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
Swiss pharma giant Roche has become the latest large biopharma company to team up with Austrian arenaviral technology firm Hookipa Pharma. 20 October 2022
Data on Incyte’s Opzelura (ruxolitinib) cream from the pivotal Phase III TRuE-V clinical trial program have been published in The New England Journal of Medicine (NEJM). 20 October 2022
While there has been a dearth mega-billion M&A activity in the pharma sector this year, smaller deals are coming through, now with US pharma major AbbVie announcing its second acquisition this year. 20 October 2022
Bristol Myers Squibb has presented data that reinforces the benefits of its immuno-oncology blockbuster Opdivo (nivolumab) in the earlier stages of melanoma. 20 October 2022
An alternative to mRNA-based coronavirus vaccines has received an Emergency Use Authorization in the USA, providing a new option for a first booster dose. 20 October 2022
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. 20 October 2022
US messenger RNA (mRNA) Moderna today announced new clinical data on its bivalent Omicron-containing booster, mRNA-1273.214, demonstrating its superiority of the biotech’s original COVID-19 vaccine Spikevax. 19 October 2022
An exclusive licensing agreement has been reached between Jazz Pharmaceuticals and Zymeworks, granting the former extensive development and commercialization rights to zanidatamab. 19 October 2022
New Jersey, USA-based rare disease drug developer PTC Therapeutics saw its shares close down 11% yesterday and fall a further almost 12% to $43.00 pre-market today, after it revealed it has paused US enrollment in a Phase II study of PTC518 in Huntington's disease. 19 October 2022
Spanish plasma-derived medicines company Grifols ( today announced that its drug Tavlesse (fostamatinib) has a been recommended by UK health technology assessor the National Institute for Health and Care Excellence (NICE) to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments. 19 October 2022
UK-based Nucleome Therapeutics, a spinout from Oxford University founded with the aim to unlock the non-coding regulation of the genome for human health, has closed an oversubscribed £37.5 million ($42.4 million) Series A financing round. 19 October 2022
Cambridge, USA-based clinical-stage biotech Synlogic has announced positive top-line data from its Phase II Synpheny-1 study in phenylketonuria (PKU). 19 October 2022
Bolstering its presence in the gene therapy sector, US pharma major Eli Lilly today announced it is acquiring Akouos, a precision genetic medicine company that is developing a portfolio of first-in-class adeno-associated viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss. 18 October 2022
After several setbacks in its product development and partnering deals in the last few years, US oncology focussed biotech AVEO Oncology has agreed to be acquired by South Korea’s LG Chem. 18 October 2022
Gilead Sciences has won European approval for Yescarta (axicabtagene ciloleucel) for the treatment of certain adults with different kinds of large B-cell lymphoma (LBCL). 18 October 2022
Shares of US messenger RNA (mRNA) therapeutics and vaccines maker Moderna closed up almost 4% at $139.25 yesterday, after it announced that the company and Gavi, the Vaccine Alliance, have mutually agreed to cancel remaining pending orders under the current COVID-19 vaccine supply agreement for 2022. 18 October 2022
Privately-held Swiss ophthalmology company Oculis and European Biotech Acquisition Corp (Nasdaq: EBAC), a special purpose acquisition company (SPAC), have entered into a definitive business combination agreement. 18 October 2022
Kineta, a privately-held immuno-oncology company, has announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co. 17 October 2022