Moreover, Arrowhead will be solely responsible for the activities involved during pre-clinical phases of development, while Horizon will be advancing the asset further towards clinical phases of trials along with the commercialization of the drug.
Dr Reddy’s Lab’s Icosapent Ethyl Capsules See Daylight in the US
Dr. Reddy’s Laboratories announced the launch of Icosapent Ethyl Capsules of strength 1 gram to reduce triglyceride (TG) levels in severe (≥ 500 mg/dL) hypertriglyceridemia in adult patients.
The drug is not approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
Listed limitations of the drug include risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Targovax’s ONCOS-102 Receives Fast Track Designation in Melanoma
The USFDA grants Fast Track Designation to Targovax’s ONCOS-102 under investigations for PD-1-refractory advanced melanoma from the US FDA. Targovax is a clinical-stage immune-oncology company that is developing immune activators to target hard-to-treat solid tumors.
The designation was granted on the basis of the promising evidence demonstrated by the drug in inducing immune activation and generating tumor responses. The drug has already been awarded the same designation, however, in malignant pleural mesothelioma.
The additional destination coupled with the existing one further amplifies the PD-1-refractory advanced melanoma.
RedHill Biopharma Assertive of its Oral Opaganib in COVID-19
RedHill Biopharma announced the presentation of the positive Phase 2 safety and efficacy data of its oral drug, Opaganib, in hospitalized patients with COVID-19 pneumonia at the World Microbe Forum (WMF) 2021 (poster #: 5574).
As per the presentation of the data from a 40-patient U.S. Phase 2 study titled “Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia (NCT: 04414618)”, the drug managed to shine and ought to emerge as the first novel, oral therapy in the treatment of COVID-19 in a large late-stage study. The drugmaker shows full confidence in its drug and plans to advance to a phase II/III study for which the enrollment has already been done.
