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 approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, from bluebird bio the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. 18 August 2022
Blueprint Medicines has announced positive top-line results from the registrational Part 2 of the PIONEER clinical trial of Ayvakit (avapritinib). 17 August 2022
UK pharma major GSK announced today that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for momelotinib for the potential treatment of myelofibrosis patients. 17 August 2022
The contract development and manufacturing organization (CDMO) AGC Biologics and RoosterBio, a supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media and bioprocess development services, have announced a strategic partnership. 17 August 2022
The European Investment Bank (EIB) is providing 22 million euros ($22.4 million; above 100 million polish zlotys) in financing to Ryvu Therapeutics, Poland’s largest biotech firm that is focusing on novel small molecule therapies that address unmet medical needs in oncology. 17 August 2022
Ideaya Biosciences has announced its financials for second-quarter 2022, saying it has a strong balance sheet of ~$324 million cash, cash equivalents and marketable securities as of June 30, 2022, which is anticipated to fund planned operations into 2025. 17 August 2022
US biotech Viridian Therapeutics has commenced an underwritten public offering of $175 million of shares of its common stock and series B preferred stock. 16 August 2022
Big pharma has come knocking at the door of Orna Therapeutics, a biotech launched a few years ago by MIT alumni with the goal of developing a new kind of RNA therapeutic. 16 August 2022
USA and Israel-based-BrainStorm Cell Therapeutics is to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS). 16 August 2022
Deerfield Management is to take a stake in Swiss firm ADC Therapeutics, an antibody-drug conjugate company based in Lausanne, as the company restructures its obligations. 16 August 2022
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab). 16 August 2022
US biotech major Gilead Sciences has entered into an agreement with China’s Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. 16 August 2022
US clinical-stage biotech CinCor Pharma, which is developing its lead clinical candidate, baxdrostat, for the treatment of hypertension and other cardio-renal diseases, yesterday announced the closing of its upsized underwritten public offering consisting of an aggregate of 8,625,000 shares of common stock and pre-funded warrants. 16 August 2022
US biotech major Gilead Sciences’ shares were up 4% at $65.48 in early trading today, as it announced statistically-significant and clinically-meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase III TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. 15 August 2022
US mRNA biotech Moderna edged up less than 1% pre-market this morning, despite announcing the first-ever approval worldwide for its next-generation bivalent COVID-19 vaccine. 15 August 2022
Swiss pharma giant Novartis has announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab, an inhibitor of interleukin-1beta did not meet its primary endpoint of disease-free survival versus placebo. 15 August 2022
Terns Pharmaceuticals saw it shares fly up more than 25% to $3.02 on Friday, after it announced a $65 million underwritten public offering, which is expected to close on August 16, 2022, subject to customary closing conditions. 15 August 2022
Switzerland-headquartered biotech Addex Therapeutics today announced that its collaboration agreement with UK-based Indivior for discovering and developing novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates has been extended until March 31, 2023. 15 August 2022
Investments in research and development continue to pay dividends for British drugmaker AstraZeneca, with the firm’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) passing an important test in breast cancer. 15 August 2022
An arbitrator issued a decision on Friday in a dispute between Japan’s Daiichi Sankyo and the USA’s Seagen, denying all claims made by Seagen. 14 August 2022