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
US biotech Arvinas on Thursday signed its most lucrative collaboration agreement, sending the firm’s shares up 9% to $84.51 by close of trading. 23 July 2021
A California federal jury hit Novartis with a $177.8 million verdict Thursday for selling a skin cancer drug that infringes two patents owned by Daiichi Sankyo US subsidiary Plexxikon, rejecting Novartis' arguments that the patents are invalid and awarding the entire sum the plaintiff sought. 23 July 2021
Dutch biotech firm Synaffix today announced the signing of a license and option agreement with ProfoundBio, an emerging oncology biotherapeutics company headquartered in China. 22 July 2021
The USA continues to wrestle with the legacy of an epidemic of opioid abuse, believed to have cost the lives of over half a million people through overdose. In this episode, we talk to Mesoblast CEO Silviu Itescu about the a stem cell-based alternative currently subject to advanced regulatory discussions. 22 July 2021
The US Food and Drug Administration approved Keytruda (pembrolizumab) from Merck & Co in combination with Japanese drugmaker Eisai’s Lenvima (lenvatinib) for patients with advanced endometrial carcinoma' 22 July 2021
Pfizer and BioNTech have agreed for The Biovac Institute, a South African biopharmaceutical company, to manufacture their COVID-19 vaccine for distribution within Africa. 22 July 2021
Swiss pharma giant Roche posted financial results this morning showing that first-half 2021 net profit rose 2% to 8.22 billion Swiss francs ($8.96 billion) and sales increased by 8% at constant exchange rates to a better-than expected 30.71 billion francs. 22 July 2021
Swedish biotech Calliditas Therapeutics and Germany’s STADA Arzneimittel have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states, Switzerland and the UK. 22 July 2021
US clinical-stage biotech Magenta Therapeutics’ shares closed down more than 9% at $8.07 on Wednesday, after the company revealed it has received a clinical hold letter from the US Food and Drug Administration related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase I/II clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). 22 July 2021
The international medical humanitarian organization Médecins Sans Frontières (MSF) says that trial results in HIV-related cryptococcal meningitis with a Gilead Sciences drug further compel the company to improve access. 21 July 2021
Following a positive recommendation from the European Medicines Agency’s human medicines committee (CHMP) in May, the European Commission (EC) has granted marketing authorization of Skysona (elivaldogene autotemcel, Lenti-D), developed by US biotech bluebird bio. 21 July 2021
Venclexta (venetoclax), in combination with azacytidine, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International prognostic scoring system (IPSS-R). 21 July 2021
The US Food & Drug Administration approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC), developed by Boston, USA-based Albireo Pharma. 21 July 2021
Japan’s Eisai has outlined details of 11 presentations slated for the upcoming annual Alzheimer’s Association International Conference (AAIC), taking place from 26 July in Colorado, USA. 21 July 2021
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics has inked a strategic partnership agreement with Seattle, USA-based biotech Kineta. 20 July 2021
The European Medicines Agency’s human medicines committee (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. 20 July 2021