DUBLIN – Allarity Therapeutics A/S plans to file an NDA with FDA for dovitinib in renal cell carcinoma (RCC) in the fourth quarter this year, after unveiling a new analysis at the European Society for Molecular Oncology’s virtual congress, which suggest that its companion diagnostic, DRP, can identify patients who obtain a survival benefit from the therapy.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
The Tokyo University of Science (TUS) has developed a self-powered diaper biosensor that can monitor urine sugar levels, which could be a boon for both diabetic patients and their caregivers. Caregivers at nursing homes currently open patients’ diapers every few hours to check for urination, thus increasing the caregivers’ workload. The psychological impact on the patient is also increased, for example when their sleep is disturbed.
Illumina Inc. and Merck & Co. Inc. are partnering to commercialize tests identifying genetic mutations used in the assessment of homologous recombination deficiency.
LONDON – One in seven children and young people who have COVID-19 go on to develop symptoms of Long COVID, according to the first cut of data from a large national study involving 6,804 participants ages 11 to 17 who had PCR tests between January and March this year.
The U.S. Federal Trade Commission (FTC) is hardly alone in its antipathy toward Illumina Inc.'s acquisition of Grail Inc., and FTC attorney Susan Musser said Aug. 24 that Illumina’s dominance of the market for next-generation sequencing (NGS) is perhaps the key aspect of the FTC’s case. Musser invoked the wide number of companies that jumped into the fray to develop a vaccine for the COVID-19 pandemic as an illustration of the need to maintain competition in the multicancer testing space.
Illumina Inc.’s acquisition of cancer diagnostic specialist Grail Inc. is on go in a $7.1 billion transaction that is structured so that it can be unwound with limited impact on Illumina. However, a number of regulatory entities are closely scrutinizing the deal for a potential regulatory challenge, a fact of life that shaved nearly 10% off the value of the company’s shares in early Aug. 19 trading, and which could ultimately scuttle the transaction altogether.
Burning Rock Biotech Ltd. has formed a global strategic partnership with Impact Therapeutics Inc. to develop companion diagnostics for a pipeline of drugs in the field of synthetic lethality.
While regulators and policymakers across the world are stressing the need for equitable access to COVID-19 vaccines, therapies and devices, their own policies and regulations may be getting in the way of that goal. The World Trade Organization (WTO) released a list of trade-related bottlenecks July 20 that are hindering access to pandemic-related medical products.
DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing.
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