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
Positive top-line results from the Phase III AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A, were released today by US pharma giant Pfizer. 24 July 2024
Sage Therapeutics’ shares plunged nearly 22% to $10.25 in pre-market activity, as it announced disappointing top-line results from the Phase II KINETIC 2 dose-range study of the oral investigational drug SAGE-324 (BIIB124) as a potential treatment in essential tremor (ET). 24 July 2024
US pharma giant Merck & Co has released positive top-line results from its Phase IIb/III clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), 24 July 2024
Former executives at Johnson & Johnson (NYSE: JNJ) have teamed up to launch a new biotech company, Third Arc Bio, with significant backing from investors. 24 July 2024
Tuesday was not a good day for shareholders in US biopharma Cellectar Biosciences—a US biopharma focused on the discovery, development and commercialization of drugs for the treatment of cancer. 23 July 2024
Cambridge, USA-based biotech incubator Flagship Pioneering today unveiled Abiologics, a company reimagining biologics with the creation of a new class of supranatural and programmable medicines, called Synteins. 23 July 2024
Swiss pharma giant Roche and US biotech Regeneron are on the cusp of transforming the vascular endothelial growth factor A (VEGF-A) therapy market with their revolutionary treatments, Vabysmo (faricimab), and Eylea HD (aflibercept). 23 July 2024
UK-based Touchlight, a CDMO advancing enzymatic DNA production to enable the genetic medicine revolution, has announced a license agreement with London-based pharma major GSK (LSE: GSK). 23 July 2024
Latigo Biotherapeutics, a privately-held US biotech focused on developing non-opioid pain medicines, has appointed Nima Farzan as chief executive. 23 July 2024
California-based liver and viral disease specialist Aligos Therapeutics (Nasdaq: ALGS) has announced a clinical trial collaboration with Amoytop Biotech. 23 July 2024
Agilent Technologies has signed a definitive agreement to acquire Biovectra, a leading specialized contract development and manufacturing organization (CDMO), for $925 million. 23 July 2024
A new collaboration in the area of stem cell therapies is to get underway in Japan, as Tokyo-based drugmaker Astellas Pharma (TSE: 4503) pairs up with Osaka University. 22 July 2024
A recent draft report from the Institute for Clinical and Economic Review (ICER) has evaluated the cost-effectiveness of therapies for transthyretin amyloid cardiomyopathy (ATTR-CM), warning that in some cases, the price is too high. 22 July 2024
Israel’s Teva Pharmaceutical Industries has presented positive topline results from its Phase III SPACE study of Ajovy (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged six to 17 years. 19 July 2024