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 US regulator has approved Trulicity (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in certain adults with type 2 diabetes. 24 February 2020
Successful Danish biotech company Genmab (Nasdaq: GMAB) said late Friday that its chairman, Mats Pettersson, has decided to step down from the post on March 26, when his election period expires. 24 February 2020
Danish CNS specialist Lundbeck late on Friday revealed that Vyepti (eptinezumab-jjmr) has been approved by the US Food and Drug Administration for the preventive treatment of migraine in adults and will be available in April 2020. 22 February 2020
Bristol-Myers Squibb has announced the approval of Opdivo (nivolumab) for unresectable advanced or recurrent esophageal cancer in Japan. 21 February 2020
The US Food and Drug Administration has accepted for Priority Review the Biologics License Application (BLA) for the investigational AAV5 gene therapy Valrox (valoctocogene roxaparvovec) for adults with hemophilia A submitted by California-based biotech BioMarin Pharmaceutical. 21 February 2020
US health technology assessor the Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the comparative clinical effectiveness and value of treatments for cystic fibrosis. 21 February 2020
Agenus has unveiled data from pre-planned interim analyses, including for a combination of the checkpoint blocker balstilimab and the anti-CTLA-4 agent zalifrelimab. 20 February 2020
Privately-held German immune-oncology firm Immatics Biotechnologies has entered into a strategic collaboration agreement with UK pharma major GlaxoSmithKline to develop novel adoptive cell therapies targeting multiple cancer indications. 20 February 2020
Beleaguered oncology biotech Five Prime Therapeutics has been thrown a lifeline by Seattle Genetics, the antibody-drug conjugate (ADC) specialist, in the form of a global licensing agreement. 20 February 2020
USA-based FORMA Therapeutics today announced the US Food and Drug Administration has granted Fast Track designation and Rare Pediatric Disease designation for its lead clinical asset, FT-4202, in development as a disease-modifying treatment for sickle cell disease (SCD). 20 February 2020
US biotech major Gilead Sciences announced today that Michael Quigley has joined the company as senior vice president, Research Biology, bringing to the role deep experience in oncology and immuno-oncology biology. 19 February 2020
Israeli company NeoTX, a biotech firm with a selective t-cell redirection (STR) platform for developing targeted anticancer immunotherapies, has closed a $45 million Series C financing. 19 February 2020
Australian biotech firm Immutep today announced positive interim data from its ongoing Phase II TACTI-002 study, news of which pushed its share up 14.1% to A$0.44 by close of trading. 19 February 2020
A second Phase III study from Incyte’s TRuE-AD clinical trial program in mild-to-moderate atopic dermatitis (AD) has met its primary endpoint. 19 February 2020
Shares of biotech firm Cellectis were up more than 2% at 16.09 euros by early afternoon today, after it announced the execution of a binding term sheet with fellow France-based Servier to enter into an amendment to the agreement initially signed between the two companies in 2014. 19 February 2020
The US Food and Drug Administration has awarded Priority Review status to a supplemental Biologics License Application for Tecentriq (atezolizumab) in non-small cell lung cancer (NSCLC). 19 February 2020
Belgian bioprocessing provider Univercells has received an injection of 50 million euros from Gamma Biosciences, a new investment platform supported by private equity giant KKR that is focused on technologies for the production of advanced biologic therapies including gene and cell therapies. 19 February 2020