Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Shots: Genentech has reported the P-III (MAJESTY) trial results assessing Gazyva vs tacrolimus in 142 pts with primary membranous nephropathy Trial met its 1EP, showing higher CR at Wk. 104 & achieved its key 2EPs, incl. improved overall remission & CR at Wks. 104 & 76, respectively; data to be presented in the future &…

ByRidhi RastogiFebruary 16, 2026

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Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

Shots: The global P-III (ALIGN) trial assessed Vanrafia (0.75mg, QD, PO) vs PBO for 132wks. in 340 IgAN pts at risk of progressive loss of kidney function. An additional 64 pts received an SGLT2 inhibitor alongside a RAS inhibitor for at least 12wks. In the trial, Vanrafia showed a 2.39 mL/min/1.73m² difference in eGFR change…

ByRidhi RastogiFebruary 13, 2026

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

Shots: The P-III (LOGOS & KALOS) trials evaluated 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 with uncontrolled asthma; Regulatory filings in asthma are under review in all major regions In pooled analysis, Breztri improved lung function by 76 mL in morning pre-dose trough…

ByRidhi RastogiFebruary 13, 2026

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The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Uplizna (inebilizumab) as an add-on treatment of anti-AChR & anti-MuSK antibody positive adults with gMG Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading doses followed by 2 doses/year Pts on steroids began tapering at Wk. 4,…

ByRidhi RastogiFebruary 13, 2026

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Moderna Reports the EC Approval of mNEXSPIKE to Protect Against COVID-19

Shots: The EC has approved mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (aged≥12 yrs) Approval was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (aged ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination mNEXSPIKE showed 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in a descriptive sub-group analysis mNEXSPIKE showed 13.5%…

ByDipanshu DixitFebruary 12, 2026

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Acrotech Biopharma and Otsuka Pharmaceutical Receive the US FDA Approval for Adquey to Treat Mild-to-Mod. Atopic Dermatitis

Shots: The US FDA has approved Adquey (difamilast 1%) ointment for treating mild-to-mod. atopic dermatitis in adults and children aged≥ 2 yrs. Approval was based on multiple pivotal P-III trials, which showed a significantly higher proportion of patients treated with ADQUEY achieving IGA success after 4 wks vs vehicle, with a consistent safety profile Adquey is a non-steroidal topical PDE-4 inhibitor for BID treatment…

ByDipanshu DixitFebruary 12, 2026

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Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Shots: Approval was based on the P-III (PANOVA-3) trial assessing Optune Pax, a TTFields device used concomitantly with gemcitabine & nab-paclitaxel (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In mPP (198 received Optune…

ByRidhi RastogiFebruary 12, 2026

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Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Shots: The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…

ByRidhi RastogiFebruary 12, 2026

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Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

Shots: The global P-II (VALIANT) trial data assessed Verekitug vs PBO in 478 pts with severe asthma for ~60wks., with a minimum of 24wks. of treatment. Eligible pts could then enroll in the VALOUR LTE trial Trial met its 1EP, reducing annualized asthma exacerbation rates by 56% (100mg; Q12W) & 39% (400mg, Q24W), with FEV1…

ByRidhi RastogiFebruary 11, 2026

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THX Pharma Grants Biocodex Licenses for Batten-1 and TX01 in Rare Diseases

Shots: THX has granted Biocodex an exclusive global license to develop & commercialize Batten-1 for juvenile Batten disease (CLN3), along with exclusive US & Canada rights to develop & commercialize TX01 for Gaucher & Niemann-Pick type C disease As per the deal, THX will lead clinical development with financial & scientific support from Biocodex, which will…

ByRidhi RastogiFebruary 11, 2026

Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

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

The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Moderna Reports the EC Approval of mNEXSPIKE to Protect Against COVID-19

Acrotech Biopharma and Otsuka Pharmaceutical Receive the US FDA Approval for Adquey to Treat Mild-to-Mod. Atopic Dermatitis

Novocure Receives the US FDA Approval of Optune Pax with CT for Pancreatic Cancer

Merck Receives the FDA Approval for Keytruda and Keytruda Qlex, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma

Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

THX Pharma Grants Biocodex Licenses for Batten-1 and TX01 in Rare Diseases

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