Novartis Reports P-III (KALUMA) Trial Data of KLU156 for Uncomplicated Malaria

Shots: The P-III (KALUMA) trial assessed KLU156 (ganaplacide/lumefantrine, or GanLum) vs Coartem for treating acute, uncomplicated malaria due to Plasmodium falciparum in 1,668 adults & children (≥10kg) across 12 African countries Trial showed non-inferiority to the SoC (1EP), achieving a PCR-corrected adequate clinical & parasitological response (APCR) of 97.4% vs 94% (post hoc per-protocol cure…

ByRidhi Rastogi3 days ago

NEWS

Novartis to Acquire Avidity Biosciences for ~$12B, Boosting its Neuroscience Pipeline

Shots: Novartis has agreed to acquire Avidity Biosciences, strengthening its neuroscience pipeline with Avidity’s Antibody Oligonucleotide Conjugates (AOCs) platform & 3 late-stage programs As per the deal, Novartis will acquire Avidity for $72/share, valuing the company at ~$12B with an enterprise value of ~$11B; closing expected in H1’26 Before the merger, Avidity will transfer its early-stage precision…

ByRidhi RastogiOctober 27, 2025

NEWS

Novartis Reports Cosentyx P-III trial met 1 & 2 EPs for Patients with Polymyalgia Rheumatica (PMR)

Shots: Novartis has reported that Cosentyx met all 1 & 2 EPs in the P-III trial in adults with PMR The global P-III (REPLENISH) trial showed that Cosentyx (secukinumab) significantly improved sustained remission at Wk 52 in PMR pts vs PBO, with a reduced steroid dose and a safety profile consistent with prior use. Conducted…

ByDipanshu DixitOctober 23, 2025

NEWS

Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy

Shots: Novartis has reported the P-III (APPLAUSE-IgAN) trial findings assessing Fabhalta (200mg; BID; PO) vs PBO, both on top of SoC in 477 adults with IgA nephropathy (IgAN) Trial showed that Fabhalta reduced IgAN progression measured by annualized total slope of eGFR decline over 2yrs., & demonstrated favorable safety; data to be used for 2026…

ByRidhi RastogiOctober 16, 2025

NEWS

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Rhapsido for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Regulatory filings are also made in the EU, Japan & China, with priority review granted in China Approval was backed by P-III (REMIX-1 & 2) trials in CSU, which showed improved…

ByRidhi RastogiOctober 1, 2025

NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…

ByRidhi RastogiSeptember 29, 2025

TOP 20

Top 20 Monoclonal Antibodies of 2025

Shots: Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…

ByPrince GiriSeptember 18, 2025

NEWS

Monte Rosa Therapeutics Enters a ~$5.7B with Novartis to Develop Degraders for Immune-Mediated Diseases

Shots: Monte Rosa has collaborated with Novartis to develop novel degraders for immune-mediated diseases, leveraging Monte Rosa’s QuEEN discovery engine As per the deal, Novartis will gain an exclusive license to an undisclosed discovery target & options to license 2 programs from Monte Rosa’s preclinical immunology portfolio The deal is valued at ~$5.7B, with Monte…

ByRidhi RastogiSeptember 16, 2025

NEWS

Bio-Thera Solutions Collaborates with Jamjoom Pharmaceuticals to Commercialize BAT2306 (Biosimilar, Cosentyx)

Shots: Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA) As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development…

ByRidhi RastogiSeptember 15, 2025

NEWS

Novartis to Acquire Tourmaline Bio for ~$1.4B, Complementing its Cardiovascular Portfolio

Shots: Novartis has entered into an agreement to acquire Tourmaline Bio, incl. its asset pacibekitug, expanding its cardiovascular portfolio As per the deal, Novartis, through its subsidiary, will acquire Tourmaline for $48/share, representing an aggregate of ~$1.4B, & will merge the subsidiary into Tourmaline upon completion, making it an indirect wholly owned unit of Novartis; closing…

ByRidhi RastogiSeptember 9, 2025

Novartis Reports P-III (KALUMA) Trial Data of KLU156 for Uncomplicated Malaria

Novartis to Acquire Avidity Biosciences for ~$12B, Boosting its Neuroscience Pipeline

Novartis Reports Cosentyx P-III trial met 1 & 2 EPs for Patients with Polymyalgia Rheumatica (PMR)

Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy

Novartis’ Rhapsido (Remibrutinib) Receives the US FDA’s Approval for Chronic Spontaneous Urticaria

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Top 20 Monoclonal Antibodies of 2025

Monte Rosa Therapeutics Enters a ~$5.7B with Novartis to Develop Degraders for Immune-Mediated Diseases

Bio-Thera Solutions Collaborates with Jamjoom Pharmaceuticals to Commercialize BAT2306 (Biosimilar, Cosentyx)

Novartis to Acquire Tourmaline Bio for ~$1.4B, Complementing its Cardiovascular Portfolio

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