Dipanshu Dixit
Shots:
Pilatus Biosciences & Roche have entered into a clinical trial collaboration to evaluate PLT012 + atezolizumab for HCC pts
Under the collaboration, Roche will supply atezolizumab (Tecentriq) for Pilatus' P-I study of PLT012 in combination therapy for HCC, with plans to expand to other cancers
PLT012 is a humanized mAb that blocks CD36-driven lipid uptake, targeting…
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Basilea Pharmaceutica entered into an exclusive license deal with Venatorx Pharmaceuticals to acquire global rights to ceftibuten-ledaborbactam etzadroxil, a P-III oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for complicated urinary tract infections (cUTI), incl. pyelonephritis
Under the agreement, Venatorx will receive an upfront payment along with potential milestone payments in 2025 and will also be eligible…
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PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2025
The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry
The major highlighted drug was Regeneron’s Lynozyfic, securing…
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The P-III (KEYNOTE-905/EV-303) trial randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed 6 cycles of the combination, then 8 cycles of Keytruda alone)
Arms C & B showed improved…
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Fapon Biopharma has enrolled the first patient in China for its P-I trial of FP008 for advanced solid tumors, conducted at Zhejiang Cancer Hospital. The patient completed the DLT observation with a favorable safety profile. The trial focuses on evaluating FP008's safety and tolerability
FP008 demonstrated favorable safety and PK in monkey studies and…
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The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy
The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…
Knight Therapeutics and Incyte Expand Latin America Agreement to Include Retifanlimab and Axatilimab
Shots:
Knight Therapeutics has amended its agreement with Incyte Biosciences to gain exclusive distribution rights for retifanlimab (Brand name: Zynyz in the US and EU) and axatilimab (Brand name: Niktimvo in the US) in LATAM
Under the amended deal, Incyte will develop, manufacture, and supply retifanlimab and axatilimab, while Knight will handle regulatory approvals and…
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The FDA has granted accelerated approval for Jazz Pharmaceuticals’ Modeyso (dordaviprone) to treat diffuse midline glioma with an H3 K27M mutation in pts (aged≥ 1 yrs.) with progressive disease after prior therapy. Continued approval depends on results from the P-III (ACTION) trial
Approval was based on data from 50 pts across 5 studies, showing…
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Intas Pharmaceuticals, through its Accord subsidiaries, has completed the acquisition of Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv), a biosimilar of Neulasta
With the acquisition, Accord BioPharma, Intas’ U.S. specialty arm, continues Udenyca commercialization, offering patient-friendly administration options autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS)
Udenyca is a leukocyte growth factor used to reduce infection risk in…