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
Infectious diseases company Aridis Pharmaceuticals closed nearly 7% down on Tuesday following the failure of AR-105 in a Phase II study in ventilator-associated pneumonia (VAP) caused by gram-negative Pseudomonas aeruginosa. 4 September 2019
Regenxbio today announced exclusive worldwide option and license agreement with Clearside Biomedical for evaluation of in-office delivery platform of RGX-314 to the suprachoroidal space in the eye for the treatment of wet age-related macular degeneration (wet AMD). 4 September 2019
The US Department of Health and Human Services (HHS) has committed to buying large volumes of a smallpox vaccine called ACAM2000 as part of its preparedness efforts against biodefense threats. 4 September 2019
Chugai Pharmaceutical has announced the launch of Rozlytrek (entrectinib), an anticancer agent/tyrosine kinase inhibitor, for the treatment of NTRK fusion-positive advanced or recurrent solid tumors. 4 September 2019
China’s National Medical Products Administration (NMPA) has granted marketing authorization for Tagrisso (osimertinib) as a first-line treatment for adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions. 4 September 2019
Around the world, life expectancy continues to increase while birth rates fall, leading to aging populations that are increasingly vulnerable to dementia. 4 September 2019
US drugmaker Vertex Pharmaceuticals has taken another gamble outside its traditional cystic fibrosis specialty, this time with the aim of developing curative cell-based treatments for type 1 diabetes. 3 September 2019
Shares of US biotech Cidara Therapeutics rocketed 79% to $3.01 in active pre-market trading this morning, after announcing a partnership with UK-based Mundipharma with a total potential value of $568 million to Cidara. 3 September 2019
Germany-based biotech Velabs Therapeutics has agreed a deal with alytas therapeutics to jointly develop modulatory and functional antibodies for a novel immune-based therapy against obesity. 3 September 2019
The Indian medicines regulator has approved a novel biologic, Twinrab (rabimabs), in combination with a rabies vaccine, for rabies post-exposure prophylaxis. 3 September 2019
Detailed results have been presented by The Medicines Company from the ORION-11 trial evaluating the efficacy, safety, and tolerability of inclisiran to decrease LDL-cholesterol (LDL-C) through twice-yearly dosing. 3 September 2019
UK biotech start-up Achilles Therapeutics says it has closed a £100 million ($120.6 million) Series B financing led by incoming US investor RA Capital Management, corner-stoned by founding investor Syncona and joined by important new investors including Forbion, Invus, Perceptive Advisors and Redmile Group. 3 September 2019
UK-based drugmaker AstraZeneca has presented detailed results from the Phase III DAPA-HF trial of Farxiga (dapagliflozin) at the ESC Congress 2019 in Paris. 3 September 2019
Privately-held German biotech and radiopharmaceutical group ITM Isotopen Technologien München has agreed with DuChemBio (DCB) for the Korean company to develop and commercialize Solucin (177Lu-edotreotide) targeted radionuclide therapy (TRT) in South Korea. 2 September 2019
Astellas Pharma today revealed a worldwide licensing agreement with Japanese research organization RIKEN for the research, development and commercialization of cell therapy formulations applying RIKEN’s artificial adjuvant vector cell (aAVC) technology in oncology. 2 September 2019
Shares of US biotech firm Alexion Pharmaceuticals crashed 8% in pre-market trading on Friday, reacting to the news that peer Amgen is challenging of three patents covering top seller Soliris (eculizumab). 31 August 2019
Immunicum failed to show superiority in 18-month survival rates by adding its off-the-shelf cell therapy ilixadencel to Pfizer’s Sutent (sunitinib) in metastatic renal cell carcinoma, according to Phase II results. 30 August 2019
Shares in Swiss pharma giant Novartis were 1.7% higher after two hours of trading on Friday following the company’s presentation of Phase III data on its multiple sclerosis (MS) prospect, ofatumumab. 30 August 2019
Following on from big-selling Herceptin (trastuzumab), Roche could have another big player in breast cancer, in the shape of its PD-L1 inhibitor Tecentriq (atezolizumab). 29 August 2019