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
Taisho Pharmaceutical has submitted an application for approval to manufacture and market the anti-TNFα Nanobody therapeutic ozoralizumab to the Ministry of Health, Labor and Welfare (MHLW) for the planned indication of rheumatoid arthritis (RA), which is to-date inadequately managed by the current available treatments. 23 March 2021
The US Food and Drug Administration has approved a label update for Merck & Co’s blockbuster checkpoint blocker, targeting advanced esophageal or gastroesophageal (GEJ) cancer. 23 March 2021
Californian aging specialist CohBar is using mitochondrial science to treat diseases, but chief executive Steven Engle doesn’t rule out offering a “cure for ageing” at some point. 23 March 2021
US oral peptides specialist Chiasma’s shares were up 13% at $3.89 pre-market today, after the company announced the presentation of new positive clinical data from its MPOWERED Phase III trial of Mycapssa (octreotide) at the Endocrine Society’s annual meeting, ENDO 2021, being held virtually March 20-23, 2021. 23 March 2021
Top-line data from a trial testing an antibody cocktail in non-hospitalized people with the novel coronavirus show a reduction in the risk of hospitalization or death by 70%. 23 March 2021
The odds for and against betting on Provention Bio’s teplizumab, which is being studied in the prevention of type 1 diabetes (T1D) among at-risk patients, have been assessed. 22 March 2021
US biotech VistaGen Therapeutics has presented data highlighting the proposed mechanism of action (MOA) of its Phase III investigational drug candidate, PH94B nasal spray at the Anxiety and Depression Association of America’s 2021 Virtual Annual Conference. 22 March 2021
London-listed Finnish biopharma company Faron Pharmaceuticals saw its shares rise as much as 20% to 377 pence this morning, after it said its cancer drug had reduced risk of death by 88% in a clinical trial. 22 March 2021
Roche has announced that the Phase III IMpower010 study of Tecentriq (atezolizumab) met its primary endpoint of disease-free survival (DFS) at the interim analysis. 22 March 2021
Germany-based biotech Evotec has entered into a multi-RNA target alliance with Takeda Pharmaceutical with the aim of discovering and developing RNA targeting small molecule therapeutics for highly attractive targets that are difficult to address via more conventional approaches. 22 March 2021
A long-awaited USA-based Phase III trial of Covid-19 Vaccine AstraZeneca has proved successful, paving the way for its use in the country. 22 March 2021
US biotech Clovis Oncology saw its shares leap as much as 60% to $8.5 on Friday, after the company announced that its Rubraca (rucaparib) treatment for ovarian cancer met its primary endpoint in a Phase III trial 20 March 2021
UK-based Oxford Biomedica, a gene and cell therapy group, announced today that French pharma major Sanofi has given notice that it intends to terminate the collaboration and license agreement for process development and manufacturing of lentiviral vectors to treat hemophilia. 19 March 2021
USA-based oncology specialist Idera Pharmaceuticals has been dealt a severe blow by a negative result from the pivotal ILLUMINATE-301 trial. 19 March 2021
The US Food and Drug Administration has approved Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older. 19 March 2021
Marking a second disappointment for Incyte in the novel coronavirus setting, the company announced results from the Phase III DEVENT study evaluating the efficacy and safety of Jakafi (ruxolitinib) 5mg and 15mg plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS), a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. 19 March 2021
Another major manufacturing investment from Japanese conglomerate Fujifilm Corp will significantly up its presence in cell culture production for biologic therapies. 19 March 2021
In just a little over a week, Selexis has announced three agreements with drug developers – Pandion, BITT and now UK biotech firm SpyBiotech – that are levering Selexis’ SUREtechnology Platform to develop a variety of biologics and vaccines. 19 March 2021
Japan’s largest drugmaker Takeda Pharmaceutical has been an active deal-maker, particularly since its $62 billion buy of Shire, both acquiring and selling assets, and today continued that trend. 18 March 2021
US biotech Gilead Sciences and Danish diabetes specialist Novo Nordisk have announced that the companies have expanded their clinical collaboration in non-alcoholic steatohepatitis (NASH). 18 March 2021