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J&J

Johnson & Johnson Receives the CHMP Positive Opinion on Label Extension to SC Rybrevant for the Treatment of Advanced EGFR-Mutated NSCLC

Shots:The CHMP recommended label extension to SC Rybrevant (Q1W x 4wks, then Q2W) + Lazcluze for 1L advanced NSCLC harboring EGFRm exon 19 del/ exon 21 L858R substitution & as monotx. for NSCLC pts with EGFRm exon 20 insertions unresponsive to Pt-based CT Opinion was backed by P-III (PALOMA-3) trial, evaluating SC vs…

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Key Biosimilars Events of January 2025

Key Biosimilars Events of January 2025

Shots:      Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency       Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients       A major highlight was the Samsung Bioepis & Teva Partners to Commercialize Epysqli in…

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Bavarian Nordic

Bavarian Nordic Receives CHMP’s Positive Opinion for Vimkunya to Prevent Chikungunya

Shots:The CHMP has recommended Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.), with the EC’s decision & launch expected in H1’25 for the EU, Iceland, Liechtenstein, & Norway Opinion was based on 2 P-III studies showing a rapid immune response in 1wk. with ~97.8% of participants (n=3,500) developing neutralizing antibodies by day…

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Jupiter Neurosciences Collaborates with Zina Biopharmaceuticals to Advance Jotrol in P-II Trial for Parkinson’s Disease

Shots:Jupiter has partnered with Zina to support its P-IIa trial of Jotrol for assessing its safety & tolerability (1EP), and PK/PD (2EP) in Parkinson’s pts As per the agreement, Zina will provide services for P-IIa trial such as protocol design assistance (PK, biomarkers), regulatory strategy, & trial site selection Jotrol (micellar formulation)…

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Novo-Nordisk

Novo Nordisk Reports the US FDA’s Approval for Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in Type 2 Diabetes & Chronic Kidney Disease (CKD) Adults

Shots:The US FDA has approved Ozempic to reduce the risk of kidney disease worsening & CV death in adults with type 2 diabetes & CKD Approval was based on P-IIIb (FLOW) trial assessing Ozempic (1mg, Q1W, n=1767) vs matching PBO (n=1766) in type 2 diabetes & CKD pts (N=3533) Study met its 1EP of 24% relative…

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MERCK

Merck Receives CHMP’s Positive Opinion for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD)

Shots:The CHMP has recommended Capvaxive for active immunization against invasive disease & pneumonia caused by Streptococcus pneumoniae in adults (≥18yrs.), with the EC’s decision expected in Q2’25 for EU, Iceland, Liechtenstein and Norway. Ongoing regulatory review in Japan, plus multiple filings are underway Opinion was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20…

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Astrazeneca & Daiichi Sankyo

AstraZeneca and Daiichi Sankyo Receive CHMP’s Positive Opinion for Datroway to Treat HR+/HER2- Breast Cancer

Shots:The CHMP has recommended Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts receiving endocrine-based therapy & CT. Ongoing regulatory review in China & other regions Opinion was supported by a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent…

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Sanofi

Sanofi Receives China’s NMPA Approval for Sarclisa + SoC VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots:China’s NMPA has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM pts based on data showing improved PFS in P-III (IMROZ) trial; ongoing regulatory review in Japan for HSCT- ineligible NDMM pts This was preceded by NMPA approval of Sarclisa + pomalidomide & dexamethasone (Pd) for R/R MM pts who received ~1L…

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