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
Positive Phase III results for Shanghai’s Junshi Biosciences will lift the company’s prospects in the competitive market for lung cancer therapies. 20 January 2023
Patient groups have expressed disappointment that USA-based drugmaker Eli Lilly has not been granted an Accelerated Approval for its Alzheimer’s disease candidate, donanemab. 20 January 2023
Cambridge, USA-based genome editing company Editas Medicine has entered into a definitive agreement with US biotech Shoreline Biosciences (Shoreline) to license Editas Medicine’s proprietary SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies and acquire Editas Medicine’s pre-clinical gene edited induced pluripotent stem cell (iPSC) derived natural killer cell (iNK) programs and related manufacturing technologies. 20 January 2023
On Thursday, the US Food and Drug Administration (FDA) granted accelerated approval for Seagen’s Tukysa (tucatinib) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. 20 January 2023
After a difficult year for investment, look for the biotech industry to engage in creative dealmaking in the market, leading to faster innovation in the lab, Protagonist Therapeutics CEO Dinesh Patel writes in Bio.News. 20 January 2023
Following on from European Commission (EC) approvals in November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Brukinsa (zanubrutinib) in Great Britain. 19 January 2023
The UK health technology assessor, the National Institute for Health and Care Excellence (NICE) has issued a Final Evaluation Document recommending Translarna (ataluren) for reimbursement and use across the National Health Service (NHS) in England and Wales in the treatment of Duchenne muscular dystrophy (DMD). 19 January 2023
RNAi specialist Alnylam Therapeutics’ Amvuttra (vutrisiran) has been recommended for use on the National Health Service (NHS) in England as an option for treating hereditary transthyretin-related (ATTRv) amyloidosis. 19 January 2023
The pivotal Phase III IMbrave050 study, which investigated PD-L1 inhibitor Tecentriq (atezolizumab) plus anti-VEGF antibody Avastin (bevacizumab) in people with early-stage hepatocellular carcinoma or HCC at high risk of recurrence following surgery, met primary endpoint of recurrence-free survival at the prespecified interim analysis, according to Swiss pharma giant Roche. 19 January 2023
Sino-American biotech BeiGene saw its shares rise 3.5% to 160.51 renminbi, after it announced that the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include four new indications for its PD-1 inhibitor tislelizumab. 19 January 2023
Neurodegenerative diseases specialist APRINOIA Therapeutics has announced a merger with Ross Acquisition Corp II, a special purpose acquisition company (SPAC) founded by former US Secretary of Commerce Wilbur Ross. 18 January 2023
Negotiations with the China National Healthcare Security Administration (NHSA) have borne fruit for Hutchmed and its product Orpathys (savolitinib). 18 January 2023
EVOQ Therapeutics and fellow USA-based Amgen today announced they are advancing their ongoing license and collaboration agreement for the discovery and development of novel therapeutics including the receipt of a milestone payment and expansion of the scope of collaboration to include a total of three indications in autoimmune disorders. 18 January 2023
SFJ Pharmaceuticals is claiming victory in its legal dispute with cardiopulmonary diseases focussed US firm PhaseBio Pharmaceuticals regarding a blood thinner reversal agent, announcing the closing of the sale and transfer of assets related to bentracimab from PhaseBio to SFJ. 18 January 2023
Phase III success for Moderna will help the company catch up with rivals GSK and Pfizer in the upcoming battle to treat respiratory syncytial virus (RSV) infections. 18 January 2023
Privately-held US cancer drug biotech Elicio Therapeutics has entered into a definitive merger agreement with Angion Biomedica under which Elicio will merge with a wholly-owned subsidiary of Angion in an all-stock transaction. 18 January 2023
Spanish plasma-derived medicines specialist Grifols has announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding obtained positive top-line results from a Phase IIIb clinical trial in pediatric patients. 17 January 2023
Dianthus Therapeutics, a biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, today announced the appointment of Susan Kalled, as chief scientific officer. 17 January 2023