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…

2 hours ago

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…

3 hours ago

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…

4 hours ago

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…

6 hours ago

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 ±…

7 hours ago

Revolution Medicines Reports the US FDA Approval of Rasonque (Daraxonrasib) for Previously Treated Metastatic PDAC

Shots: FDA has approved Revolution’s Rasonque to treat pts with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received ≥1 prior systemic therapy or who are not candidates for multiagent systemic therapy Approval was backed by P-III (RASolute 302) trial assessing Rasonque (300mg, QD, PO) vs CT, in the above-mentioned pts, regardless of RAS mutation, which met…

8 hours ago

Biohaven Licenses Kv7 Epilepsy Platform to SK Biopharmaceuticals in $795M Deal

Shots: Biohaven has granted SK Biopharmaceuticals exclusive worldwide rights to its Kv7 ion channel platform, led by opakalim (BHV-7000), a P-II/III candidate for focal epilepsy, with RISE3 topline results are expected in H2’26 Biohaven will receive upfront & milestone payments up to $795M for the Kv7 platform, incl. $400M in cash ($350M at closing &…

1 day ago

Abbott Secures FDA Authorization for Libre Duo 10 Day, a Dual Glucose-Ketone Sensing Technology

Shots: FDA has approved Libre Duo 10 Day, a dual glucose-ketone sensing biowearable, to provide real-time glucose monitoring while continuously detecting rising ketones for diabetic ketoacidosis (DKA) emergency, with launch expected later this year Libre Duo 10 Day met FDA standards for both integrated continuous glucose monitoring (iCGM) & the new integrated continuous glucose &…

1 day ago

Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

Shots: Akeso and Summit have reported interim analysis from the P-III (AK112-309/HARMONi-GI1) trial assessing ivonescimab + CT vs durvalumab + CT for the 1L treatment of advanced biliary tract cancer (BTC) Trial met its 1EP of OS, plus achieved all key 2EPs of PFS & ORR; data will be presented at the academic conference & published…

1 day ago

BeOne Medicines Reports the US FDA Approval of Tevimbra + Ziihera to Treat HER2+ GEA

Shots: The US FDA has approved the sBLA for Tevimbra (tislelizumab) + Ziihera (zanidatamab) & CT for the 1L treatment of adults with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA) Approval was based on the P-III (HERIZON-GEA-01) assessing the efficacy & safety of Ziihera+ CT, with and without Tevimbra, to the…

1 day ago

NEWS

Osivax and GC Biopharma Partner on Next-Generation Influenza Vaccine

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

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

Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

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

Revolution Medicines Reports the US FDA Approval of Rasonque (Daraxonrasib) for Previously Treated Metastatic PDAC

Biohaven Licenses Kv7 Epilepsy Platform to SK Biopharmaceuticals in $795M Deal

Abbott Secures FDA Authorization for Libre Duo 10 Day, a Dual Glucose-Ketone Sensing Technology

Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

BeOne Medicines Reports the US FDA Approval of Tevimbra + Ziihera to Treat HER2+ GEA

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