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
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
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 clinical stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma. 1 August 2024
Eisai and Biogen have announced that Israel has approved their Alzheimer's treatment, Leqembi (lecanemab), adding to nods in the USA, Japan, China, South Korea, and Hong Kong. 12 July 2024
Contract research and development organization (CDMO) Emergent BioSolutions has announced that Johnson & Johnson will pay $50 million to resolve claims linked to a terminated manufacturing deal for the latter’s COVID-19 vaccine. 11 July 2024
Japan’s Eisai and US biotech Biogen have announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment of Alzheimer’s disease (AD). 11 July 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
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
As drugmakers around the world rush to embrace the potential of artificial intelligence (AI) in the design and development of new medications, the World Health Organization has urged caution. 23 October 2023
US biotech giant Amgen released new data on its global Phase II DeLLphi-301 study, evaluating its DLL3-targeting bispecific T-cell engager tarlatamab, during the European Society for Medical Oncology (ESMO) meeting. 22 October 2023
UK pharma major GSK has entered into an exclusive license agreement with Chinese biopharma firm Hansoh Pharma for HS-20089, a B7-H4 targeted antibody-drug conjugate (ADC) currently in Phase I (NCT05263479) clinical trials in China. 21 October 2023
The European Commission has unconditionally approved the proposed $43 billion acquisition of US biotech Seagen by pharma giant Pfizer, under the EU Merger Regulation. 21 October 2023
Traditionally, the pharmaceutical landscape has been dominated by small molecules. In contrast to this dominance, biologics have become the leading molecule type within the solid tumor indication, accounting for 64% of drugs. 21 October 2023
Britain’s largest drugmaker, AstraZeneca, has reported positive results from a planned interim analysis of the Phase III MATTERHORN trial. 20 October 2023
No cancer conference would be complete without Merck & Co presenting a mountain of data on its blockbuster anti-PD-1 therapy Keytruda (pembrolizumab). 20 October 2023
Ohio, USA-based contract development and manufacturing organization (CDMO) Andelyn Biosciences has partnered with Purespring Therapeutics in the area of nephrology. 20 October 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine called, Tepkinly (epcoritamab), as a treatment for diffuse large B-cell lymphoma (a type of blood cancer) in adults. 20 October 2023
Shares of Japanese pharma major Daiichi Sankyo soared 14.4% to 4,095 yen by close of Tokyo trading today, after it announced what, if all goes according to plan, could be the biggest pharma licensing deal ever seen. 20 October 2023
Osaka, Japan-based biotech RegCell today announced the appointment of experienced life science exec Michael McCullar, as its new president, chief executive and representative director. 19 October 2023
Singapore-based biotech Hummingbird Bioscience today announced that San Diego, USA-based Endeavor BioMedicines has acquired exclusive worldwide rights to Hummingbird’s antibody-drug conjugate (ADC), HMBD-501. 19 October 2023