NEWS

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Shots: The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks. Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was…

March 25, 2026

The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes

Shots: The P-II trial assessed UBT251 (2, 4 & 6 mg, QW, SC) vs PBO & semaglutide (1mg) in 211 Chinese T2D pts, which showed HbA1c reduction of 2.16% vs 1.77% (semaglutide) & 0.66% (PBO) at 24wks. from a baseline of 8.12% Trial also showed weight loss of up to 9.8% vs 4.8% (semaglutide) &…

March 25, 2026

Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty

Shots: Pixee Medical has received CE mark for Knee+ NexSight, its AR-based total knee arthroplasty solution, with initial procedures completed in EU & a 510(k) submission under FDA review Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need for a robot, console, or disposables, while delivering robotic-level accuracy with…

March 25, 2026

Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

Shots: The US FDA has accepted NDA & granted priority review to zilganersen for the treatment of Alexander disease (AxD), with PDUFA target action date of Sep 22, 2026 NDA was backed by the P-III trial assessing zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for 60wks., followed by an open label…

March 25, 2026

Karyopharm Therapeutics Reports Topline P-III (SENTRY) Trial Data on Selinexor + Ruxolitinib for Myelofibrosis

Shots: The P-III (SENTRY) trial assessed Selinexor (60mg, QW) + ruxolitinib vs PBO + ruxolitinib in 353 pts with frontline myelofibrosis; FDA discussions on SENTRY data & its sNDA strategy is underway, with potential compendia inclusion in H2’26 As of Feb 20, 2026, trial met its first co-1EP, with 50% vs 28% achieving SVR35 at…

March 25, 2026

Quotient Therapeutics & Merck Enter ~$2.2B Partnership to Discover Novel Drug Targets in IBD

Shots: Quotient has entered into a multi-year research collaboration agreement with Merck to discover novel drug targets in inflammatory bowel disease leveraging Quotient’s somatic genomics platform tech Through its somatic genomics platform, Quotient analyzes patient tissue to identify disease-causing or protective mutations, generating insights that inform novel therapeutic strategies across multiple conditions, including IBD As…

March 24, 2026

Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Shots: Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…

March 24, 2026

Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Shots: Apogee has reported maintenance data from Part A of the P-II (APEX) trial assessing zumilokibart (APG777; 360mg at Q3M or Q6M) in pts with mod. to sev. atopic dermatitis Trial showed 75% (Q3M) & 85% (Q6M) of Wk. 16 zumilokibart-responders maintained EASI-75, while 86% (Q3M) & 78% (Q6M) sustained vIGA 0/1, with continued deepening…

March 24, 2026

Cencora to Acquire EyeSouth’s Retina Business for ~$1.1B

Shots: Cencora has entered into a definitive agreement to acquire the retina business of EyeSouth Partners in a transaction of ~$1.1B The deal will bring EyeSouth’s affiliated retina physicians under Retina Consultants of America (RCA), expanding Cencora’s footprint in retina care Through this integration, physicians will gain access to RCA’s clinical, research, & operational infrastructure,…

March 24, 2026

Gilead to Acquire Ouro Medicine for ~$2.1B

Shots: Gilead to acquire Ouro for a total of $1,675M in upfront cash & up to $500M in contingent milestone payments. Acquisition will add Ouro’s P-I/II asset OM336 (gamgertamig) to Gilead’s inflammation portfolio, with registrational studies to begin in 2027 Also, Gilead is in advanced discussions with Galapagos for a potential R&D collaboration on the…

March 24, 2026

NEWS

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes

Pixee Medical’s Knee+ NexSight Receives the European CE Mark for Knee Arthroplasty

Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

Karyopharm Therapeutics Reports Topline P-III (SENTRY) Trial Data on Selinexor + Ruxolitinib for Myelofibrosis

Quotient Therapeutics & Merck Enter ~$2.2B Partnership to Discover Novel Drug Targets in IBD

Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Cencora to Acquire EyeSouth’s Retina Business for ~$1.1B

Gilead to Acquire Ouro Medicine for ~$2.1B

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