The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
The UK’s largest pharma company AstraZeneca has rejected claims that it is moving its vaccine operations to the USA, according to media reports. 23 August 2024
Mitsubishi Tanabe Pharma announced the termination of its exclusive sales rights agreements with AnGes for the HGF gene therapy product, Collategene (beperminogene perplasmid) intramuscular injection targeting peripheral arterial diseases in Japan and the USA. 23 August 2024
UK pharma major AstraZeneca has become the only current UK-lis¬ted company to reach a £200 billion ($256.4 billion) valuation, the Financial Times reported today, noting that it is a vindication of the company’s bet on developing a leading portfolio of cancer drugs. 14 August 2024
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US pharma giant Pfizer has announced the publication of real-world results from a cohort of the longitudinal, observational Phase IV THAOS (Transthyretin Amyloidosis Outcomes Survey) study in the Journal of Cardiac Failure. 8 August 2024
Japanese drugmaker Shionogi says that its New Drug Application (NDA) for cefiderocol has been accepted for review by the Center for Drug Evaluation, National Medical Products Administration (NMPA). 5 August 2024
Germany’s Bayer has submitted to the US Food and Drug Administration for approval to market elinzanetant for moderate to severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. 2 August 2024
In the world of outsourced clinical research, ICON is a big fish in a pond full of other increasingly big fish. In this episode of the podcast, we chat with the company’s CCO, George McMillan. 24 October 2023
San Francisco, USA-based biotech start-up Aiolos Bio has today emerged out of stealth, backed by an oversubscribed $245 million Series A investment. 24 October 2023
Germany’s BioNTech has presented positive Phase I/II on its CAR-T cell therapy candidate BNT211 in advanced solid tumors at the European Society of Medical Oncology (ESMO) Congress 2023. 24 October 2023
Privately-held French company Orphelia Pharma, which is focused on pediatric and orphan medicines, has filed a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Kizfizo, the first oral liquid formulation of temozolomide. 24 October 2023
Medicines regulator Health Canada has approved Orgovyx (relugolix), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer, Japanese drugmaker Sumitomo Pharma announced. 24 October 2023
Seven vaccine research proposals have been chosen for funding, the latest development in a partnership between the Bill and Melinda Gates Foundation and the National Natural Science Foundation of China (NSFC). 24 October 2023
The European Commission has today adopted a set of actions to better prevent and mitigate critical medicine shortages in the European Union (EU), this winter, next winter and beyond. 24 October 2023
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Byooviz (ranibizumab-nuna) as a biosimilar product interchangeable with Lucentis (ranibizumab). 24 October 2023
The US business of South Korea's Celltrion Healthcare has secured approval for Zymfentra (infliximab-dyyb), a subcutaneous reformulation of infliximab. 24 October 2023
In October 2022, the US Food and Drug Administration (FDA) released its “Multiple Endpoints in Clinical Trials” document to provide guidance for drug sponsors and other stakeholders regarding best practices in assessment methodologies for medications. 24 October 2023
At the 2023 annual congress of the European Society of Medical Oncology (ESMO), Johnson & Johnson has presented important new data for Rybrevant (amivantamab-vmjw). 24 October 2023
Chinese drugmaker Sichuan Kelun Pharmaceutical on Monday revealed that Merck & Co was abandoning the joint development of two candidate cancer drugs which have yet to start clinical trials. 24 October 2023
The TROPION-Lung01 Phase III trial has yielded positive data for datopotamab deruxtecan (Dato-DXd), an investigational TROP2-directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. 23 October 2023
Swiss pharma giant Novartis today presented data from the Phase III PSMAfore trial of Pluvicto (lutetium (177Lu) vipivotide tetraxetan) at the 2023 European Society for Medical Oncology (ESMO) Congress. 23 October 2023
Shanghai-based gene therapy company Belief BioMed (BBM) has out-licensed certain rights for the commercialization of its hemophilia candidate, BBM-H901. 23 October 2023
Bristol Myers Squibb has announced the first presentation of results from the Phase III CheckMate -901 trial involving Opdivo (nivolumab) at the 2023 European Society for Medical Oncology (ESMO) Congress. 23 October 2023
At the annual congress of the European Society for Medical Oncology (ESMO), Seagen and Astellas Pharma have presented detailed data from the Phase III EV-302 study. 23 October 2023
Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). 23 October 2023