The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.
Grail LLC reported a new study with the U.K.’s NHS to assess the clinical utility of its Galleri multi-cancer early detection test (MCED) for reducing late-stage cancer diagnoses. Menlo Park, Calif.-headquartered Grail presented the study design during the American Society of Clinical Oncology (ASCO) meeting in Chicago. The randomized controlled trial will enroll 140,000 asymptomatic participants aged 50-77 living across England to determine if Galleri can find cancers at an early stage when they are less advanced.
The “showdown” at the American Society of Clinical Oncology (ASCO) meeting foreseen by one analyst between breast cancer drugs from Gilead Sciences Inc. and Astrazeneca plc with partner Daiichi Sankyo Co. Ltd. didn’t quite materialize. Or the showdown happened, but turned out more nuanced than a one-to-one, high-noon gunfight on Main Street. Gilead ended considerable suspense June 4 by offering at ASCO phase III data from the Tropics-02 study with Trodelvy (sacituzumab govitecan), expectations for which already had grown lukewarm. Astrazeneca and Daiichi dazzled the next-day meeting with phase III data from the Destiny-Breast04 (DB04) study with Enhertu (fam-trastuzumab deruxtecan).
An unknown U.K. biotech, RQ Biotechnology Ltd., has emerged from stealth mode with a $157 million licensing deal with Astrazeneca plc for its monoclonal antibodies, aimed at protecting vulnerable and immunosuppressed people against SARS-CoV-2.
Astrazeneca plc has signed up for more of the heavy-duty structure-based drug discovery services Proteros Biostructures GmbH specializes in, inking an extension to their existing collaboration agreement.
A congressional investigation into COVID-19 vaccine manufacturing failures at Emergent Biosolutions Inc. unveiled more troubling issues at the company’s Bayview facility in Baltimore, which had been awarded a lucrative U.S. government contract to produce vaccines for Johnson & Johnson.
First results from the U.K. Cov-Boost trial, looking at responses to a fourth dose of an mRNA COVID-19 vaccine, show that antibody levels increase more than after the third dose, confirming the precautionary move to give the most vulnerable a second COVID-19 booster in advance of immune response data being available.
Even though at least two different U.S. district courts have ruled that the 340B enforcement letters the Department of Health and Human Services’ (HHS) Health Resources and Services Administration has sent to biopharma companies violate the Administrative Procedures Act, the agency continues to send the letters, along with threats of civil money penalties, to companies that place restrictions on the 340B discounts to contract pharmacies.
Orphalan SA is laying the ground for a 2023 U.S. launch of Cuvrior for the treatment of Wilson’s disease, following FDA approval of the copper chelating drug. Cuvrior (trientine tetrahydrochloride) is a new salt of trientine that was designed to have superior properties to Syprine (trientine hydrochloride) from Bausch Health Companies Inc. and Cufence from Univar Solutions BV, which are approved as second-line treatments for the rare inherited copper transport disorder, in the U.S. and EU respectively.
China’s Amoy Diagnostics Co. Ltd. (Amoydx) signed a development and commercialization agreement under which Amoy will develop multiple companion diagnostics for Astrazeneca plc across China, the E.U. and Japan.
