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
Shares of RNAi therapeutics company Alnylam Pharmaceuticals fell 2.37% to $80.01 by close of trading on Monday, after the company revealed that it would not aim for accelerated approval of givosiran. 16 October 2018
Two pivotal Phase III placebo-controlled trials evaluating Dupixent (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP) met all primary and secondary endpoints. 16 October 2018
Swedish firm Medivir has announced that Uli Hacksell will replace Christine Lind as chief executive, with immediate effect, just 18 months after she took up the position. 16 October 2018
Combinations involving checkpoint therapies are starting to be used as the standard of care in certain metastatic cancer types, such as Merck & Co’s Keytruda (pembrolizumab) with chemotherapy in advanced squamous non-small cell lung cancer. 16 October 2018
Cell therapy specialist SQZ Biotechnologies has expanded a collaboration with Swiss giant Roche to bring forward candidates based on antigen presenting cells (APCs). 15 October 2018
New Jersey’s Merck & Co has reportedly backed away from taking a biosimilar follow-on product to market in the USA, despite already having tentative approval to do so from the US Food and Drug Administration. 15 October 2018
Germany’s Probiodrug (AMS: PBD) announced to the stock market that a cumulative loss of more than half of the nominal share capital of the company has been incurred, due to operating losses resulting from ordinary business operations. 15 October 2018
Shares in West Coast, USA-based oncology specialist Immune Design have fallen more than a third since it announced an unfavorable early analysis of a Phase II trial of its cancer vaccine candidate CMB305. 15 October 2018
Top-line results from the Phase III CheckMate-331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy, did not meet its primary endpoint of overall survival (OS) versus chemotherapy. 12 October 2018
US cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of therapies for long-term prophylaxis against hereditary angioedema (HAE) attacks. 12 October 2018
Privately-owned Austrian biotech Themis Bioscience has bought in additional assets from a German research group to expand its immunomodulation platform into oncology. 12 October 2018
The USA’s MEI Pharma has lined up with China’s BeiGene on a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies. 12 October 2018
A post-hoc analysis of the SUSTAIN study of crizanlizumab, Novartis’ humanized anti-P-selectin monoclonal antibody being investigated for the treatment of sickle cell disease (SCD), have been presented ahead of an expected US filing in 2019. 11 October 2018
The firm that calls itself the leading oncology company in Japan strengthened its position on Wednesday with the approval of its breast cancer drug in a new indication in the Asian country. 11 October 2018
Israel-based Compugen saw its share leap 18% in pre-market trading on news of a collaboration with a US pharma major on COM701, an investigational anti-PVRIG antibody. 11 October 2018
The US Food and Drug Administration has lifted the clinical hold placed in May this year and accepted the Investigational New Drug application (IND) for CTX001 for the treatment of sickle cell disease (SCD). 11 October 2018
Initial public offerings (IPOs) are often seen as attractive by business owners in the life sciences or biotech field, writes Alan Wovsaniker, a partner with Lowenstein Sandler, in an Expert View column on the topic. 11 October 2018
German biotech Evotec today revealed that it will receive a $6 million payment from Celgene following Celgene's decision to expand the collaboration to include additional cell lines. 11 October 2018