A new once daily formulation of the HIV-1 medicine Isentress (raltegravir) has shown statistical non-inferiority to the marketed version of the same drug, paving the way for possible registration in both the US and Europe, according to Merck & Co. Inc.
Romosozumab, a monoclonal antibody that targets the protein sclerostin, has reduced the incidence of new spinal fractures in postmenopausal women with osteoporosis, according to results from a new Phase 3 study. The data were reported by UCB SA and Amgen Inc on 22 February.
Briviact (brivaracetam), a new medicine for patients with epilepsy, has been approved by the US Food and Drug Administration. The drug was developed by UCB SA of Belgium.
Ipsen SA, the French specialty pharmaceutical company, is separating the function of chief executive from that of chairman. Until now, both positions were held by Marc de Garidel.
Shield Therapeutics Plc has raised £32.5 million in an initial public offering of shares on the AIM market of the London Stock Exchange in the wake of a positive opinion from the European Medicines Agency for its drug for iron deficiency anaemia.
Shire Plc, the acquisition-oriented specialty pharma company, reported a 6.6% rise in revenue to $6.4 billion for 2015 and a 16.4% decline in operating profit to $1.4 billion using US GAAP. On a non-GAAP basis it reported an 11% rise in both revenue and operating income.
H. Lundbeck A/S, the Danish specialist in brain diseases, said the worst is over after reporting an operating loss of DKK 6.8 billion (€910 million) for 2015, reflecting the cost of a major restructuring programme and a reclassification of certain product rights.
The European Medicines Agency has set up a committee of experts with specialised knowledge of vaccines and infectious disease to contribute to the global response to Zika virus infection. Although not new, the virus has spread to Brazil where cases of neurological disorders have been reported.
The European Medicines Agency has given a positive opinion to a new immune-stimulating therapy for multiple myeloma using an accelerated procedure that is reserved for medicines addressing a major public health need.
Sanofi SA reported a 9% increase in net sales to €34.5 billion for 2015 but its operating income slid by 7.3% to €5.6 billion because of a rise in all major expenses. The net sales figure excludes revenue from animal health products, which are set to be sold to Boehringer Ingelheim GmbH.