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Novartis has reported topline P-III (GCAptAIN) trial results on Cosentyx to treat adults with newly diagnosed or relapsing giant cell arteritis (GCA)
The P-III (GCAptAIN) trial assessed efficacy & safety of Cosentyx (300 or 150mg) vs PBO, both in combination with a glucocorticoid taper regimen, in GCA pts across 27 countries
In the trial,…
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Health Canada has approved Kisqali (ribociclib) + an aromatase inhibitor (AI) for adj. treatment of adults with HR+/HER2-, stage II-III early breast cancer (EBC) at high risk of recurrence
Approval was supported by global P-III (NATALEE) study assessing Kisqali + AI vs AI alone as an adj. treatment of pts (n=5101) with stage II & III…
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Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab)
Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…
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Novartis has reported interim P-III (PSMAddition) trial data assessing Pluvicto + SoC (ARPI + ADT) vs SoC in PSMA+ mHSPC adults, with pts switching to Pluvicto upon confirmation of radiographic progression & per physician's discretion
Trial met its 1EP of improved rPFS, with favorable OS trend (2EP) observed; data to be shared in future…
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GSK to acquire Boston’s lead asset, efimosfermin alfa, a P-III candidate for steatotic liver disease (SLD)
As per the deal, GSK will acquire BP Asset IX (Boston’s subsidiary) for ~$2B to access efimosfermin, incl. $1.2B upfront & $800M in milestones, plus GSK will also be responsible for royalties & milestone payments owed to Novartis…
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Novartis to acquire Regulus Therapeutics incl. its lead asset, farabursen via its wholly owned subsidiary, which will merge with Regulus upon closing, resulting in Regulus becoming an indirect wholly owned subsidiary of Novartis
As per the deal, Regulus will get ~$0.8B upfront, with shareholders receiving $7/share in cash, & ~$0.9B upon achievement of a…
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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…
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The US FDA has granted accelerated approval to Vanrafia for proteinuria reduction in adults with primary IgAN at risk of rapid disease progression based on the ongoing P-III (ALIGN) trial, with no requirement for REMS program; traditional approval will be supported by eGFR results expected in 2026
Trial assessed atrasentan (0.75mg, PO, QD) +…
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Imaging, precision diagnostics, and targeted therapies are among the many ways radiopharmaceuticals improve patient outcomes and meet unmet healthcare needs
In 2024, the global radiopharmaceuticals market was valued at $6.74B and is envisioned to grow to $13.67B by 2033, exhibiting a CAGR of 8.2% from 2024 to 2033. Lilly ranks first in our list…
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The US FDA approved Tevimbra (tislelizumab-jsgr) + Pt containing CT as 1L treatment in unresectable or metastatic esophageal squamous cell carcinoma (ESCC) adults whose tumors express PD-L1 (≥1)
The approval was based on the P-III (RATIONALE-306) study (n=649) evaluating Tevimbra + CT vs. PBO + CT in unresectable, locally advanced recurrent, or metastatic…

