Pharma News

Niramai, the deep-tech healthcare company offering an innovative AI-based, radiation-free breast cancer screening test has now received the CE mark approval, ISO 13485 and MDSAP (Medical Device Single Audit Programme) international certifications. The CE mark approval indicates that the product may be sold freely in any part of the European Economic Area (EEA) as well as applicable to many Asian, African and Middle East countries.

The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo. Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.

Ionis Pharmaceuticals, Inc announced the initiation of a Phase 3 clinical trial of ION363 in patients with amyotrophic lateral sclerosis (ALS) with mutations in the fused in sarcoma gene (FUS). Patients with a mutation in the FUS gene develop a rare form of ALS, referred to as FUS-ALS, which is the most common cause of juvenile-onset ALS. There is substantial evidence that mutations in the FUS gene are responsible for a toxic gain of function that can lead to rapid, progressive loss of motor neurons in patients with FUS-ALS.

People suffering from Human Immunodeficiency Virus (HIV) infection can now hope to have a better quality of life with researchers at the Bengaluru-based Indian Institute of Science (IISc) developing a nano alternative to a natural enzyme that is used to block reactivation and replication of the virus in the host’s immune cells.

For centuries, people in Baltic nations have used ancient amber for medicinal purposes. Even today, infants are given amber necklaces that they chew to relieve teething pain, and people put pulverized amber in elixirs and ointments for its purported anti-inflammatory and anti-infective properties. Now, scientists have pinpointed compounds that help explain Baltic amber's therapeutic effects and that could lead to new medicines to combat antibiotic-resistant infections.

When people with human immunodeficiency virus (HIV) develop high blood pressure, the type of medication chosen for their initial treatment may influence their risk of heart disease, stroke and heart failure, according to new research published today in Hypertension, an American Heart Association journal.

Zydus Cadila announced that its Phase III clinical trials with Pegylated Interferon Alpha 2b, PegiHepTM has shown promising results in treating COVID-19. In what could be a breakthrough in the disease management of COVID-19, the interim results indicate that PegIFN when administered early on, could help patients recover faster and avoiding much of the complications seen in the advanced stages of the disease. PegIFN in COVID19 has several add-on advantages compared to other anti-viral agents.

The Directorate General of Foreign Trade (DGFT) has delayed the implementation of track and trace system for export of pharmaceuticals to maintain the parent-child relationship in packaging levels and its uploading on Central portal till April 1, 2022 for both SSI (small scale industry) and non-SSI manufactured drugs.

Prior, the last date was extended till April 1, 2021 due to the ongoing situation of COVID-19. And again it is further extended for one year of time period.

Genome sequencing of thousands of SARS-CoV-2 samples shows that surges of COVID-19 cases are driven by the appearance of new coronavirus variants, according to new research from the School of Veterinary Medicine at the University of California, Davis, published April 1 in Scientific Reports.