News
Todd H. Lanman to Present First Full U.S. IDE Trial Results for FDA-Approved Synergy Disc(R) at ISAS
1+ day, 21+ hour ago (302+ words) Beverly Hills spine surgeon and principal investigator will present pooled clinical outcomes following recent FDA approval of motion-preserving cervical disc technology The Synergy Disc received FDA approval after demonstrating superiority to anterior cervical discectomy and fusion (ACDF) on the study's…...
Merck Announces Initiation of Pivotal Phase 2b/3 Trial Evaluating MK-8748 (Tiespectus), an Investiga
2+ day, 7+ hour ago (1089+ words) RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of a pivotal Phase 2b/3 trial evaluating MK-8748 (also known as Tiespectus, EYE201), a novel investigational bispecific antibody that directly activates Tie2 signaling…...
Clarametyx Biosciences Strengthens Executive Leadership to Accelerate Clinical Development Efforts
2+ day, 4+ hour ago (739+ words) Veronica Hall, PhD, Promoted to Chief Development Officer and Head of R&D; Brendan Doran, PharmD, Promoted to Chief Operating OfficerCOLUMBUS, Ohio--(BUSINESS WIRE)--Clarametyx Biosciences, Inc. (Clarametyx), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven…...
Glycomine Completes Enrollment in Global Phase 2b POLAR Study of GLM101 for the Treatment of PMM2-CD
2+ day, 8+ min ago (739+ words) POLAR is a randomized, double-blind, placebo-controlled study that enrolled 43 patients with PMM2-CDG across 15 sites globally with topline data expected in the fourth quarter of 2026Primary endpoint evaluates change in ataxia at 24 weeks, as measured by the International Cooperative Ataxia Rating Scale…...
CanWell Pharma Announces FDA Clearance of the IND for CAN016, a Dual-Payload ADC Targeting HER2, for
2+ day, 5+ hour ago (514+ words) IND approval from the FDA allows CanWell Pharma to assess the safety, tolerability and pharmacokinetics of CAN016 in a Phase I clinical studyCAN016, a novel antibody-drug conjugate (ADC), is expected to overcome the resistance mechanisms that limit the efficacy of conventional, single-payload…...
Tenpoint Therapeutics Ltd and PHIL Partner to Launch YUVEZZI™ Direct-to-Patient Cash Program to Make
2+ day, 2+ hour ago (552+ words) SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Tenpoint Therapeutics, a leading ophthalmic manufacturer, and PHIL Inc., an all-in-one digital hub and Direct-to-Patient platform, today announced the launch of a Direct-to-Patient (DTP) cash program for YUVEZZI, the first and only dual-agent prescription eye drop…...
Wugen Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot P
2+ day, 4+ hour ago (797+ words) -- FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports manufacturing readiness for therapies with expedited clinical development timelines -- WU-CART-007 (Soficabtagene Geleucel "Sofi-cel) is selected for participation enabling additional FDA engagement on CMC strategy ahead of a potential…...
PureTech Founded Entity Seaport Therapeutics Announces Positive Proof of Concept Topline Results fro
2+ day, 5+ hour ago (271+ words) Based on the data shared today, Seaport announced plans to advance GlyphAgo into two parallel trials, a Phase 2a proof-of-pharmacology trial to evaluate the potential sleep benefit of GlyphAgo in patients with GAD and a Phase 2b randomized placebo-controlled trial in GAD…...
Seaport Therapeutics Announces Positive Proof of Concept Topline Results from Ongoing Phase 1 Trial
2+ day, 4+ hour ago (142+ words) GlyphAgo achieved therapeutic exposures of agomelatine at doses projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing that has previously limited agomelatine's clinical use GlyphAgo was well-tolerated across all evaluated doses, and no…...
Triple Hair Doses First Patient in Phase III Clinical Trial in Canada for Male Androgenic Alopecia
2+ day, 4+ hour ago (315+ words) MONTR'AL--(BUSINESS WIRE)--Triple Hair Group Inc. (Triple Hair" or the Company"), a company specializing in the development of innovative treatments for androgenic alopecia (pattern baldness), today announced that the first patient has been dosed in its Phase III clinical…...