The FDA placed a clinical hold Wednesday on a phase I trial by Unum Therapeutics Inc. after a patient experienced serious adverse events that included grade 3 neurotoxicity and cytomegalovirus infection, and grade 4 respiratory distress.
HONG KONG - Incyte Corp. entered a collaboration and licensing deal to flip its greater China rights to an investigational anti-PD-1 monoclonal antibody to Zai Lab Ltd., of Shanghai. The candidate, INCMGA-0012, is currently being evaluated as a monotherapy in registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer.
Boston Biomedical Inc. shuttered phase III study Canstem111P of napabucasin for patients with metastatic pancreatic ductal adenocarcinoma, adding to the list of studies that have fallen in pancreatic cancer.
The Warburg effect – the marked preference of tumors for fueling themselves via anaerobic metabolism – was described more than 90 years ago. Otto Warburg won the Nobel Prize for his discovery in 1931, and research into the phenomenon long dominated the field of tumor metabolism. Over the past decade, however, there has been increased attention to the fact that tumor metabolism is deregulated in multiple ways beyond the Warburg effect.
Japanese biopharma Carna Biosciences Inc. and Gilead Sciences Inc., of Foster City, Calif., have signed a $470 million R&D collaboration to develop and commercialize small-molecule compounds in immuno-oncology. Under the agreement, Gilead will license worldwide rights to develop and commercialize inhibitors against an undisclosed immuno-oncology target from Kobe, Japan-based Carna. Additionally, Gilead will have access to Carna's lipid kinase drug discovery platform.
Since being diagnosed with cancer a few months ago, I have been in an unwanted crash course on the patient perspective of everything I’ve been writing about biopharma for the past several years. It’s an eye-opener. Genetic testing, lack of research, unmet medical need, off-label use, drug shortages, adverse events, informed consent, clinical trial data that don’t represent real-world practice, drug-drug interactions, co-morbidities, labeling precautions, reimbursement, data-sharing vs. privacy issues. ... Up until now, these were all topics I wrote about or discussed with my colleagues during our news meetings. Now, they’re personal. They impact my daily life and could...
This isn’t exactly “funny” – nothing about cancer is – but during the American Society of Clinical Oncology (ASCO) meeting in Chicago I couldn’t help noticing the multitude of hand-sanitizer vending devices posted around McCormick Place. They seemed … odd there. “Scrub some alcohol gel on your hands, so you don’t catch cold! Oh, cancer? Not a lot we can do about that. We’re working on it.” So they are. The number of abstracts submitted and attendees set records this year. I’m not always assigned to cover ASCO, but I’ve done my share, and 2014’s meeting seemed uncommonly active. Of...
As the biggest names in cancer care gather at the American Society of Clinical Oncology's 50th annual meeting in Chicago, talk of the exorbitant cost of new cancer drugs is no doubt echoing in the halls of McCormick Place. Outrage is easy to summon. At nearly $10,000 a month the average cost for a branded oncology drug in the U.S. is double what it was a decade ago and a full fifth of annual median household income. Last year, 10 new oncology drugs joined the fray, helping drive global spending on cancer therapeutics to $91 billion. Newer targeted therapies accounted for nearly half the...
So urgently did I think I wanted to read Ben Goldacre’s Bad Pharma, that I ordered it from Amazon’s UK site last November, unwilling to wait for U.S. publication – which happened just as I reached the end, polishing off the book’s afterword, called “Better Data.” Goldacre, it turns out, is as much bothered by the secrecy of data as by its quality, and he has also set up an activist website, where the public can petition for “all [clinical] trials to be registered, for all summary results to be reported, and for full clinical study reports [CSRs] to be...
This week, researchers are presenting their latest and greatest at the annual meeting of the American Association of Cancer Research. The excitement of all those novel findings, though, received something of an advance puncturing last week by a commentary in Nature that reported a successful replication rate of just over 10 percent for roughly 50 landmark studies in cancer research. From my perspective, the study makes it even more difficult to figure out which of the many research findings that (briefly) come to my attention every day to write about, and which to ignore. Is this study more interesting, or...