Shots:
Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes
In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…
Shots:
AbbVie adds an eighth indication to Rinvoq’s label with the European Commission’s approval for treating adult patients with giant cell arteritis (GCA)
Sofie Berg, Therapeutic Area Head of International Immunology at AbbVie, in a conversation with PharmaShots, shares insights from the SELECT-GCA trial evaluating Rinvoq in GCA, highlighting both primary and secondary endpoints
Rinvoq…
Shots:
AbbVie has entered into a definitive agreement to acquire Capstan Therapeutics, including its P-I CPTX2309 and proprietary tLNP platform for in vivo RNA delivery to treat B-cell-mediated autoimmune diseases
As per the deal, Capstan will receive up to $2.1B in cash, pending customary closing conditions and regulatory approvals
CPTX2309 is a tLNP delivering mRNA…
Shots:
The P-III (TEMPLE) trial assessed Qulipta (60mg, QD) vs the highest tolerated dose of topiramate (50, 75 or 100mg; QD) over 24wks. in 545 adults with ≥4 monthly migraine days (MMD) across 73 sites in the EU, Israel & Canada, followed by a 52wk. open-label phase, where all pts received Qulipta
Trial met its…
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 cirrhosis
Label 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…
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…
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 +…
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…

