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
Genentech announced late Wednesday that the US Food and Drug Administration has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have had flu symptoms for no more than 48 hours. 25 October 2018
In its initial public offering (IPO) on the Hong Kong Stock Exchange, China’s Innovent Biologics has reportedly sold around $421 million worth of shares priced at the top end of estimates, at about $1.78 per share. 25 October 2018
US companies Dicerna Pharmaceuticals and Alexion Pharmaceuticals today announced a research collaboration and license agreement to discover and develop novel GalXC RNAi therapeutics for the treatment of complement-mediated diseases. 24 October 2018
The UK Secretary of State for Health and Social Care has announced that the PCSK9 inhibitor class has been selected as a treatment that needs to see a rapid increase in uptake to ensure that patients, and the National Health Service (NHS), get the benefits of this class of medicines. 24 October 2018
Beijing’s CANbridge Pharmaceutical and Shanghai’s WuXi Biologics have entered into a strategic partnership to develop and sell rare disease therapies. 24 October 2018
Canadian drugmaker Zymeworks closed Tuesday’s trading more than 2% up after announcing that it had signed a deal with the privately-held Danish dermatology specialist, LEO Pharma. 24 October 2018
Campaign group Médecins Sans Frontières (MSF) has called on Johnson & Johnson to slash the price of its tuberculosis (TB) drug Sirturo (bedaquiline) by 50%. 24 October 2018
US biotech Celgene has appointed Dr Alise Reicin as president, global clinical development, reporting to Mark Alles, chairman and chief executive, effective November 1, 2018. 24 October 2018
US biotech major Biogen today posted strong third-quarter 2018 financials, showing that total revenues of $3.4 billion increased 12% versus the like prior-year period, just beating analysts’ estimates of $3.33 billion. 23 October 2018
Simon Jose, a Brit who has spent more than 30 years in pharma, is to become chief commercial officer of Idorsia, the research-based spin-out from Actelion following the latter’s acquisition by Johnson & Johnson. 23 October 2018
French biotech firm Enterome has entered into a global licensing, co-development and co-promotion agreement with Japan’s Takeda Pharmaceutical. 23 October 2018
The race to grab market share in the migraine space is becoming one of the most keenly-watched in pharma – and Aimovig (erenumab) is forecast to be the top-selling drug by 2026. 23 October 2018
AstraZeneca and its global biologics research and development arm MedImmune are expanding their presence in the competitive immuno-oncology (I-O) with a new deal and equity stake in a French biotech firm. 23 October 2018
Shares in Bristol-Myers Squibb fell 6% on Monday, after the firm made public regulatory setbacks in the USA and Europe related to its Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination therapy. 23 October 2018
UK-headquartered Hemogenyx is collaborating with US biopharma Orgenesis to rapidly develop and bring to market its human postnatal hemogenic endothelial cell technology (Hu-PHEC). 22 October 2018
Bristol-Myers Squibb could now have to wait till May 2019 to hear if the US Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for the use of Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in metastatic first-line non-small cell lung cancer. 22 October 2018
The US Food and Drug Administration has granted Rare Pediatric Disease (RPD) designation to lonafarnib in the treatment of both Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies. 22 October 2018
Merck & Co has presented striking data in head and neck cancer which, in line with the theme of this year’s ESMO congress, demonstrate the growing breadth of indications in which immune modulation may be an effective strategy. 22 October 2018