Shots:
AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in pts with a mean baseline SALT score of 84
Trial incl. 2 replicate studies (Study 1 & 2) in AA pts (n=1399; 12-64yrs.), where in both studies' Period A, pts were randomized to Rinvoq 15mg, 30mg, or PBO…
Shots:
Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being
The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…
Shots:
The US FDA has received sNDA of Venclexta (venetoclax) & acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL)
sNDA was supported by AstraZeneca-sponsored P-III (AMPLIFY) trial assessing Venclexta + acalabrutinib ± Obinutuzumab vs chemoimmunotherapy in previously untreated CLL pts without del(17p) or TP53 mutation
Trial showed that Venclexta + acalabrutinib a 35% reduction…
Shots:
AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in adults & adolescents with a mean baseline SALT score of 83.8
Trial incl. 2 replicate studies (Study 1 & 2) in AA pts (n=1399; 12-64yrs.), where both studies' Period A, pts were randomized to Rinvoq 15mg, 30mg, or…
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…
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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…
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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…
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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…
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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…

