AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the EC’s Approval to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Shots: The EC has approved Wainzua to treat ATTRv-PN (stage 1/2 polyneuropathy) in adults pts based on P-III (NEURO-TTRansform) trial assessing eplontersen vs external PBO over 66wks., with follow-up to Wk. 85 & an end-of-trial evaluation. Eligible pts could then enter an ongoing OLE study Trial showed sustained benefits in co-1EPs of serum transthyretin…

ByRidhi RastogiMarch 11, 2025

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Eli Lilly and Incyte Highlight P-III (BRAVE-AA-PEDS) Trial Data of Baricitinib for Alopecia Areata at AAD 2025

Shots: The P-III (BRAVE-AA-PEDS) trial assessed baricitinib (2 or 4mg, QD, PO) vs PBO in 257 pts (12 to <18yrs.) with severe AA, where 89% had significant scalp hair loss, 65% had minimal/no eyebrow hair, & 57% had minimal/no eyelash hair with ClinRO of 2/3; next cohort (6 to <12yrs) enrollment to start in 2026…

ByRidhi RastogiMarch 11, 2025

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The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

Shots: The US FDA has granted 510(k) clearance to Persona Revision SoluTion Femur as an alternative for knee implant in pts with metal sensitivities; commercially available in the US in Q3’25 SoluTion Femur, part of the Persona Revision Knee System, utilizes surface-hardening treatment for enhanced wear performance & provides surgeons with anatomic components, incl.…

ByRidhi RastogiMarch 10, 2025

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Sun Pharma to Acquire Checkpoint Therapeutics For ~$355M

Shots: Sun Pharma to acquire Checkpoint Therapeutics for ~$355M to strengthen its onco-derm innovative portfolio with Unloxcyt (cosibelimab-ipdl); closing expected in Q2’25 As per the deal, Checkpoint stockholders will get $4.10 cash/share (~66% premium) upfront & CVR/share without interest allowing stockholders to receive additional $0.70 cash/share if Unloxcyt is approved before certain deadlines in…

ByRidhi RastogiMarch 10, 2025

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Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Shots: J&J has reported P-III trial data incl. ICONIC-LEAD (vs PBO) & ICONIC-ADVANCE 1&2 (vs Sotyktu) assessing icotrokinra (JNJ-2113, QD, PO) to treat mod. to sev. plaque Ps OICONIC-LEAD showed that pts achieved IGA 0/1 (65% vs 8%) & reached PASI 90 (50% vs 4%) at 16wks. By Wk. 24, 74% achieved IGA 0/1,…

ByRidhi RastogiMarch 10, 2025

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Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Shots: Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…

ByRidhi RastogiMarch 10, 2025

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The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

Shots: The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025) Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…

ByRidhi RastogiMarch 10, 2025

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GumPaws Launches Gummy Supplements to Promote Dental Health in Dogs

Shots: GumPaws has launched gummy supplements to support dental health in dogs GumPaws gummies are designed with specific density & chewiness to improve friction, helping clean plaque & support dental care in dogs, offering dual-benefit compared to conventional supplements Gummies are formulated with scientifically-backed natural ingredients that start absorbing through the gums &…

ByRidhi RastogiMarch 7, 2025

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Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

Shots: Biocon Biologics has entered into strategic collaboration agreement with Civica to extend access & affordability of Insulin Aspart in the US As per the deal, Biocon will supply Insulin Aspart drug substance to Civica, which will manufacture prefilled pens & vials of insulin at its Petersburg, Virginia facility. Civica will commercialize it in the US…

ByRidhi RastogiMarch 7, 2025

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AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

Shots: AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…

ByRidhi RastogiMarch 7, 2025

Ridhi Rastogi

AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the EC’s Approval to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

Eli Lilly and Incyte Highlight P-III (BRAVE-AA-PEDS) Trial Data of Baricitinib for Alopecia Areata at AAD 2025

The US FDA Grants 510(k) Clearance to Zimmer Biomet’s Persona Revision SoluTion Femur

Sun Pharma to Acquire Checkpoint Therapeutics For ~$355M

Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at AAD 2025

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

The EC Approves BMS’ Opdivo + Yervoy as 1L Treatment for Hepatocellular Carcinoma

GumPaws Launches Gummy Supplements to Promote Dental Health in Dogs

Biocon Biologics Partners with Civica to extend access of Insulin Aspart in the US

AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

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