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
GlaxoSmithKline has announced it will begin shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2019-20 flu season. 16 July 2019
Seqirus, a global leader in influenza prevention and part of Australia’s CSL Limited, announced today it is first-to-market with shipping its portfolio of seasonal influenza vaccines to customers in the USA for the 2019/20 influenza season. 15 July 2019
German privately-held drugmaker Boehringer Ingelheim has bought Swiss biotech firm AMAL Therapeutics for up to 326 million euros ($366 million). 15 July 2019
AbbVie today revealed it has bought Seattle-based Mavupharma, a privately held biopharmaceutical company focused on novel approaches to target the STING (STimulator of INterferon Genes) pathway for the treatment of cancer. 15 July 2019
Australian clinical-stage immuno-oncology company Imugene today announced that it would acquire Vaxinia Pty Ltd via a cash and share deal valued at A$1.619 million ($1.13 billion). 15 July 2019
British medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Document (FAD), confirming that Skyrizi (risankizumab) is recommended for the treatment of severe psoriasis in adult patients who have failed conventional systemic therapies. 15 July 2019
The B-cell non-Hodgkin’s lymphoma (NHL) market is expected to grow from $5.7 billion in 2017 to $9.2 billion by 2027 across the seven major markets (7MM: USA, France, Germany, Italy, Spain, UK and Japan) at a compound annual growth rate (CAGR) of 4.9%. 15 July 2019
In a deal revealed late Sunday, Galapagos is set to receive upfront payments and an equity investment of more than $5 billion from US biotech major Gilead Sciences. 15 July 2019
The Düsseldorf Regional Court has found that Praluent (alirocumab) infringes the German part of US biotech firm Amgen’s European patent (EP 2 215 124), relating to rival product Repatha (evolocumab), directed to antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). 15 July 2019
Maryland, USA-based biotech Altimmune (Nasdaq: ALT) has entered into an agreement to acquire Spitfire Pharma in a cash and stock deal worth up to $93 million. 13 July 2019
A new report from Boston, USA-based cost-effectiveness watchdog The Institute for Clinical and Economic Review (ICER) will make difficult reading for Duchenne muscular dystrophy (DMD) therapy manufacturers. 12 July 2019
US biotech major Gilead Sciences has lured high pharma profile Christi Shaw to the company as chief executive of CAR-T cancer therapy specialist Kite. 12 July 2019
In yet another setback in the quest for Alzheimer’s therapies it was decided to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase II/III studies in the Alzheimer's Prevention Initiative Generation Program. 12 July 2019
US RNAi therapies specialist Alnylam yesterday announced that Jeff Poulton joined the company on July 11, 2019, and has been appointed executive vice president and chief financial officer (CFO), effective August 13. 12 July 2019
Scientists discovered that when the breast cancer drug palbociclib was combined with the lung cancer drug crizotinib, the two-drug combination was significantly more effective against cancer cells in the laboratory than either drug used on its own. 12 July 2019
US biotech start-up Lyndra Therapeutics, the company making daily pills a thing of the past, has announced a partnership with Gilead Sciences to develop and commercialize ultra-long-acting oral HIV therapies. 10 July 2019
A bid from France’s Sanofi to market the anti-CD38 therapy isatuximab will be reviewed by the US regulator, with a decision expected by April 30, 2020. 10 July 2019
San Diego, USA based biotech Mirati Therapeutics has entered a clinical collaboration agreement with Swiss pharma giant Novartis to investigate a combination therapy for solid tumors. 10 July 2019