China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

Shots: China’s NMPA has granted full approval to sNDA of Nefecon to reduce kidney function loss in adults with primary IgAN at risk of disease progression, regardless of their proteinuria levels Approval was based on global P-III (NefIgArd) trial assessing Nefecon (16mg, QD, PO) vs PBO in above pts on RASi therapy over 2yrs. (9mos.…

ByRidhi RastogiMay 8, 2025

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AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

Shots: The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regions Approval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…

ByRidhi RastogiMay 8, 2025

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Johnson & Johnson Reports the EC’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease

Shots: Approval was based on P-III trials, incl. GRAVITI (SC induction: 400mg Q4W; maintenance: 200mg at Wk. 12 then Q4W or 100mg at Wk. 16 then Q8W) vs PBO, & GALAXI 2 & 3 (IV induction: 200mg Q4W; SC maintenance) vs Stelara; MAA of SC Tremfya for mod. to sev. UC under EMA’s review based…

ByRidhi RastogiMay 7, 2025

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Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Shots: Gilead has reported final P-III (MYR301) trial data assessing bulevirtide (QD) for 144wks. in 150 pts living with HDV, who were randomized to either bulevirtide (2mg, n=49 or 10mg, n=50) or no antiviral therapy arm (n=51); pts in no therapy arm were switched to 10mg after 48wks. In the trial, 36% adults (23/64) with…

ByRidhi RastogiMay 7, 2025

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Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca has reported topline P-III (DESTINY-Breast11) trial data assessing neoadj. Enhertu (5.4mg/kg) monotx. or Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) vs SoC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927) Trial showed that Enhertu regimen achieved significant improvement in pCR rate (1EP), while EFS (2EP) data was…

ByRidhi RastogiMay 7, 2025

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Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

Shots: J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by either Tremfya 100mg SC Q8W or 200mg SC Q4W vs PBO in adults with mod. to sev. active UC; sBLA under the US FDA’s review At Wk. 24, trial showed improved clinical remission rates…

ByRidhi RastogiMay 6, 2025

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Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Shots: The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25) Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

ByRidhi RastogiMay 5, 2025

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AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma

Shots: AstraZeneca has reported P-III (LOGOS & KALOS) trial results evaluating Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts (n=~4400) with uncontrolled asthma Trial met its 1EP, with BGF 320/28.8/9.6μg showing significant improvement in forced expiratory volume in 1 second (FEV1) AUC 0 to 3hrs. at…

ByRidhi RastogiMay 2, 2025

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Amylyx Pharmaceuticals Reports the First Participant Dosing in P-III (LUCIDITY) Study Evaluating Avexitide in PBH

S Shots: Amylyx has dosed the first participant in its pivotal P-III (LUCIDITY) study of avexitide (90mg) for post-bariatric hypoglycemia (PBH), with recruitment completion expected in 2025 and topline data in the H1’26 The P-III (LUCIDITY) study evaluating avexitide (QD) vs PBO in ~75 PBH patients post Roux-en-Y gastric bypass surgery includes a 6wks. screening…

ByRidhi RastogiMay 1, 2025

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Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200

Shots: Dimerix has granted Amicus exclusive US rights to develop & market DMX-200 for all indications, incl. focal segmental glomerulosclerosis (FSGS), with Amicus handling regulatory filings, dossier maintenance, & marketing in the US Dimerix will get $30M cash upfront, ~$75M on FDA approval, $35M on 1st sale, ~$40M for future indications & ~$410M in sales…

ByRidhi RastogiMay 1, 2025

China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)

Johnson & Johnson Reports the EC’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease

Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma

Amylyx Pharmaceuticals Reports the First Participant Dosing in P-III (LUCIDITY) Study Evaluating Avexitide in PBH

Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200

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