Pharma News

Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Otarmeni™ (lunsotogene parvec-cwha), the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program.

Researchers at VIB, VUB, and KU Leuven have identified a tiny binding site, a molecular ’keyhole’, in the TRPM3 ion channel, a crucial sensor in pain signaling. TRPM3 is also linked to rare neurodevelopmental disorders and epilepsy. In a recent study published in Nature Communications, the researchers found that even the slightest change in this keyhole can radically switch the channel’s behavior, explaining how certain mutations can flip the effects of drugs. 

Developing an effective HIV vaccine remains one of the major challenges in global health. One promising approach focuses on so-called broadly neutralizing antibodies, antibodies that can block many different variants of HIV. However, only a small fraction of people living with the virus develop these antibodies naturally.

In a regulatory update aimed at streamlining drug export processes, the Central Drugs Standard Control Organization (CDSCO) has announced the implementation of a Prior Intimation System for Form CT-05 applications. The new system will come into force from April 21, 2026, following amendments introduced under Gazette Notification G.S.R. 50(E).

In a significant move to strengthen India’s pharmaceutical research ecosystem, the National Institute of Pharmaceutical Education and Research (NIPER), Mohali has signed an agreement with Novartis Healthcare Private Limited. The collaboration aims to promote innovation and deepen industry-academia partnerships in the country.

A new experimental drug from AstraZeneca is giving fresh hope to millions of people living with Chronic Obstructive Pulmonary Disease after showing positive results in a large late-stage study.

The drug, Tozorakimab, met its main goal in the Phase III MIRANDA trial. It helped reduce the number of serious flare-ups, also called exacerbations, in patients who were already taking standard inhaled treatments but still had symptoms.

Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-322 trial of Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, plus venetoclax and rituximab versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Treatment in both study arms was administered for up to two years, after which patients do not take any CLL therapy until their disease progresses.