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
Actelion, the Swiss biotech firm acquired by Johnson & Johnson’s Janssen unit in a $30 billion deal in 2017, has entered into a collaboration with UK-based Owlstone Medical. 20 May 2019
When it comes to long-term investment in pharma stocks, looking at pipeline assets at a pre-clinical or early clinical stage gives as good a clue as any as to where the value lies. 17 May 2019
A draft issued on March 29 by China’s National Health Commission (CNHC), which regulates hospitals in China, allows qualified 3 Jia ( meaning top-level) public hospitals to develop and commercialize somatic cell therapies within their own hospitals. 17 May 2019
New Jersey, USA-based Merck & Co has announced it will present 140 abstracts at the upcoming annual meeting of the Annual Society of Clinical Oncology (ASCO), including on the anti-PD-1 blockbuster Keytruda (pembrolizumab) and Lynparza (olaparib) - in over 25 types of cancer. 17 May 2019
Privately-held Parvus Therapeutics has entered into a worldwide collaboration and license agreement with Genentech, a subsidiary of Roche, to develop, manufacture, and commercialize novel Navacim therapeutics for the treatment of inflammatory bowel disease (IBD), autoimmune liver diseases (ALD), and celiac disease (CD). 17 May 2019
A dual kinase inhibitor is entering a clinical trial for advanced pancreatic cancer in combination with the chemotherapy drug gemcitabine as part of an academic-industry initiative supported by the charity Cancer Research UK. 16 May 2019
After a slow start, there have been better recent sales of Yescarta (axicabtagene ciloleucel), the CAR-T therapy that Gilead Sciences picked up in its $11.9 billion acquisition of Kite Pharma in 2017. 16 May 2019
The Roche and AbbVie partnered asset Venclexta (venetoclax) has won US approval in combination with Gazyva (obinutuzumab) as a first-line, chemo-free option in chronic lymphocytic leukemia (CLL). 16 May 2019
US drugmaker Vertex Pharmaceuticals and biotech firm Kymera Therapeutics have entered into a four-year strategic research and development collaboration to advance small molecule protein degraders against multiple targets. 16 May 2019
German pharma major Bayer yesterday announced positive findings from new analyses and data for Vitrakvi (larotrectinib), confirming the efficacy and safety of larotrectinib in patients with TRK fusion cancer. 16 May 2019
Anglo-American pharma Adaptimmune Therapeutics and Seattle-based Alpine Immune Sciences have linked up in designing and developing specific peptide enhanced affinity receptor (SPEAR) T-cell therapies. 15 May 2019
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Biogen’s Spinraza (nusinersen) to treat infants, children and adults with spinal muscular atrophy (SMA). 15 May 2019
Chuikyo, Japan’s Central Social Insurance Medical Council, on May 15 approved the listing of Swiss pharma giant Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) on May 22, with a National Health Insurance (NHI) price tag of some 33.5 million yen ($305,800), according to media reports. 15 May 2019
The USA-based Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases Volume IV: Alzheimer’s Disease Therapeutics, the fourth in a series on the innovation landscape of highly prevalent, chronic diseases. 15 May 2019
The US Food and Drug Administration (FDA) has approved Bavencio (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC; kidney cancer). 15 May 2019
Swedish Orphan Biovitrum, the Nordic biotech company that is known as Sobi, has bumped its share price up by 5% at its Capital Markets Day 2019. 14 May 2019
Canada’s Zymeworks has entered into a licensing agreement giving Iconic Therapeutics certain rights to its proprietary ZymeLink antibody-drug conjugate (ADC) platform. 14 May 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation to Pomalyst (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi’s sarcoma. 14 May 2019