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…

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

Boehringer Ingelheim Reports the FDA Approval of Vetmedin to Delay Onset of Congestive Heart Failure in Dogs

Shots: The US FDA has granted full approval to Vetmedin chewable tablets (pimobendan) & Vetmedin oral solution for the delay of onset of CHF in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD) Approval was based on the 2 multi-site studies, with the EPIC trial showing Vetmedin delayed CHF onset or cardiac-related death…

January 20, 2026

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu + Perjeta to Treat HER2 Positive Metastatic Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer. MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer…

January 19, 2026

NEWS

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

Boehringer Ingelheim Reports the FDA Approval of Vetmedin to Delay Onset of Congestive Heart Failure in Dogs

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu + Perjeta to Treat HER2 Positive Metastatic Breast Cancer

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