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
UK biotech services firm Abzena has signed an agreement to support an integrated CMC program with Lipum, a Sweden-based company developing treatments for chronic inflammatory diseases. 20 March 2019
Germany’s Merck KGaA and US pharma giant Pfizer have discontinued the ongoing Phase III JAVELIN Ovarian PARP 100 study evaluating the efficacy and safety of Bavencio (avelumab) in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib. 20 March 2019
The much-hyped cancer drug Venclexta (venetoclax) has already been approved to treat certain patients with chronic lymphocytic leukemia and acute myeloid leukemia, but it is unlikely to become a multiple myeloma treatment any time soon. 19 March 2019
Japanese drugmaker Ono Pharmaceutical has signed a drug discovery research collaboration with twoXAR, a USA-based artificial intelligence (AI)-driven biopharmaceutical company, to jointly discover and develop novel, efficacious treatments to address unmet medical needs in a specific neurological disease. 19 March 2019
Just a week after a Tecentriq (atezolizumab) combination was the first cancer immunotherapy regimen to be approved for breast cancer in the USA, the Roche drug has achieved another milestone. 19 March 2019
Darmstadt, Germany-based Merck KGaA has entered into a strategic alliance with Chinese biotech company GenScript, based around plasmid and viral vector manufacturing. 19 March 2019
South Korean RNAi therapeutics developer OliX Pharmaceuticals has signed a license and collaboration agreement with Théa Open Innovation, a sister company of France-headquartered Laboratoires Théa, to develop and commercialize OLX301A, a novel treatment for age-related macular degeneration (AMD). 19 March 2019
Hamburg-based drug development firm Evotec has formed a new partnership with the Global Antibiotic Research and Development Partnership (GARDP) to tackle the growing threat of antimicrobial resistance. 19 March 2019
UK vaccine R&D company ImmunoBiology (ImmBio) has recently signed a licensing agreement with LIBP (Lanzhou Institute of Biological Product), a subsidiary company of China National Biotec Group (CNBG). 18 March 2019
Roche majority-owned Chugai has filed a new drug application (NDA) to Japan’s Ministry of Health, Labor and Welfare for entrectinib for the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC). 18 March 2019
Shares of Spectrum Pharmaceuticals dropped 8% in pre-market trading on Friday, after it revealed a further disappointment in the development of its lead product candidate Rolontis (eflapegrastim). 18 March 2019
The European Commission (EC) has approved a new indication for Praluent (alirocumab), to reduce cardiovascular (CV) risk in adults with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors. 18 March 2019
Nicox and China’s Ocumension Therapeutics have entered into an exclusive license agreement for the development and commercialization of Nicox' product Zerviate 15 March 2019
The European Medicines Agency has granted approval for Roche to market MabThera (rituximab) against a rare condition, pemphigus vulgaris (PV). 15 March 2019
Across the USA, insurers denied access to the new cholesterol-lowering medications known as a PCSK9 inhibitors, for as many as one in three high-risk heart patients in 2018. 14 March 2019
New Jersey, USA-based Merck & Co has picked up another approval in Europe for Keytruda (pembrolizumab), in combination with chemo, for the first-line treatment of squamous non-small cell lung cancer (NSCLC). 14 March 2019