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
Finnish biotech Rokote Laboratories has partnered with 3PBioVian to produce the drug substance and product for its intranasal COVID-19 vaccine, FINCoVac 2.1, ahead of Phase I trials. 29 August 2024
Marseille-based ImCheck Therapeutics has received 20.2 million euros ($22.4 million) in non-dilutive funding as part of the i-Démo call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government. 29 August 2024
Roche subsidiary Genentech will lay off nearly 100 employees at its San Francisco site, according to a California Worker Adjustment and Retraining Notification (WARN) notice. 29 August 2024
US firm Lindy Biosciences has announced a multitarget exclusive global licensing agreement and strategic collaboration with the US subsidiary of Swiss pharma giant Novartis. 29 August 2024
German pharma major Bayer today announced it has entered into a collaboration and license agreement with US biotech start-up NextRNA Therapeutics to develop small molecule therapeutics targeting lncRNAs in oncology. 28 August 2024
Chinese biotech DualityBio has shown that it means business in a filing to the Hong Kong stock exchange that reveals its plans for an initial public offering (IPO). 28 August 2024
Novartis today announced positive top-line results from twice-yearly Leqvio (inclisiran) in the Phase III V-MONO study, which met its primary endpoints. 28 August 2024
Chugai Pharmaceutical has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an additional indication for Alecensa (alectinib). 28 August 2024
The European Commission (EC) has approved a Type II extension of indication for Johnson & Johnson’s Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed). 27 August 2024
The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche. 27 August 2024
US privately-held biotech Navigator Medicines has announced a Series A financing alongside the in-licensing of NAV-240 and an OX40L-targeted portfolio from IMBiologics Corp. 27 August 2024
The US Food and Drug Administration on Monday revised the Emergency Use Authorization (EUA) for Invivyd’s Pemgarda (pemivibart) to limit its use to when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%. 27 August 2024
US biotech Regeneron Pharmaceuticals yesterday announced that the European Commission (EC) has approved Ordspono (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. 27 August 2024
India's biotechnology sector has seen remarkable growth, expanding 13-fold over the past decade, from $10 billion in 2014 to more than $130 billion in 2024. 26 August 2024
Bicara Therapeutics, a Phase I US biotech developing a bifunctional antibody to target solid tumors, on Thursday filed with the Securities and Exchange Commission (SEC) to raise up to $200 million in an initial public offering. 24 August 2024
Moderna today received approval from the European Commission (EC) for its mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. 23 August 2024