Base Therapeutics (Shanghai) Co. Ltd.’s NK-510 cell injection, a zero-off-target base-edited natural killer (NK) cell product, has received approvals to start clinical trials from both the U.S. FDA and China’s NMPA for clinical trials for advanced solid tumors.
Beijing Hanmi Pharm. Co. Ltd. broke ground on a ₩140 billion (US$98.65 million) large-scale project to build a near-500,000-square-foot China base near Beijing Capital International Airport in efforts to increase the company’s local production, R&D and office capabilities.
Bring your dog to work day looks a little different at Spotitearly. The Tel Aviv-based company asks its canine workers to bring their whole selves to the job – particularly their finely trained noses – to help suss out cancer in breath samples. The dogs’ unique capabilities are interpreted by AI to capture canine indicators humans might miss and the combo has remarkably high accuracy, 93% or better in three of the four common cancers tested.
52 North Health Ltd. raised $6 million in financing to bring its oncology products to the market including the Neutrocheck, a point-of-care device and app which monitors cancer patients at home at risk of developing neutropenic sepsis.
In breast cancer, neoadjuvant chemotherapy reduces the tumor before surgery. However, the response to this treatment does not depend solely on the subtype of malignancies. Other factors could play a key role in its effectiveness, as shown in a study that described how the estrous cycle phases contribute to this variation.
In breast cancer, neoadjuvant chemotherapy reduces the tumor before surgery. However, the response to this treatment does not depend solely on the subtype of malignancies. Other factors could play a key role in its effectiveness, as shown in a study that described how the estrous cycle phases contribute to this variation. The researchers propose adjusting the approach to the most suitable moment for patients.
Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease. The approval came about seven months after the FDA accepted the BLA for filing under priority review, and two months ahead of the PDUFA goal date of Feb. 4, 2025, which had been extended by three months in November as the agency reviewed CMC information submitted in response to its request.
Seeking accelerated approval as a fallback when clinical evidence is not quite strong enough for traditional approval appears destined for the dustbins of history.
Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35.
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