Pharma News

Cancer immunotherapy has transformed the treatment of many types of cancer. Yet, for reasons that remain poorly understood, not all patients get the same benefit from these powerful therapies.

Gene-editing therapy aimed at two targets – HIV-1, the virus that causes AIDS, and CCR5, the co-receptor that helps the virus get into cells – can effectively eliminate HIV infection, new research from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC) shows. The study, published online in the journal The Proceedings of the National Academy of Sciences (PNAS), is the first to combine a dual gene-editing strategy with antiretroviral drugs to cure animals of HIV-1.

FDA halts clinical trials of Deuruxolitinib due to the potential for thrombotic events seen in subjects. FDA has placed the IND on partial clinical hold and are requiring that subjects currently on studies to discontinue the dose.

It has been noted by the FDA that pulmonary embolism (Serious Adverse Events) occurring at the 12 mg BID dose in one of the long-term Open Label Extension (OLE) studies of Deuruxolitinib.

Astellas Pharma Inc and Pfizer Inc announced that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).

What the human genome is lacking compared with the genomes of other primates might have been as crucial to the development of humankind as what has been added during our evolutionary history, according to a new study led by researchers at Yale and the Broad Institute of MIT and Harvard.

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FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). Qalsody is an antisense oligonucleotide that targets SOD1 mRNA to reduce the synthesis of SOD1 protein. The approval was based on a reduction in plasma neurofilament light (NfL), a blood-based biomarker of axonal (nerve) injury and neurodegeneration. 

For the over 8 million people around the globe living with Type 1 diabetes, getting a host immune system to tolerate the presence of implanted insulin-secreting cells could be life-changing.

Rice University bioengineer Omid Veiseh and collaborators identified new biomaterial formulations that could help turn the page on Type 1 diabetes treatment, opening the door to a more sustainable, long-term, self-regulating way to handle the disease.

A new test revealed that FDA-approved antibiotics available at your neighborhood pharmacy can effectively treat superbugs. They are not prescribed, however, because the gold-standard test predicts they will not work. The new test may improve the way antibiotics are developed, tested and prescribed  and it is openly available to all.

This marketing authorisation granted to Venus Pharma GmbH, the German subsidiary of Venus Remedies, by one of the world’s most stringent healthcare regulatory agencies will enable the company to offer its affordable range of cancer drugs to the National Health Service (NHS) in the UK and neighbouring countries.