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
Shares in UK-based antibiotics developer Motif Bio are now worth just a tenth of their value of four months ago after more bad news about iclaprim, the company’s lead product. 7 June 2019
The US Food and Drug Administration yesterday approved marketing of autoinjector and prefilled safety syringe versions of GlaxoSmithKline's asthma drug Nucala (mepolizumab), enabling self-administration of the monthly dose of the interleukin (IL)-5 inhibitor. 7 June 2019
Australian biotech firm Benitec Biopharma today announced the termination of the license and collaboration agreement with Axovant Sciences. 6 June 2019
French biotech Transgene has announced the publication of two articles highlighting the potential of its virus-based immunotherapies for the treatment of solid tumors. 6 June 2019
AstraZeneca today announced positive results from the Phase III ELEVATE-TN trial of Calquence (acalabrutinib) in patients with previously-untreated chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults. 6 June 2019
Boston, USA-based Third Rock Ventures today announced today the closing of Third Rock Ventures V, raising $770 million in an oversubscribed fund, and marking the largest in its 12-year history. 6 June 2019
Germany-headquartered clinical-stage biotech InflaRx (Nasdaq: IFRX) saw its shares crash nearly 92% to $3.06 by close of trading on Wednesday, after the company revealed that IVX-1, its potential treatment for an inflammatory skin disorder, failed to demonstrate statistical significance compared to placebo. 6 June 2019
After 20 years in various leadership roles with US pharma major Eli Lilly, Pete Salzmann has left to take the top job at a company specializing in autoimmune diseases. 6 June 2019
It has now been nearly three years since Orkambi (lumacaftor-ivacaftor), the treatment for cystic fibrosis (CF) patients who have the F508del mutation, was first ruled too expensive for use on the UK’s National Health Service (NHS). 5 June 2019
The headline-grabbing results on AMG 510, the first KRASG12C inhibitor to reach the clinical stage, were not the only data to be shared by US biotech Amgen on its early-stage oncology pipeline. 5 June 2019
AbbVie has presented data from the CLL14 trial, examining Venclexta (venetoclax) plus Roche’s CD20 blocker Gazyva (obinutuzumab), as a first-line therapy for chronic lymphocytic leukaemia (CLL). 5 June 2019
California-based rare diseases specialist Eiger BioPharmaceuticals today announced the appointment of Jeysen Yogaratnam as vice president of global hepatitis Delta virus (HDV) clinical development. 5 June 2019
Independent French drugmaker Servier has linked up with Yposkesi, a Contract Development & Manufacturing Organization (CDMO) to develop and GMP manufacture lentiviral vectors to support allogenic CAR-T cell technology development. 5 June 2019
Celgene has provided cause for celebration for Bristol-Myers Squibb, which is set to take over the US biotech company, and its partner Acceleron Pharma. 5 June 2019
The US Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for RVT-802, a novel investigational tissue-based regenerative therapy designed to treat pediatric congenital athymia, and granted Priority Review. 5 June 2019
Japan’s largest drugmaker Takeda Pharmaceutical has announced new data from an ad-hoc analysis of the Phase III HELP Study, designed to evaluate the onset of action for Takhzyro (lanadelumab) during days 0-69 of treatment. 5 June 2019
The US Food and Drug Administration has approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults. 5 June 2019
Privately-held anti-infective drug specialist Prokaryotics has inked an exclusive licensing agreement with Fundación MEDINA, the not-for-profit Spanish foundation. 5 June 2019
Adding to a list of significant collaborations with big pharma, USA-based biotech Arvinas has now signed a collaboration with German pharma major Bayer, with the news sending the US firm’s share up more than 8% to $21.66 in early trading today. 4 June 2019