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
Cambridge, USA-based biotech Biogen has presented 10-year data on Tecfidera (dimethyl fumarate), demonstrating the long-term benefits for people with multiple sclerosis (MS). 11 September 2019
German pain management specialist Grünenthal and Australia’s Mesoblast (ASX: MSB) today announced a strategic partnership to develop and commercialize MPC-06-ID. 10 September 2019
Ireland-incorporated Horizon Therapeutics has announced that the US Food and Drug Administration has accepted the Biologics License Application (BLA) for teprotumumab, an investigational medicine for the treatment of active thyroid eye disease (TED), and granted it Priority Review designation. 10 September 2019
Detailed results from the Phase III CASPIAN trial show that the checkpoint inhibitor Imfinzi (durvalumab) performed well as a first-line option for people with extensive-stage small cell lung cancer (SCLC). 9 September 2019
French Blood Bank biotech spin-out PDC*line Pharma today announced that Dr Channa Debruyne joined the company in August as medical director, to lead the clinical research team. 9 September 2019
Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer. 9 September 2019
Lower insulin prices from Danish diabetes giant Novo Nordisk (NOV: N) will be welcomed by millions of Americans with diabetes who struggle to afford their medicine. 9 September 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC). 6 September 2019
Switzerland’s Roche has secured European approval for Tecentriq (atezolizumab), in combination with chemotherapy, for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). 6 September 2019
In a second deal between the companies, privately-held Boston, USA-based biotech IFM Therapeutics, through its IFM Due unit, has reached a collaboration and exclusive option agreement with Swiss pharma giant Novartis to develop a suite of immunotherapies that inhibit the cGAS/STING pathway to treat a range of serious inflammatory and autoimmune diseases. 6 September 2019
In a bold move to broaden its interests overseas, Japanese drugmaker Sumitomo Dainippon has agreed to pay $3 billion for a chunk of Roivant Sciences’ biopharmaceutical units, plus a 10% share in the rest of the company. 6 September 2019
The Phase III CheckMate -548 trial evaluating the addition of Bristol-Meyers Squibb’s blockbuster cancer immunotherapy Opdivo (nivolumab) to the current standard of care (temozolomide and radiation therapy) versus the standard of care alone did not meet one of its primary endpoints. 5 September 2019
German start-up BioNTech has signed an agreement with the Bill & Melinda Gates Foundation to develop HIV and tuberculosis programs, further expanding the company’s infectious disease portfolio. 5 September 2019
Shares of US biotech firm Magenta Therapeutics edged up more than 2% to $9.97, after it announced that the US Food and Drug Administration granted Regenerative Medicine Advance Therapy (RMAT) designation for MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders. 5 September 2019
Investors in the Atlas Venture-backed immuno-oncology specialist Surface Oncology have had a rough time since the company went public in New York, early in 2018. 5 September 2019
A novel gene therapy treatment for a rare inherited eye disorder has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for use on the National Health Service (NHS). 5 September 2019
A new study shows that the hemophilia A and B market is expected to grow from $7.0 billion in 2018 to $9.3 billion by 2028 across the eight major markets (8MM: USA, France, Germany, Italy, Spain, UK, Japan and China), expanding at a compound annual growth rate (CAGR) of 2.9%. 5 September 2019
Nearly a year after Merck & Co presented strong data for its Keytruda (pembrolizumab) combo in renal cell carcinoma (RCC), the firm has won approval in Europe. 4 September 2019