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GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012
As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…
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Syndivia has granted GSK exclusive global rights to develop and commercialize a preclinical ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
As per the deal, GSK will handle global development, manufacturing, & commercialization of the ADC in exchange for an upfront payment, along with development & commercial milestone payments up to a total of…
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The US FDA has approved Blenrep + BorDex for the treatment of r/r MM in adults who have received ≥1 prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent. NDA under NMPA’s priority review
Approval was based on P-III (DREAMM-7) trial assessing Blenrep (2.5mg/kg, IV, Q3W) in combination with BorDex for 8 cycles, then as a single…
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The CHMP has recommended Shingrix in a PFS (Recombinant Zoster Vaccine or RZV), simplifying administration by eliminating vial reconstitution for the prevention of shingles (herpes zoster). EU marketing authorization is expected in December 2025
The opinion was based on data showing that the PFS matches the existing vaccine
Shingrix combines glycoprotein E antigen with…
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China’s NMPA has approved Shingrix (Recombinant Zoster Vaccine) for the prevention of shingles (herpes zoster) in adults (≥18yrs.) at increased risk due to immunodeficiency or immunosuppression caused by known disease or therapy
Approval was supported by 6 trials in pts (≥18yrs.) who had undergone recent stem cell transplantation, kidney transplant, or had blood cancer, solid…
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ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care
In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
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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…
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The US FDA has accepted sNDA & granted priority review to Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uncomplicated urogenital gonorrhoea (PDUFA: Dec 11, 2025); regulatory review is ongoing in the UK & Australia
sNDA was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM)…
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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…
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The EC has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy. Review ongoing in the US (PDUFA: Oct 23, 2025) & China (priority review for DREAMM-7)
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade…

