Pharma News
In a setback for Rocket Pharmaceuticals, the FDA has issued a Complete Response Letter rejecting its gene therapy, Kresladi, designed to treat severe leukocyte adhesion deficiency-I (LAD-I). The agency’s decision comes with a request for additional chemistry, manufacturing, and controls (CMC) information to complete their review process. Initially slated for a March 2024 decision, Kresladi’s … Read more
The Subject Expert Committee (SEC), an advisory body to India’s national drug regulator, has recommended granting permission for the import and marketing of Eli Lilly’s weight loss drug, Mounjaro, in India. This recommendation is contingent upon the company conducting phase IV clinical trials and meeting quality standards. Eli Lilly sought approval to import and market … Read more
The Tamil Nadu Pharma Traders’ Association (TNPTA) has raised concerns over the promotional strategies of MedPlus, a prominent chain pharmacy group, urging the All India Organisation of Chemists and Druggists (AIOCD) to intervene. TNPTA President T Natarajan penned a letter to the AIOCD’s general secretary, calling for action against Akums Drugs and Pharmaceuticals, a major … Read more
Researchers at the Department of Bioengineering (BE) at the Indian Institute of Science (IISc) have developed a promising 3D hydrogel culture system aimed at tackling drug-resistant tuberculosis (TB) and shortages of TB medicines. This innovation, which has been patented in India, could potentially revolutionize drug testing and discovery in the pharmaceutical industry. The new 3D … Read more
The Department of Pharmaceuticals (DoP) has given the green light for Rs. 243 crore in funding to establish Centers of Excellence (CoEs) within the National Institutes of Pharmaceutical Education and Research (NIPERs) for the upcoming fiscal year 2024-25. This initiative is part of the broader Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP) scheme, … Read more
In a significant development for India’s pharmaceutical sector, small and medium enterprises (MSMEs) are poised for a major makeover under the revamped Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS). Dr. Arunish Chawla, Secretary of the Department of Pharmaceuticals (DoP), revealed that numerous companies are stepping up following comprehensive gap analyses. Dr. Chawla shared these insights during … Read more
Genmab A/S, a global biotechnology company focused on advancing patient care, has received positive news from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). They have recommended conditional marketing authorization for epcoritamab (Tepkinly), a novel T-cell engaging bispecific antibody. This recommendation is specifically for its use as a monotherapy in … Read more
The National Institutes of Health (NIH) is embarking on a groundbreaking clinical trial to assess the safety and effectiveness of an experimental monoclonal antibody aimed at combating enterovirus D68 (EV-D68), a virus linked to severe respiratory and neurological conditions such as acute flaccid myelitis (AFM), akin to polio. EV-D68 has been a growing concern in … Read more
Roche has received positive news from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which has recommended the approval of PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). This recommendation marks a significant step forward in offering a new treatment option for adults and adolescents (12 years and older, … Read more
The European Medicines Agency’s committee for human medicines (CHMP) has made a critical decision regarding the medicine Ocaliva (obeticholic acid), recommending that its marketing authorization be revoked across the European Union. This decision comes after a thorough review concluded that the benefits of Ocaliva no longer outweigh its risks for the treatment of primary biliary … Read more
