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. Read More
LONDON – Anjarium Biosciences AG has raised $61 million in a series A to advance development of a new class of gene therapy it is developing from the ground up to overcome shortcomings of current viral vector-based products. The Zurich, Switzerland-based company is assembling a toolkit of stable DNA vectors and targeted lipid nanoparticle and exosome delivery vehicles that it said will lead to “bespoke expression of genes” and address the underlying causes of genetic diseases in a more predictable, repeatable and lasting way. Read More
The European Society for Medical Oncology Congress 2021 has begun with a mix of education and multidisciplinary sessions in addition to symposia. Silverback Therapeutics Inc. was a presenter and took a hit on the market Sept. 16 with its interim phase I/Ib study results showing SBT-6050’s proof of mechanism was established with activated myeloid and T/natural killer cells when treating advanced or metastatic HER2-expressing solid tumors. Read More
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. Read More
Aerie Pharmaceuticals Inc.’s wide-net endpoint approach with the phase IIb study called Comet-1 seemed less than appreciated by the stock market as the firm unveiled top-line data in dry eye disease with AR-15512. Read More
As members of the White House COVID-19 Response Team talk about COVID-19 boosters as if they are a fait accompli for Americans even before the FDA completes its evaluation of the data, the controversy continues to roil around the need for another vaccine dose. Read More
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies. Read More
Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Amylyx, Aptorum, Beigene, Calliditas, Cstone, Excision, Jaguar Health, Magenta, Obseva, Pulmocide, Sage, T-Cure, Zai Lab. Read More
