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EyeYon Medical secured FDA IDE approval to initiate the first US clinical study of EndoArt, a synthetic endothelial layer and an FDA-designated Breakthrough Device for chronic corneal edema
The study will involve 10+ leading US cornea surgeons, evaluating EndoArt as a novel alternative for patients unsuitable for human tissue implantation
EndoArt has already seen…
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Orca Bio reported positive P-I study data for Orca-Q, showing rapid neutrophil recovery, low acute/chronic GvHD, reduced infections, and low non-relapse mortality, including in patients treated without any GvHD prophylaxis
Patients receiving Orca-Q with tacrolimus (Arm A, n=18) vs. without immunosuppression (Arm C, n=26) showed comparable survival and GvHD outcomes, with faster neutrophil engraftment…
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Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy
The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…
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Nurix reported updated P-Ia/I b data for bexobrutideg in which P-Ia (n=48) showed an ORR of 83% incl. 2 CRs & a median PFS of 22.1mos. across all doses (50 mg to 600 mg OD) in heavily pretreated relapsed/refractory CLL/SLL pts.; P-Ib data (n=42) indicated higher ORR i.e. 83.3% & longer PFS at the 600mg…
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Natera has acquired Foresight Diagnostics, adding its PhasED-Seq phased variant technology with LOD95 of 0.3ppm & detection below 0.1ppm, further enhancing Natera’s capabilities in solid tumor MRD and expanding its IP portfolio of >500 issued/pending patents
As per the agreement, Natera completed the acquisition in an all-stock transaction incl. $275M upfront & up to…
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CDMOs have become central to the modern biopharmaceutical ecosystem, helping companies accelerate development timelines, navigate rising technical complexity, and bring innovative therapies to market with greater efficiency
The global CDMO market continues to post strong double-digit growth and is projected to reach nearly $255B by 2025. This momentum is driven by increased outsourcing, the…
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In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…
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Harnessing in-depth research and data-driven insights, PharmaShots unveils its definitive report on the Top 20 Countries in Healthcare Innovation 2025, a comprehensive guide to the nations setting global benchmarks in healthcare advancement
Through a meticulous blend of quantitative and qualitative analysis, PharmaShots delved into the multifaceted dimensions of healthcare innovation, spotlighting emerging trends such…
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Samsara Biocapital is a California-based venture capital and registered investment adviser investing across early to post-IPO stages in healthcare, life sciences, oncology, and digital health, with a portfolio of 70+ companies including Scholar Rock and PepGen
The firm made 30 investments across PIPE (43%), Series B (23%), and other rounds, with notable deals such…
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Meitheal Pharmaceuticals received the US FDA approval for Contepo (fosfomycin) for injection to treat complicated urinary tract infections (cUTI), including acute pyelonephritis in adults caused by E. coli and K. pneumoniae
The approval was supported by the P-II/III ZEUS (ZTI-01) study that assessed the safety and efficacy of the treatment on hospitalized pts and…

