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
Building on lessons learned during the coronavirus pandemic, the UK government is to open a major new vaccine research center aimed at combating future threats. 10 August 2023
Anglo-Swedish pharma major AstraZeneca’s research into mRNA vaccines is to be aided by the use of Chinese biotech firm CanSino Biologics' manufacturing platform. 10 August 2023
US hearing loss treatment specialist Decibel Therapeutics (Nasdaq: DBTX) saw its share rocket 77% to $4.95 pre-market on Wednesday, on the news that it has agreed to be acquired by US biotech major Regeneron Pharmaceuticals. 10 August 2023
First granted US accelerated approval in 2020, the Food and Drug Administration on Wednesday converted this to regular approval of Gavreto (pralsetinib) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 10 August 2023
Positive data for a new kind of medicine, a BTK inhibitor developed by Novartis, could pave the way to improved treatment options for people with chronic spontaneous urticaria. 9 August 2023
San Diego, USA-based next generation RNA therapeutics company ADARx Pharmaceuticals today revealed it has closed an oversubscribed Series C financing of $200 million. 9 August 2023
The prevalence of non-alcoholic steatohepatitis (NASH), a more advanced stage of nonalcoholic fatty liver disease (NAFLD), continues to increase. 9 August 2023
South Korean vaccine developer SK bioscience’s shares were up 4.6% at 84,500 won, after it announced its decision to make an equity investment of around $85 million in US biotech Novavax. 9 August 2023
Sino-American biotech Terns Pharmaceuticals yesterday revealed positive top-line results from the Phase IIa DUET clinical trial of TERN-501, both alone and in combination with TERN-101, for the treatment of non-alcoholic steatohepatitis (NASH). 9 August 2023
US cancer-focused biotech Foghorn Therapeutics today announced that Dr Alfonso Quintás-Cardama will join the company as chief medical officer, on September 11, 2023. 8 August 2023
Swiss ophthalmology specialist Oculis Holding today released positive top-line results from its Phase III OPTIMIZE trial with OCS-01 eye drops. 8 August 2023
Shares of Ginkgo Bioworks were down more than 9% at $1.96 in pre-market activity this morning, despite the company announcing a potentially lucrative collaboration. 8 August 2023
The dyslipidemia market will be driven by the launch of therapies with promising efficacies and new mechanism of actions, as well as the growth of the dyslipidemia population. 8 August 2023
Nektar Therapeutics’ shares closed up a massive 82.6% at $0.98 yesterday, after it revealed announced that efficacy data previously generated by former partner Eli Lilly for Rezpeg (rezpegaldesleukin) that were presented at the September 2022 EADV Congress were incorrectly calculated by Lilly. 8 August 2023
The recent Life Sciences Competitiveness Indicators published by the UK government suggests that international investors are abandoning the country’s life sciences sector as excessive revenue clawback rates start to bite. 7 August 2023
San Diego, USA-based cancer focussed biotech Viracta Therapeutics today announced the appointment of Dr Darrel Cohen, as chief medical officer (CMO), with immediate effect. 7 August 2023
US cancer drug developer Ikena Oncology today announced the closing of its acquisition of privately-held clinical-stage biotech Pionyr Immunotherapeutics in an all-stock transaction. 7 August 2023
Increased activity and investment in the development of antibody-drug conjugates (ADCs) has been evident in the oncology market in the past two to three years. 7 August 2023
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted unanimously by 10 to 0 to recommend routine use of Beyfortus (nirsevimab-alip). 7 August 2023
Germany’s BioNTech, which shot into the limelight with the development of the first and most successful COVID-19 vaccine, Comirnaty, partnered with Pfizer), today reported financial results for the three months ended June 30, 2023. 7 August 2023