Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Shots: The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data…

ByRidhi RastogiMarch 25, 2025

NEWS

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Shots: The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025) sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…

ByRidhi RastogiFebruary 18, 2025

NEWS

Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Shots: Sanofi and J&J have discontinued the P-III (E.mbrace) study of ExPEC9V after IDMC interim analysis due to insufficient efficacy against extraintestinal pathogenic E. coli , leading to a $250M impairment charge before tax The P-III trial assessed single dose of ExPEC9V (IM) vs PBO in adults (≥60yrs.) with UTI history in past 2yrs. to prevent invasive…

ByRidhi RastogiFebruary 14, 2025

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…

ByDipanshu DixitJanuary 31, 2025

NEWS

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…

ByRidhi RastogiJanuary 22, 2025

NEWS

Alloy Therapeutics Partners with Sanofi to Advance Innovative Therapeutics in the CNS Space

Shots: Alloy Therapeutics and Sanofi have entered into a target specific partnership to leverage Alloy's AntiClastic Antisense Platform for a CNS target Sanofi will utilize its neuroscience expertise to develop genetic medicines that cross the blood-brain barrier. It will pay up to $27.5M as upfront & near-term preclinical milestones as well as $400M as…

BySenior EditorJanuary 8, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2024

Shots: The third quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Eli Lilly's acquisition of Morphic Holdings for ~$3.2B This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity Our…

BySaurabh ChaubeyOctober 1, 2024

TOP 20

Top 20 Immunology Companies of 2024

Shots: Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…

ByPrince GiriJuly 25, 2024

INSIGHTS+

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

Shots: Witness the journey of the biopharma companies over 20 years with this informative and engaging report. The report highlights the development of the biopharma industry and the key factors influencing them In 2023, JNJ reclaims the topmost position in the list from Pfizer with a revenue of $85.16B, showcasing a sharp 10.30 percent vs…

BySaurabh ChaubeyMay 1, 2024

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2024

Shots: The first quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3B This quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…

BySenior EditorApril 1, 2024

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

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

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Alloy Therapeutics Partners with Sanofi to Advance Innovative Therapeutics in the CNS Space

PharmaShots’ Key Highlights of Third Quarter 2024

Top 20 Immunology Companies of 2024

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

PharmaShots’ Key Highlights of First Quarter 2024

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