The European Medicines Agency has issued a positive opinion for the antisense oligonucleotide medicine Spinraza (nusinersen) to treat patients with spinal muscular atrophy, a rare genetic disease that causes muscle weakness and a progressive loss of movement.
Vernalis Plc has had its application for the cough-cold medicine CCP-07 turned back by the US Food and Drug Administration, with the result that the product will not reach the US market as quickly as planned.
GE Healthcare has expanded its capacity for industralising cell therapies with the acquisition of Asymptote Ltd, a UK consultancy with technology for simplifying the freezing of cells intended as therapies, and thawing them before their use in patients.
The US Food and Drug Administration has turned back an application from Eli Lilly and Company for baricitinib, a candidate treatment for rheumatoid arthritis, saying that more data is needed to determine the most appropriate doses of the drug for use in patients.
The management of Stada Arzneimittel AG, Germany’s leading generics producer, has accepted a €4.1 billion offer for the company from two private equity firms, Bain Capital Private Equity LP of Boston Massachusetts, US and Cinven Partners LLP of London, UK.
Roche said that its kinase inhibitor Alecensa (alectinib) has produced better results in a Phase 3 trial of patients with a specific type of lung cancer than a rival treatment marketed by Pfizer Inc.
David Meeker, who has led Genzyme since Sanofi SA took over the US specialty pharma company in 2011, is to step down at the end of June to make way for Bill Sibold, head of Genzyme’s multiple sclerosis, oncology and immunology businesses.
Sweden-based Medivir AB has reported positive Phase 2 data for a recently acquired histone deacetylase (HDAC) inhibitor in a trial of patients with early-stage cutaneous T cell lymphoma (CTCL), a haematologic cancer that presents in the skin.
Nanobiotix SA, which is developing technology for enhancing radiotherapy treatments, has raised €25.1 million in a private share placement to finance its portfolio and the expected European market launch of its lead product NBTXR3.
Switzerland-based Symetis GmbH has made a major step onto the US medical device market after agreeing to be acquired by Boston Scientific Corp. The deal, announced on 30 March, consolidates the two companies’ technologies for treating valvular heart disease.