Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

Shots: Merck partnered with Google Cloud in a multi-year deal worth up to $1B to deploy an AI-driven agentic platform across R&D, manufacturing, commercial, and corporate functions The collaboration will integrate advanced AI tools, incl. Gemini Enterprise, to enhance productivity, digitize data, & support Merck’s global workforce of ~75,000 employees The partnership aims to accelerate…

ByRidhi RastogiApril 23, 2026

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AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Shots: AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression Trial met its 1EP of reduced proteinuria based on 24-hr. UPCR at 34wks., with effect seen as early as 10wks., while the 1EP of change in eGFR will be…

ByRidhi RastogiApril 23, 2026

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Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Shots: Utepreva has launched the Utepreva Endometrial Sampler, a single-use device designed to improve tissue capture & enable early diagnostic evaluation of endometrial cancer, with availability expected in Oct 2026 The device combines three mechanisms for single-pass sampling: a sponge tip absorbs tissue & fluid, a plunger-driven suction aspirates cells & prevents loss, & the…

ByRidhi RastogiApril 23, 2026

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Amneal Pharmaceuticals to Acquire Kashiv Biosciences for ~$1.1B

Shots: Amneal Pharmaceuticals has entered into a definitive agreement to acquire 100% of Kashiv BioSciences, accelerating its biosimilar pipeline & strengthening US commercial position As per the deal, Amneal will acquire Kashiv for $375M cash & $375M equity at closing, plus up to ~$350M in regulatory milestone payments, potential royalties tied to commercial milestones, &…

ByRidhi RastogiApril 22, 2026

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Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The Regeneron's P-III (NIMBLE) trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to either cemdisiran monotx. (600mg, SC, Q12W), pozelimab monotx. (200 mg, Q4W), cemdi-poze (200mg each, Q4W), or PBO (Q4W) cemdisiran (Q12W; n=64) vs PBO (n=59) improved gMG within 2wks., sustained to Wk. 24; MG-ADL (1EP) improved by 4.5 vs…

ByRidhi RastogiApril 22, 2026

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Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Shots: The EC has granted conditional approval to Ipsen's Ojemda as a monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy, across all 30 EEA states Approval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…

ByRidhi RastogiApril 22, 2026

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Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD

Shots: The Genentech's P-III (METEOROID) trial data assessed Enspryng (60, 120 or 180mg based on body weight; SC) vs PBO, administered at 0, 2 & 4wks., then Q4W thereafter in pts (≥12yrs.) with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) Trial met its 1EP with 87% vs 67% relapse-free pts at 48wks., & response onset as…

ByRidhi RastogiApril 22, 2026

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Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…

ByRidhi RastogiApril 22, 2026

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Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Shots: The US FDA approved MSD's Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…

ByRidhi RastogiApril 22, 2026

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Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)

Shots: Health Canada has granted NOC to Biocon's Bosaya (60mg/mL, SC, PFS) & Vevzuo (70mg/mL, SC, single-dose vial), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) Approval was based on extensive data, incl. analytical, nonclinical, & clinical data, showing that both biosimilars matched the reference product in quality, safety & efficacy Bosaya & Vevzuo are anti-RANKL monoclonal…

ByRidhi RastogiApril 21, 2026

Ridhi Rastogi

Merck Partners with Google Cloud in ~$1B Deal to Build AI-Enabled Enterprise Platform

AstraZeneca Reports the P-III (I CAN) Trial Data on Ultomiris for IgA Nephropathy

Utepreva Launches Utepreva Endometrial Sampler to Support Early Diagnosis of Endometrial Cancer

Amneal Pharmaceuticals to Acquire Kashiv Biosciences for ~$1.1B

Regeneron Reports P-III (NIMBLE) Trial Data on Cemdisiran for Generalized Myasthenia Gravis (gMG)

Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)

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