Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

Shots: Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED) The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…

ByRidhi RastogiApril 7, 2026

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The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC

Shots: The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC Imdylltra is…

ByDipanshu DixitMarch 26, 2026

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The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Uplizna (inebilizumab) as an add-on treatment of anti-AChR & anti-MuSK antibody positive adults with gMG Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading doses followed by 2 doses/year Pts on steroids began tapering at Wk. 4,…

ByRidhi RastogiFebruary 13, 2026

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Amgen Acquires Dark Blue Therapeutics for ~$840M

Shots: Amgen has acquired Dark Blue Therapeutics, strengthening its early oncology discovery efforts & pipeline As per the deal, Amgen acquired Dark Blue Therapeutics in a transaction valued at ~$840M, integrating Dark Blue into its existing research organization Acquisition will add a preclinical small molecule that degrades MLLT1/3 in select acute myeloid leukemia subtypes, showing differentiated anti-cancer activity…

ByRidhi RastogiJanuary 7, 2026

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The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Shots: The US FDA has approved Amgen's Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG) Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering…

ByRidhi RastogiDecember 12, 2025

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Accord Healthcare Launches Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva) in the EU

Shots: Accord Healthcare has launched Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab), following patent expiry of reference products on Nov 27, 2025 Osvyrti (60mg PFS) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It is also used to treat bone loss in pts on…

ByRidhi RastogiDecember 2, 2025

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Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on…

ByRidhi RastogiDecember 1, 2025

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Alvotech Reports the EC Approval of AVT03 (Biosimilar, Prolia and Xgeva)

Shots: The EC has approved AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab), in 60mg/mL PFS (Prolia) & 70mg/mL single-use vial (Xgeva) presentation Approval was based on extensive clinical data, incl. analytical, PK & PD data, plus data from AVT03-GL-C01 trial (vs Prolia) among postmenopausal women with osteoporosis, as well as AVT03-GL-P01 trial (vs…

ByRidhi RastogiNovember 24, 2025

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Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)

Shots: The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026 The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy Intas has an exclusive…

ByDipanshu DixitNovember 20, 2025

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GlycoNex Doses Last Patient in P-III Trial of SPD8 (Biosimilar, Prolia/Xgeva) to Treat Osteoporosis

Shots: GlycoNex has dosed the last patient with SPD8, a biosimilar version of Prolia/Xgeva (denosumab), in its P-III trial for the treatment of primary osteoporosis from solid tumors Trial will assess the PK, efficacy, & safety of SPD8 vs reference denosumab in postmenopausal women with osteoporosis; top-line results are expected in Q2’26 & data will support…

ByRidhi RastogiOctober 31, 2025

Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC

The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Amgen Acquires Dark Blue Therapeutics for ~$840M

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Accord Healthcare Launches Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva) in the EU

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Alvotech Reports the EC Approval of AVT03 (Biosimilar, Prolia and Xgeva)

Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)

GlycoNex Doses Last Patient in P-III Trial of SPD8 (Biosimilar, Prolia/Xgeva) to Treat Osteoporosis

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