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.
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
Indian generics drugmaker Cadila Pharmaceuticals, together with the Russian investment fund the Russian Direct Investment Fund (RDIF), will invest more than 10 billion roubles ($112 million) in the establishment of a pharmaceutical complex and an injection drug plant in Russia. 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
Genfit, a biopharmaceutical company focused on rare liver diseases, has announced that it has received an Accelerated Approval for Iqirvo (elafibranor). 11 June 2024
The US Food and Drug Administration issued a Federal Register Notice announcing the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered through the Center for Drug Evaluation and Research’s (CDER) newly established Emerging Drug Safety Technology Program (EDSTP). 11 June 2024
Biotechnology star-tup Alumis is set to go public, filing with the US Securities and Exchange Commission for an initial public offering (IPO). 11 June 2024
The Association of the British Pharmaceutical Industry (ABPI) has issued a challenge to the UK’s political parties ahead of next month’s election. 10 June 2024
Calico Life Sciences, a biotech company specializing in aging and age-related diseases, has had its candidate fosigotifator accepted into the US Food and Drug Administration’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program. 10 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
British pharma major AstraZeneca's bid to broaden the label for Tagrisso (osimertinib) will be considered under the Priority Review scheme. 10 June 2024
Swiss ophthalmology specialist Oculis Holding has announced positive top-line results from its Phase IIb RELIEF trial with licaminlimab (OCS-02). 10 June 2024
The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall, to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm. 10 June 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.