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
There was more good news for Swiss company Roche on Wednesday, as the US regulator’s scientific panel voted to maintain another Accelerated Approval for Tecentriq (atezolizumab). 29 April 2021
Going to the global market for Chinese pharmas is a complicated process that requires a well devised strategy that often entails differentiation and partnerships, said speakers at the DJSeedin innovation partnering conference held last week in Shanghai. 28 April 2021
Spanish plasma specialist Grifols is to establish a global R&D hub in Andorra, focused on the human immune system and the potential for novel immune therapies. 28 April 2021
While the US regulator has been taking a hard look at Accelerated Approvals which lack confirmatory data, Tecentriq (atezolizumab) appears set to retain its approval in breast cancer at least. 28 April 2021
Swedish biotech Calliditas Therapeutics says that the US Food and Drug Administration has accepted its New Drug Application for Nefecon (budesonide) for priority review as a treatment for IgA nephropathy (IgAN). 28 April 2021
A hugely disappointing first quarter for Amgen saw revenues slide to $5.9 billion, down from $6.2 billion and below most analysts’ expectations. 28 April 2021
Nearly 18 months on from Enzyvant’s receipt of a Complete Response Letter (CRL) relating to its initial Biologics Licensing Application (BLA) for RVT-802, the company has filed an amended submission. 28 April 2021
The US Food and Drug Administration has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788), Japan’s largest drugmaker Takeda Pharmaceutical announced today. 28 April 2021
Privately-held Pyxis Oncology has announced the targets of its three antibody-drug conjugate (ADC) candidates along with additional details and preclinical data supporting the potential of its ADC platform. 27 April 2021
USA-based LogicBio Therapeutics has announced a strategic collaboration and option agreement with China-based CANbridge Pharmaceuticals leveraging LogicBio’s gene editing and gene delivery platforms. 27 April 2021
As anticipated, the European Union launched a legal action against AstraZeneca in the Belgian courts on Friday, alleging the British firm failed to live up to its contractual obligations on vaccine supplies. 27 April 2021
Responding to the rapid increase in COVID-19 cases in India, US biotech Gilead Sciences says it is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up production of remdesivir. 27 April 2021
Samsung Biologics and US biotech TG Therapeutics have announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. 27 April 2021
GlaxoSmithKline has gained European Commission conditional marketing authorization for Jemperli (dostarlimab), a programmed death receptor-1 (PD-1)-blocking antibody, for use in women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. 26 April 2021
Krakow, Poland-based oncology specialist Ryvu Therapeutics today announced that Vatnak Vat-Ho has joined the company as chief business officer. 26 April 2021
Health Canada has begun the review of the rolling submission for Medicago’s plant-derived COVID-19 vaccine candidate in combination with GlaxoSmithKline’s pandemic adjuvant. 26 April 2021
US clinical-stage biotech Pieris Pharmaceuticals’ shares edged up 4% to $2.37 in early trading today after it announced an exclusive product license agreement with Boston Pharmaceuticals to develop PRS-342, a 4-1BB/GPC3 pre-clinical immuno-oncology Anticalin-antibody bispecific fusion protein. 26 April 2021
The US Food and Drug Administration (FDA) has removed the clinical hold on uniQure’s hemophilia B gene therapy program after determining that Dutch gene therapy company had satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial of AMT-061. 26 April 2021
Large-scale research undertaken by the University of Oxford, published as two pre-prints, shows a significant fall in COVID-19 infections after a single vaccine dose. 26 April 2021
US biotech Inovio Pharmaceuticals saw its shares crash nearly 25% to $6.85 by close of trading on Friday, after it revealed that the US government had pulled the plug on funding for its Phase III trial of COVID-19 vaccine candidate INO-4800. 26 April 2021