Boehringer Ingelheim signs option to acquire Trutino Biosciences
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- Category: Boehringer Ingelheim
Boehringer Ingelheim announced the signing of an option to acquire Trutino Biosciences Inc. (the "Transaction"), a San Diego-based biotech company.
Trutino Biosciences is a pre-clinical stage biotech company dedicated to the discovery and development of next-generation cytokine therapies to treat immuno-oncology and autoimmune diseases.
Positive Phase 1 data from mRNA-based individualized neoantigen specific immunotherapy in patients with resected pancreatic cancer
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- Category: Business
BioNTech SE (Nasdaq: BNTX, "BioNTech") announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability of the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC).
Pfizer to invest $120 million to produce COVID-19 oral treatment in the U.S.
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- Category: Pfizer
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.
FDA approves RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for adults with moderate to severe rheumatoid arthritis
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- Category: Amgen
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 announces new global 'Act4Biosimilars' initiative
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- Category: Novartis
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 to acquire clinical-stage biopharmaceutical company Affinivax, Inc.
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- Category: GlaxoSmithKline
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.
FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)
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- Category: Roche
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.
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