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
On Wednesday, AbbVie reported results from its ongoing Phase III clinical trial, DBL3001, investigating the effectiveness of Imbruvica (ibrutinib) in diffuse large B-cell lymphoma, revealing that the study had failed to meet its primary endpoint. 11 July 2018
French biotech Transgene has signed a series of agreements with China’s Tasly Biopharmaceuticals involving T601 and T101, two immunotherapeutics developed by the Transgene-Tasly joint venture 3 in China. 11 July 2018
US pharma major Bristol-Myers Squibb has scored an approval in a third tumor type with the combination of its two immuno-oncology drugs, Opdivo (nivolumab) and Yervoy (ipilimumab). 11 July 2018
US biotech Advaxis closed 8% down on Tuesday after feedback from the European Medicines Agency (EMA) led the company to announce the withdrawal of its conditional Marketing Authorization Application (MAA) for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy. 11 July 2018
The announcement on January 22 this year that US biotech firms BioCryst Pharmaceuticals and Idera Pharmaceuticals were merging did not go down well with investors, with their shares plunging by as much as 12% and 28%, respectively. 11 July 2018
In March 2018, Celgene announced its intention to co-develop and co-market bb2121, a bluebird bio CAR-T cell therapy for relapsed multiple myeloma. In conversation with The Pharma Letter, Tuomo Pätsi, worldwide president for hematology and oncology markets, makes a strong case for the drug. 11 July 2018
Sanofi Genzyme says that it is disappointed with the recent recommendation by the Canadian Agency for Drugs and Technologies in Health (CADTH) to not reimburse Dupixent (dupilumab), one of the most important recent pharmacological innovations for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). 10 July 2018
Starpharma just announced its product VivaGel (astodrimer sodium) BV’s New Drugs Application (NDA) has advanced to the next stage of review by the US Food and Drug Administration. 10 July 2018
Results from a Phase III, randomized, double-blind, multi-center clinical study (BELIEVE) showed that luspatercept achieved a highly statistically-significant improvement in the primary endpoint of erythroid response, adding to earlier positive data a couple of weeks ago. 10 July 2018
German immunotherapeutics specialist BioNTech has inked a deal with RNA therapy specialist Genevant to guarantee further cooperation between the two on fighting rare diseases. 10 July 2018
France’s TxCell announced late Monday that it has exercised its exclusive option to in-license the intellectual property rights of one of its academic partners, the University of British Columbia (UBC), onto the HLA-A2 CAR-Treg program. 10 July 2018
San Diego-based Regulus Therapeutics, a microRNA specialist biotech, saw its share price collapse on Thursday following news of an imminent restructuring. 9 July 2018
When Seattle Genetics announced it had bought exclusive global rights to an an exciting new antibody-drug conjugate (ADC), sacituzumab govitecan (IMMU-132), shares in the candidate’s developer shot up by a third. 9 July 2018
Shares of Australian biotech firm Benitec Biopharma more than doubled after the company announced a lucrative licensing deal for a rare genetic disorder affecting the muscles of the upper eyelids and the throat with USA-based Axovant Sciences. 9 July 2018
NHS England has approved the reimbursement of Hemlibra (emicizumab) for the prevention of bleeding episodes in adults and children with hemophilia A who have factor VIII inhibitors, according to the drug’s marketers. 7 July 2018
Actelion, which is now part of US healthcare giant Johnson & Johnson, has announced that Uptravi (selexipag) will not be funded on the National Health Service (NHS) in England, meaning patients with life-limiting disease, pulmonary arterial hypertension (PAH), are forced to continue to wait for access. 7 July 2018
There was good news for US pharma major Bristol-Myers Squibb yesterday, with an expanded approval for its already blockbuster blood cancer drug Sprycel (dasatinib) in Europe. 6 July 2018
A new industry report highlights the importance of introducing novel technologies early in the cell line development and production processes. 6 July 2018