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NEWS

Formosa Pharmaceuticals Submits a CTA for TSY-110 (Biosimilar, Kadcyla) 

 Shots:  Formosa has submitted a CTA to European regulatory authorities for a pivotal trial of TSY-110 (ado-trastuzumab emtansine), a biosimilar Version of Roche’s Kadcyla for HER2-positive breast cancer  The trial will evaluate TSY-110’s safety, tolerability, PK, and immunogenicity versus the reference product; preclinical data show high biosimilarity, consistent DAR, and comparable plasma kinetics  TSY-110 (EG12043) is an ADC biosimilar…
August 28, 2026

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NEWS

Natera and Angiex Partner to Monitor AGX101 Response Using Signatera

Shots: Natera has entered into collaboration with Angiex to use longitudinal Signatera testingfor circulating tumor DNA (ctDNA) to assess treatment response monitoring during AGX101 treatment AGX101 is designed to target TM4SF1-expressing tumor cells & tumor-associated endothelial cells, delivering a cytotoxic payload to both the tumor & its vasculature Angiex is conducting a P-I trial of…
August 28, 2026

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NEWS

HighLife Receives CE Mark Approval for Clarity Valve for Use with the HighLife TMVR System

Shots: HighLife received CE Mark approval for its HighLife Clarity Mitral Heart Valve for use with HighLife TMVR System for adults with symptomatic mod. to sev. or sev. mitral valve regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair Four-year follow-up of the first 35 consecutively treated pts showed durable valve performance, with…
August 28, 2026

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NEWS

Osivax and GC Biopharma Partner on Next-Generation Influenza Vaccine

Shots: Osivax & GC Biopharma have entered a long-term collaboration to develop & commercialize a next-generation seasonal influenza vaccine combining OVX836, Osivax’s T-cell vaccine, with GC FLU, GC Biopharma’s WHO-prequalified seasonal flu vaccine The single-injection combination is designed to generate complementary immune responses, with T cells targeting the conserved NP antigen alongside antibodies against the…
August 27, 2026

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Abbvie
NEWS

AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

Shots: The EMA has received an application seeking approval for Skyrizi (risankizumab; SC induction) for the treatment of adults with moderately to severely active Crohn's disease (CD) Application was backed by the P-III (AFFIRM) trial assessing Skyrizi (SC) as an induction treatment in above-mentioned pts (n=289) in 3 periods: Period A compared Skyrizi against PBO for 12wks., blinded…
August 27, 2026

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NEWS

AstraZeneca and Amgen Report P-III (CROSSING) Trial Data on Tezspire for Eosinophilic Esophagitis

Shots: Amgen & AstraZeneca have reported the top-line P-III (CROSSING) trial results assessing Tezspire at one of two doses (tezepelumab-ekko; SC, Q4W) vs PBO in pts living with eosinophilic esophagitis (EoE) Trial showed improvements across co-1EPs (histologic remission, and the frequency & severity of dysphagia) & key 2EPs at Wk. 24 which were sustained through Wk. 52; data…
August 27, 2026

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Roche
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Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Shots: The US FDA has granted approval to expand the use of Pathway HER2 (4B5) & Ventana HER2 Dual ISH tests to identify HER2+ metastatic gastroesophageal adenocarcinoma (GEA), incl. gastric, GEJ & esophageal adenocarcinoma The companion diagnostics can help identify pts who may be eligible for HER2-targeted treatment with two Ziihera (zanidatamab-hrii) regimens for 1L…
August 27, 2026

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Celcuity
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Celcuity Reports the US FDA sNDA Submission for Revtorpyk for HR+/HER2-, PIK3CA Mutant Breast Cancer

Shots: The US FDA has received sNDA for Revtorpyk (gedatolisib) for the treatment of pts with HR+, HER2-, locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on or after treatment with ≥1L of endocrine therapy sNDA was supported by the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of Revtorpyk + fulvestrant ±…
August 27, 2026

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