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 approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. 18 March 2022
RNAi therapeutics company Alnylam Pharmaceuticals has begun patent infringement proceedings in respect of technologies used to develop two novel coronavirus vaccines. 17 March 2022
France-based biotech OSE Immunotherapeutics’ shares closed up more than 5% at 7.54 euros yesterday, after it announced positive analysis of the long-term immune T cell responses of CoVepiT, its prophylactic vaccine candidate against COVID-19. 17 March 2022
Texas, USA-headquartered T-cell therapeutics company Triumvira Immunologics today announced the completion of an extension of its Series A financing, bringing the total round to approximately $100 million. 17 March 2022
US biopharma Apellis Pharmaceuticals closed 13% higher at the end of Wednesday’s trading after announcing longer-term data from the Phase III DERBY and OAKS studies. 17 March 2022
Further positive results from the OlympiA Phase III trial showed that AstraZeneca and Merck & Co’s Lynparza (olaparib) demonstrated a statistically-significant and clinically meaningful-improvement in overall survival (OS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy. 17 March 2022
Alexion, AstraZeneca’s Rare Disease group, has entered into a settlement agreement with Japan’s Chugai Pharmaceutical resolving all patent disputes between the two companies related to Ultomiris (ravulizumab). 17 March 2022
Shares of 2seventy bio were up almost 10% at $13.40 this morning, after the US immuno-oncology cell therapy company announced it has agreed to sell around13,934,427 shares of its common stock to a select group of institutional and accredited investors in a private placement. 16 March 2022
French pharma major Sanofi and US biotech company Seagen have announced an exclusive collaboration agreement to design, develop, and commercialize antibody-drug conjugates (ADCs) for up to three cancer targets. 16 March 2022
UK-based biopharma Hemogenyx Pharmaceuticals has achieved proof of concept (POC) for its chimeric bait receptor (CBR) platform technology, news that sent its share price up by 9% in Wednesday morning’s trading. 16 March 2022
Krystal Biotech, which is focussed on redosable gene therapies for rare diseases, saw its shares rise as much as 4.6% to $62.61 on Monday, as is said it has reached a binding term sheet with fellow US biotech firm PeriphaGen - and former lab partner - to resolve all claims it copied the latter’s gene therapy technology litigation filed by PeriphaGen on May 20, 2020. 16 March 2022
Metagenomi, a California, USA-based genetic medicines company with a versatile portfolio of next-generation gene editing tools, today announced the appointment of Christine Foster, as chief business officer and Alan Cohen, as chief medical officer and senior vice president of Monogenic Diseases. 15 March 2022
Japanese drugmaker Eisai has backed out of its 50:50 profit sharing deal with US biotech company Biogen on the Alzheimer’s drug Aduhelm (aducanumab). 15 March 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Darzalex (daratumumab) monotherapy for adult patients with relapsed and refractory multiple myeloma that has previously been treated with three therapies, including a proteasome inhibitor and an immunomodulator, and who have demonstrated disease progression on the last therapy. 15 March 2022
Shares of US clinical-stage biotech AnaptysBio fell as much as 13% in after-hours trading Monday, as it announced that top-line data from its Phase II clinical trial of imsidolimab, formerly known as ANB019, for the treatment of moderate-to-severe acne, also known as the ACORN trial, did not demonstrate efficacy over placebo on primary or secondary endpoints. 15 March 2022
Nosopharm, an innovator in the antibiotics space, is partnering with a French national research institute to develop chemical libraries of new bioactive molecules for further consideration. 15 March 2022
US biotech companies Exelixis yesterday announced results from the final analysis of the second primary endpoint of overall survival (OS) from the Phase III COSMIC-312 trial, which evaluated Cabometyx (cabozantinib) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC). 15 March 2022