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NEWS

QIAGEN Launches QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing

Shots: QIAGEN has launched the CE-IVDR certified QIAstat-Dx BCID GPF Plus AMR Panel, marking its entry into syndromic testing for bloodstream infections  The panel identifies 20 gram-positive bacterial & fungal pathogen targets & 10 antimicrobial resistance markers, delivering results in ~1 hour to support rapid clinical decision-making & antimicrobial stewardship The panel was showcased at…
April 15, 2026

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Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots: The US FDA has received the sBLA of Bizengri (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion sBLA was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive cancers, incl. cholangiocarcinoma, showing an ORR of 36.8% & mDOR of 12.9mos. per BICR, in…
April 15, 2026

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Henlius Receives NMPA IND Clearance for HLX05-N (Biosimilar, Erbitux)

Shots: The NMPA has granted IND clearance to Henlius’ HLX05-N, a biosimilar version of Erbitux (cetuximab), for the treatment of metastatic colorectal cancer (mCRC) HLX05-N showed high similarity to reference cetuximab in analytical & non-clinical studies, with Henlius planning to initiate an international multi-center P-I trial upon meeting required conditions Cetuximab is an anti-EGFR monoclonal…
April 15, 2026

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NEWS

Eli Lilly to Acquire CrossBridge Bio for ~$300M

Shots: Eli Lilly has entered into a definitive agreement to acquire CrossBridge Bio, incl. its synergistic dual payload platform for the development of differentiated therapeutics As per the deal, Lilly will acquire CrossBridge Bio for ~$300M in cash, incl. an upfront payment & a subsequent milestone payment CrossBridge Bio is advancing CBB-120, a TROP2-targeting TOP1i/ATRi…
April 15, 2026

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SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Shots: SynOx has reported the global P-III (TANGENT) trial data assessing emactuzumab (1000 mg Q2W × 5 doses over 8wks.) vs PBO in TGCT for 6mos., followed by 18mos. follow-up with option for open-label emactuzumab upon disease progression Trial met 1 & 2EPs with high significance, improving ORR (RECIST v1.1) & Tumor Volume Score, along…
April 14, 2026

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NEWS

Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization  The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…
April 14, 2026

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Travere Therapeutics
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Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Shots: The US FDA has granted full approval to Filspari (sparsentan) to reduce proteinuria in pts (≥8yrs.) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome Approval was based on the global P-III (DUPLEX) trial assessing Filspari vs irbesartan in 371 pts (8–75 yrs.) with biopsy-proven or genetic FSGS, following a 2wk. washout, with dose titration…
April 14, 2026

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Eli lilly
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Eli Lilly Reports P-III (BRUIN CLL-322) Trial Data on Jaypirca Combination for CLL/SLL

Shots: The P-III (BRUIN CLL-322) trial assessed Jaypirca + venetoclax & rituximab vs venetoclax & rituximab in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), with both arms treated ~2yrs. followed by therapy-free period until disease progression The trial met its 1EP, demonstrating improved PFS per IRC, with consistent results across clinically relevant subgroups…
April 14, 2026

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