Pfizer Inc. announced that the European Commission approved Trumenba (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.
Merck announced that the U.S. FDA approved Isentress HD, a new 1,200 mg once-daily dose of the company’s integrase inhibitor Isentress (raltegravir).
Kite Pharma announced that the U.S. FDA accepted for priority review the BLA for axicabtagene ciloleucel for refractory aggressive non-Hodgkin lymphoma (NHL).
Havas Group is expanding its capabilities and footprint in the important and burgeoning Indian market by adding Sorento to its roster of agencies.
The U.S. FDA Oncologic Drugs Advisory Committee recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications.
Merck announced that it has entered into an exclusive worldwide license agreement with Teijin Pharma for the development, manufacture and commercialization of an investigational preclinical antibody candidate targeting the protein tau. Changes in tau are associated with a number of diseases affecting the nervous system, including Alzheimer’s disease (AD).
The U.S. FDA accepted a supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma after prior sorafenib therapy.
Chiesi Group announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for the extrafine triple combination ICS/LABA/LAMA, under the brand name Trimbow, for the first time in a single inhaler for the treatment of Chronic Obstructive Pulmonary Disease.
Merck’s Keytruda (pembrolizumab) received FDA approval for two new indications for certain patients with locally advanced or metastatic urothelial carcinoma, including first-line treatment in patients ineligible for cisplatin-containing chemotherapy.
Greater Than One Inc. (GTO) announced the appointment of Kieran Walsh as President of its US operations. Walsh is responsible for leading the GTO staff and offices in New York and San Francisco, and for providing oversight on all US-based accounts.
