AstraZeneca Pharma gets CDSCO nod to market Enhertu for additional indication

AstraZeneca reported Phase III CLARITY-Gastric01 results for sonesitatug vedotin, a CLDN18.2-targeted antibody-drug conjugate, in previously treated CLDN18.2-positive advanced gastric and related cancers. The trial met the primary overall-survival endpoint in third-line or later patients and a key secondary OS endpoint. PFS favored but was not significant; safety was consistent with prior profiles. Data will be submitted to regulators.

AstraZeneca Pharma India said, according to its Aug. 7, 2026 statement, that India’s CDSCO approved permission to import and distribute Enhertu (trastuzumab deruxtecan) for an additional indication. The new label covers adjuvant treatment of adults with HER2-positive breast cancer and residual invasive disease after specified neoadjuvant therapy, enabling broader sales in India subject to further approvals.

Reuters reports a senior source close to AstraZeneca and Bristol Myers Squibb denied merger talks, saying no discussions are underway and no deal was planned. The denial follows a Financial Times report of preliminary talks for a potential roughly $400 billion combination. The focus shifts to drone last-mile delivery and Kenco’s rollout of AI agents in pharma logistics.

NICE issued final draft guidance recommending AstraZeneca’s acalabrutinib (Calquence) in two first-line combination regimens in England for untreated mantle cell lymphoma and chronic lymphocytic leukaemia. For MCL, acalabrutinib plus bendamustine and rituximab for ~350 patients not eligible for stem cell transplant. For CLL, acalabrutinib plus venetoclax for ~440, including high-risk disease. NHS funding is due within 90 days; trials report longer progression-free survival and improved overall s

Reuters reports, citing a confidential source, that AstraZeneca and Bristol Myers Squibb have not held substantive merger talks and that no deal or discussions exist. The denial reversed market moves: AstraZeneca shares rose about 2.9% while BMS fell about 2.6%. Speculation followed a Financial Times report of potential $400 billion exploratory talks.

Reuters, citing a senior source, said there is no deal and no current merger discussions between AstraZeneca and Bristol Myers. The clarification followed Financial Times speculation about talks that could have created a nearly $400 billion pharma group. AstraZeneca shares reportedly rebounded about 3% after Reuters; Bristol Myers fell about 3%. Neither company commented.