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
German clinical-stage biopharma company Affimed has announced a plan to focus its research and development investments on advancing on-going and previously announced clinical trials for its innate cell engager candidates, AFM13 and AFM24. 23 May 2019
Oncology heavyweight Robin Taylor has made the switch from VP level at big pharma to chief commercial officer at an emerging, multi-product biotech company. 23 May 2019
Tokyo-based Chugai Pharmaceutical is to close two research centers and transfer their functions to a new facility that it will build in Yokohama. 23 May 2019
ElevateBio, a newly-launched cell and gene therapy incubator, has announced that AlloVir, formerly known as ViraCyte, has joined its fledgling portfolio. 23 May 2019
It’s ASCO time again. The annual meeting of the American Society of Clinical Oncology (ASCO) is now almost upon us, with the event due to start in Chicago on Friday, May 31. 22 May 2019
Less than a year after Japanese drugmaker Takeda’s Entyvio was approved in the company’s home country to treat ulcerative colitis, a further indication for the drug has been authorized. 22 May 2019
Amgen today offered to acquire all the shares of its research partner, Copenhagen, Denmark-headquartered Nuevolution, for a consideration of 32.50 Swedish kronor in cash per share. 22 May 2019
Russia’s first original drug for the treatment of severe psoriasis has been registered by one of the leading local drugmakers Biocad, according to the company. 22 May 2019
US pharma giant Merck & Co announced yesterday that it will acquire privately held Peloton Therapeutics in a deal which could exceed $2.2 billion, and which would bring the company a late-stage kidney cancer candidate. 22 May 2019
Merck & Co’s Keytruda (pembrolizumab) is the world’s top-selling immuno-oncology drug with approvals across 12 different cancer types, but even it cannot help in the metastatic triple-negative breast cancer (TNBC) setting. 21 May 2019
At the ATS International Conference, the New Jersey, USA-based rare disease specialist Insmedmhas presented new data from the ongoing Phase III CONVERT study. 21 May 2019
German biotech Evotec has bought Seattle, USA-based Just Biotherapeutics for up to $90 million, including performance-based payments over the next three years. The initial consideration upon closing is $ 60 million. 21 May 2019
STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, and Dizal Pharmaceutical, a biotechnology company, today announced a strategic partnership. 21 May 2019
Ocular Therapeutix (Nasdaq: OCUL) late Monday announced top-line results from the first pivotal Phase III clinical trial of OTX-TP, which failed to meet primary endpoint but achieved statistically-significant reduction of intraocular pressure versus placebo. 21 May 2019
As China is becoming an incubator for an increasing number of innovative biotech startups, multinationals are actively seeking potential novel assets to enrich their global pipelines, said speakers at the ChinaBio forum held recently in Shanghai, reports The Pharma Letter’s local correspondent Wang Fangqing. 20 May 2019
Actelion, one of the Janssen companies of Johnson & Johnson, presented new data on its pulmonary drug yesterday at the American Thoracic Society (ATS) conference 2019. 20 May 2019
Belgian biopharma UCB started the week by announcing that the US Food and Drug Administration (FDA) approval of Nayzilam (midazolam) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy. 20 May 2019
Actelion, the Swiss biotech firm acquired by Johnson & Johnson’s Janssen unit in a $30 billion deal in 2017, has entered into a collaboration with UK-based Owlstone Medical. 20 May 2019