Shots:
The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC
Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…
Shots:
AbbVie has entered into collaboration & license option agreement with ADARx to develop siRNA therapeutics across multiple disease areas, incl. neuroscience, immunology & oncology, leveraging ADARx's RNA tech
As per the deal, ADARx will receive $335M upfront & will be eligible to receive several billion in additional contingent payments incl. option fees, milestones, plus tiered royalties…
Shots:
The US FDA has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) following the EC’s Approval in Apr 2025
Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…
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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…
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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…
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…
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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…
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…
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…
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…

