Pharma Flash - The FDA gives Fast Track Designation to Two Treatments and Lilly Makes an Acquisition

1. Lilly to Acquire Sigilon Therapeutics

Eli Lilly and Company announced its acquisition of Sigilon Therapeutics, a biotechnology firm specializing in advanced therapies for chronic diseases, for approximately $35M. The deal is aimed at enhancing Lilly's capabilities in the field of cell therapy and gene therapy. Sigilon's innovative Afibromer™ technology, which protects cells from immune system responses, is a key asset that can potentially revolutionize treatment approaches for various medical conditions.

2. AC Immune Receives FDA Fast Track Designation for Alzheimer’s Treatment

AC Immune, a Swiss-based biopharmaceutical company, has received FDA Fast Track Designation from for its potential Alzheimer's disease treatment. AC Immune's therapy targets the accumulation of tau protein in the brain, a key factor in Alzheimer's disease progression, and the Fast Track Designation signifies the FDA's recognition of its potential to provide a meaningful advancement in Alzheimer's treatment options. This designation accelerates the regulatory process, bringing the treatment closer to patients in need.

3. Wood Wins Significant US Life Sciences Project with GSK

Wood, a consulting and engineering company, has won an award valued around $50M from GSK for a U.S. capital project to sustain the company’s  production of critical specialty medicines. Wood will provide engineering, procurement, construction management and validation (EPCMV) enhancement services for GSK’s global production facility in Rockville, Maryland. Wood’s three-year contract will support GSK’s production of innovative specialty medicines for the U.S. and globally as part of GSK’s plan to develop the site with the latest state-of-the-art scientific research technology and equipment.

4. Yposkesi Opens $65M Biomanufacturing Site for Cell and Gene Therapies

Yposkesi, a contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, has inaugurated a new $65 million biomanufacturing site in Corbeil-Essonnes, France. The state-of-the-art facility is designed to support the production of advanced therapies, including viral vectors used in gene therapies. With a total floor area of 5,000 square meters, the site is equipped with cutting-edge technologies to ensure efficient and scalable manufacturing processes. Yposkesi's investment in this facility aims to meet the growing demand for cell and gene therapies and contribute to advancing innovative treatments in the field of biomedicine.

5. Genprex Receives FDA Fast Track Designation for Small Cell Lung Cancer Treatment

Genprex, a clinical-stage gene therapy company, has received Fast Track Designation from the FDA for its investigational treatment for extensive-stage small cell lung cancer (ES-SCLC) . Genprex's treatment utilizes TUSC2, a tumor suppressor gene, to inhibit cancer cell growth and enhance immune response in es SCLC patients. This designation by the FDA recognizes the potential of Genprex's therapy to provide a significant advancement in the treatment of (ES-SCLC) and accelerates the regulatory process, facilitating its potential availability to patients.

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