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.
Belgium’s largest drugmaker UCB today announced an update on its progress at its annual shareholder meeting (AGM), with the news edging its shares up 1.7% to 122.90 by midday. 25 April 2024
The UK’s second-largest drugmaker, GSK, expects to hear by the end of August whether the US regulator will expand the label for Jemperli (dostarlimab). 25 April 2024
Colombia’s government yesterday issued its first-ever compulsory license (CL) for use by the country’s Ministry of Health, to improve access to less-expensive generic versions of the key HIV medicine dolutegravir. 25 April 2024
The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 25 April 2024
On Wednesday, the US Food and Drug Administration (FDA) announced a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. 25 April 2024
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
In San Francisco, a new company focused on using artificial intelligence to power drug discovery has launched with more than $1 billion of committed capital. 24 April 2024
Swiss pharma giant Roche first-quarter 2024 sales figures this morning that were disappointing in some respects and saw the firm’s shares fall 3.5% to 221.70 francs. 24 April 2024
Norway-based clinical-stage immunologics company Calluna Pharma today announced the appointment of Margrethe Sørgaard to the position of senior vice president of clinical operations and pharmacovigilance. 24 April 2024
Swiss pharma giant Novartis and the product development partnership Medicines for Malaria Venture (MMV) have announced positive data from their Phase II/III CALINA study. 24 April 2024
Swedish biopharma Calliditas Therapeutics today announced positive global open-label extension (OLE) Phase III NefIgArd study results in IgA nephropathy (IgAN) patients treated with Nefecon/Tarpeyo (budesonide). 24 April 2024
The US Food and Drug Administration has approved Lutathera (lutetium Lu 177 dotatate, from Advanced Accelerator Applications USA, a Novartis company). 24 April 2024
UK pharma major AstraZeneca has appealed to the Russian Investigative Committee and the Federal Anti-Monopoly Service (FAS) against Russian drug firm Akrikhin, which produces a generic of the diabetes drug Forxiga (dapagliflozin) during the validity of the patent. 24 April 2024
A single-line order from the US Supreme Court has scotched hopes on the part of Vanda Pharmaceuticals of resurrecting patents for Hetlioz (tasimelteon). 23 April 2024
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 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
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 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
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. 3 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
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 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
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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.