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
Biotech funder and incubator Flagship Pioneering and Tessera Therapeutics, a biotechnology company pioneering GENE WRITING technology backed by Flagship, today announced that Michael Severino has joined Tessera as chief executive. 3 June 2022
US biotech major Gilead Sciences has announced that Stacey Ma will join the company as executive vice president, pharmaceutical development and manufacturing, and will become a member of the company’s senior leadership team, reporting to chairman and chief executive, Daniel O’Day. 3 June 2022
Japanese drug major Astellas Pharma’s subsidiary Xyphos Biosciences and Cambridge, Massachusetts-based GO Therapeutics have entered into a strategic research collaboration and license agreement to develop novel immuno-oncology therapeutics. 2 June 2022
Immatics Biotechnologies saw its American-traded shares rise just a modest 3.2% to $7.79 this morning, despite signing a multi-billion-dollar deal, albeit heavily back-loaded. 2 June 2022
Shares of Canada-based clinical-stage precision cancer drugs developer Repare Therapeutics were up 27.5% at $11.16 pre-market today, on the news of a worldwide license and collaboration agreement with Swiss pharma giant Roche for the development and commercialization of camonsertib (also known as RP-3500). 2 June 2022
China-based CNS drug developer SciNeuro Pharmaceuticals yesterday announced the execution of an exclusive, worldwide license and option agreement with UK pharma major GlaxoSmithKline. 2 June 2022
TauRx Pharmaceuticals, a company that claims to be the global leader in tau-based research in Alzheimer’s disease, has announced the unblinding of initial data from completion of the randomized portion of its pivotal Phase III trial, LUCIDITY. 1 June 2022
Belgian biotech Galapagos has announced that the UK's National Institute of Health and Clinical Excellence (NICE) has recommended the use of Jyseleca (filgotinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) when other treatments have not been successful. 1 June 2022
Sage Therapeutics rose as much as 10% to $34.81 after, along with partner Biogen, it announced that the Phase III SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key secondary endpoints. 1 June 2022
Shares of US biotech TG Therapeutics were down more than 9% at $4.35 by mid-afternoon today, after it announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, for the Biologics License Application (BLA) for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis (RMS). 1 June 2022
US pharma major Bristol-Myers Squibb has become the first foreign pharmaceutical manufacturer that has decided to leave Russia due to the ongoing military conflict and associated with the sanctions imposed on Russia. 1 June 2022
Swedish Orphan Biovitrum (Sobi) and French pharma major Sanofi have been awarded Breakthrough Therapy designation in the USA, for efanesoctocog alfa (BIVV001). 1 June 2022
US biotech Biohaven Pharmaceutical migraine nasal spray zavegepant is set to generate annual sales of $206.8 million in the USA following the potential approval of its new drug application (NDA), which was received by the Food and Drug Administration (FDA) last week. 1 June 2022
Bruised by its failure to enter the superlatively lucrative market for coronavirus shots, British drug developer GlaxoSmithKline is to spend billions boosting its vaccines business. 31 May 2022
Today, California, USA-based Ultima Genomics emerged from stealth mode with a new high-throughput, low-cost sequencing platform that delivers the $100 genome. 31 May 2022
US clinical-stage biotech Eledon Pharmaceuticals saw its share gain 8% to $3.92 pre-market, after it announced positive top-line results from a Phase IIa clinical trial of tegoprubart (formerly AT-1501) in patients with amyotrophic lateral sclerosis (ALS). 31 May 2022
US mRNA biotech Moderna and Japan’s largest drugmaker Takeda have announced the transfer of the marketing authorization in Japan for Moderna’s COVID-19 vaccine Spikevax (mRNA-1273) from Takeda to Moderna as of August 1, 2022. 31 May 2022
Spain’s Minoryx Therapeutics, a Phase III stage biotech company focused on the development of treatments for orphan central nervous system (CNS) disorders, today announced it has closed a 51 million-euro ($55 million) financing, including Series C equity financing and complementary bank debt. 31 May 2022
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. 31 May 2022