UK biopharma Motif Bio was up 6% in late London trading on Tuesday after the US Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for iclaprim, a targeted, gram-positive investigational antibiotic for acute bacterial skin and skin structure infections (ABSSSI). 14 August 2018
The US Food and Drug Administration (FDA) announced on Monday that it had accepted a New Drug Application for Circassia Pharmaceuticals' Duaklir (aclidinium/formoterol). 13 August 2018
The European Union is supporting Danish biotech company Bavarian Nordic with a 30 million-euro ($34.7 million) loan from the European Investment Bank (EIB). 10 August 2018
Japanese drugmaker Shionogi has applied for approval to manufacture and sell Intuniv (guanfacine hydrochloride) tablets attention for adults with attention deficit hyperactivity disorder (ADHD) in Japan. 10 August 2018
Artios Pharma, a specialist in DNA damage response (DDR) therapy, has announced the conclusion of an $84 million series B funding round. 10 August 2018
Swiss biotech Therachon has raised $60 million in a financing round led by Novo Holdings, with money also from Cowen Healthcare Investments, Pfizer Ventures and others. 9 August 2018
Eli Lilly’s Taltz (ixekizumab) has been recommended for use within the National Health Service (NHS) in England and Wales for active psoriatic arthritis, after inadequate response to disease modifying antirheumatic drugs (DMARDs). 9 August 2018
BeiGene has announced the closing of its previously announced Hong Kong initial public offering and global offering of 65,600,000 ordinary shares, par value US$0.0001 per share, at a public offering price of HK$108.00 per hare. 9 August 2018
Boston-based Akouos, a precision medicine company developing gene therapies that restore and preserve hearing, has raised $50 million in Series A financing. 7 August 2018
Glenmark Pharmaceuticals and Harbour BioMed have entered into a license agreement for the Greater China territory to develop, manufacture and commercialize lead I-O candidate GBR 1302. 6 August 2018
Ionis Pharmaceuticals announced on Thursday that its novel Huntington's therapy, licensed to Roche, had been granted PRIME designation by the European Medicines Association (EMA). 3 August 2018
Karuna Pharmaceuticals, a subsidiary of PureTech Health, has announced a successful Series A funding round of $42 million. This financing round included ARCH Venture Partners, the Wellcome Trust, PureTech Health and other undisclosed investors. 2 August 2018
RegeneRx has announced that its licensee for RGN-137, a therapy for the orphan condition epidermolysis bullosa, is to begin the process toward commercialization. 2 August 2018
Swiss pharma giant Novartis and UK biotech Albumedix have entered into an agreement to evaluate the development of several first-in-class therapeutics using Albumedix’ Veltis technology platform and associated technologies. 2 August 2018
The European Commission (EC) has approved Xeljanz (tofacitinib citrate) for moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. 1 August 2018
Israeli biotech firm C saw its shares rise 5.55% to 336.90 shekels in morning trading after it announced today the expansion of its immuno-oncology collaboration with Merck & Co. 30 July 2018
US biotech firm bluebird bio closed down 7.67% at $163.65 on Tuesday, after it announced the pricing of an underwritten public offering of 3,384,616 shares of its common stock at a public offering price of $162.50 per share, before underwriting discounts. 25 July 2018
The USA’s Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report assessing the comparative clinical effectiveness of inotersen from Akcea Therapeutics and patisiran from Alnylam Pharmaceuticals for hereditary transthyretin-related amyloidosis (HTA), a rare genetic condition that can affect that can affect multiple organ systems. 23 July 2018
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Privately-held Ferring Pharmaceuticals has announced the opening of a global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). 3 October 2024
Shares of UK drug developer Hemogenyx Pharmaceuticals rose as much as 9% and closed up 5.9% at 1.70 pence yesterday on the news of a further investment from Prevail Partners. 3 October 2024
UK-based biotech Resolution Therapeutics has announced the completion of a £63.5 million ($76.8 million) series B financing round led by Syncona. 3 October 2024
The BioIndustry Association (BIA), in collaboration with the Centre for Process Innovation (CPI), has published a new report on the UK’s mRNA sector. 2 October 2024
Aspen Neuroscience, a private biotechnology company specializing in autologous cell therapies, has announced the opening of a major new facility near its headquarters in San Diego. 2 October 2024
Privately-held UK biotech Curve Therapeutics today announced the further strengthening of its leadership team with the appointments of Andre Hoekema as chairman of the board and Cora Griffin as head of business development. 2 October 2024