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
US biotech major Gilead Sciencestoday announced that Johanna Mercier will join the company as chief commercial officer, and will become a member of the company’s senior leadership team. 29 May 2019
Juvenescence, a privately-held investment firm with a focus on increasing healthy human longevity, has announced the creation of a new biotech company to target the epigenetic underpinnings of neurodegeneration. 29 May 2019
Phase III findings on BioMarin Pharmaceutical’s valoctocogene roxaparvovec were announced on Tuesday, leading the US biotech’s share value to fall by 5% by the close. 29 May 2019
The US Food and Drug Administration has approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. 29 May 2019
US pharma major has signed a licensing agreement to acquire the exclusive worldwide rights for CNTX-0290 from privately-held US pain specialist Centrexion Therapeutics Corporation. 28 May 2019
Cambridge, Massachusetts-based genome editing company Intellia Therapeutics has named Laura Sepp-Lorenzino as its new executive vice president and chief scientific officer. 28 May 2019
Dutch biotech firm Synaffix announced that ADC Therapeutics has triggered a third target-specific license under its existing commercial license agreement dated October 2016. 28 May 2019
Italian biopharma Newron Pharmaceuticals looked set to close around 13% down on Tuesday after bad news was announced surrounding evenamide, a potential add-on therapy for the treatment of patients with positive symptoms of schizophrenia. 28 May 2019
The US Food and Drug Administration has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older 28 May 2019
The US Food and Drug Administration on Friday approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality. 25 May 2019
Investors stand to play a crucial role in driving healthcare sustainability as well as supporting scientific innovation, write Nathalie Flury and Michael Schröter, founding partners at Swiss asset manager Viopas Partners, and Kate Dion, healthcare value communications consultant at 3D Communications, in an Expert View piece. 24 May 2019
Medical data provider Cegedim has announced a collaboration with French pharma major Sanofi (Euronext: SAN) to use real world evidence to improve healthcare in Europe. 24 May 2019
As industry majors prepare to make a splash at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO), 2003-founded nanomedicine specialist Nanobiotix hopes it can punch above its weight. 24 May 2019
China must take measures to largely improve its clinical data quality to be a competitive player in the global biotech market, said speakers at China’s recent clinical development summit held in Shanghai, reports The Pharma Letter’s local correspondent Wang Fangqing. 24 May 2019
Biotherapeutics revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for its TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy. 24 May 2019
The Province of Ontario has become Canada’s first to reimburse Venclexta (venetoclax) monotherapy under its Drugs and Devices Division's (DDD) Exceptional Access Program. 23 May 2019
Akrevia Therapeutics, a privately-held biopharma that was launched in September 2018 by Atlas and F-Prime, has now named its first chief executive. 23 May 2019
US biotech Nektar Therapeutics today announced the formation of Inheris Biopharma, a wholly-owned subsidiary of Nektar and a central nervous system (CNS)-focused company, as well as an oncology collaboration with fellow USA-based Trovagene. 23 May 2019