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
Privately-held Chinese biopharma CStone Pharmaceuticals has paid $40 million upfront for a license to develop and commercialize three drugs from US biotech Blueprint Medicines Corporation in China, either as monotherapies or combination therapies. 5 June 2018
The US Food and Drug Administration has granted approval for a new indication for Eli Lilly’s Alimta (pemetrexed for injection) in combination with carboplatin and Keytruda (pembrolizumab) for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. 5 June 2018
The pressure for companies with cancer assets to come to the party at the American Society of Clinical Oncology (ASCO) Annual Meeting with impressive data presentations is real – and there is a feeling that those that do not steal the show have to present a picture of progress just to keep pace. 5 June 2018
A combination of Imbruvica (ibrutinib) and Rituxan/MabThera (Rituxan) has shown greater efficacy than the latter drug alone in patients with Waldenström’s macroglobulinemia (WM), a rare and incurable form of non-Hodgkin’s lymphoma (NHL). 5 June 2018
The USA’s Institute for Clinical and Economic Review has released an Evidence Report assessing the comparative clinical effectiveness and value of three calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine attacks. 5 June 2018
Presenting at the annual meeting of the American Society of Clinical Oncology (ASCO), France’s Sanofi and USA-based Regeneron Pharmaceuticals have released new positive data for their oncology candidate cemiplimab. 5 June 2018
Shares in US biotech Nektar Therapeutics were down by as much as 40% after the morning's trading on Monday as markets mulled over news on its development of NKTR-214. 4 June 2018
There are plenty of immuno-oncology (I-O) drugs in development and Bristol-Myers Squibb’s Opdivo (nivolumab) is the current best-seller of those on the market, but Merck & Co has proven beyond doubt that it undoubtedly has the hottest asset in the space at the present time. 4 June 2018
Swiss pharma giant Roche has announced its decision to stop the development of olesoxime, a neuroprotective drug that showed benefit in spinal muscular atrophy (SMA), via a statement to TreatSMA (Treat Spinal Muscular Atrophy, which the latter has re-released to the wider community. 4 June 2018
Early data from two clinical trials show reduced survival with Keytruda (pembrolizumab) and Tecentriq (atezolizumab) when used as first-line treatments for urothelial cancer (cancer of the bladder and urinary tract) in patients with low levels of a protein called PD-L1, the European Medicines Agency stated on Friday. 4 June 2018
The US Food and Drug Administration has lifted a partial clinical hold placed on CA209-602 (CheckMate-602), a randomized, open-label Phase III study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (MM). 4 June 2018
The news of US approval for Olumiant (baricitinib), while clearly welcomed, was not as good as it could have been for the drug’s developers, Eli Lilly and Incyte, which have already faced long delays, and it came with some caveats. 2 June 2018
Swiss pharma giant Roche saw its shares close up 2.32% at 215.95 euros on Friday after it announced that its combination treatment for breast cancer had received approval in Europe. 2 June 2018
South Korean company Celltrion Healthcare is already proving itself to be one of the leaders globally in biosimilar drug development, but a new deal is a sign of its potential as a developer of new biopharmaceuticals. 1 June 2018
French biotech Adocia and Tonghua Dongbao Pharmaceuticals announced today an expansion of their strategic alliance with the latter to manufacture and supply insulin lispro and insulin glargine APIs to Adocia worldwide, excluding China. 1 June 2018
The Johnson & Johnson unit Janssen appears to have one of the hottest prospects in neuroscience on its hands in the shape of esketamine, but that it not to say it is proving immune to encountering the challenges of this tricky therapy area. 1 June 2018
Zug, Switzerland-based oncology specialist Tesaro has received a positive reimbursement decision from the UK’s health technology assessor for Zejula (niraparib). 31 May 2018
In what is becoming a growing trend, another big pharma senior executive has left to take on a position with a growing biotechnology company, this time to the advantage of Cambridge, Massachusetts-based Axcella Health and loss for Swiss giant Novartis. 31 May 2018