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Unlocking Approval: John Hayslip from Verastem Oncology in an Illuminating Conversation with PharmaShots 
Shots:  Did you know that more than 80 % of Low-grade Serous Ovarian Cancer (LGSOC) patients experience recurrence?  The US FDA recently approved Verastem Oncology’s Avmapki Fakzynja Co-Pack, as the first ever treatment of patients with KRAS-mutated recurrent LGSOC  In an illuminating dialogue exchange with PharmaShots, John Hayslip, CMO at Verastem Oncology, provides a detailed overview…
4 hours ago0Comments
News
Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia
Shots: The US FDA has approved Doptelet to treat thrombocytopenia in pts (≥1yrs.) with persistent or chronic ITP who have not responded to prior treatments. Approval also incl. a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for children (1-6yrs.) Approval was based on P-III (AVA-PED-301) study assessing Doptelet in pediatric ITP pts, which showed that…
5 hours ago0Comments
News
Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients
Shots: Memo Therapeutics has reported P-II (SAFE KIDNEY II) trial data assessing potravitug vs PBO for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients (n=95) Trial didn’t meet its 1EP of undetectable BKPyV DNAemia but showed superior viral response (≥1-log₁₀ reduction) & resolution of biopsy-proven BKPyVAN by Wk. 20, with histological improvement from…
6 hours ago0Comments
News
GSK Enters a ~$12.5B Deal with Hengrui Pharma to Develop up to 12 Novel Therapeutics Across Various Indications
Shots: GSK will obtain an exclusive global license to HRS-9821, an add-on maintenance therapy for COPD, along with exclusive option rights to develop & commercialize ~11 more programs in oncology, respiratory, immunology, & inflammation globally (excl. mainland China, Hong Kong, Macau, & Taiwan for both) Each of the ~11 additional programs will have its own…
10 hours ago0Comments
News
KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema
Shots: The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries KONFIDENT data…
11 hours ago0Comments
Weekly Snapshot
PharmaShots Weekly Snapshots (Jun 21, 2025 – Jul 25, 2025)  
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health and Biosimilars. Check out our full report below:  AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC  Read More: AstraZeneca  Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of…
3 days ago0Comments