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.
Japanese pharma company Nippon Shinyaku and privately-held UK small activating RNA (RNAa) therapeutics specialist MiNA Therapeutics have announced a collaboration. 5 April 2024
A near tripling in the stock price of Candel Therapeutics reflects a swing in investor confidence following mid-stage data from the firm’s lead immunotherapy program. 5 April 2024
Israel-headquartered drugmaker Teva Pharmaceutical Industries and Spain-based mAbxience have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. 5 April 2024
UK pharma major AstraZeneca today released positive high-level results of the ADRIATIC Phase III trial with its already blockbuster drug Imfinzi (durvalumab). 5 April 2024
In a filing with the US Securities and Exchange Commission (SEC), Canadian biotech Zymeworks has revealed the sudden replacement of its chief financial officer. 4 April 2024
Amylyx Pharmaceuticals’ shares were up 5.9% at $2.78 mid-morning, despite the company revealing that it was pulling its lead product from the market after the drug failed in a confirmatory trial that was announced last month. 4 April 2024
The UK’ Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Exblifep, the combined antibiotic cefepime/enmetazobactam. 4 April 2024
A second Expert View piece from Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex. 4 April 2024
The US Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection), developed by Swiss drugmaker Basilea Pharmaceutica. 4 April 2024
UCB's Bimzelx (bimekizumab-bkzx) has taken a step closer to a new US approval, with the regulator accepting a supplemental Biologics License Application in hidradenitis suppurativa (HS). 4 April 2024
Polish biotech company PolTREG has published new data on PD-1+ T-cells, outlining their usefulness as a biomarker for the efficacy of its candidate PTG-007. 4 April 2024
April is Fabry disease awareness month, which we are taking as an opportunity to explore advances in the pharmacological treatment of this rare disease. 4 April 2024
LENZ Therapeutics, a biopharma focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, is a step closer to realizing its ambition. 4 April 2024
First approved in 2009 as a treatment for schizophrenia, Vanda Pharmaceuticals’ Fanapt (iloperidone) has now won US regulatory approval for a new indication, with the news sending the US drugmaker’s shares up 33% to $5.23. 4 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.