IntraBio’s Aqneursa Receives the EC Approval for Treating Niemann-Pick Disease Type C (NPC)

Shots: The EC has approved Aqneursa (levacetylleucine), available as 1g granules for oral suspension, with or without miglustat for treating adults & pediatric pts (≥6yrs.; ≥20kg) with NPC Approval was backed by P-III (IB1001-301) crossover study assessing Aqneursa vs PBO in NPC pts, which showed improved neurological symptoms & function after 12wks. as measured by…

ByRidhi Rastogi4 days ago

NEWS

The EC Approves Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The EC has approved Dawnzera (SC autoinjector; Q4W/Q8W) for the routine prevention of HAE attacks in pts (≥12yrs.) Approval was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate, with 94% overall mean monthly reduction at 1yr. in the OASISplus OLE study Approval…

ByRidhi Rastogi4 days ago

NEWS

Insilico Medicine and Hygtia Therapeutics Partner to Advance ISM8969 for CNS Disorders

Shots: Insilico Medicine & Hygtia Therapeutics have entered into a co-development global collaboration agreement for Insilico's ISM8969 program for CNS disorders As per the deal, Hygtia will receive 50% worldwide rights to research, develop, register, manufacture, & commercialize ISM8969 in exchange for ~$66M, incl. milestone payments & $10M initial upfront payment Under the agreement, Insilico…

ByRidhi RastogiJanuary 21, 2026

NEWS

LEO Pharma Initiates P-III (DELTA CARE 1) Trial of Anzupgo (Delgocitinib) for Lichen Sclerosus

Shots: LEO Pharma has initiated P-III (DELTA CARE 1) trial assessing Anzupgocream vs cream vehicle for the treatment of adults with mild to sev. lichen sclerosus (LS) DELTA CARE 1 will enroll ~652 adults with LS, starting with 300 female pts for dose selection, followed by evaluation vs vehicle in ~352 additional female & male pts…

ByRidhi RastogiJanuary 21, 2026

NEWS

SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

Shots: The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…

ByRidhi RastogiJanuary 21, 2026

NEWS

GSK and Shionogi Restructure ViiV Healthcare Ownership as Pfizer Exits

Shots: GSK & Shionogi, together with Pfizer, have agreed to replace Pfizer’s 11.7% economic interest in ViiV Healthcare with an investment by Shionogi, reshaping the ownership structure of ViiV Healthcare As per the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125B, cancel Pfizer’s stake, pay Pfizer $1.875B, & distribute a $0.25B special…

ByRidhi RastogiJanuary 21, 2026

NEWS

Abbott Secures European CE Mark for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation

Shots: Abbott has reported CE Mark approval of TactiFlex Duo Ablation Catheter, Sensor Enabled to treat pts with atrial fibrillation (AF) Approval was based on the global FOCALFLEX CE Mark study assessing TactiFlex Duo, which showed clinically meaningful efficacy & favorable safety in the AF pts Also being evaluated in the FLEXPULSE IDE trial in the…

ByRidhi RastogiJanuary 21, 2026

NEWS

Pfizer Signs ~$530M Deal to Use Novavax’s Adjuvant in Product Development

Shots: Novavax has entered into a non-exclusive license agreement with Pfizer for the use of Novavax's Matrix-M adjuvant with Pfizer's products in up to two disease areas As per the deal, Novavax will supply Matrix-M for $30M upfront, ~$500M in development & sales milestones, & tiered high mid-single-digit % royalties on product sales Pfizer will be solely…

ByRidhi RastogiJanuary 21, 2026

NEWS

The US FDA Accepts Levicept’s LEVI-04 IND Application for Osteoarthritis

Shots: The US FDA has accepted IND application for LEVI-04 for the treatment of osteoarthritis Levicept has completed the P-II trial of LEVI-04 in 518 patients with pain & disability due to knee OA, with ACR Convergence data showing the 1EP was met & demonstrated significant analgesia & symptom control across all doses Further analyses…

ByRidhi RastogiJanuary 20, 2026

NEWS

Tesaro (GSK) Licenses Alteogen’s ALT-B4 to Develop & Commercialize SC Formulation of Dostarlimab

Shots: Tesaro (GSK’s subsidiary) has entered into an exclusive license agreement to use Alteogen’s ALT-B4 for the development & commercialization of a SC formulation of dostarlimab As per the deal, Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Tesaro, in exchange for $20M upfront & ~$265M in development, regulatory & sales milestones,…

ByRidhi RastogiJanuary 20, 2026

Ridhi Rastogi

IntraBio’s Aqneursa Receives the EC Approval for Treating Niemann-Pick Disease Type C (NPC)

The EC Approves Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Insilico Medicine and Hygtia Therapeutics Partner to Advance ISM8969 for CNS Disorders

LEO Pharma Initiates P-III (DELTA CARE 1) Trial of Anzupgo (Delgocitinib) for Lichen Sclerosus

SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

GSK and Shionogi Restructure ViiV Healthcare Ownership as Pfizer Exits

Abbott Secures European CE Mark for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation

Pfizer Signs ~$530M Deal to Use Novavax’s Adjuvant in Product Development

The US FDA Accepts Levicept’s LEVI-04 IND Application for Osteoarthritis

Tesaro (GSK) Licenses Alteogen’s ALT-B4 to Develop & Commercialize SC Formulation of Dostarlimab

Contact US

FOLLOW US