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First US Patient Enrolled in SELUTION SLR IDE Peripheral Study

By asianet

The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval. “We are very excited to finally have … Continued

Zerion Pharma and Hovione extend partnership to cover use of the Dispersome(R) technology platform in nutraceuticals

By asianet

Hovione and Zerion Pharma A/S (Zerion) today announced an extension of their collaboration on Zerion’s Dispersome(R) technology into the nutraceutical/dietary supplements field. Many dietary supplements suffer from low solubility. This results in poor bioavailability and consequently limits the physiological effect of the supplement. To overcome these limitations, the two companies will collaborate and apply the … Continued

Prominent ophthalmologist will guide Turn Bio’s search for therapies to cure eye diseases

By asianet

— Albert Wu, MD, PhD, a recognized advocate of using stem cell therapy to treat eye conditions, will advise company’s development of ocular tissue rejuvenation therapeutics Turn Biotechnologies, a cell rejuvenation company developing novel mRNA medicines to cure untreatable, age-related conditions, today announced that Albert Wu, MD, PhD, will oversee its development of ophthalmic therapeutic … Continued

Menarini Group’s Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer

By asianet

– Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union – Submission supported by results from the pivotal Phase 3 EMERALD study showing a statistically significant difference in the … Continued

Kronos Bio and Invivoscribe Partner on Companion Diagnostic for Use with Entospletinib, Kronos Bio’s Investigational Compound Being Developed for Patients with AML

By asianet

– Companion diagnostic would be used following potential regulatory approval of entospletinib to screen for NPM1 mutation present in approximately one-third of all patients with AML – Entospletinib is currently being studied in the Phase 3 AGILITY registrational study, with data anticipated in second half of 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated … Continued

Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

By asianet

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from 2L and 3L ER+/HER2- advanced or metastatic breast cancer Submission supported by results from the pivotal Phase 3 EMERALD study of elacestrant showing statistically significant efficacy over current standard-of-care (SOC) medications for both the overall … Continued

MedAlliance SELUTION SLR Receives Second FDA IDE Approval

By asianet

SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months after the company received IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications … Continued

Novaliq Submits New Drug Application Seeking Approval For First-Of-A-Kind Dry Eye Disease Treatment CyclASol(R)

By asianet

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol(R) water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol(R) (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye … Continued

FRONTIER BIOTECHNOLOGIES ANNOUNCES POSITIVE PHASE 1 RESULTS OF ITS FIRST CORONAVIRUS MAIN PROTEASE (MPRO) SMALL MOLECULE INHIBITOR, LAYING FOUNDATION FOR THE TREATMENT OF ACUTE AND LONG COVID

By asianet

– FB2001 (Bofutrelvir) is a Coronavirus Mpro inhibitor, which exhibited potent anti-SARS-CoV-2 activity in vitro and in vivo – Phase 1 results show FB2001 to be generally safe and well tolerated. No significant difference was observed between Chinese and American populations. Single-agent antiviral concentrations have been reached in the blood plasma and lung tissues without … Continued