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 US mRNA-focussed biotech Moderna slid more than 11% pre-market yesterday, before recovering to close down 0.76% at $147.50, as it reported financial results. 4 November 2022
Germany’s Affimed saw its shares leap more than 17% to $1.98 today, after it revealed a collaboration with privately held US biotech Artiva Biotherapeutics. 3 November 2022
Revenues at Regeneron came in at $2.9 billion in the third quarter of 022, slightly higher than most analysts’ were expecting, but still 15% lower than the same period of 2021. 3 November 2022
Times are tough for cell medicine specialist Rubius Therapeutics, with the firm announcing plans to slash its workforce by 84%, part of a drastic effort to avoid bankruptcy. 3 November 2022
Ireland-incorporated biotech Alkermes’ shares closed up 3.5% at $24.06 yesterday, as it pleased investors when it revealed that it is to explore separating its commercial-stage neuroscience business and development-stage oncology business. 3 November 2022
Arcturus Therapeutics, a US messenger RNA (mRNA) company focused on the development of infectious disease vaccines, saw its shares rocket up nearly 24% to $22.63 yesterday on news of what could be an up to $4.5 billion deal relating to its technology. 3 November 2022
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published an evidence report on the comparative clinical effectiveness of hemophilia treatments. 2 November 2022
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofovir alafenamide) 25mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease. 2 November 2022
A landmark approval in infectious diseases could be achieved by the end of the year, after New York pharma giant Pfizer reported fast progress in its respiratory syncytial virus (RSV) vaccine program. 2 November 2022
Spain's AELIX Therapeutics, a spin-off of the HIVACAT vaccine research consortium, has published in Nature results from the AELIX-002 trial. 2 November 2022
Switzerland-headquartered antibody-drug conjugate specialist ADC Therapeutics today announced the appointment of Kristen Harrington-Smith as chief commercial officer, effective November 17, 2022, and Peter Graham as chief legal officer, effective today. 1 November 2022
Adding to a string of recent research collaborations, Japanese drugmaker Ono Pharmaceutical has signed a drug discovery agreement for drugs in the immuno-oncology field with Swiss biotech Memo Therapeutics (MTx), an innovator in the field of antibody discovery and development. 1 November 2022
US pharma major AbbVie communicated during its third-quarter financial results on October 28, that it has decided to stop the development of cedirogant (ABBV-157), an oral RORg inverse agonist jointly discovered by French firm Inventiva and AbbVie for the treatment of autoimmune diseases. 1 November 2022
Having soared as much as 164% earlier in the day, shares of USA-based Coeptis Therapeutics closed down 45% at $6.50 on the Nasdaq, after it announced the completion of its business combination with Bull Horn Holdings, a special purpose acquisition company (SPAC). 1 November 2022
Long available in Europe under an emergency nod, AstraZeneca's COVID-19 vaccine, Vaxzevria, has finally been granted full approval in the region. 1 November 2022
New top-line data released this morning by US pharma major Bristol Myers Squibb suggest that its already-marketed drug Reblozyl (luspatercept-aamt) should be able to address a larger proportion of myelodysplastic syndromes (MDS) patients. 31 October 2022
Sino-American biotech BeiGene claims significant progress in its efforts to unlock global opportunities for its Brukinsa (zanubrutinib) with recent regulatory approvals in six Latin American countries. 31 October 2022
Shares of French biotech Quantum Genomics were decimated on Friday after its revealed efficacy results for firibastat in its Phase III study FRESH in treatment-resistant hypertension (TRH), are non-significant versus placebo. The stock plunged 90% to 0.33 euros. 31 October 2022