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 announcement of preliminary data from a Phase III clinical trial evaluating casimersen and golodirsen in Duchenne muscular dystrophy (DMD) patients amenable to skipping exons 45 and 53, respectively saw shares of Sarepta Therapeutics rise, 29 March 2019
The growth of the UK’s biotech sector stands in stark and impressive contrast to many other elements of an economy that is being stagnated by financial and economic uncertainty. 28 March 2019
A broker’s report on Alexion Pharmaceuticals has found that the popular perception of the US pharma as the 'Soliris (eculizumab) company' does not do justice to its pipeline. 28 March 2019
Immuno-oncology (I-O) company Elicio Therapeutics has launched with a $30 million financing to treat a range of cancers with a new vaccine and immunotherapy platform. 28 March 2019
Poland-based Selvita, a clinical stage company engaged in the research and development of novel cancer therapies as well as provision of drug discovery and development services, today announced that it plans to separate into two companies. 28 March 2019
London-listed AstraZeneca has received a positive reimbursement decision from the UK’s health technology assessor, for the immuno-oncology product Imfinzi (durvalumab). 28 March 2019
Japanese pharma giant Takeda Pharmaceutical has entered a collaboration and license deal to develop in vivo novel adeno-associated viral (AAV) based therapies for Friedreich's Ataxia (FA) and two additional undisclosed targets. 28 March 2019
US biotech major Gilead Sciences today announced HepConnect, a five-year, multi-million dollar initiative aimed at addressing the sharp increase in chronic hepatitis C (HCV) infections fueled by the nation’s opioid crisis. 28 March 2019
Merck KGaA today announced an investment of 150 million euros ($169 million) in its manufacturing site at Aubonne, Switzerland, to expand manufacturing capacity for its biotech medicines. 28 March 2019
Ringing the opening bell at the Nasdaq stock exchange on Wednesday, Lille-based biotech Genfit (EPA: GNFT) celebrated its listing in New York, raising 130 million euros ($146 million) in the process. 28 March 2019
Aldeyra Therapeutics has announced positive results from the Phase III ALLEVIATE trial of 0.25% and 0.5% reproxalap topical ophthalmic solution in patients with allergic conjunctivitis. 27 March 2019
Leaders at Swiss pharma giant Novartis hope that 2019 could see the launch of up to four new drugs that go on to become blockbusters, and the first of these won an approval in the USA on Tuesday. 27 March 2019
US biotech RegeneRx Biopharmaceuticals and Lee's Pharmaceutical, a Hong Kong-based pharmaceutical company, are accelerating development of RGN-259 in China for ophthalmic indications. 27 March 2019
On Tuesday, Israeli biotech Can-Fite BioPharma announced disappointing trial results for its orphan drug candidate namodenoson, but found a good news story hidden in the secondary endpoints. 27 March 2019
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. 26 March 2019
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kymriah (tisagenlecleucel) for the treatment of two distinct indications – CD19-positive relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and CD19-positive r/r diffuse large B-cell lymphoma (DLBCL). 26 March 2019
Smyraf (peficitinib hydrobromide) 50mg and 100mg tablets, an oral Janus kinase (JAK) inhibitor, received manufacturing and marketing approval in Japan for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapies. 26 March 2019
US biotech major Celgene has re-submitted a New Drug Application to the US Food and Drug Administration for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS). 26 March 2019
Teijin Pharma, the core company of the Teijin Group’s healthcare business, announced today that it has acquired marketing approval for Revcovi (elapegademase [genetical recombination]) from the Ministry of Health, Labor and Welfare (MHLW). 26 March 2019
Thermo Fisher Scientific has reached a definitive agreement to acquire Brammer Bio, a leader in viral vector manufacturing for gene and cell therapies, with the news nudging its share 1.26% higher to $267.13 in early afternoon trading on Monday. 26 March 2019