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.
US pharma major Eli Lilly has provided an update on compounding litigation relating to tirzepatide, its drug for type 2 diabetes and weight loss that is marketed as Mounjaro and Zepbound. 16 May 2024
Blackstone has announced the launch of the Blackstone Life Sciences portfolio company Uniquity Bio, a clinical-stage drug developer on immunology and inflammation. 16 May 2024
The USA’s House Committee on Oversight and Accountability held a markup meeting yesterday to consider a series of bills that address federal agency procurement of biotechnology equipment, safeguarding taxpayer dollars, improving federal cybersecurity, and more. 16 May 2024
USA and UK-based cancer cell therapy developer Adaptimmune Therapeutics has secured $125 million in financing, with the first tranche of $25 million available upon closing. 16 May 2024
The US Food and Drug Administration yesterday granted accelerated approval to Breyanzi (lisocabtagene maraleucel; liso-cel), from US pharma major Bristol Myers Squibb, for a new indication. 16 May 2024
US radiopharmaceuticals company Lantheus Holdings has appointed Dr Jeffrey Humphrey as chief medical officer (CMO) and Dr Jean-Claude Provost as chief science officer (CSO), effective May 28, 2024. 16 May 2024
Israeli generics giant Teva Pharmaceutical Industries has appointed Matthew Shields as executive vice president of Teva Global Operations (TGO), the company’s manufacturing and supply division, effective June 3, 2024. 15 May 2024
Shares in Merck KGaA rose by around 5% in Wednesday’s trading after the Germany-based company presented its first quarter financial results and latest forecast for 2024. 15 May 2024
May 15, 2024
Texas, USA-based drugmaker Lexicon Pharmaceuticals saw its shares edge up 2.7% to by close of trading yesterday and a further 2% to $1.96 pre-market as its announced new research results on its heart failure drug. 15 May 2024
Sands Capital, an active, long-term investor in leading innovative businesses globally, today announced the close of its third life sciences fund, Sands Capital Life Sciences Pulse Fund III (Pulse II”), raising $555 million. 15 May 2024
A US Food and Drug Administration (FDA) panel will consider Lykos Therapeutics’ filing for midomafetamine capsules (MDMA) as a therapy-assisted treatment for post-traumatic stress disorder (PTSD) in early June. 15 May 2024
Japanese drugmaker Eisai has started the rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Leqembi (lecanemab-irmb) subcutaneous (SC) autoinjector for weekly maintenance dosing. 15 May 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA) for Heplisav-B vaccine, said US immunotherapy specialist Dynavax Technologies. 15 May 2024
More leading oncology companies have outlined their planned highlights for the upcoming annual meeting of the American Society of Clinical Oncology (ASCO). 15 May 2024
Four-year data from the SELECT trial will significantly bolster Novo Nordisk’s bid to become the GLP-1 company of choice for payers and prescribers. 15 May 2024
Danish CNS specialist Lundbeck today reported first-quarter 2024 financials, showing that revenues grew 7% at constant exchange rates (CER) and 5% in kroner terms to 5,288 million kroner ($766 million). 15 May 2024
Norwich Pharmaceuticals has submitted to the US regulator for approval to market a generic version of Xifaxan (rifaximin), a treatment for irritable bowel syndrome. 15 May 2024
Russia has faced with the shortage of oncology drug Uromitexan (mercapto ethane sulphonacid; mesna), for which last deliveries to the country were in the spring of 2023, reports The Pharma Letter’s local correspondent. 15 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.