The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities.
Biontech SE agreed to pay up to nearly $1.26 billion in two separate settlements to resolve royalty disputes with the U.S. NIH and the University of Pennsylvania related to the COVID-19 vaccine the company partnered with Pfizer Inc.
Though Pyxis Oncology Inc.’s preliminary phase I data with antibody-drug conjugate (ADC) PYX-201 in solid tumors were characterized as positive, findings sent the Boston-based firm’s stock (NASDAQ:PYXS) into a tailspin. Shares dropped from $3.82 to $2.01 between Nov. 20 and the morning of Nov. 21, even as experts along with Wall Street agreed that the compound shows particular promise in head and neck squamous cell carcinoma – a space where developers aplenty remain busy.
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September.
Ausperbio Therapeutics Inc. raised $110 million from two financing rounds in 2024 to advance its lead antisense oligonucleotide candidate as a functional cure for chronic hepatitis B.
In November 2024, BioWorld tracked 180 clinical trial updates, down from 219 in October and 252 in September but up from 92 in August. The month included 13 successful phase III outcomes and five trial failures.
In a deal worth up to $1 billion, Ideaya Biosciences Inc. is in-licensing Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s SHR-4849, a phase I DLL3-targeting opo-I-payload antibody-drug conjugate (ADC). Under terms of the deal, San Francisco-based Ideaya will develop and commercialize SHR-4849 worldwide outside of greater China, and Shanghai-based Hengrui is eligible to receive up to $1.04 billion that includes a $75 million up-front fee, $200 million in development and regulatory milestone payments, and commercial success-based milestone payments. Hengrui is also eligible to receive royalties on net sales outside of greater China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Beigene, Takeda.
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