Recent findings with the sodium glucose transporter-2 inhibitor Jardiance (empagliflozin) from Boehringer Ingelheim International GmbH and Eli Lilly and Co. drew more attention to the cardiovascular space.
DUBLIN – Shares in Oncopeptides AB dropped 26% July 8 on news that the FDA had placed a partial clinical hold on a raft of trials involving its newly approved multiple myeloma drug Pepaxto (melphalan flufenamide; melflufen), following a bizarre incident involving the incomplete handover to an independent review committee of data from a phase III head-to-head trial in myeloma, which had pitted melflufen against Pomalyst (pomalidomide).
In infectious disease research, most of the research into genetic determinants of susceptibility to infection and disease severity are focused on the host. For COVID-19, for example, the delta variant’s infectivity, and how likely infection is to lead to severe disease, is the focus of an intense research agenda. But host genetics, too, contribute to the consequences of infections. An ongoing study into the host genetics of SARS-CoV-2 infection has identified 13 such factors that affected either the likelihood of contracting SARS-CoV-2, or the severity of disease, gleaned from the data of 50,000 infected persons and 2 million controls.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abeona, Alx, Eloxx, Epimab, Moderna, Nextcure, NGM, Nrx, Opiant, Stratatech, Tetherex, Trevena, Xenon.
A collaboration between Oncosec Medical Inc. and Merck and Co. that yielded positive phase II study data has paved the way for a phase III study between the two companies. Oncosec’s DNA-plasmid interleukin-12 (IL-12) Tavo (tavokinogene telseplasmid) will be combined with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a randomized, global phase III study for treating late-stage metastatic melanoma.
New research suggests that ultraviolet (UV) light that operates at lower bandwidth than what currently exists in the market could be just as useful in inactivating the SARS-CoV-2 virus with less harmful effects on skin cells. Joint research by Asahi Kasei Corp. and Nara Medical University confirmed that 226 nanometer ultraviolet-C (UVC) LEDs can inactivate the SARS-CoV-2 virus that causes COVID-19 while having less effect on animal skin cells compared to 270 nm UVC LEDs.
Getting cell therapies to work against solid tumors is proving difficult – but two biopharma firms have begun early-stage studies with technologies that aim to crack this tough nut. Gadeta B.V. and Apeiron Biologics AG are using two different approaches to cell therapy that they hope will be effective against tough-to-treat solid tumors.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apeiron, Athira, Boehringer Ingelheim, Clover, Eiger, Eli Lilly, Hutchmed, Innate, Longeveron, Marker, Trillium, Ysopia.
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
In a new chapter for the ongoing story of sodium glucose transporter-2 inhibitor (SGLT2) inhibitors, Boehringer Ingelheim International GmbH and Eli Lilly and Co.'s Jardiance (empagliflozin) has become the first therapy of the class to significantly reduce the risk of cardiovascular death or hospitalization vs. placebo for heart failure patients with preserved ejection fraction (HFpEF). The finding comes from the phase III Emperor-Preserved study, which tested once-daily Jardiance 10 mg vs. placebo in nearly 6,000 adults living with HFpEF, with and without diabetes.
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