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GenFleet Therapeutics’ SLS009 Receives FDA Fast-Track Status for PTCL Treatment
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Shanghai-based biotech GenFleet Therapeutics has announced that its investigational drug SLS009 (GFH009) has received fast-track status from the US FDA for the treatment of recurrent/refractory adult peripheral T-cell lymphoma (PTCL) patients. This CDK9 inhibitor was previously awarded an orphan drug designation (ODD) by the FDA in mid-October, highlighting its potential…
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CStone Pharmaceuticals Receives NMPA Approval for Sugemalimab in R/R ENKTL
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R…
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Simcere Pharmaceutical Group Secures Full Approval for Cosela in China
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Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August…
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Novartis Announces Positive Interim Results for Atrasentan in IgA Nephropathy Phase III Study
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Novartis (NYSE: NVS), a global healthcare company, has released interim results from an ongoing Phase III study for its endothelin A receptor antagonist (ERA) atrasentan, indicating a significant milestone in the treatment of IgA nephropathy (IgAN), a rare kidney disease. The trial successfully met its primary endpoint, demonstrating a clinically…
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BMS and Karyopharm Partner to Evaluate Mezigdomide and Xpovio in Relapsed/Refractory Multiple Myeloma
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Bristol Myers Squibb (BMS; NYSE: BMY) has entered into a collaboration and supply agreement with Karyopharm Therapeutics (NASDAQ: KPTI) to evaluate the combination of BMS’s cereblon E3 ligase modulator (CELMoD) candidate, mezigdomide, with Karyopharm’s first-in-class Exportin 1 (XPO1) inhibitor, Xpovio (selinexor), plus dexamethasone. This combination is targeted at relapsed/refractory multiple…
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Novartis Seeks Access to Takeda’s Business Records Over Confidentiality Concerns
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Swiss pharmaceutical giant Novartis (NYSE: NVS) filed a complaint with a US court last week, seeking discovery to gain access to certain business records of Japan-based Takeda (TYO: 4502). Novartis aims to determine whether Takeda has potentially benefited from confidential documents that may have been inappropriately transferred by a former…
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Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
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Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
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AbbVie’s Q3 2023 Report Shows 6.0% YOY Decline in Net Revenues
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AbbVie (NYSE: ABBV) released its Q3 2023 financial report last week, revealing a 6.0% year-on-year (YOY) decline in net revenues for the first nine months of the year, amounting to USD 40.0 billion. The decrease was attributed to underperformance across most business areas, with the exception of neuroscience, which reported…
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