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
US biotech major Gilead Sciences’ Japanese subsidiary and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). 24 December 2019
Sarepta has signed a licensing agreement providing Swiss pharma giant Roche with exclusive commercial rights to SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), Sarepta’s investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the USA. 23 December 2019
With yet another earlier-than-expected US regulatory approval, on Friday, the US Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 23 December 2019
Danish dermatology specialist LEO Pharma recently announced that its anti-interleukin-13 (IL-13) biologic therapy tralokinumab, which is in development for the treatment of moderate-to-severe atopic dermatitis, met all its primary and secondary endpoints across three pivotal Phase III studies as part of the company’s ECZTRA trial series. 23 December 2019
The Chinese National Medical Products Administration (NMPA) has approved Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. 21 December 2019
In a second licensing deal signed by the Japanese pharma major this week, Takeda Pharmaceuticals has entered into a billion-dollar deal with privately-held Canadian biotech Turnstone Biologics to develop multiple products from its proprietary vaccinia virus platform targeting a broad range of cancer indications. 20 December 2019
Announcing its first commercial deal, US biotech start-up Rheos Medicines yesterday said that it has entered into a worldwide exclusive collaboration, option and license agreement with Swiss pharma giant Roche to discover, develop and commercialize novel therapeutics in the field of immunometabolism. 20 December 2019
US RNA-targeted drug developer Ionis Pharmaceuticals yesterday revealed that Biogen, a collaboration partner for neurological diseases, has licensed IONIS-MAPTRx, an antisense therapy designed to selectively reduce production of microtubule-associated protein tau (MAPT), or tau, in the central nervous system. 20 December 2019
A more personalized series of options are emerging to treat human epidermal growth factor receptor 2 negative (HER2) hormone receptor positive (HR+) breast cancer, according to GlobalData. 19 December 2019
Oxford Biomedica today announced an extension to its commercial supply agreement with Novartis for the manufacture of lentiviral vectors for the Swiss pharma giant’s CAR-T portfolio including five lentiviral vectors for CAR-T products 19 December 2019
East Coast, USA-based cancer specialist Epizyme has scored a unanimous vote in favor of its candidate tazemetostat, from the US regulator's cancer advisory panel. 19 December 2019
Minerva Neurosciences yesterday announced disappointing Phase IIb trial of MIN-117 in adult patients suffering from moderate to severe major depressive disorder (MDD) and presenting with symptoms of anxious distress failed to meet its primary and key secondary endpoints. 19 December 2019
The US Food and Drug Administration has accepted US pharm giant Pfizer’s supplemental New Drug Application (sNDA) for Braftovi (encorafenib), in combination with Erbitux (cetuximab; Braftovi Doublet) based on the results from the Phase III BEACON CRC trial. 19 December 2019
European Commission has granted approval for Rinvoq (upadacitinib) for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). 19 December 2019
The US Food and Drug Administration’s (FDA) Janet Woodcock has delivered a statement on the impact of the agency’s proposals on bringing low-cost biosimilar and interchangeable protein products to market. 18 December 2019
Keytruda (pembrolizumab) looks set to become the first in its class to win approval for a hard-to-treat kind of bladder cancer, following a positive vote from the US regulator’s cancer advisory panel. 18 December 2019
Californian company Adamas Pharmaceuticals closed 43% down after Tuesday’s trading, despite the firm announcing that a Phase III trial had met its primary endpoint. 18 December 2019