Synopsis: In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with median…
Diagnostics
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The British Big Pharma has launched an innovative rebranding, a tech-flavoured logo, and an impactful transformation for the future as GlaxoSmithKline turns…
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Global MarketIntellectual Property (IP)Patents
Johnson & Johnson, Momenta Pharma File Patent Infringement Lawsuit Against Natco, Mylan in US for Glatiramer Acetate Injection.
by adminby adminSummary : Johnson & Johnson and Momenta Pharmaceuticals lawsuit alleges infringement of two old patents associated with 20mg/ml and 40mg/ml Glatiramer Acetate…
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RegulatoryU.S FDA
Alnylam Scores Another FDA Nod for Amvuttra (Vutrisiran) for the Treatment of Hereditary Transthyretin-Mediated Amyloidosis (hATTR)
by adminby adminSummary : Amvuttra (vutrisiran) from Alnylam Pharmaceuticals has been licenced by the US Food and Drug Administration for the treatment of hereditary…
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RegulatoryRocheU.S FDA
FDA Approves Roche’s Evrysdi for Use in Babies under Two Months with Spinal Muscular Atrophy (SMA)
by adminby adminSummary : Roche announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include…
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Merger / Acquisition
GSK to Acquire Clinical-Stage Biopharmaceutical Company Affinivax, Inc. for 2.1 Billlon
by adminby adminSummary : GSK plc announced that it has entered into a definitive agreement to acquire Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company…
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Amgen Inc.RegulatoryU.S FDA
FDA Approves RIABNI™ (Rituximab-arrx), a Biosimilar to Rituxan® (Rituximab), for adults with moderate to severe Rheumatoid Arthritis
by adminby adminSummary : Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan®, in…
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GskRegulatoryU.S FDA
GSK Announces US FDA Approval of Priorix For the Prevention of Measles, Mumps and Rubella .
by adminby adminSummary : US Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunisation for the prevention of…
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Summary: Lipocine Inc. , a clinical-stage biopharmaceutical company focused on developing innovative products for neuroendocrine and metabolic disorders, announced today that Antares…
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CompaniesSun Pharma
Sun Pharma Acquires Uractiv portfolio from Fiterman Pharma in Romania
by adminby adminSummary Indian multinational pharma company Sun Pharmaceutical on Friday announced that one of its subsidiaries, S.C. Terapia S.A, has acquired the Uractiv…