Pharma News

The Subject Expert Committee (SEC) on Oncology has declined Roche Products (India) Private Limited's request for a waiver of local Phase III and Phase IV clinical trials for Glofitamab and has instead recommended that the company conduct Phase III clinical trials in India before the drug can be considered for marketing approval.

AstraZeneca and its partner Ionis Pharmaceuticals have announced that the Phase III CARDIO-TTRansform trial evaluating Wainua (eplontersen) for adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) did not meet its primary efficacy endpoint, marking a significant setback for the investigational indication.

The U.S. Food and Drug Administration (FDA) has issued a Letter to Lundbeck Seattle Biopharmaceuticals, alleging that promotional materials for its migraine treatment Vyepti (eptinezumab-jjmr) contained false or misleading claims that overstated the drug's benefits.

The Indian Pharmacist Association (IPA) has submitted a detailed representation to Union Health Minister Jagat Prakash Nadda, urging the Government of India to comprehensively revise the Draft National Pharmacy Commission (NPC) Bill, 2026 before it is introduced in Parliament. The association has also separately requested the Ministry of Health & Family Welfare to issue nationwide implementation directions for the recently notified Pharmacist Recruitment, Promotion and Service Regulations.

The Central Government has officially amended the Drugs Rules, 1945, allowing Navi Mumbai Airport to be used as an authorized entry point for the import of drugs into India. The amendment has been notified through the Drugs (Ninth Amendment) Rules, 2026, which came into force upon its publication in the Official Gazette.

Marksans Pharma Ltd. has announced the acquisition of 100% share capital of ABCnow GmbH, a Germany-based pharmaceutical wholesale and distribution company, in a strategic move to strengthen its presence across regulated European markets. The company has entered into a definitive agreement to acquire the business as part of its forward integration strategy.

The acquisition will be completed through a cash consideration of €892,384, with the transaction expected to close by July 31, 2026. Marksans stated that no government or regulatory approvals are required for the acquisition.

The U.S. Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj) to reduce proteinuria (excess protein in the urine) in adults with primary Immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The approval provides a new treatment option for patients with this rare kidney disease, which can eventually lead to kidney failure.

Researchers have identified critical antibody binding sites on the JC polyomavirus (JCPyV), a breakthrough that could pave the way for the first effective treatments and vaccines against the virus responsible for progressive multifocal leukoencephalopathy (PML), a rare but usually fatal brain disease affecting people with severely weakened immune systems. The findings were published in the journal PNAS.