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 &…
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…
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…
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…
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…
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,…
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…
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…
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…
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…

