Shots:Cumberland reported topline data from P-II (FIGHT DMD) trial assessing ifetroban (150/300mg, QD) vs PBO in DMD pts (n=41) for 12mos.; funded via the US FDA orphan products grant
Study showed that ifetroban (300mg) led to 3.3% overall LVEF improvement (1EP), with a 1.8% increase vs 1.5% decline; on comparison with matched natural…
NEWS
Shots:Formycon has signed an exclusive license agreement with Lotus Pharmaceutical to commercialize FYB203/Ahzantive in APAC countries, including Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. Additionally, Formycon will supply the finished product to Lotus
As per the agreement, Klinge will receive upfront and milestone payments, along with royalties on Lotus’ net…
Shots:The US FDA has granted 510(k) clearance to the Gyder Hip System for positioning of the acetabular cup during anterior hip arthroplasty following approval from Australia’s TGA
Gyder Hip System eliminates the use of metallic pins & pre-operative/intra-operative imaging for landmark registration, offering a less invasive approach than conventional hip navigation
System features 1min…
Shots:TriLink & Aldevron have entered into a non-exclusive license & supply agreement for TriLink’s patented CleanCap mRNA capping tech, allowing Aldevron’s clients to use it for developing mRNA-based therapeutics & vaccines
As per the agreement, TriLink will provide CleanCap M6, CleanCap AG 3’OMe, CleanCap AG, & CleanCap AU cap analogs to Aldevron for…
Shots:The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME
Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in
Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation
Study demonstrated sustained vision…
Shots:Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243)
Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR…
Shots:Algiax reported topline data from the P-IIa PoC trial assessing AP-325 (GABA-A modulator) vs PBO in 99 pts with peripheral post-surgical neuropathic pain in Germany, Spain, the Czech Republic, Belgium, & France
Data showed rapid PI-NRS reduction in <2wks., sustained effects, plus significantly higher ≥50% & ≥70% responder rates with ~25% vs. 11% pts…
Datar Cancer Genetics Launches Exacta AI to Offer Personalized Treatment Options for Cancer Patients
Shots:Datar Cancer Genetics has introduced Exacta AI (multi-analyte platform) to provide ~10 evidence-based drug combinations as a treatment for cancer patients who have exhausted SoC options
Exacta AI integrates 360° tumor work-up with AI-driven analysis of complex tumor interactome data to assess drug interactions, toxicity, & side effects for ADCs, CPIs, targeted therapies,…
Shots:Vanda received exclusive rights to develop, manufacture & commercialize imsidolimab which has completed 2 P-III (GEMINI-1 & GEMINI-2) trials for generalized pustular psoriasis
As per the terms, Anaptys will get $10M upfront, $5M for existing drug supply, & ~$35M in regulatory & sales milestones, plus 10% royalty on net sales, whereas Vanda will…
Shots:The EMA received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits approval in US and China, with global applications planned
Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed…
