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International Clinical Researcher of the Year 2022

Optimization of design transfer from device development to final assembly

CPhI Discover 2021

New oral medicine to treat inflammatory bowel disease developed

An innovative capsule could take treatment for Crohn’s disease and ulcerative colitis – the two main types of inflammatory bowel disease (IBD) – out of hospital and into patients’ homes.

The first-choice biologic treatment usually administered by intravenous infusion, potentially painful, and requiring two hours in hospital each administration, may have an alternative in the form of a safer, more effective, and more convenient oral capsule.

Sun Pharma to launch first-in-class oral lipid-lowering drug in India

Sun Pharma has said that it is planning to launch a medication to reduce low-density lipoprotein (LDL) cholesterol.

The Mumbai-based drug major said that one of its wholly-owned subsidiaries plans to launch a first-in-class oral drug, Bempedoic Acid, for reducing LDL cholesterol in India.

The company will launch the drug under the name Brillo. The drug is a first-in-class drug which has a new mechanism of action compared to the currently available lipid-lowering agents.

Open Orphan lands £7.3mln influenza human challenge study

Open Orphan has said that its hVIVO subsidiary has landed a £7.3 million influenza challenge study.

Under the terms of this agreement, the company researchers will carry out a double-blind, placebo, controlled assessment of the drug, which means one cohort will receive the active treatment, while the other half will be administered a substance with no medicinal value.

The scientists will analyse the drug’s potential to ward off the flu virus (its prophylactic properties) and the post-inoculation activity of the drug in healthy volunteers.

Plant-based COVID-19 vaccine demonstrates 70% efficacy

The vaccine was developed by researchers at Canadian biotechnology company Medicago, and it contains coronavirus-like particles (CoVLP) produced in plants, which are combined with an adjuvant (ASO3) that helps vaccines work better.

The jab, Covifenz, was found to be highly effective in preventing disease caused by five different viral strains or variants in a human trial conducted by researchers. The study was published in the journal New England Journal of Medicine (NEJM).

Hypertensive pregnancy disorders linked to future cardiac events

A study funded by the US National Institutes of Health (NIH) has explained factors linked to increased risk for heart attack or stroke among women who have pregnancy problems related to high blood pressure.

Patients who experienced complications related to developing high blood pressure or hypertension during pregnancy had a 63% increased risk factor for developing cardiovascular disease later in life, according to research funded by the National heart, Lung, and Blood Institute (NHLBI), part of the NIH.

Phase III trial reveals positive results for Crohn’s disease treatment

AbbVie has announced positive topline results from U-ENDURE, its Phase III maintenance study, evaluating upadacitinib in adult patients with Crohn’s disease.

The trial analysed adults who had an inadequate response or were intolerant to a conventional or biologic therapy. The results showed that more patients treated with either dose of upadacitinib (15mg or 30mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo.

FDA approve Lilly-Incyte’s treatment for hospitalised COVID patients

The FDA has granted approval for Eli Lilly and Incyte’s Olumiant (baricitinib) to treat COVID-19 in adult patients admitted to the hospital. The drug is a Janus kinase (JAK) inhibitor and is approved for patients requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The approval is supported by results from two randomised, double-blind, placebo-controlled Phase III studies (ACTT-2 and COV-BARRIER, which includes the COV-BARRIER OS7 addendum study.

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