Merck today announced that its Carlsbad, California-based manufacturing facility for the production of BioReliance® viral and gene therapy products has completed both a U.S. Food & Drug Administration (FDA) Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization Application inspection.

AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA also previously granted Breakthrough Therapy Designation for this application,

AbbVie (NYSE: ABBV), a global biopharmaceutical company, and Turnstone Biologics, a clinical-stage immuno-oncology company, have announced a research, option and license agreement whereby AbbVie obtained an exclusive option to license up to three of Turnstone's next-generation oncolytic viral immunotherapies.

Pfizer Inc. is reviewing strategic alternatives for its Consumer Healthcare business. A range of options will be considered, including a full or partial separation of the Consumer Healthcare business from Pfizer through a spin-off, sale or other transaction, and Pfizer may ultimately determine to retain the business. This announcement is part of Pfizer's continuing efforts to allocate resources and capital to best serve patients and maximize value for its shareholders.

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

Roche (SIX: RO, ROG; OTCQX:RHHBY), has announced the launch of the NAVIFY Tumor Board solution, a clinical workflow and decision support software that optimises decision-making for cancer patient case reviews in tumor boards, or multi-disciplinary team meetings. The solution fundamentally changes the way these meetings are organised and conducted.