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 stand-off between Vertex Pharmaceuticals and the UK’s cost watchdog for medicines over the cystic fibrosis (CF) drug Orkambi (lumacaftor/ivacaftor) has now gone on for two-and-a-half years. 12 November 2018
Shares in Anglo-Swedish pharma major AstraZeneca were nearly 7% higher than they were a week ago on Monday lunchtime as data on Farxiga (dapagliflozin) bumped up the company’s stock further. 12 November 2018
US clinical stage biotech Provention Bio saw its shares leap 12.4% after it announced a deal with its much larger peer Amgen for the co-development of AMG 714, now re-designated by Provention as PRV-015. 9 November 2018
As far as PARP inhibitors are concerned, AstraZeneca stole the show at the annual congress of ESMO this month, with the SOLO-1 trial of Lynparza (olaparib) showing striking data in the first-line maintenance setting for ovarian cancer patients. 9 November 2018
UK-headquartered commercial-stage biotech firm Orchard Therapeutics today announced two additions to its global commercial leadership team, appointing Robin Kenselaar as senior vice president and general manager, EMEA commercial operations, and Brad Mathis as vice president, US commercial operations. 8 November 2018
China’s BeiGene (Nasdaq: BGNE) has disclosed a delay in plans to file a New Drug Application (NDA) for zanubrutinib in relapsed/refractory (R/R) Waldenstrom's macroglobulinemia (WM) from first-half 2019 to 2019-Early 2020 in light of updated US Food and Drug Administration feedback. 8 November 2018
US biotech firm Immunomedics has announced its current clinical collaboration with AstraZeneca and its MedImmune unit for the development of Imfinzi (durvalumab) and sacituzumab govitecan combination therapy has been broadened to include second-line metastatic non-small cell lung cancer (NSCLC). 8 November 2018
Vaccines Europe, a trade group representing vaccines manufacturers in Europe, warns that vaccines have become “a victim of their own success,” as the absence of severe diseases has created a perception that vaccination is no longer necessary. 8 November 2018
The UK’s Medicines Discovery Catapult is joining forces with the Medical Research Council (MRC) Centre for Drug Safety Science (CDSS) at the University of Liverpool in a new research collaboration based around cell and gene therapy technologies. 7 November 2018
Foamix Pharmaceuticals was up by 20% in pre-market trading on Wednesday after releasing results from Phase III studies of FMX103 1.5% minocycline foam. 7 November 2018
The US Food and Drug Administration has approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 7 November 2018
Regeneron Pharmaceuticals has posted upbeat financial results for the third quarter of 2018, with revenues of $1.6 billion, a little under many analysts’ expectations, but still 11% higher than the same period last year. 6 November 2018
Japanese pharma major Daiichi Sankyo says that the European Medicines Agency has validated for review and granted accelerated assessment to the Marketing Authorization Application (MAA) for quizartinib for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive. 6 November 2018
San Franciscan oncology specialist Nektar Therapeutics has entered into a collaboration with Pfizer to evaluate several combination regimens in multiple cancer settings. 6 November 2018
US gene therapy developer Abeona Therapeutics says that it has been granted new exclusive licenses to develop gene therapies for treatment of four rare lysosomal storage disorders using US biotech Regenxbio’s NAV AAV9 vector platform technology. 6 November 2018
South Korean pharma company Yuhan Corp has licensed out its new clinical-stage lung cancer drug to Janssen Biotech, in a deal potentially valued at up to $1.25 billion. 6 November 2018
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to US biopharma Trevena in relation to the opioid painkiller, oliceridine. 5 November 2018