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 (FDA) has placed a clinical hold on the FORTIS PhI/II trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants. 27 June 2022
Family-owned Italian drugmaker Menarini Group and USA-based Radius Health have announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer. 27 June 2022
Novartis presented new data at the European Academy of Neurology (EAN) Congress demonstrating treatment with Kesimpta (ofatumumab) significantly increased the odds of achieving no evidence of disease activity (NEDA-3, defined as having no MS relapses, no disability worsening and no MRI activity) versus switching from teriflunomide in people living with relapsing multiple sclerosis (RMS). 27 June 2022
Leading PARP blocker Lynparza (olaparib) looks set to secure a new marketing authorization in Europe, after a positive scientific opinion. 27 June 2022
Canadian clinical-stage biotech Zymeworks today announced that it is strengthening its senior leadership team with the appointment of Paul Moore, as chief scientific officer, reporting directly to the chief executive Officer. 27 June 2022
French drugmaker Ipsen this morning announced it is to acquire US epigenetic therapies firm Epizyme in order to expand its oncology portfolio. 27 June 2022
Italy’s privately-held Italfarmaco Group has released positive top-line data from its completed Phase III EPIDYS trial with givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor, in boys with Duchenne muscular dystrophy (DMD). 27 June 2022
Another win for the coronavirus vaccine developed by Pfizer and BioNTech will help ensure the products continued success in a world where Omicron-type variants now dominate. 27 June 2022
The European Medicines Agency’s human medicines committee (CHMP) recommended seven novel medicines for approval at its June 2022 meeting, including the first gene therapy for hemophilia A. 24 June 2022
Belgian drugmaker UCB was trading 3% lower on Friday afternoon as markets digests its acceptance of the need to revise its 2022 financial guidance to a more pessimistic outlook. 24 June 2022
Merck & Co today announced that the European Commission (EC) has approved Keytruda (pembrolizumab) Merck’s mega-blockbuster anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. 24 June 2022
Shares of Sarepta Therapeutics dropped almost 9% to $65.39 in after-hours trading yesterday, after the company said the US Food and Drug Administration put a clinical hold on SRP-5051 (vesleteplirsen), a treatment for patients with Duchenne muscular dystrophy (DMD). 24 June 2022
Shares of Dutch gene therapy company uniQure rose 26% to $19.15 on Thursday as it announced safety and biomarker data from 10 patients enrolled in the low-dose cohort of the ongoing Phase I/II clinical trial of AMT-130 for the treatment of Huntington’s disease (HD). 24 June 2022
Shares of German biotech BioNTech closed up almost 7% at $132.29 yesterday, after the company – which burst on the scene with its hugely successful COVID-19 vaccine Comirnaty – announced a important development for its wider portfolio. 24 June 2022
The European Medicines Agency (EMA) has recommended granting a marketing authorization for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, developed by developed by French company Valneva, for use in the primary vaccination of people from 18 to 50 years of age. 23 June 2022
Swiss pharma giant Novartis has received an Accelerated Approval in the USA for its combination BRAF/MEK inhibitor therapy, for certain biomarker-defined tumors. 23 June 2022
Swiss pharma giant Novartis today announced that the European Commission (EC) approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. 23 June 2022
invoX Pharma, a wholly-owned subsidiary of Sino Biopharmaceutical that is focused on research and development (R&D) and business development activities outside of China, today announced that it has entered into a definitive agreement to acquire all of the issued and outstanding shares of F-star Therapeutics’ common stock. 23 June 2022
US biotech Moderna announced new clinical data on its bivalent (Omicron) COVID-19 booster candidate, mRNA-1273.214, leading the company’s share price to close 5% higher on Wednesday. 23 June 2022