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…

January 21, 2026

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 &…

January 21, 2026

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…

January 21, 2026

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…

January 21, 2026

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…

January 21, 2026

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…

January 20, 2026

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,…

January 20, 2026

GSK to Acquire RAPT Therapeutics for ~$2.2B

Shots: GSK has entered into a definitive agreement to acquire RAPT Therapeutics, incl. its P-II asset ozureprubart with data expected in 2027, strengthening GSK’s inflammatory & immunology pipeline As per the deal, GSK will acquire RAPT for $58/share, representing the aggregate equity value of $2.2B & an estimated upfront investment of $1.9B cash; closing expected…

January 20, 2026

iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

Shots: The US FDA has granted RMAT designation to NouvNeu001 for the treatment of Parkinson's disease The P-I data showed marked improvements in MDS-UPDRS Part III motor scores, as low-dose pts achieved 30.6 (OFF; 52.82% improvement) & 12.9 (ON; 54.67% improvement) points at 12mos. & high-dose pts 23.3 (OFF) & 9.67 (ON) at 9mos., with…

January 20, 2026

Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

Shots: The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS) sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…

January 20, 2026

NEWS

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

GSK to Acquire RAPT Therapeutics for ~$2.2B

iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis

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