Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer. Read More
In a flurry of catch-up following the coronavirus outbreak in China, a number of biopharma companies have announced development within the last few weeks to address the ever-spreading infection known as COVID-19. Read More
DUBLIN – Could a recombinant human protein drug rejected by Glaxosmithkline plc in 2019 benefit patients with COVID-19 infection? Apeiron Biologics AG disclosed Wednesday Feb. 26 that an investigator-initiated pilot study of APN-01 is getting underway in Guangzhou, China. Read More
BEIJING – While repurposing drugs may be a quick solution to an epidemic like COVID-19 that has a limited research window, it’s just luck as to whether an already available drug candidate exists for newly emergent diseases. Experts say it’s more realistic to develop better drugs instead of attempting to repurpose old ones. Read More
Everything’s good for something. Including, it turns out, 5’ untranslated trinucleotide repeats. In the Feb. 17, 2020, issue of Nature Neuroscience, researchers have demonstrated a role for such repeats in controlling protein levels of fragile X mental retardation protein (FMRP). Read More
With the CDC saying Tuesday that it’s not if but when COVID-19 becomes more widespread in the U.S., now is not the time to cut the budgets of programs and agencies in the Department of Health and Human Services (HHS). Read More
Readouts from two ambitious pruritus trials this week yielded starkly different reactions from investors seeking broader meaning in the outcomes. Read More
While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands. Read More
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab). Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcus, Dialectic, Novavax, Promis, Pvp Biologics, Taiho, Takeda, Tonix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Kiadis, Puma, Translate Bio. Read More
