Apotex`s Generic Ceftaroline Fosamil Receives Approval In US
According to Coherent Market Insights, the global methicillin-resistant Staphylococcus aureus (MRSA) drugs market is estimated to be valued at US$ 922.2 million in 2018, and is projected to exhibit a CAGR of 4.1% over the forecast period (2018–2026).
The European Medicines Agency’s (EMA) latest human medicines committee (CHMP) decisions have been announced, including recommendations for three medicines and one rejection for a marketing authorisation. The Committee also recommended granting a marketing authorisation for La Jolla’s Giapreza, among other decisions.
Apotex's Generic Ceftaroline Fosamil Receives Tentative Approval in US
Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant bacterial infections, today announced the appointment of David Melnick, M.D., as Chief Medical Officer to oversee Spero’s clinical development and regulatory strategy. Dr. Melnick brings significant clinical experience to Spero with 18 years in anti-infective drug development including seven successful anti-infective drug approvals.
Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for TEFLARO® (ceftaroline fosamil). If approved, this filing will expand the label of TEFLARO beyond adults to include the treatment of children two months of age and older with acute bacterial skin and skin structure infections (ABSSSI) including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and community-acquired bacterial pneumonia (CABP) caused by Staphylococcus pneumoniae and other designated susceptible bacteria.
Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to update the label for TEFLARO® (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Actavis Announces FDA Acceptance of sNDA to Expand TEFLARO