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
A Phase III trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival at a planned interim analysis of the LACEWING trial. 21 December 2020
The European Medicines Agency’s advisory committee today recommended granting a conditional marketing authorization for Pfizer and BioNTech’s vaccine Comirnaty (previously known as BNT162b2), to prevent COVID-19 in people from 16 years of age. 21 December 2020
Swiss pharma giant Roche has announced positive top-line results from two identically designed global Phase III studies, testing the novel biologic faricimab. 21 December 2020
The US Food and Drug Administration on Friday issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. 21 December 2020
US biotech major Biogen has agreed to pay $22 million to resolve claims that it violated the False Claims Act by illegally using charitable foundations as a conduit to pay the co-pays of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex (interferon beta 1a) and Tysabri (natalizumab), according to the US Justice Department. 19 December 2020
Shares of UK-based rare diseases specialist Mereo BioPharma (Nasdaq: MREO) shot up almost 63% to $3.60 on Friday, after it announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta (OI). 19 December 2020
Janux Therapeutics has announced a strategic collaboration with Merck & Co valued at more than $1 billion to develop novel T cell engager (TRACTr) immunotherapies for the treatment of cancer. 18 December 2020
Any doubts that Moderna’s (Nasdaq: MRNA) COVID-19 vaccine is moving swiftly closer to patients in the USA and European Union (EU) have all but vanished this week. 18 December 2020
Privately-held US biopharma firm Cadent Therapeutics has reached a definitive agreement with Novartis, under which the latter will acquire all of the outstanding capital stock of Cadent, and marking the third M&A deal for the Swiss pharma giant this year. 18 December 2020
Coronavirus vaccine co-developer Pfizer has refuted suggestions that there is any delay to its manufacturing and distribution schedule. 18 December 2020
GlaxoSmithKline today said it will co-lead a Series A investment in Adrestia Therapeutics, a UK-based biotechnology company using cutting edge molecular biology to develop precision medicines. 18 December 2020
The US Food and Drug Administration has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. 18 December 2020
The Institute for Clinical and Economic Review (ICER) has published its final recommendations on two drugs in development for non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guerin (BCG) intravesical therapy. 17 December 2020
There are eight mRNA COVID-19 vaccine candidates currently in Phase II or Phase III clinical trials. These vaccines are faster to develop than traditional vaccine formulations, as they use only the genetic sequence of the virus. 17 December 2020
MacroGenics has won US Food and Drug Administration approval for its HER2-targeting biologic Margenza (margetuximab-cmkb) in breast cancer. 17 December 2020
The chief scientific adviser to the US government’s Operation Warp Speed program has said that only 5% to 20% of the roughly 65,000 doses of COVID-19 antibody treatments shipped to states around the country every week end up going to patients. 17 December 2020
US biotech Novavax has announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, the company’s candidate vaccine against COVID-19. 17 December 2020
French biotech firm AB Science yesterday announced that the Phase IIb/III study (AB09004 - NCT01872598) evaluating oral masitinib in patients with mild and moderate Alzheimer’s disease met its predefined primary endpoint. 17 December 2020
Irish biotech ONK Therapeutics has inked three new exclusive option agreements, boosting its off-the-shelf natural killer (NK) cell therapy platform. 17 December 2020