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NEWS

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Shots: The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…
July 3, 2025

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Vertex Pharmaceuticals
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Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

Shots:    The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New Zealand In 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…
July 2, 2025

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Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

Shots: The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026 Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…
July 2, 2025

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BioVersys Partners with Shionogi to Jointly Develop Non-Tuberculous Mycobacteria (NTM) Clinical Candidate

Shots: BioVersys & Shionogi have entered into a global research & exclusive license option agreement to co-develop novel ansamycin compounds from BioVersys’ BV500 program into clinical candidates for treating NTM infections Shionogi will gain access to BioVersys’ ansamycin chemistry platform & BV500 program, with an exclusive option to license selected molecules for clinical development &…
July 2, 2025

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Unnatural Products Collaborates with argenx to Develop Oral Macrocyclic Peptides Across Multiple Indications

Shots: Unnatural Products (UNP) & argenx have entered into a strategic multi-target research collaboration to identify & develop oral macrocyclic peptide drugs for hard-to-target diseases leveraging UNP’s drug discovery platform As per the deal, UNP will receive upfront payment, equity investment, near-term, & R&D payments, plus ~$1.5B in research, development, regulatory, & commercial milestones as well as…
July 2, 2025

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Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Shots: The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapy Approval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…
July 2, 2025

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Valorum Biologics and Formycon
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Valorum Biologics and Formycon Collaborate to Commercialize FYB203 (Biosimilar, Eylea) Across US and Canada 

Shots:  Formycon has reported that Klinge Biopharma, holder of global rights to FYB203/Ahzantive (aflibercept-mrbb), has signed an exclusive licensing deal with Valorum Biologics for commercialization across the US and Canada  As per the deal, Klinge will receive upfront, milestone, and royalty payments on net sales. Formycon will receive a mid-single—to low-double-digit percentage of all payments…
June 25, 2025

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Harbour BioMed Enters a ~$670M Partnership with Otsuka Pharmaceutical to Advance HBM7020 for Autoimmune Diseases

Shots: Harbour BioMed & Otsuka Pharmaceutical have entered into a global strategic collaboration to advance HBM7020 for the treatment of autoimmune diseases As per the deal, Otsuka will receive an exclusive global license to develop, manufacture, & commercialize HBM7020 excl. Mainland China, Hong Kong, Macau & Taiwan in exchange for $47M in upfront & near-term…
June 23, 2025

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