Pharma News

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.

In this age of “big data,” artificial intelligence (AI) has become a valuable ally for scientists. Machine learning algorithms, for instance, are helping biologists make sense of the dizzying number of molecular signals that control how genes function. But as new algorithms are developed to analyze even more data, they also become more complex and more difficult to interpret. Quantitative biologists Justin B. Kinney and Ammar Tareen have a strategy to design advanced machine learning algorithms that are easier for biologists to understand.

University of Illinois researchers achieved the highest reported rates of inserting genes into human cells with the CRISPR-Cas9 gene-editing system, a necessary step for harnessing CRISPR for clinical gene-therapy applications.

The National Biopharma Mission under the Department of Biotechnology has called for applications for a five-day hands-on training programme on the topic of downstream bioprocess development at the Technology Business Incubator of Kalinga Institute of Industrial Technology (KIIT-TBI) in Bhubaneswar from January 20 to 24. 

Council of Scientific and Industrial Research- Central Drug Research Institute (CSIR-CDRI) have signed an agreement for collaboration to jointly develop new drugs for treating various medical conditions and repurposing of drugs for India and global markets with Cipla Limited.

Indian Pharmacopoeia has been recognised formally by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of Islamic Republic of Afghanistan. The quality, efficacy and safety of the medicines are important from healthcare prospective. In order to ensure the quality of medicinal products, the legal and scientific standards are provided by Indian Pharmacopoeia Commission (IPC) in the form of Indian Pharmacopoeia (IP).

U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA) announced that they have seized 44 websites advertising the sale of illicit vaping cartridges containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. The action, which is part of Operation Vapor Lock, reflects ongoing work by federal, state and local authorities to investigate the supply chain of vaping products associated with recent lung injuries.

An experimental Zika vaccine lowered levels of virus in pregnant monkeys and improved fetal outcomes in a rhesus macaque model of congenital Zika virus infection, according to a new study in Science Translational Medicine. The research was conducted by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and their collaborators from the University of California, Davis; Duke University, Durham, North Carolina; and the University of California, Los Angeles. NIAID scientists developed the experimental vaccine and currently are evaluating it in a Phase 2 human clinical trial. The vaccine uses a small circular piece of DNA, or plasmid, containing genes that encode Zika virus surface proteins to induce an immune response.

U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.

Gilead Sciences, Inc announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.