Industry News

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.

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.

Vertex Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of CASGEVY (exagamglogene autotemcel), allowing its use in children 2 years of age and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises (VOCs) and transfusion-dependent beta thalassemia (TDT). The therapy was previously approved only for patients aged 12 years and older.

Mankind Pharma has announced a strategic collaboration with Denovo Sciences to strengthen its drug discovery capabilities through artificial intelligence (AI), marking a significant step toward technology-enabled pharmaceutical research. The partnership aims to accelerate the identification of promising drug candidates while reducing the time and cost associated with early-stage drug development.

Global contract development and manufacturing organization (CDMO) Lonza has announced a major expansion of its highly potent active pharmaceutical ingredient (HPAPI) and payload-linker manufacturing capabilities at its Visp, Switzerland facility. The investment aims to strengthen the company's integrated support for the rapidly growing antibody-drug conjugate (ADC) market.

Glenmark Specialty S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark) announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug conjugate (ADC), for patients with platinum-resistant ovarian cancer (PROC).