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
Adam Keeney has been appointed president and chief executive of NodThera, a biotech focused on the discovery and development of NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation. 24 September 2018
A High Court case win by 12 National Health Service (NHS) Clinical Commissioning Groups (CCGs) in favor of prescribing the significantly cheaper anti-vascular endothelial growth factor (anti-VEGF), Avastin (bevacizumab), over Novartis’ (NOVN: VX) and Bayer’s (BAYN: DE) licensed anti-VEGF eye drugs has import implications, says analyst. 24 September 2018
US biotech Amarin today announced positive top-line results from the Vascepa (icosapent ethyl) cardiovascular (CV) outcomes trial, REDUCE-IT, a global study of 8,179 statin-treated adults with elevated CV risk. 24 September 2018
With CAR-T therapies closer than ever to delivering on their promise but still facing significant obstacles, Eva Marchese and Cécile Matthews from Charles River Associates provide an Expert View on the topic. 24 September 2018
After raising a bumper $96 million through its Nasdaq listing last week, Y-mAbs Therapeutics continued to gain value in its first day of trading, rising 50% to $24 per share. 24 September 2018
Swiss pharma giant Novartis on Sunday announced a new data analysis showing that retinal fluid was detected less often in patients treated with brolucizumab (RTH258) 6mg versus aflibercept over four visits between weeks 36 to 48. Retinal fluid is a key marker of disease activity in neovascular age-related macular degeneration (nAMD). 24 September 2018
When Novartis’ Kymriah (tisagenlecleucel) was made available to a small group of young patients in an agreement with NHS England less than a month ago, the decision came just 10 days after the drug was approved in Europe. 23 September 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its September 2018 meeting recommended 13 medicines for approval, including three orphan medicines, with the latter being the following. 21 September 2018
San Franciscan microbial genomics specialist uBiome has raised $83 million in a series C financing round directed at funding an expansion into therapeutics. 21 September 2018
South Korean drugmaker Celltrion has signed an ‘incubation’ agreement with Emory University in Atlanta, USA, to support the research and development of new drug candidates for atherosclerosis. 20 September 2018
A few short months after Merck & Co won its first Chinese approval for flagship immuno-oncology product Keytruda (pembrolizumab), the firm has reportedly agreed a price reduction plan that will enable patients to gain access for around half the US list price. 20 September 2018
Following US approval last month, soon-to-be Takeda Pharmaceutical acquisition Shire has now also been granted authorization in Canada for Takhzyro (lanadelumab), as a treatment for hereditary angioedema (HAE). 20 September 2018
A possible $1 billion initial public offering on the Hong Kong Stock Exchange could give the lie to rumors that the spate of bullish biotech listings in China is about to end. 20 September 2018
Although Novartis’ CAR-T therapy Kymriah (tisagenlecleucel-T) was accepted onto the UK’s Cancer Drugs Fund (CDF) for children with a type of leukemia, adults with diffuse large B-cell lymphoma (DLBCL) have not yet been afforded the same treatment. 19 September 2018
Two tech clusters in Paris are lending their support to the Hu-PreciMED project (Human Precision MEDicine), designed to bolster the precision medicine industry in France. 19 September 2018
Having only in July announced an agreement with an unnamed US biopharma company for its hRPC retinal stem cell technology and therapeutic programs, shares of UK cell-based therapies company ReNeuron plunged nearly 20% to 65.00 pence by early afternoon today, when it revealed that the American firm has pulled out of the deal. 19 September 2018
US biotech firm Viking Therapeutics shares rocketed 140% in pre-market trading on Tuesday, hitting an all time high of $24, after the company reported positive results in a mid-stage trial of a treatment for non-alcoholic fatty liver disease (NAFLD). 19 September 2018
Netherlands-based Pharming Group saw its share plunge 29.05% to 0.69 euros by mid-morning today, after it revealed a further setback in its attempt to widen the use of its leading drug. 19 September 2018
Japanese drugmaker Ono Pharmaceutical and US biotech Fate Therapeutics have signed a deal to develop and commercialize two off-the-shelf CAR-T therapies for cancer. 18 September 2018