3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
After two previous setbacks, US pharma giant Pfizer yesterday released disappointing new data for its Duchenne muscular dystrophy (DMD) gene therapy candidate. 13 June 2024
Belgium’s UCB is sharing results from three studies supporting the value of Cimzia (certolizumab pegol) for women of childbearing age living with chronic immune-mediated diseases and people with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels. 13 June 2024
One of the most important medical meetings in rheumatology is underway in Vienna, Austria, and leading drugmakers in the field have lifted the lid on data they intend to present. 12 June 2024
US gene therapy company Regenxbio has announced that co-founder Kenneth Mills is to step down as president and chief executive following 15 years of leadership at the company. 12 June 2024
Bright Peak Therapeutics yesterday announced that it raised $90 million in a Series C financing, as the privately-held biotech looks to make a name for itself in the immunoconjugate space. 12 June 2024
Belgian biotech UCB has presented promising two-year data from Phase III studies on Bimzelx (bimekizumab) at the European Congress of Rheumatology, EULAR 2024. 12 June 2024
Shares of Germany drug discovery company Evotec were up 2.2% at 9.06 euros as it announced it has reached important scientific progress within its neuroscience collaboration with Bristol Myers Squibb . 12 June 2024
The Center for Drug Evaluations of the National Medical Products Administration (NMPA) in China has accepted the biologics license application (BLA) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (BTC). 11 June 2024
Shares of Skye Bioscience fell as much as 25% in pre-market activity on Monday, after it revealed that its Phase IIa clinical trial of SBI-100 ophthalmic emulsion (OE) did not meet its primary endpoint for lowering intraocular pressure (IOP). 11 June 2024
Privately-held Spanish CNS specialist Minoryx Therapeutics today announced encouraging results from a compassionate use study of leriglitazone for treatment of progressive cerebral adrenoleukodystrophy (cALD) in adult male patients, which are published in the peer-reviewed journal Brain. 11 June 2024
UK pharma major GSK and US biotech SpringWorks Therapeutics are to end their collaboration combining Blenrep (belantamab mafodotin) and Ogsiveo (nirogacestat). 11 June 2024
The US Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee yesterday unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer’s disease. 11 June 2024
Japanese drugmaker Kyowa Kirin yesterday revealed it is establishing a new, state-of-the-art manufacturing facility in Sanford, North Carolina, in the USA. 11 June 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 10 June 2024
US mRNA specialist Moderna today announced that its Phase III trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints. 10 June 2024
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
NK:IO, a London startup developing a cell therapy for treating solid tumors, has announced the appointment of a permant chief executive and the finalization of a seed funding round. 2 October 2024
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Company Spotlight
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.