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.
Th US Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) for the treatment of primary biliary cholangitis (PBC), a rare liver disease, said Gilead Sciences 15 August 2024
Japanese drugmaker Chugai Pharmaceutical has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for gene therapy delandistrogene moxeparvovec, for the treatment of Duchenne muscular dystrophy (DMD). 15 August 2024
Pharmaceutical companies supplying products under the UK’s freshly-launched antibiotics subscription model must now certify compliance with a new industry standard. 14 August 2024
Shares of American dermatology company Verrica Pharmaceuticals had a roller-coaster start to the day after announcing what it called positive trial results. 14 August 2024
Accord Healthcare might not be as well-known as certain preeminent pharma corporations in the UK and Europe, but you would struggle to find any company making a greater contribution to the production and supply of medicines across the continent. 14 August 2024
Texas-based Lexicon Pharmaceuticals has announced that, following a strategic review of the company’s commercial and pipeline programs, it will refocus resources across the portfolio and cut jobs. 14 August 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Astellas Pharma's (TYO: 4503) targeted cancer treatment, Vyloy (zolbetuximab). 14 August 2024
Acelyrin (Nasdaq: SLRN) has announced that its Phase III trial for izokibep in hidradenitis suppurativa (HS) met the primary endpoint, achieving a measure of efficacy at 12 weeks. 14 August 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Yselty (linzagolix) for the treatment of moderate to severe symptoms of uterine fibroids (UFs). 14 August 2024
Rivus Pharmaceuticals, a clinical-stage drug developer based in Virginia and California, announced that its Phase IIa HuMAIN trial met its primary endpoint of weight reduction. 14 August 2024
The National Institute for Health and Care Excellence (NICE) has published its final guidance recommending Accord Healthcare’s Orgovyx (relugolix) for the treatment of hormone-sensitive prostate cancer, recognizing the treatment as cost-effective in England. 14 August 2024
US oncology focused biotech Syros Pharmaceuticals announced that it will discontinue enrollment in the SELECT-AML-1 Phase II clinical trial. 14 August 2024
The US Food and Drug Administration (FDA) has approved Galderma’s Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. 14 August 2024
The US subsidiary of South Korea’s Celltrion announced its US Food and Drug Administration (FDA)-approved biosimilar adalimumab-aaty has been added to the Costco member prescription program. 14 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
A survey reflecting the opinions of more than 400 current and former US Food and Drug Administration (FDA) advisory committee members about issues i 13 August 2024
The shortage of drugs in Russia is deepening, and is currently being observed in almost 70 regions throughout the country and forcing the local state to consider ways to resume stable supplies to local market, reports The Pharma Letter’s local correspondent. 13 August 2024
CRISPR genome-editing biopharma company Caribou Biosciences has announced the appointment of Tina Albertson as chief medical officer (CMO). 13 August 2024
Daiichi Sankyo’s shares rose 5.5% to 5,758 yen this morning, after it announced a third approval in China for Enhertu (trastuzumab deruxtecan). 13 August 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
Abivax ABVX) today announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with ulcerative colitis (UC). 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.