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
Shares of vTv Therapeutics (Nasdaq:VTVT) rocketed as much as 46% to $2.43 in early trading, and were still up more than 30% to $2.17 by mid-morning today after it announced an exclusive licensing agreement with Newsoara Biopharma. 31 May 2018
Canadian drugmaker Acerus Pharmaceuticals will take forward Pharmanest's gynecological pain relief drug SHACT (short acting lidocaine product) in its home country. 31 May 2018
Syndax Pharmaceuticals and Nektar Therapeutics have agreed a non-exclusive clinical collaboration to test NKTR-214 in combination with Syndax’s entinostat. 31 May 2018
The US Food and Drug Administration (FDA) announced on Wednesday the expansion of Pfizer's Xeljanz (tofacitinib) label to encompass adults with ulcerative colitis. 30 May 2018
Zai Lab and privately-owned UK company Crescendo Biologics have announced an exclusive, worldwide licensing agreement under which the Chinese biopharma will develop, commercialize, and manufacture a topical, innovative antibody V domain therapeutic for potential application in inflammatory indications. 30 May 2018
Despite an inexorable rise in the global population of type 2 diabetics, linked to changing lifestyle choices, markets for insulin are becoming ever more competitive. 30 May 2018
Following a favorable opinion from the European Medicines Agency advisory committee in March this year, the European Commission (EC) has now approved the first poly ADP-ribose polymerase (PARP) inhibitor licensed for ovarian cancer in the European Union. 30 May 2018
The chances of Fasenra (benralizumab) adding to its existing approval as an add-on treatment for severe eosinophilic asthma by proving its efficacy in chronic obstructive pulmonary disease (COPD) now look slim. 30 May 2018
The China State Drug Administration (CSDA) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 30 May 2018
News of positive regulatory development for its larotrectinib – which has been called the biotech firm’s ‘golden goose’ – sent shares of Loxo Oncology up 2.12% to $169.24 in morning trading. 29 May 2018
France’s AB Science will not fight the latest negative recommendation that it has received from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) for masitinib. 29 May 2018
The outcome of an upcoming Phase II trial could provide a clue as to whether French biotech firm Valneva will realize its aim of becoming the leading commercial stage vaccine company. 29 May 2018
Belgian drugmaker UCB has entered the field of immuno-dermatology with the US Food and Drug Administration’s (FDA) approval of a label expansion for the blockbuster inflammatory diseases drug Cimzia (certolizumab pegol). 29 May 2018
Danish biotech Genmab saw its share plunge as much as 25% to 880.80 Danish kroner on Monday, after its partner Janssen decided to terminate a study using its blockbuster cancer drug Darzalex (daratumumab). 29 May 2018
In a second deal expansion announced last week, Cambridge, UK-based Bicycle Therapeutics revealed the receipt of a milestone payment in connection with the initiation of a Phase I clinical study evaluating THR-149, under its ophthalmology alliance with Belgium’s ThromboGenics. 29 May 2018
The USA’s Karyopharm Therapeutics and China’s biotech start-up Antengene Corp have entered into an exclusive license agreement for the development and commercialization of four of Karyopharm's novel, oral drug candidates. 25 May 2018
Cambridge, UK-based biotech firm Bicycle Therapeutics is to expand its collaboration with AstraZeneca, to include additional targets in respiratory and cardio-metabolic diseases. 25 May 2018