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
Japanese drug major Astellas Pharma saw its shares gain 2.44% to 1,699 yen after it revealed it had entered into an exclusive, worldwide (excluding China) option and license agreement for US biotech Juventas Therapeutics’ lead product candidate, JVS-100. 22 November 2018
British cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) that recommends inclusion of Keytruda (pembrolizumab) in the Cancer Drugs Fund (CDF) in lung cancer. 22 November 2018
With current Gilead Sciences chief executive John Milligan standing down at the end of the year, the announcement on his successor is one of the most eagerly-awaited in biopharma at present. 21 November 2018
In the latest example of biotech belying the trade tensions between political leaders, Chinese and US investors have joined in the financing of an oncology-focused biopharma based in China. 21 November 2018
Santhera Pharmaceuticals has entered into an agreement with fellow Switzerland-based Idorsia under which Santhera will acquire the option to exclusively in-license, by way of sub-license, the first-in-class dissociative steroid vamorolone in all indications and all countries worldwide except Japan and South Korea. 21 November 2018
Weeks after a US Food and Drug Administration (FDA) panel overwhelmingly voted in support of the benefit-risk profile of Sage Therapeutics’ Zulresso (brexanolone) in postpartum depression (PPD), the agency has delayed a decision on whether to approve it. 21 November 2018
The US Food and Drug Administration has granted the Biological Product Designation for Israel-based biotech BioLineRx’ novel immunotherapy compound AGI-134. 21 November 2018
The US Food and Drug Administration (FDA) has approved Gamifant (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody, in an ultra-rare syndrome of hyperinflammation with high morbidity and mortality and for which there was previously no drug on the market. 20 November 2018
Dutch biotech uniQure, the company which failed with its attempts to market Glybera (alipogene tiparvovec), the world’s first approved gene therapy, could have consigned its troubles to the past through a successful rebuilding program. 20 November 2018
There was disappointment for Germany’s Merck KGaA and pharma giant Pfizer yesterday when they announced that their late-comer checkpoint inhibitor had failed in another Phase III trial, this one in ovarian cancer. 20 November 2018
Switzerland-headquartered Roivant Sciences and South Korea’s iNtRON Biotechnology have entered into a landmark global licensing agreement for SAL200, a novel investigational biologic for the treatment of infectious diseases caused by antibiotic-resistant staphylococci. 20 November 2018
As expected, following a positive recommendation from its advisory panel in September, the European Medicines Agency has granted approval for Emgality (galcanezumab), in the treatment of migraines. 19 November 2018
UK-based Mundipharma has agreed a deal worth up to $600 million to acquire exclusive Japanese rights for Invossa (TissueGene-C) with South Korean firm Kolon Life Science. 19 November 2018
The China National Medical Products Administration (NMPA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35kg). 19 November 2018
Sitravatinib, a drug from Californian cancer specialist Mirati Therapeutics, is to be tested as part of Cancer Research UK’s Stratified Medicine Programme. 19 November 2018
Admitting that its trial results are not strong enough, Roche has told the European Medicines Agency (EMA) not to consider a type II variation to extend the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab). 19 November 2018
Immunocore, a T Cell Receptor (TCR) biotech company, today announces it has entered into a new partnership with Genentech to expand an existing discovery collaboration that was signed in 2013. 19 November 2018
Influential cost-effectiveness watchdog ICER - the Institute for Clinical and Economic Review - has found that three therapies for the ultra-rare and potentially fatal disorder hereditary angioedema (HAE) are not cost-effective. 19 November 2018