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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EMA initiates OPEN collaboration; NICE evaluating guidance processes; Florida researcher indicted.
Multiple tactics employed by the biopharma industry to improve the recruitment and retention of participants in clinical trials seem to be paying off. More than three of four (77%) studies now fully enroll on or ahead of schedule, according to researchers at the Tufts Center for the Study of Drug Development (CSDD), reporting in the January/February Tufts CSDD Impact Report on global recruitment performance benchmarks.
More than a decade after one of its early splashes in therapeutic development caused ripples in the U.S. patent tide pool, the Wisconsin Alumni Research Foundation, better known as WARF, is taking a more seasoned approach to drug discovery and development.
The oncology field pioneered adaptive trial designs through efforts such as I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2), Puma Biotechnology Inc.’s phase II study of the pan-HER tyrosine kinase inhibitor neratinib (Nerlynx) as neoadjuvant therapy in metastatic breast cancer, and the ongoing multidrug, biomarker-driven
non-small-cell lung cancer trial known as Lung-MAP.
Two recent deals signaled to the industry that efforts to target previously undruggable RNA with small-molecule therapies may be moving from academic endeavor to fruitful application.
A year after landing a $37 million series A to support its mission of addressing the most desperate of rare diseases, Rallybio LLC linked up with Exscientia Ltd. to form RE Ventures, a joint venture designed to accelerate the discovery of small-molecule drug therapies targeting rare disease indications.
Nearly a decade in the making, Philadelphia-based Renovacor Inc. set sail with its first institutional raise. The company closed an $11 million series A co-led by Novartis Venture Fund, Broadview Ventures and Bioadvance and joined by New Leaf Venture Partners and Italy-based Innogest Capital.
The hunt is on for a dry eye disease (DED) therapy to replace Allergan plc's blockbuster, Restasis (ciclosporin), which the Dublin-based firm sought to shield behind the protective estate of 27 patents, including six famously assigned in 2017 to the Saint Regis Mohawk Tribe and then licensed back in perpetuity, seeking to prevent their expiry in 2024.
The hunt is on for a dry eye disease (DED) therapy to replace Allergan plc's blockbuster, Restasis (ciclosporin), which the Dublin-based firm sought to shield behind the protective estate of 27 patents, including six famously assigned in 2017 to the Saint Regis Mohawk Tribe and then licensed back in perpetuity, seeking to prevent their expiry in 2024.
The hematology world is a-twitter about the imminent approval of Zynteglo (betibeglogene darolentivec), the lentiglobin cell and gene therapy from Bluebird Bio Inc. that’s expected to become the first gene therapy to address the blood disease beta-thalassemia and the company’s first product to market.
