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Key Biosimilars Events of January 2025
INSIGHTS+
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…
February 4, 20250Comments
Bavarian Nordic
News
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…
February 3, 20250Comments
News
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)…
February 3, 20250Comments
Novo-Nordisk
News
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…
February 3, 20250Comments
MERCK
News
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…
February 3, 20250Comments
Astrazeneca & Daiichi Sankyo
News
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…
February 3, 20250Comments
Viewpoints_Chris Gasink
VIEWPOINTS
Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots
Shots:Johnson & Johnson’s (J&J) Tremfya recently received its third approval from the US FDA, supported by the pivotal QUASAR study, which demonstrated significant remission after one year of treatment in adults with moderately to severely active ulcerative colitisTremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammationAt…
February 3, 20250Comments
Weekly Snapshot
PharmaShots Weekly Snapshots (January 27, 2025 – January 31, 2025)
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below:   Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma Read More: Merck and Eisai Novo Nordisk Completes P-Ib/IIa Study…
January 31, 20250Comments
Sanofi
News
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…
January 31, 20250Comments

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