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.
New data from Japanese drugmaker Shionogi’s largest European real-world evidence study of cefiderocol (PERSEUS), demonstrates strong efficacy in critically ill patients with difficult to treat carbapenem-resistant (CN) Gram-negative (GN) bacterial infections. 19 April 2024
Japanese pharma giant Takeda has picked up a new approval for subcutaneous Entyvio (vedolizumab), for maintenance therapy of severely active Crohn’s disease. 19 April 2024
The US Food and Drug Administration (FDA) has approved the first and only ALK inhibitor for people with ALK-positive early-stage NSCLC (eNSCLC). 19 April 2024
US immune therapies and vaccines developer Corner Therapeutics has raised $54 million to create vaccines that confer lifelong protection from cancer and infectious diseases. 19 April 2024
US pharm major Eli Lilly and German partner Boehringer Ingelheim recently presented results of the Phase III EMPACT-MI trial, which examined patients treated with sodium-glucose co-transporter-2 inhibitor (SGLT-2I) Jardiance (empagliflozin) following a heart attack, at the American College of Cardiology’s (ACC). 19 April 2024
New York USA-based Metsera, a company accelerating the next generation of medicines for obesity and metabolic diseases, announced its launch today. 18 April 2024
American biopharma companies have criticised new European pharmaceutical legislation designed to make medicines more available, accessible and affordable. 18 April 2024
US biotech Vertex Pharmaceuticals’ shares gained ground in early trading today after the company signaled progress in the development of its experimental non-opioid pain treatment. 18 April 2024
A division of Medicines for Europe, the trade group representing the region's generics and biosimilars firms, has called for a new strategy to promote the biosimilars sector. 18 April 2024
Indian drugmaker Biocon has entered an exclusive licensing and supply agreement with Brazil’s Biomm for the commercialization of its vertically integrated drug product, semaglutide. 18 April 2024
Like its rivals in the GLP-1 space, Eli Lilly continues to explore the potential of Zepbound (tirzepatide) in addressing the broad range of comorbidities linked to obesity. 18 April 2024
Global supply problems have caused a “shock rise” in shortages of life-saving drugs like antibiotics and epilepsy medication, new research reveals today. 18 April 2024
The prices of certain active pharmaceutical ingredients (APIs) have experienced a significant decline over the past two months, as compared to the elevated prices reigning during the Covid pandemic. 18 April 2024
At the American College of Cardiology’s 73rd Annual Scientific Session, a study from the Gardy Health system in Atlanta, Georgia, USA, was presented investigating the rates of heart failure hospitalizations (HFH) in heart failure with preserved ejection fraction (HFpEF) patients and diabetes patients on semaglutide. 18 April 2024
UK pharma major GSK has announced positive results from the pivotal EAGLE-1 Phase III trial for gepotidacin, a potential first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. 18 April 2024
Western drugmakers are reducing their presence in Russia, which is reflected by the drop of demand and sales of their drugs in the local market, The Pharma Letter’s local correspondent reports. 18 April 2024
US pharma major Eli Lilly is on the brink of reshaping the pharmaceutical landscape with its ground-breaking treatments, Mounjaro (tirzepatide) for diabetes and marketed as Zepbound for obesity and the highly anticipated donanemab for early symptomatic Alzheimer’s disease. 17 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.