Pfizer to invest $120 million to produce COVID-19 oral treatment in the U.S.
Pfizer Inc. (NYSE: PFE) announced today that it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). The investment will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer's laboratories, which will create more than 250 additional high-skilled jobs at Pfizer's Kalamazoo site. 
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. 
Sandoz, a global leader in generic and biosimilar medicines, announced the launch of a new global initiative called 'Act4Biosimilars' to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A's) of biosimilars. 
GSK plc (LSE/NYSE: GSK) announced that it has entered into a definitive agreement to acquire Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company based in Cambridge, Boston, Massachusetts, for a $2.1 billion upfront payment and up to $1.2 billion in potential development milestones. Affinivax is pioneering the development of a novel class of vaccines, the most advanced of which are next-generation pneumococcal vaccines. 
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. 
AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.