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.
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024
Japan’s Nxera Pharma has expanded its strategic R&D partnership with UK-based computational biology company PrecisionLife into autoimmune disorders with the potential to identify new drug targets for the treatment of complex, chronic conditions. 30 May 2024
US genetic diseases and cancer drug developer BridgeBio Pharma has announced positive results of five new analyses of clinical endpoint events from its Phase III ATTRibute-CM study of acoramidis in transthyretin amyloidosis cardiomyopathy (ATTR-CM). 30 May 2024
The US Food and Drug Administration granted accelerated approval to Retevmo (selpercatinib) from US pharma major Eli Lilly for pediatric patients two years of age and older. 30 May 2024
Globally, the devastating and widespread impact of neurological disorders like Alzheimer's disease, epilepsy, Parkinson’s disease and depression is only getting worse. 30 May 2024
Bio-Thera Solutions has partnered with STADA Arzneimittel for the commercialization of BAT2506, a biosimilar candidate to Simponi (golimumab). 30 May 2024
Cell and gene therapy (CGT) manufacturing specialist Ori Biotech has introduced its IRO platform, aiming to streamline and scale the manufacturing process for CGTs. 30 May 2024
The US Food and Drug Administration has approved US biotech major Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. 30 May 2024
The US Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) submitted by Jazz Pharmaceuticals for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody. 30 May 2024
Johnson & Johnson has announced positive results from the Phase III MDD3001 trial for seltorexant, a selective orexin-2 receptor antagonist. 30 May 2024
New research published in Nature Communications shows another potential application for GLP-1 agonists, adding to established benefits in type 2 diabetes, obesity and heart disease. 30 May 2024
An Expert View from Danie du Plessis, executive vice president, pharmaceutical operations at Kyowa Kirin International, and chair of the Medical Affairs Professional Society (MAPS) board. 29 May 2024
Dublin, Ireland-headquartered protein specialist Prothena announced that US pharma major Bristol Myers Squibb has obtained the exclusive global license for PRX019. 29 May 2024
With the annual meeting of the American Society of Clinical Oncology (ASCO) now just days away, multiple large drugmakers have lifted the lid on data that they intend to present. 29 May 2024
Market and contract research organization IQVIA has published its Global Oncology Trends report for 2024, projecting a significant rise in cancer cases. 29 May 2024
The US Food and Drug Administration (FDA) has accepted the New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, under development by Swiss pharma giant Roche. 29 May 2024
Less than two years after it was launched, San Francisco-based start-up Cartography Biosciences has announced a deal with nearby biotech major, Gilead Sciences. 29 May 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.