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Exelixis & Ipsen
NEWS

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The EC has approved Cabometyx for inoperable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts, who progressed on ≥1 prior systemic therapy other than somatostatin analogues in all 30 EEA states Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts, which were…
July 25, 2025

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Alnylam & Sanofi
NEWS

Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

Shots: The US FDA has approved Qfitlia to treat routine prophylaxis and prevent or reduce the frequency of bleeding episodes in pts. (age≥ 12yrs.) with hemophilia A or B, with or without factor VIII or IX inhibitors. Regulatory submissions have been completed in China & Brazil Qfitlia published clinical data in the NEJM in 2017, showing…
April 1, 2025

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Exelixis
NEWS

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.) Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…
March 27, 2025

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Astrazeneca
NEWS

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots: The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…
March 17, 2025

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VIEWPOINTS_Andrew Menzies-Gow1_Michael Wechsler2_2024
VIEWPOINTS

EGPA Remission with Fasenra: Michael Wechsler and Andrew Menzies Gow in Conversation with PharmaShots

Shots:  An already established biologic treatment for SEA in the US, EU5 & Japan. Fasenra is now showing exemplary remission for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA)  Today, at PharmaShots, we have a distinguished panel of speakers shedding light on advancements under the P-III MANDARA study and the recent publication of the study…
May 15, 2024

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Viewpoints_Philip M. Brown
VIEWPOINTS

PharmaShots Interview: Dermavant’s Philip M. Brown Shares Insights on the Clinical Data of Tapinarof Published in NEJM

In an interview with PharmaShots, Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant shares his views on the P-III (PSOARING 1 & 2) trials of tapinarof for the treatment of Plaque Psoriasis Shots: The P-III (PSOARING 1 & 2) trials evaluate the efficacy and safety of tapinarof (1%, qd) vs vehicle-controlled cream in a ratio (2:1) in 1025 patients aged…
February 8, 2022

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