Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) got approval from EU for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.
Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) got approval from EU for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.
GlaxoSmithKline plc (GSK) announces that its three-part transaction with Novartis has completed today. As a result of this transaction, GSK has acquired Novartis’s global Vaccines business (excluding influenza vaccines) for an initial cash consideration of $5.25 billion; has created a new world-leading Consumer Healthcare joint venture with Novartis in which GSK will have majority control and an equity interest of 63.5%; and has divested its Oncology business for an aggregate cash consideration of $16 billion.
-- Major European markets can finally benefit from the availability of Inflectra following the patent expiry of reference product Remicade® (infliximab)
-- Inflectra provides an alternative, potentially more affordable treatment option for people suffering from severe, debilitating diseases such as rheumatoid arthritis and inflammatory bowel disease while maintaining comparable quality, efficacy and safety to the reference product
GSK has acquired GlycoVaxyn AG, a specialist vaccine biopharmaceutical company based in Switzerland and seems to stregthen their vaccine pipeline. Since forming a scientific collaboration in 2012, GSK has held a minority stake in GlycoVaxyn and has now acquired the remaining shares for US $190 million (approximately £124 million) in cash to take full ownership of the company.
Natco Pharma Limited has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, with the U.S. Federal Drug Administration (USFDA), through its respective marketing partners in the USA.
Cipla Ltd., a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, today announced that it’s wholly owned subsidiary, Cipla (EU) Limited, U.K. has entered into a joint venture (JV) agreement with Cipla’s existing business partners in Morocco – Societe Marocaine De Cooperation Pharmaceutique (“Cooper Pharma”) and The Pharmaceutical Institute (PHI).
U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
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Sun Pharma and Ranbaxy Laboratories announced that the U.S. Federal Trade Commission (FTC) has completed its review of the proposed acquisition of Ranbaxy by Sun Pharma and has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).
Novartis announced results from the pivotal Phase III clinical trial demonstrating Jakavi® (ruxolitinib) significantly improved hematocrit control without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells) and reduced spleen size in patients with polycythemia vera (PV) who had an inadequate response to or unacceptable side effects from hydroxyurea as defined according to the modified European LeukemiaNet (ELN) criteria, which is published in The New England Journal of Medicine (NEJM). In PV, hematocrit control and spleen size reduction are key measures of a patient's response to therapy.
Piramal Enterprises Limited today announced that it is in final stages of discussion with the University of Kentucky for the potential acquisition of Coldstream Laboratories Inc. (‘Coldstream’) for a total consideration of USD 30.65 million.