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
The HELIOS-A Phase III study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR) amyloidosis, met its primary and both secondary endpoints at nine months in patients with hATTR amyloidosis with polyneuropathy. 8 January 2021
Shares in rare disease specialist Sarepta Therapeutics fell around 45% after hours on Thursday, following mixed results from a Phase II study in Duchenne muscular dystrophy (DMD). 8 January 2021
MilliporeSigma, a unit of German pharma and life sciences group Merck KGaA, today announced the acquisition of AmpTec, a Germany-based, mRNA contract development and manufacturing organization (CDMO). 7 January 2021
Privately-held US biotech Ribomtrix has announced a strategic collaboration with Genentech, a subsidiary of Swiss pharma giant Roche , Group, to discover and develop novel RNA-targeted small molecule therapeutics against several targets. 7 January 2021
In a wide-ranging clinical update, East Coast, USA-based gene therapy firm Regenxbio announced that its pivotal trial program for RGX-314 in wet AMD is now active. 7 January 2021
Messenger ribonucleic acid (mRNA) specialist CureVac has reached a deal with fellow German firm Bayer to advance its COVID-19 vaccine candidate, CVnCoV. 7 January 2021
USA-based biotech Xencor has signed a second strategic research collaboration and commercialization agreement with the University of Texas MD Anderson Cancer Center, this one to develop novel CD3 bispecific antibody therapeutics for the potential treatment of patients with cancer. 7 January 2021
The Gilead Sciences subsidiary Kite has agreed to set up a cell therapy research collaboration with UK-based Oxford BioTherapeutics (OBT). 6 January 2021
UK pharma major AstraZeneca has announced that its COVID-19 vaccine AZD1222 has been granted emergency-use authorization in India, as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunization of adults. 6 January 2021
US rare and orphan diseases drug developer Cerecor has announced results from its exploratory Phase II US-based randomized, double-blind, placebo-controlled proof of concept trial (NCT04412057) of the human anti-LIGHT (TNFSF14) monoclonal antibody (MAb) CERC-002. 6 January 2021
The European Medicines Agency today announced its recommendation for conditional marketing authorization to be granted to another novel coronavirus vaccine. 6 January 2021
US drugmaker AbbVie has announced positive top-line results from two Phase III studies of Skyrizi (risankizumab) in adults with active psoriatic arthritis. 6 January 2021
Eleva GmhH, a Germany-based manufacturer of biologics, has secured up to 60 million euros ($73.7 million) in funding from Zukunftsfonds Heilbronn (ZFHN). 6 January 2021
Specialty biopharma Marius Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of Kyzatrex, its oral testosterone undecanoate soft gelatin capsule for the treatment of primary and secondary hypogonadism in men. 5 January 2021
French oncology-focussed biotech Innate Pharma SA closed up more than 5% at 3.68 euros today, after it revealed that Sanofi has made the decision to progress IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. 5 January 2021
Swiss pharma giant Roche’s novel cancer immunotherapy tiragolumab has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration, in combination with Tecentriq (atezolizumab). 5 January 2021