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
The European Medicines Agency’s EMA’s human medicines committee (CHMP) has recommended six medicines, three of which are novel drugs, for approval at its February 2021 meeting. 26 February 2021
GlaxoSmithKline has announced results from the Phase II proof of concept OSCAR study in COVID-19 with otilimab, an anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody. 26 February 2021
US biotech Moderna, which is pioneering messenger RNA (mRNA) therapeutics and vaccines, reported financial results for the fourth quarter and fiscal year 2020 and highlighted pipeline progress yesterday. 26 February 2021
The European Medicines Agency has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV-2) variants. 26 February 2021
The US Food and Drug Administration has granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. 26 February 2021
The US Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. 26 February 2021
US biotech Pandion Therapeutics’ shares rocketed 133% to $59.63 in morning trading, after it was revealed that it has agreed to be acquired by US pharma giant Merck & Co. 25 February 2021
US biotech Regeneron Pharmaceuticals today announced changes to the Phase III trial assessing investigational REGEN-COV (casirivimab with imdevimab) in non-hospitalized patients (outpatients) with COVID-19, following recommendations from the Independent Data Monitoring Committee (IDMC). 25 February 2021
Chinese biotech Clover Biopharmaceutical has raised nearly a quarter of a billion dollars in a series C financing round, bringing the total amount raised in the last 12 months to $400 million. 25 February 2021
The US Food and Drug Administration (FDA) has placed bluebird bio’s Phase I/II and Phase III studies of LentiGlobin gene therapy for sickle cell disease (SCD) on a clinical hold. 25 February 2021
Shares of US biotech Moderna were up more than 4% at $151.10, after it announced on Wednesday that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa. 25 February 2021
The Austrian Center of Industrial Biotechnology (acib) has published research in Scientific Reports describing less common coronavirus mutations which could be of significance for researchers. 24 February 2021
US biotech Beam Therapeutics saw its shares fall 12.6% to $96.48 yesterday, after it announced it has completed the acquisition of Guide Therapeutics (GuideTx). 24 February 2021
US clinical-stage biopharma firm Day One Biopharmaceuticals has entered into a global licensing agreement with Germany’s Merck KGaA, for an exclusive license to develop and commercialize pimasertib as well as a second compound, MSC2015103B. 23 February 2021
Hopes that BrainStorm Cell Therapeutics could deliver a new option in amyotrophic lateral sclerosis (ALS) have been dealt a blow by negative feedback from the US regulator. 23 February 2021
A third US approval for checkpoint blocker Libtayo (cemiplimab-rwlc) has been won by Regeneron Pharmaceuticals and its partner, French pharma major Sanofi. 23 February 2021
The UK subsidiary of US biotech firm Seagen today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in Great Britain for Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. 22 February 2021
The Parkinson’s disease (PD) pipeline has been hit significantly with a string of failures among its most anticipated mid-stage pipeline candidates. 22 February 2021