Shots:
The CHMP has recommended approval of the MAA & EU-M4all application of lenacapavir as PrEP for individuals at risk of HIV across all 30 EEA states. It will be marketed in the EU as Yeytuo, if approved by the EC by late 2025
Opinion was based on P-III (PURPOSE 1 & PURPOSE 2) trials…
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…
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…
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…
Shots:
Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI)
A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025
StaySure, marketed as Navina Insert in the EU, is…
Shots:
The EC has approved Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs (≥12mos.)
As part of the EU approval process, Elanco conducted an H2H non-inferiority study in 338 dogs across 25 sites in 4 countries, which showed that Zenrelia (QD) is at least…
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…
Shots:
Eli Lilly has entered into a collaboration & license agreement with Gate Bioscience to identify, develop, & commercialize molecular gate drugs, leveraging Gate’s molecular gate drug discovery engine
As per the deal, Gate will receive ~$856M in total, incl. an upfront payment, equity investment, & development, regulatory, & commercial milestones, along with tiered royalties…
Shots:
Matchpoint & Novartis have entered into an exclusive option & license agreement to develop & commercialize oral covalent inhibitors targeting a transcription factor in inflammatory diseases using Matchpoint’s ACE platform
As per the deal, Matchpoint will lead all research activities through development candidate selection with funding from Novartis. Matchpoint will receive $60M in upfront & funding…
Shots:
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…

