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 new Sanofi survey has found that only 6% of cardiologists are currently prescribing PCSK9 blockers, while 97% say they are satisfied with outcomes from these treatments. 3 February 2020
London-listed Affimer developer Avacta has signed a collaboration and license agreement with AffyXell Therapeutics, a new joint venture formed together with Daewoong Pharmaceutical. 3 February 2020
Israeli drugmaker Teva Pharmaceutical Industries and its partner for the Japanese market, Otsuka Pharmaceutical, have edged closer to approval for Ajovy (fremanezumab) in the Asian country. 3 February 2020
Shares of US biopharma firm Orgenesis rocketed more than 35% to $6.77 in pre-market trading today, after announcing that Catalent has agreed to acquire MaSTherCell Global, a contract development manufacturing organization (CDMO) subsidiary of Orgenesis, which is also backed by Great Point Partners and SFPI-FPIM. 3 February 2020
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for belantamab mafodotin in relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. 3 February 2020
New Jersey, USA-based oncology giant Bristol-Myers Squibb has withdrawn a European application to market Opdivo (nivolumab) and Yervoy (ipilimumab) for certain people with advanced non-small cell lung cancer (NSCLC). 3 February 2020
On Friday, the US Food and Drug Administration approved Palforzia (Peanut [Arachis hypogaea] allergen powder-dnfp) as the first ever treatment for patients with peanut allergy. 1 February 2020
Shares of US biotech giant Amgen were down 2.5% at $220.56 in after-hours trading on Thursday, after the company announced fourth-quarter and full-year 2019 financial results year. 31 January 2020
Dutch rare disease specialist ProQR Therapeutics (Nasdaq: PRQR) has been given Rare Pediatric Disease (RPD) designation for its candidate QR-421a. 30 January 2020
US biotech Alexion Pharmaceuticals today announced financial results for the fourth quarter and full year of 2019 which were above expectations, but its full year sales forecast missed, sending the firm’s shares down nearly 4.7% to $101.85 in mid-morning trading. 30 January 2020
US biotech major Biogen today reported full year and fourth quarter 2019 financial results which beat expectations and saw the firm’s shares up 2.15% at $288.60 in pre-market trading. 30 January 2020
Shares of USA-based Inovio Pharmaceuticals were up more than 15% at $4.74 pre-market today, as the company revealed it is collaborating with Beijing Advaccine Biotechnology Co to advance the development in China of INO-4800, Inovio's vaccine against the recently emerged strain of coronavirus (2019-nCoV) that has killed numerous people and infected thousands more in China to date. 30 January 2020
Olipudase alfa, an investigational recombinant human acid sphingomyelinase, demonstrated positive results in two separate clinical trials evaluating olipudase alfa for the treatment of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. 30 January 2020
The European Commission (EC) has approved a second indication in prostate cancer for Erleada (apalutamide), from the Johnson & Johnson unit Janssen. 29 January 2020
Shanghai, China-based WuXi Biologics says it has increased efforts in enabling the development of multiple neutralizing antibodies for the current outbreak of a novel coronavirus (2019-nCoV), centered in Wuhan, China. 29 January 2020