Astrazeneca plc and Daiichi Sankyo Co. Ltd. rolled out phase III data from the Tropion-Lung 1 trial in non-small-cell lung cancer in previously treated patients with locally advanced or metastatic disease. The TROP2-directed antibody-drug conjugate turned up a statistically significant improvement in progression-free survival vs. standard chemotherapy and the trial is continuing to evaluate the other primary endpoint: overall survival. Shares of Astrazeneca (NASDAQ:AZN) were trading midday at $65.25 down $6.32. Daiichi’s stock (OTC:DSNKY) was selling for $27.04, down $4.81, or 15%.

Industry not placated by changes to US negotiations guidance

In releasing a revised guidance detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services (CMS) addressed some of the issues raised in last month’s constitutional challenges to the guidance and the provision in the Inflation Reduction Act (IRA) that created the program. The revisions include easing a gag clause and expediting termination from CMS programs to give manufacturers a way out of the negotiations. But industry isn’t impressed. “The very few substantive changes to the final guidance demonstrate CMS saw this as a box-checking exercise, not an opportunity to mitigate the negative impacts this price-setting policy will have on patients or the broader health care sector,” according to the Pharmaceutical Research and Manufacturers of America, which signed on to one of the four court challenges.

Innovent-Iaso first to finish line in China for multiple myeloma CAR T therapy

Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory (r/r) multiple myeloma (MM). Fucaso is a human anti-B cell maturation antigen CAR T therapy designed to treat r/r MM patients who have had three or more lines of therapy including at least one proteasome inhibitor and an immunomodulatory agent.

US FTC proposes to drastically broaden scope of inquiry into proposed mergers

The U.S. Federal Trade Commission (FTC) has proposed to expand the volume and type of information it will require of companies seeking to merge with competitors, a move the agency said is predicated in part on concerns about the influence of non-U.S. entities in American markets. Whatever one thinks of the justifications, this proposal would not only dramatically expand the volume of data required of those who propose to merge with other companies, but also add a large volume of work to agency staff at a time when the FTC is complaining that it lacks the resources to do its job.

Newco news: Haemalogix’s Kappamab hits endpoints in phase IIb myeloma trial

Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments. Kappamab targets a receptor called kappa myeloma antigen (KMA) found only on the surface of myeloma cells in kappa-type multiple myeloma patients and not on normal immune cells, which means normal immune cells are not damaged by the treatment, Haemalogix’s scientific co-founder Rosanne Dunn told BioWorld.

EAN 2023: Answer to AI’s big data pitfalls is more data

Artificial intelligence (AI) continues to entice. On the exhibition floor at the 2023 Congress of the European Academy of Neurology, one company’s booth featured “Mindart” technology. A passersby could answer a short series of prompts, and get a unique image based on the input made by generative AI. Entertainment aside, medically speaking, AI applications “are still research,” Riccardo Soffietti told his audience at one of several sessions devoted to AI. “But obviously, research is the future.” At the meeting, Soffietti was one of a number of speakers giving a taste of what that future might look like if things go well – but also if they don’t.

Nonprofit deal value plummets while biopharma grant value holds steady

Both the value and number of reported biopharma nonprofit deals has fallen significantly, being at the lowest amount in the past five years. Compared to the first five months of last year, the value of biopharma nonprofit deals has decreased by about 63%. Meanwhile, money raised via grants has fallen slightly, 6.11%, but is vastly less than the value and number seen in 2020.

Sinotau nets $152M in financing to develop radiopharmaceuticals in China

Sinotau Pharmaceutical Group raised ¥1.1 billion (US$152 million) in a financing round to develop its radiopharmaceutical drugs for diagnostic and therapeutic interventions. Founded in 2005, the Beijing-based company has developed a product pipeline with more than 10 radiopharmaceutical candidates for cardiovascular disease, Alzheimer's disease and cancer, developing some in-house and others through collaborations.

Holiday notice

BioWorld's offices will be closed in observance of Independence Day in the U.S. No issue will be published Tuesday, July 4.

Also in the news

Abeona, Alnylam, Argenx, Astrazeneca, Axsome, Biomarin, Boehringer Ingelheim, Camena, Capricor, Celltrion, Coherus, Cyclo, Delta-Fly, Drug Farm, Enterome, Exeliom, Fresenius Kabi, Genfit, Gilead, Ipsen, Kyverna, Madrigal, Merus, Nanoviricides, Neuren, Organon, Pharmaessentia, PTC, Sandoz, Scisparc, Shionogi, SK, Teva, Tonix, Transcenta, Unicycive, Zai Lab, Zymedi