Vir Biotechnology Secures the US FDA Fast Track Designation for VIR-5500 to Treat Prostate Cancer

Shots: The US FDA has granted Fast Track designation to VIR-5500 for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC) VIR-5500 is being evaluated in a P-I study across 6 dose-expansion cohorts, incl. monotx. in taxane-naïve, radioligand therapy-naïve & radioligand therapy-exposed mCRPC, & combinations with enzalutamide or docetaxel in early-line mCRPC, or darolutamide in…

ByRidhi RastogiOctober 9, 2026

NEWS

Kairos Pharma Reports Positive Interim P-II Data for ENV-105 in Metastatic Prostate Cancer

Shots: Kairos Pharma announced positive interim efficacy data from its ongoing P-II study evaluating ENV-105 (carotuximab) in combination with apalutamide in pts. with metastatic castration-resistant prostate cancer (mCRPC) The combination demonstrated a statistically significant improvement in progression-free survival, with median PFS of 17.7 mons. vs 2 mons. with apalutamide alone (P=0.0008) Following the interim results,…

ByPrince GiriOctober 6, 2026

NEWS

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

Shots: Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases Trial showed improved OS (2EP), with a 24% reduction in death risk &…

ByRidhi RastogiFebruary 27, 2026

NEWS

Minghui Pharmaceutical and Qilu Pharmaceutical Enter an Exclusive Licensing and Collaboration Agreement for MHB088C

Shots: Minghui has granted Qilu exclusive rights to develop, manufacture & market MHB088C in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan) As per the deal, Minghui will receive ~$185.9M (CN¥ 1.345B) incl. $38.7M as upfront & near-term milestone payments & ~$147.2M in development, regulatory & sales milestones, plus double-digit net sales-based royalties;…

ByRidhi RastogiMay 9, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2024

Shots: The Fourth quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Roche's acquisition of Poseida Therapeutics for ~$1.5B This quarter also showcased multiple clinical trial results including Pfizer's P-III Study Data of Talzenna + Xtandi to treat mCRPC …

ByDipanshu DixitJanuary 13, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA's EUA for REGN-COV2 Ab combination while Health Canada accelerated…

ByDipanshu DixitJanuary 14, 2021

Vir Biotechnology Secures the US FDA Fast Track Designation for VIR-5500 to Treat Prostate Cancer

Kairos Pharma Reports Positive Interim P-II Data for ENV-105 in Metastatic Prostate Cancer

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

Minghui Pharmaceutical and Qilu Pharmaceutical Enter an Exclusive Licensing and Collaboration Agreement for MHB088C

PharmaShots’ Key Highlights of Fourth Quarter 2024

PharmaShots’ Key Highlights of Fourth Quarter 2020

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