Pharma News

U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.

Clinicians have a new standard for graft-versus-host disease (GVHD) prevention after allogeneic hematopoietic stem cell transplantation, according to results from a phase III study published June 22 in the New England Journal of Medicine. The new standard is more effective at preventing GVHD and came with less side effects, compared with the current gold standard.

A team of researchers at Baylor College of Medicine is gaining ground in their search for solutions to the global problem of bacterial antibiotic resistance, which was responsible for nearly 1.3 million deaths in 2019.

The Department of Science and Technology has announced the revised stipends for PhD students and research scholars. However,research scholars are not happy with increments by the government.

DST took to twitter to announce that Govt. has approved enhancing emoluments for JRF/SRF/RAs engaged in R&D activities whereby they will receive following fellowships /month w.e.f 01/01/2023:
JRF - Rs 37,000
SRF - Rs 42,000
RA1 - Rs 58,000
RA2 - Rs 61,000
RA3 - Rs 63,000

AGEPHA Pharma USA, LLC announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved LODOCO as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

The U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.

The World Health Organization (WHO) has certified Belize as malaria-free, following the country’s over 70 years of continued efforts to stamp out the disease.

“WHO congratulates the people and government of Belize and their network of global and local partners for this achievement”, said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Belize is another example of how, with the right tools and the right approach, we can dream of a malaria-free future.”

The Department of Biotechnology (DBT) has announced that the Omicron-specific mRNA-based Booster vaccine developed using the indigenous platform technology by Gennova Biopharmaceuticals Ltd. and supported under the Mission COVID Suraksha, implemented by Biotechnology Industry Research Assistance Council (BIRAC), has got a nod from the office of the Drug Control General of India (DCGI) for Emergency Use Authorization (EUA).

Pharmacy council of India (PCI) notified that the pharmacy is an independent profession, and should not be linked with para-medical courses.

There was periodic debate in the pharmacy profession that it should fall under paramedical courses or not, which was ended by an official notification from PCI.