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HUS Helsinki University Hospital, University of Helsinki, Janssen Finland and Janssen EMEA have agreed on extensive international collaboration. Its aim is to promote the development of value-based healthcare and to carry out research and development especially related to precision medicines. The agreement enables multi-year projects in different areas of disease treatment. At the beginning of […]

AstraZeneca and Daiichi Sankyo’s Enhertu has been recommended for approval in the European Union as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca and […]

EpiEndo Pharmaceuticals has received regulatory approval to commence a Phase 2a clinical trial with lead molecule EP395 in COPD (Chronic Obstructive Pulmonary Disease) patients. EP395 is an orally available macrolide or ‘Barriolide,’ with reduced antimicrobial resistance potential, which aims to address the unmet medical need for a treatment for COPD. “This is the first time […]

Evaxion Biotech has announced that it intends to further increase its focus on its lead oncology assets EVX-01 and EVX-02/03 to bring them to clinical proof of concept followed by out-licensing. The company further plans preclinical partnering of its early-stage programs under its infectious disease platforms, it states in a press release. “I am deeply […]

The two companies announce that the European Commission has granted a marketing authorization for Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis. This follows the positive opinion issued by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) in September 2022. The centralized marketing authorization for Ximluci 10 mg/ml solution for injection […]

Devyser announces its decision to establish a CLIA lab in Atlanta, Georgia, USA. By operating a CLIA lab, Devyser obtains complete control of the selling process, including reimbursement management, ensuring value-based pricing and improved margins. It also allows for closer interaction with physicians and patients. The company aims to have the lab CLIA certified and […]

Nordic Nanovector and all shareholders of APIM Therapeutics have entered into a definitive merger agreement to combine the companies in an all-stock transaction. Subject to completion of the agreement, Nordic Nanovector will purchase shares in APIM, and become the parent entity of APIM. The agreement follows the review that Nordic Nanovector conducted, in conjunction with […]

The U.S. Food and Drug Administration has granted RMC-035 the designation for reducing the risk of an irreversible loss of kidney function, initiation of kidney replacement therapy or death following open-chest cardiac surgery in patients who are at increased risk for acute kidney injury. “It is gratifying that our investigational drug is granted Fast Track […]

Salipro Biotech has entered into a research collaboration and license agreement with Sanofi on the discovery of therapeutic biologics against a challenging drug target. The collaboration brings together Salipro Biotech’s expertise in developing stable antigens of GPCRs, ion channels and transporters via its platform with Sanofi’s discovery programs to identify biologics with the desired therapeutic […]

The company has opened an office in Boston to support its increasing US clinical development, partnering and fund-raising activities. The new office is at the CIC in Boston, Massachusetts which has been a home for great entrepreneurs leading fast-growing companies since 1999, describes the company. “Boston is at the heart of one of the world’s […]