AbbVie’s Mavyret Receives the US FDA’s Approval for Acute Hepatitis C Virus

Shots:The US FDA has approved label expansion of Mavyret (glecaprevir/pibrentasvir) to treat pts (≥3yrs.) with acute or chronic HCV infection, without cirrhosis or with compensated cirrhosisLabel expansion was supported by P-III (M20-350) trial assessing Mavyret (QD, PO) in 286 treatment-naïve adults with acute HCV infection for 8wks. & then followed for 12wks.Trial…

ByRidhi Rastogi3 days ago

INSIGHTS+

The US FDA New Drug Approvals in May 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025 The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was AbbVie’s Emrelis securing…

ByDipanshu DixitJune 10, 2025

News

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

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…

ByRidhi RastogiMay 16, 2025

News

AbbVie Partners with ADARx Pharmaceuticals to Develop siRNA Therapies Across Multiple Disease Areas

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 techAs 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…

ByDipanshu DixitMay 15, 2025

News

AbbVie’s Rinvoq (Upadacitinib) Receives the US FDA’s Approval for Giant Cell Arteritis

Shots:The US FDA has approved Rinvoq (15mg; QD) to treat adults with giant cell arteritis (GCA) following the EC’s Approval in Apr 2025Approval 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 +…

ByRidhi RastogiApril 30, 2025

News

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 linesBLA 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 ptsTrials 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 statesApproval 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

AbbVie’s Mavyret Receives the US FDA’s Approval for Acute Hepatitis C Virus

The US FDA New Drug Approvals in May 2025

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

AbbVie Partners with ADARx Pharmaceuticals to Develop siRNA Therapies Across Multiple Disease Areas

AbbVie’s Rinvoq (Upadacitinib) Receives the US FDA’s Approval for Giant Cell Arteritis

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

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