Synopsis: In the pivotal Phase 3 TRANSFORM trial, single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with median…
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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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Global MarketRegulatorySanofi Inc.U.S FDA
FDA Approves Dupixent®(Dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis
by adminby adminSummary : Children treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced…
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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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Global Market
Halozyme Announces Commercial Launch of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy
by adminby adminSynopsis : Halozyme (NASDAQ: HALO) (“Halozyme”) today announced the commercial launch of TLANDO™ (testosterone undecanoate), an oral treatment indicated for testosterone replacement…
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