Novartis Reports del-desiran P-III HARBOR Study Data in Myotonic Dystrophy Type 1

Shots: Novartis announced that the P-III HARBOR study of delpacibart etedesiran (del-desiran) in people with myotonic dystrophy type 1 (DM1) did not meet its 1EP of video hand opening time (vHOT) Del-desiran showed evidence of clinical activity in 2EPs and exploratory analyses, while safety findings were generally consistent with previously reported data; Novartis is evaluating…

ByPrince GiriSeptember 8, 2026

NEWS

Novartis Reports the P-III (Lp(a)HORIZON) Trial Data on Pelacarsen in Patients with Elevated Lp(a) and Established CV Disease

Shots: Novartis has reported the topline P-III (Lp(a)HORIZON) trial data assessing pelacarsen vs PBO on the incidence of 4-point major adverse CV events (MACE) in 8,323 pts with elevated Lp(a) & established CVD Pelacarsen did not meet its 1EP of reducing major CV events, despite lowering Lp(a) levels in pts receiving guideline-directed lipid-lowering & antihypertensive…

ByRidhi RastogiSeptember 7, 2026

NEWS

Novartis and Alteogen Partner for ALT-B4 to Advance SC Formulations of Multiple Products

Shots: Alteogen has entered into an option & license agreement with Novartis for the development & commercialization of SC products leveraging ALT-B4 powered by Alteogen's Hybrozyme tech As per the deal, Novartis can obtain exclusive rights to develop & commercialize SC formulations of multiple products using Alteogen’s ALT-B4, with Alteogen eligible for ~$3.223B in option…

ByRidhi RastogiSeptember 3, 2026

NEWS

Novartis Reports P-III (REMODEL-1/-2) Trial Data on Remibrutinib for Relapsing Multiple Sclerosis

Shots: Novartis has reported topline data from P-III (REMODEL-1/-2) trials assessing remibrutinib (100mg) vs teriflunomide in ~2,000 adults with relapsing multiple sclerosis (RMS) Remibrutinib met the 1EP, significantly reducing annualized relapse rate (ARR), plus trial showed clinically meaningful reductions in key 2EPs related to disability progression, with a positive trend in 3mCDP & nominally significant…

ByRidhi RastogiSeptember 1, 2026

INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2026

Shots: The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca. EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…

ByDipanshu DixitAugust 18, 2026

NEWS

Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Shots: The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC…

ByRidhi RastogiAugust 3, 2026

TOP 20

Top 20 R&D Spending Biopharma Companies of 2026

Shots: Merck & Co., Roche, and Johnson & Johnson emerged as the leading pharmaceutical companies by R&D expenditure in 2025, investing $15.78B, $15.49B, and $14.66B, respectively. Continued investments in late-stage clinical programs, pipeline expansion, advanced technologies, and strategic business development reinforced their commitment to driving pharmaceutical innovation Global biopharmaceutical R&D investment continues to accelerate as…

ByPrince GiriJuly 31, 2026

TOP 20

Top 20 Immunology Companies of 2026

Shots: AbbVie led the global immunology market with $30.4B in immunology revenue in 2025, followed by Sanofi ($19.08B) and Johnson & Johnson ($15.72B). Continued demand for biologics and targeted therapies across autoimmune and inflammatory diseases supported strong commercial performance among leading companies. The global immunology market, valued at $108.4B in 2024, is projected to…

ByPrince GiriJuly 17, 2026

NEWS

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Shots: The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…

ByRidhi RastogiJuly 17, 2026

NEWS

Novartis to Acquire Myricx Bio for ~$1.5B

Shots: Novartis has entered into an agreement to acquire Myricx Bio, strengthening Novartis’ oncology pipeline & advancing next-generation targeted drug conjugates with novel payload mechanisms Myricx is developing ADCs, using NMT inhibitor (NMTi) payloads designed to disrupt key cancer cell processes, with preclinical data showing broad activity across solid tumors, incl. TOPO-1-resistant models As per…

ByRidhi RastogiJuly 6, 2026

Novartis Reports del-desiran P-III HARBOR Study Data in Myotonic Dystrophy Type 1

Novartis Reports the P-III (Lp(a)HORIZON) Trial Data on Pelacarsen in Patients with Elevated Lp(a) and Established CV Disease

Novartis and Alteogen Partner for ALT-B4 to Advance SC Formulations of Multiple Products

Novartis Reports P-III (REMODEL-1/-2) Trial Data on Remibrutinib for Relapsing Multiple Sclerosis

EMA Marketing Authorization of New Drugs in July 2026

Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Top 20 R&D Spending Biopharma Companies of 2026

Top 20 Immunology Companies of 2026

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Novartis to Acquire Myricx Bio for ~$1.5B

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