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EVENTS

Evolution Summit By Marcus Evans | May 7-8, 2026 | The Ritz-Carlton, Fort Lauderdale, Florida

The Evolution Summit returns May 7-8, 2026 at The Ritz-Carlton, Fort Lauderdale, Florida, bringing together leading clinical trial executives with innovative suppliers and solution providers in an invitation-only, premium setting.  Expect visionary keynotes, real-world case studies, and interactive forums aligned to the most pressing challenges in clinical operations and drug development. Featured leaders include…
5 days ago

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Roche
NEWS

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

Shots: Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications Gazyva is…
January 28, 2026

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Telix Pharmaceuticals
NEWS

Telix Reports First US Patient Dosing in the P-III Trial of Illuccix and Gozellix, for the Diagnosis of Prostate Cancer

Shots: The company has reported dosing of the first patient in the US  P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting Building…
January 19, 2026

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NEWS

D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
January 19, 2026

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INSIGHTS+

The US FDA New Drug Approvals in December 2025 

Shots:  Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision  Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…
January 13, 2026

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NEWS

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin) 

 Shots:  The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab)  BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity  Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…
January 13, 2026

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NEWS

BioNet’s VacPertagen Receives the EC Approval for Pertussis Disease 

Shots:  The EC has approved VacPertagen as a booster aganist Pertussis for pts (age≥12) and for passive infant protection via maternal immunization during pregnancy     CHMP recommendation was supported by data from three clinical trials and nine supportive studies, all consistently demonstrating that VacPertagen is safe for use in teenagers, adults, and pregnant women across populations  VacPertagen is an acellular pertussis vaccine with two components, including recombinant…
January 9, 2026

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Teva and Alvotech
NEWS

Alvotech and Teva Enter into an Agreement with Regeneron to Launch AVT06 (Biosimilar, Eylea) Across US  

Shots:  Alvotech and Teva reached a settlement and license agreement with Regeneron, allowing the US launch of AVT06, a biosimilar version of Eylea (aflibercept) in Q4’26 or earlier under certain conditions   AVT06 is an aflibercept (Eylea) biosimilar that inhibits VEGF and has been approved as Mynzepli in the UK and EEA and as Aflibercept BS in Japan   On…
December 19, 2025

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NEWS

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis) 

Shots:  The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)  Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India  Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…
December 17, 2025

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