Category Press Releases

European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

 Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small…

Read MoreEuropean Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

Beyfortus approved in China for the prevention of RSV disease in infants

AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a long-acting monoclonal antibody, has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.1 Beyfortus is anticipated to be available…

Read MoreBeyfortus approved in China for the prevention of RSV disease in infants

Roche enters into a definitive agreement to acquire LumiraDx’s Point of Care technology combining multiple diagnostic modalities on a single platform

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the entry into a definitive agreement to acquire select parts of the LumiraDx group (NASDAQ GS: LMDX) related to LumiraDx’s innovative Point of Care technology. Following closing of the transaction, which is…

Read MoreRoche enters into a definitive agreement to acquire LumiraDx’s Point of Care technology combining multiple diagnostic modalities on a single platform

Hansoh Pharma’s Saint Luolai is added to the National Reimbursement Drug List, opening a new chapter in the long-term treatment for CKD renal anemia in China

On December 13, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security of the People’s Republic of China jointly released the “National Medicines Catalogue for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance (2023)”…

Read MoreHansoh Pharma’s Saint Luolai is added to the National Reimbursement Drug List, opening a new chapter in the long-term treatment for CKD renal anemia in China

Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics

Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for…

Read MoreBristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics

Wainua granted first-ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis

AstraZeneca and Ionis’ Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN.1 Wainua is the only approved medicine for the treatment of ATTRv-PN that can be…

Read MoreWainua granted first-ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis

BioMarin Announces Governance Enhancements and Value Creation Initiatives

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced several initiatives to enhance corporate governance and long-term shareholder value creation. The Board has approved the appointment of three new independent directors: Barbara…

Read MoreBioMarin Announces Governance Enhancements and Value Creation Initiatives

ICON wins industry accolades from TIME Magazine, Forbes and Financial Times in second half of 2023

 ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation (CRO), finishes the second half of 2023 with positive recognition as a top-rated employer and leader in clinical trial innovation.  In recognition of its Environmental, Social and Governance (ESG)…

Read MoreICON wins industry accolades from TIME Magazine, Forbes and Financial Times in second half of 2023

Two Phase 3 Trials of Datopotamab Deruxtecan Plus DurvalumabInitiated in Patients Across Two Breast Cancer Subtypes

The first patient has been dosed in two global, randomized phase 3 trials evaluating the efficacy and safety of Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) datopotamab deruxtecan (Dato-DXd) in combination with durvalumab, AstraZeneca’s anti-PD-L1 therapy, in two types…

Read MoreTwo Phase 3 Trials of Datopotamab Deruxtecan Plus DurvalumabInitiated in Patients Across Two Breast Cancer Subtypes