All articles by Mekala ShivaramPrasad
AbbVie’s glioblastoma multiforme therapy receives orphan drug designation
AbbVie has obtained orphan drug designation from the European Medicines Agency (EMA) and the US FDA for its anti-epidermal growth factor receptor monoclonal antibody drug conjugate, ABT-414, as a treatment for glioblastoma multiforme.
Alexion receives orphan drug designation for Soliris in Europe
The European Commission has granted orphan drug designation to Alexion Pharmaceuticals’ Soliris (eculizumab), a terminal complement inhibitor, to treat patients with myasthenia gravis (MG).
Bristol-Myers Squibb and Allied Minds form new research enterprise
Bristol-Myers Squibb and Allied Minds have formed a new jointly owned enterprise, Allied-Bristol Life Sciences, aimed at advancing discoveries of biopharmaceutical innovations at leading US academic research institutions.
Vertex obtains receives European approval for cystic fibrosis oral medicine
The European Commission has approved Vertex Pharmaceuticals’ oral medicine Kalydeco (ivacaftor) for people with cystic fibrosis (CF).
FDA approves Jardiance tablets for type 2 diabetes
The US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) tablets, developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, as an addition to diet and exercise to improve glycemic control in adults with type II diabetes.
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Pfizer to acquire Baxter’s portfolio of marketed vaccines for $635m
Pfizer and Baxter have entered into a definitive agreement under which Pfizer will acquire Baxter’s portfolio of marketed vaccines for $635m.
Meda agrees to acquire Rottapharm for €2.3bn
Swedish drugmaker Meda has agreed to acquire Italy-based Rottapharm Madaus for around €2.3bn as part of its strategy to boost its profits and its presence in emerging markets.
FDA approves Bayer’s Eylea to treat diabetic macular edema
Bayer has announced the US Food and Drug Administration’s (FDA) approval of Eylea, an aflibercept solution for injection into the eye for the treatment of diabetic macular edema (DME).
AstraZeneca to have rights of Almirall’s respiratory franchise
Spain-based Almirall and AstraZeneca have entered into an agreement, involving Almirall transfering the rights to its respiratory franchise to Astrazeneca for an initial consideration of $875m on completion, and up to $1.22bn in development, launch and sales-related milestones.
EMA committee recommends approval of Gilead Sciences’ Zydelig
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences’ marketing authorisation application for Zydelig to treat chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL).