Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots:FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapyNDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapyTrial showed improved PFS (1EP) by 43%…

ByRidhi RastogiJune 9, 2025

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Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

Shots:3SBio & its subsidiaries will grant Pfizer exclusive license to develop, manufacture & market SSGJ-707 worldwide, excl. China, with an option to obtain marketing rights in ChinaAs per the deal, 3SBio will receive $1.25B upfront & ~$4.8B in development, regulatory & commercial milestones, plus double-digit tiered royalties on SSGJ-707 sales; closing is expected…

ByRidhi RastogiMay 20, 2025

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Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 2025

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Pfizer to Discontinue Danuglipron’s Development Program for Chronic Weight Management

Shots:Pfizer has discontinued the development of danuglipron (PF-06882961) as a potential therapy for chronic weight managementDanuglipron was evaluated in 2 P-I trials (NCT06567327 & NCT06568731), meeting key PK objectives & confirming formulation & dose with potential for strong efficacy & tolerability in P-III. However, a case of drug-induced liver injury & recent regulatory input led…

ByRidhi RastogiApril 14, 2025

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Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

Shots:The EC has approved Abrysvo to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals (aged 18-59yrs.) across all EU states including Iceland, Liechtenstein, and Norway.Approval was based on a pivotal P-III (MONeT) study that assesses the safety, tolerability & immunogenicity of Abrysvo vs PBO in adults (aged 18-59yrs.) at risk…

ByDipanshu DixitApril 1, 2025

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Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Shots:The EC has approved Tivdak an ADC, as a monotx. for adults (n=502) with recurrent or metastatic cervical cancer with disease progression on or after systemic therapyApproval was backed by P-III (innovaTV 301) global trial evaluating Tivdak vs CT alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)The trial met its 1EP of OS,…

ByDipanshu DixitApril 1, 2025

News

Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Shots:Arvinas & Pfizer have reported topline data from ongoing P-III (VERITAC-2) trial of vepdegestrant in ER+/HER2- advanced or metastatic breast cancer pts who had progression with CDK 4/6 inhibitors & endocrine therapy Pts received either vepdegestrant (PO, QD) for 28 days or fulvestrant (intramuscular) on Day 1 & 15 of first 28-day cycle,…

ByRidhi RastogiMarch 12, 2025

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Summit Therapeutics Partners with Pfizer to Assess Ivonescimab in Combination with Pfizer’s ADCs for Various Solid Tumor Settings

Shots:Summit has entered into a clinical trial collaboration with Pfizer to assess safety & anti-tumor activity of ivonescimab with multiple Pfizer’s vedotin ADCs in solid tumors; trials are expected to initiate in mid-2025 As per the deal, Summit will supply ivonescimab for proposed trials & Pfizer will handle operations, with both firms jointly…

ByRidhi RastogiFebruary 25, 2025

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Pfizer Reports Data from P-III (TALAPRO-2) Trial of Talzenna + Xtandi for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Shots:The P-III (TALAPRO-2) trial assessed Talzenna + Xtandi vs PBO + Xtandi in mCRPC ± HRRm pts for >4yr. (mFU: 52.5mos.) that were randomized into 2 Arms (A1: no genetic selection & A2: HRRm pts) A1 showed reduced death risk by 20% & mOS of 45.8 vs 37mos. while A2 depicted death risk…

ByRidhi RastogiFebruary 14, 2025

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Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots:The US FDA has approved sBLA for Adcetris + lenalidomide + Rituxan to treat adults with r/r LBCL (incl. DLBCL NOS, indolent lymphoma associated DLBCL, or HGBL), previously treated with ≥2L of therapy & are not eligible for auto-HSCT or CAR-T therapy Approval was based on P-III (ECHELON-3) trial assessing Adcetris with lenalidomide +…

ByRidhi RastogiFebruary 13, 2025

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

Pfizer Enters a ~$6.05B Exclusive Licensing Agreement with 3SBio for SSGJ-707

Top 20 Biopharma Companies of 2025

Pfizer to Discontinue Danuglipron’s Development Program for Chronic Weight Management

Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Arvinas & Pfizer Reports Topline Data from P-III (VERITAC-2) Trial of Vepdegestrant for Breast Cancer

Summit Therapeutics Partners with Pfizer to Assess Ivonescimab in Combination with Pfizer’s ADCs for Various Solid Tumor Settings

Pfizer Reports Data from P-III (TALAPRO-2) Trial of Talzenna + Xtandi for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Pfizer Reports the US FDA Approval of Adcetris Regimen to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

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