Pharmaceuticals, Biotechnology and Life Sciences
Bristol-Myers Squibb and Apexigen, a clinical-stage biopharmaceutical company focused on discovering and developing antibody-based therapeutics for the treatment of cancer, have started a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Apexigen’s APX005M in patients with advanced solid tumors.
Roche’s randomised phase III ALEX study showed that Alecensa (alectinib) as an initial (first-line) treatment significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared to crizotinib in people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
U.S. Food and Drug Administration (FDA) has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application (NDA) for Nicox’s Zerviate (cetirizine ophthalmic solution) 0.24%.
Akers Biosciences, a developer of rapid health information technologies, has reported its financial results for the fiscal year ended December 31, 2016.
Johnson & Johnson’s company Codman Neuro has acquired Neuravi Limited, a company dedicated to advancing neurovascular therapies and improving clinical outcomes for acute ischemic stroke patients.
The European Medicines Agency has had expressions of interest to host the London-based regulator from 21 of the 27 countries that will form the European Union once Britain leaves, revealing rivalry from Amsterdam to Zagreb for a prized institution.
Akers Biosciences, a developer of rapid health information technologies, has begun marketing its rapid test for heparin-induced thrombocytopenia (“HIT”) to the large number of hospital facilities in Puerto Rico as an extension of the company’s strategy to accelerate U.S. sales of its flagship product.
After receiving and analyzing legally binding transaction offers from two consortia for a public tender offer for all outstanding shares, Stada’s Executive and Supervisory Board has reached the conclusion to support the bid by Bain Capital and Cinven.
U.S. Food and Drug Administration (FDA) has approved supplemental indications for Gilead Sciences’s Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg.
There are few drugs available for the treatment of the disease, and those currently available have generally poor tolerability. As a result, CTCL patients and their physicians require safe and effective new treatment options, said Dr Richard Bethell, Medivir’s Chief Scientific Officer.