral compound for the treatment of HCV. The transaction is valued at $11 billion.
The US Food and Drug Administration has approved a new recombinant fusion protein, Eylea (aflibercept), to treat patients with wet, age-related macular degeneration, a leading cause of vision loss and blindness in the elderly.
The US Food and Drug Administration is revoking its approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use. The decision was announced by Commissioner Margaret Hamburg on 18 November 2011 following a long review of the drug’s use in patients.
Zealand Pharma A/S, a developer of peptide drugs, raised its guidance for 2011 revenue and other operating income in its interim report for the first nine months, suggesting that it would break even on an operating basis for the year.
The Swiss molecular diagnostics company, Biocartis SA, has raised €71 million in a Series C round to support the development of its products including an integrated diagnostic that is expected to be launched in 2013.