Pharming Group NV has reached an agreement with the US Food and Drug Administration on the design of a Phase 3 trial for its prospective treatment for hereditary angioedema (HAE), Rhucin. Under the agreement, Pharming will amend the protocol of the study and introduce a new method for assessing its primary endpoint.
Novo Nordisk A/S had sales of diabetes products of DKK 23.9 billion (€3.2 billion) in the first half of 2011, up by 10% from a year earlier, raising its share of the global market for diabetes products to 24%. Victoza and modern insulins drove growth.
Genmab A/S has revised downward its expected operating loss in 2011. But losses are still forecast to exceed those of the previous year largely because milestones paid in 2010 will not be repeated this year.
Vectura Group Plc has given an undisclosed partner US rights to a generic version of a therapy for asthma and chronic obstructive pulmonary disease that is being developed for delivery in a dry powder inhaler. The upfront payment is $10 million.
MediGene AG expects to report earnings before interest, taxes, depreciation and amortisation of €10 to €16 million in 2011, helped by milestone payments from Astellas Pharma Europe Ltd for the hormone therapy Eligard.
Transgene SA said that its in-licensed oncolytic virus therapy, JX-594, has shown a “mechanistic proof-of-concept” in an early clinical trial of patients with metastatic melanoma. The results of the trial have been reported in Molecular Therapy.
Shire Plc reported revenue of $1.1 billion in the second quarter of 2011, up by 25% from a year earlier on increased sales of products for rare diseases and for attention deficit hyperactivity disorder (ADHD). GAAP operating income was $283 million.
Three core products continued to drive growth at UCB SA during the first half of 2011 setting the Belgian company on course for revenue of about €3.1 billion for the year as a whole.
Merck & Co has announced a second round of staff reductions which could eliminate as many as 13,000 jobs on top of the 17,000 jobs already scheduled for elimination. The plans were disclosed in the company’s Q2 results on 29 July.
SkyePharma Plc has initialed a licensing agreement with Sanofi SA under which the French multinational will pursue marketing authorisation applications for the asthma drug, Flutiform, in Mexico, and Central and South America.