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
China-based WuXi Biologics, a contract development and manufacturing organization (CDMO), will focus on overseas development as well as efficiency improvement in 2020, said the firm’s chief executive Chris Chen at a press meeting in Shanghai on Friday, reports The Pharma Letter’s correspondent Wang Fangqing. 31 March 2020
Bristol-Myers Squibb and bluebird bio have submitted for US approval for idecabtagene vicleucel, a CAR-T cell immunotherapy, in multiple myeloma. 31 March 2020
USA-based CNS specialist biotech Axsome Therapeutics fell almost 15% after it revealed that its depression drug candidate AXS-05 had failed to achieve its primary endpoint in a Phase III study. 31 March 2020
US biopharma firm Hoth Therapeutics today said it has entered into a non-binding letter of intent (LOI) with Isoprene Pharmaceuticals to acquire the full licensing rights of VNLG-152 novel retinamides (retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases. 30 March 2020
Jiangsu Alphamab Biopharmaceuticals has established strategic partnership with Simcere and 3D Medicines to advance the development and commercialization of a checkpoint inhibitor for programmed cell death ligand-1 (PD-L1), for oncology indications in mainland China. 30 March 2020
After winning Priority Review from the US regulator in December 2019, Imfinzi (durvalumab) has now been approved as a first-line option for people with extensive-stage small cell lung cancer (ES-SCLC). 30 March 2020
Numab has expanded its relationship with Japan’s Ono Pharmaceutical by executing another research and option agreement to discover and develop a multi-specific antibody drug candidate for the treatment of various cancers. 30 March 2020
Swiss pharma giant Novartis recently announced new anticipated long-term positive data for its one-time infusion gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), which is set to help the drug generate global sales of $2.5 billion by 2025 and lead the spinal muscular atrophy (SMA) market, says analyst. 30 March 2020
More details of Sanofi and Regeneron’s hotly-anticipated Phase II/III Kevzara (sarilumab) program targeting COVID-19 symptoms have been announced. 30 March 2020
Novartis has announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class investigational treatment for hyperlipidemia in adults. 30 March 2020
Japan’s JCR Pharmaceuticals has reached an agreement to acquire ArmaGen, a privately held US biopharmaceutical company, along with all its assets. 27 March 2020
Sanofi Pasteur, the vaccines global business unit of French pharma major Sanofi (Euronext: SAN), and Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, will collaborate to develop a novel mRNA vaccine for COVID-19. 27 March 2020
Oxford University biotech spinout Evox Therapeutics has entered into a rare disease-focused partnership with Japan’s largest drugmaker Takeda Pharmaceutical. 27 March 2020
Bristol-Myers Squibb has received US approval for Zeposia (ozanimod) for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 26 March 2020
The New England Journal of Medicine (NEJM) has published results from BELIEVE, the pivotal Phase III study evaluating the safety and efficacy of Reblozyl (luspatercept-aamt) for the treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions. 26 March 2020
US biotech Alector and Chinese company Innovent Biologics have signed a regional licensing agreement to develop and commercialize AL008 for oncology indications in China. 26 March 2020
USA-based biotech Xencor has entered into a technology license agreement with Vir Biotechnology, in which Vir will have non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. 26 March 2020
US biotech Gilead Sciences said on Wednesday that it has submitted a request to the US Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. 26 March 2020