Bayer announced that the investigational compound sevabertinib (BAY 2927088) has been granted Priority Review status by the US Food and Drug Administration (FDA) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2/ERBB2) mutations and who have received a prior systemic therapy.[1] Sevabertinib is an oral, small molecule, tyrosine kinase inhibitor (TKI).

Pfizer Inc. (NYSE: PFE) announced it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it will invest USD 50 billion into the United States of America in the next five years. These investments further strengthen Roche's already significant US footprint with 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions, and are expected to create more than 12,000 new jobs, including nearly 6,500 construction jobs, as well as 1,000 jobs at new and expanded facilities.

Novartis today announced that it has entered into an agreement to acquire Regulus Therapeutics, a San Diego-based, publicly traded (Nasdaq: RGLS) clinical-stage biopharmaceutical company focused on developing microRNA therapeutics. Regulus' lead asset, farabursen, is a potential first-in-class, next-generation oligonucleotide targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, announced the publication of the 18-month data from its Phase 1 exPDite clinical trial for bemdaneprocel in the journal Nature.

"The concept of "rebuilding" brain networks that have been lost to disease is compelling," said Claire Henchcliffe, MD, chair of the UC Irvine School of Medicine's Department of Neurology at the University of California, Irvine and one of the study's Principal Investigators,

Pfizer Inc. (NYSE: PFE) announced that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:

Bayer and Suzhou Puhe BioPharma Co., Ltd., a clinical-stage biotechnology company, announced that they have entered into a global license agreement for Puhe BioPharma's oral, small molecule PRMT5 inhibitor that selectively targets MTAP-deleted tumors. Under the agreement, Bayer obtains an exclusive worldwide license to develop, manufacture and commercialize the MTA-cooperative PRMT5 inhibitor.