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
The US Food and Drug Administration on Friday approved Welireg (belzutifan), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) – a rare kidney disease. 14 August 2021
Mustang Bio, a cell & gene therapy specialist based in Massachusetts, USA, has executed an exclusive license agreement with the prestigious Mayo Clinic, related to its CAR-T cell technology. 13 August 2021
The US Department of Veterans Affairs (VA) has snubbed Biogen and Eisai’s Aduhelm (aducanumab-avwa) by excluding it from its national formulary. 13 August 2021
US messenger RNA (mRNA) therapeutics and vaccines company Moderna has announced the publication of new data on the durability of the COVID-19 Vaccine Moderna, now trade-marked Spikevax and recorded first-half sales of $5.9 billion, in generating neutralizing antibodies against variants of concern. 13 August 2021
The US Food and Drug Administration has placed a clinical hold on US cancer focussed bioharma company Aprea Therapeutics’ clinical trial evaluating eprenetapopt (APR-246) with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. 13 August 2021
The Brazilian Health Regulatory Agency (ANVISA) has granted an emergency use authorization (EUA) for South Korea’s Celltrion Healthcare’s monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59) for the treatment of adults with mild-to-moderate COVID-19 who do not require supplemental oxygen and who are at high risk of progression to severe COVID. 12 August 2021
German CNS specialist atai Life Sciences has announced the launch of Revixia Life Sciences, a wholly-owned subsidiary developing Salvinorin A (SalA) to treat a variety of mental health disorders. 12 August 2021
The US Food and Drug Administration (FDA) has issued a new approval for the combination of Merck & Co’s anti-PD-1 therapy, Keytruda (pembrolizumab) and Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. 12 August 2021
The US Food and Drug Administration (FDA) has recently lifted a clinical hold on the spinal muscular atrophy (SMA) drug OAV-101, an intrathecal (IT) formulation of Zolgensma (onasemnogene abeparvovec). 11 August 2021
UK clinical-stage biotech PureTech Health today announced that Imbrium Therapeutics, a subsidiary of Purdue Pharma, has exercised a license option under the companies’ R&A collaboration agreement to develop PureTech’s LYT-503/IMB-150 (formerly designated as ALV-107), a non-opioid therapeutic candidate being developed for interstitial cystitis/bladder pain syndrome (IC/BPS). 11 August 2021
Yet another public listing via special purpose acquisition company (SPAC) demonstrates the growing popularity of the approach, as an alternative to the traditional initial public offering. 11 August 2021
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. 11 August 2021
In a further move to increase its COVID-19 and other vaccines production capacity, US messenger RNA (mRNA) therapeutics and vaccines company Moderna on Tuesday announced a Memorandum of Understanding (MoU) with the government of Canada to build a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada including access to Moderna’s mRNA development engine. 11 August 2021
The Parkinson’s disease (PD) market is expected to almost triple in sales in the seven major markets (7MM: The USA, France, Germany, Spain, Italy, the UK, and Japan) by 2029, rising from $4 billion in 2021 to $11.5 billion in 2029 at an impressive 12.6% compound annual growth rate (CAGR). 11 August 2021
US biotech Seagen and Chinese biopharma RemeGen have announced that the two companies have entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin, a novel HER2-targeted antibody-drug conjugate (ADC). 10 August 2021
German biotech BioNTech saw its shares close up 15% at $447.23 on Monday, after it provided an update on its corporate progress and reported financial results for the second quarter ended June 30, 2021. 10 August 2021
Shares of Canada’s Liminal BioSciences shot up nearly 28% to $3.65 by close of trading on Monday, after it announced that, its subsidiary Prometic Biotherapeutics (PBT) has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $105 million. 10 August 2021