AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

Shots: The US FDA has received BLA for TrenibotE (botulinum neurotoxin serotype E) for the treatment of mod. to sev. glabellar lines BLA was supported by 2 pivotal P-III (M21-500 & M21-508) trials & an open-label P-III (M21-509) safety study assessing TrenibotE in over 2,100 pts Trials met their 1 & 2EPs, with onset of…

ByRidhi RastogiApril 25, 2025

TOP 20

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

NEWS

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The EC has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) in 30 EEA states Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in first study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO + 52wk. CS taper regimen…

ByRidhi RastogiApril 8, 2025

NEWS

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

Shots: AbbVie has reported final analysis data from P-III (MIRASOL) trial assessing Elahere vs CT in FRα+ PROC pts (n= 453) who had previously received 1-3L of therapy At 30.5mos. mFU, trial showed 37% improved PFS (mPFS: 5.59 vs 3.98mos.) & superior ORR (41.9% vs 15.9%), while mOS was 16.85 vs 13.34mos., with 32% reduced…

ByRidhi RastogiMarch 17, 2025

NEWS

AbbVie Enters into a Global License Agreement with Gubra to Develop & Commercialize GUB014295 to Treat Obesity

Shots: AbbVie and Gubra entered into a global license agreement to develop & commercialize GUB014295, a potential long-acting amylin analog for obesity treatment As per the deal, AbbVie will lead GUB014295's global development & commercialization, whereas Gubra will get $350M upfront, up to $1.875B development, commercial, sales milestones, with tiered royalties; transaction closure is…

ByRidhi RastogiMarch 4, 2025

NEWS

The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The CHMP has recommended Rinvoq (15mg; QD) for the treatment of Giant Cell Arteritis (GCA) in adults with the EC’s decision expected in H1’25 Opinion was based on P-III (SELECT-GCA) trial assessing safety & efficacy of Rinvoq, where GCA pts (≥50yrs.) in first study period received either Rinvoq (7.5/15mg, QD) + 26wk. corticosteroid (CS) taper…

ByRidhi RastogiFebruary 28, 2025

NEWS

AbbVie Collaborates with Xilio Therapeutics to Develop Next-Generation Tumor-Activated Immunotherapies

Shots: AbbVie & Xilio have entered into a collaboration & option-to-license agreement to leverage Xilio's proprietary tech for developing tumor-activated Abs As per the deal, Xilio will get $52M upfront (incl. $10M equity investment), & is entitled to receive ~$2.1B in contingent payments for option-related fees, milestones, & tiered royalties Xilio’s platform develops…

ByRidhi RastogiFebruary 13, 2025

NEWS

Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Shots: The US FDA has approved Emblaveo (IV) + metronidazole for pts (≥18 yrs) with few or no therapy options for cIAI caused by susceptible gram -ve bacteria, incl. E. coli, K. pneumoniae, K. oxytoca, ECC, C. freundii complex, & S. marcescens; commercially available in Q3’25 Approval was based on prior aztreonam’s efficacy & safety data…

ByRidhi RastogiFebruary 10, 2025

NEWS

Abbvie Partners with Neomorph to Develop Novel Molecular Glue Degraders for Oncology and Immunology

Shots: AbbVie & Neomorph have partnered in a collaboration & option-to-license deal to develop molecular glue degraders for oncology & immunology, using Neomorph's molecular glue discovery As per the terms, Neomorph will receive upfront & is eligible for ~$1.64B in future option fee & milestones, plus net sales-based royalties Molecular glue degraders are…

BySenior EditorJanuary 24, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in November 2024

Shots: The EMA’s CHMP has granted positive opinions to 3 Biologics and 2 New Chemical Entities in November 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B PharmaShots has compiled a list of…

ByDipanshu DixitDecember 19, 2024

AbbVie Reports the US FDA’s BLA Submission for TrenibotulinumtoxinE (TrenibotE) to Treat Glabellar Lines

Top 20 Biopharma Companies of 2025

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

AbbVie Reports P-III (MIRASOL) Trial Data of Elahere for FRα-Positive Platinum-Resistant Ovarian Cancer (PROC)

AbbVie Enters into a Global License Agreement with Gubra to Develop & Commercialize GUB014295 to Treat Obesity

The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

AbbVie Collaborates with Xilio Therapeutics to Develop Next-Generation Tumor-Activated Immunotherapies

Abbvie Reports the US FDA Approval for Emblaveo to Treat Complicated Intra-Abdominal Infections (cIAI)

Abbvie Partners with Neomorph to Develop Novel Molecular Glue Degraders for Oncology and Immunology

EMA Marketing Authorization of New Drugs in November 2024

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