Skip to content Skip to footer
Subscribe Now
NEWS

Antares Therapeutics Inks ~$1.9B Deal with Novartis for Undruggable Oncology Targets

Shots: Antares Therapeutics has entered into a strategic collaboration with Novartis to discover, develop & commercialize small molecule therapies against undruggable oncology targets Antares will lead research & apply its discovery engine to a select number of historically undruggable targets until option exercise, while continuing to advance its wholly owned & partnered precision medicine pipeline…
June 25, 2026

Read more

INSIGHTS+

EMA Marketing Authorization of New Drugs in May 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.  CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
June 23, 2026

Read more

Hutchmed
NEWS

HUTCHMED Reports the P-II/III (ESLIM-02) Trial Data on Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia at EHA 2026

Shots: HUTCHMED has reported the P-III data (n=90) from P-II/III (ESLIM-02) assessing sovleplenib in in adult patients with primary or secondary wAIHA who had relapsed or were refractory to prior ≥1L of standard treatment; NDA accepted under NMPA priority review in Apr 2026 Trial met its 1EP of improved durable response rates (66% vs 15%),…
June 12, 2026

Read more

NEWS

Novartis Reports P-III (RemIND) Trial Data on Remibrutinib for Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial showed higher CR rates at Wk. 12 across symptomatic dermographism (29.3% vs 14%), cold urticaria (56.3% vs 14.6%), & cholinergic urticaria (29.3% vs 15.8%), with responses emerging as early as Wk.…
June 12, 2026

Read more

NEWS

Novartis Reports the Biomarker Data from P-I/II (FORTITUDE) study of del-brax in FSHD

Shots: Novartis has reported data from the biomarker cohort of the P-I/II (FORTITUDE) study assessing delpacibart braxlosiran (2mg/kg, Q6W) vs PBO in 90 pts (16-70yrs.) with facioscapulohumeral muscular dystrophy (FSHD) Trial met its 1 & key 2EPs, showing reductions in KHDC1L (cDUX) & creatine kinase biomarker levels, which indicates potent target engagement & decrease in…
June 11, 2026

Read more

NEWS

Novartis Inks a ~$1.44B Deal with Orionis to Advance Molecular Glue Therapies for Multiple Targets

Shots: Orionis Biosciences has entered into a multi-year collaboration with Novartis to discover & design molecular glue drugs for challenging therapeutic targets across multiple disease areas As per the deal, the companies will leverage Orionis’s Allo-Glue platform & AI-powered discovery engine to accelerate target & ligase profiling, as well as molecular glue optimization, enabling the…
June 10, 2026

Read more

NEWS

Novartis Receives the CHMP Positive Opinion of Vijoice for PROS Disorders 

Shots:  The CHMP has recommended Vijoice (alpelisib) for pts (age≥2 yrs) with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders who require systemic therapy  EMA’s recommendation is supported by a retrospective study of 57 PROS pts (age≥2 yrs) treated with alpelisib through a compassionate use program. Pts achieving at least a 20% reduction in the size of 1–3 abnormal growths or tumours after 24 wks, based…
May 21, 2026

Read more

INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026    

Shots:  The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma  CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS  The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…
May 19, 2026

Read more

NEWS

Novartis’ Rhapsido Receives the EC’s Approval for Chronic Spontaneous Urticaria 

Shots:  The EC has approved Rhapsido (Remibrutinib) for the treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment  Approval was supported by P-III (REMIX-1 & 2) trials (n=925) in CSU pts, where remibrutinib showed superior improvements in itch, hives & weekly urticaria activity at Wk.12 vs PBO in pts uncontrolled on H1-antihistamines, with a favorable safety profile…
April 23, 2026

Read more

Load more