While it sorts out a second phase III study design for its cancer therapy and light device with the U.S. FDA, Soligenix Inc. produced positive results from a compatibility study evaluating Hybryte (synthetic hypericin sodium) for treating early stage cutaneous T-cell lymphoma (CTCL). The therapy was activated using the Daavlin Series 7 visible light device. The positive data, according to Soligenix, bolster findings from the phase III FLASH study in treating CTCL. The FDA issued a refusal to file letter in February and said it wants an additional phase III study. The company stock (NASDAQ:SNGX) had jumped 60% at midday to about $2.30 per share.
Day of reckoning looms for Morphosys
By the end of this year, it will become apparent whether Morphosys AG has executed one of the biopharma industry’s boldest pivots in recent years or has instead blown $1.7 billion of investor cash on a dud. The day of reckoning is coming a little sooner than expected for the Planegg, Germany-based firm, as it has completed recruitment onto a phase III trial of pelabresib in first-line myelofibrosis ahead of schedule. Top-line data from the study are now expected before year-end, instead of early 2024. If positive, a filing would follow in 2024 and a potential approval could land the following year.
Newco news: Integrated Biosciences trains neural networks to identify novel senolytic drugs
Integrated Biosciences Inc., an early stage startup that is combining synthetic biology and machine learning in the hunt for drugs that tackle cell senescence, has demonstrated its capabilities in a newly published study in Nature Aging on May 4, 2023, which employed artificial intelligence to identify three novel compounds that are highly selective for Bcl-2 and that exhibit favorable medicinal chemistry profiles.
LSX World Congress 2023: Fewer NMEs, less funding, more M&A: Navigating the industry post-pandemic
The industry is not over the post-COVID-19 funding crash, and as the dust settles there are mixed signs for future prospects, with some metrics in decline, others more or less back to pre-pandemic levels, and some showing signs of improvement.
Biopharma CEOs urge Japan for open dialogue on innovation, pricing reforms ahead of G7 summit
Ahead of the upcoming G7 summit to be hosted in Japan this month, a delegation of 24 CEOs from the Biopharmaceutical CEOs Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan. The country has long been a global leader in life sciences and is a critically important partner in developing new medicines for patients around the world. The biopharma industry has invested ¥14 trillion (US$104 billion) in R&D in Japan over the last decade, and it is developing more than 1,500 new medicines in Japan.
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