17 September 2024 The HERTHENA-Lung02 Phase III trial of patritumab deruxtecan, in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment, has met its primary endpoint.
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
MAIA Biotechnology, a US biopharmaceutical company developing targeted immunotherapies for cancer, has announced a positive update on its lead clinical candidate. 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Los Angeles, USA-based cancer research center City of Hope has received a $150 million donation, boosting its work targeting pancreatic cancer. 18 September 2024
Gene therapy research in Japan has gained significant momentum due to the SAKIGAKE designation system and government-led initiatives like the “Project for Regenerative/Cellular Medicine and Gene Therapies” to accelerate research and development (R&D) to create new technologies for gene/cell therapy. 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Structure Therapeutics, a specialist in small molecule treatments for metabolic and pulmonary diseases, has announced key leadership appointments. 18 September 2024
The HERTHENA-Lung02 Phase III trial of patritumab deruxtecan, in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment, has met its primary endpoint. 17 September 2024
US biotech Capricor Therapeutics has entered into a binding term sheet with Japanese drugmaker Nippon Shinyaku for the commercialization and distribution in Europe of Capricor’s lead asset, deramiocel. 17 September 2024
US biotech major Regeneron has shown that the addition of its investigational LAG-3 inhibitor fianlimab to its PD-1 inhibitor Libtayo (cemiplimab) offers impressive results in advanced melanoma. 17 September 2024
Dystonia is a neurological movement disorder characterized by involuntary muscle contractions that cause repetitive movements, abnormal postures, or twisting. 17 September 2024
A cancer drug in-licensed by German biotech major BioNTech from China-based Biotheus could be a good one, if mid-stage results shared at the European Society for Medical Oncology (ESMO) are anything to go by. 17 September 2024
The US Food and Drug Administration (FDA) has approved Crexont (carbidopa and levodopa; formerly IPX2023) extended-release capsules for the treatment of Parkinson’s disease (PD), from US drugmaker Amneal Pharmaceuticals. 9 August 2024
US drugmaker Eli Lilly wowed investors with expectation-busting second-quarter financial results on Thursday, sending its shares spiralling 8% higher by early afternoon trading. 8 August 2024
Germany-based Medigene’s shares were down 3.7% at 1.04 euros in late afternoon trading, after it revealed a collaboration with China’s WuXi Biologics. 8 August 2024
Vertex Pharmaceuticalsrevealed a reimbursement agreement with NHS England for eligible transfusion-dependent beta thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), from today. 8 August 2024
US cell and gene therapy company Precigen has announced a strategic reprioritization of the company's clinical portfolio and streamlining of resources. 8 August 2024
Takeda announced that the European Commission (EC) has approved Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP). 8 August 2024
The US Food and Drug Administration (FDA) has granted accelerated approval for Novartis’ Fabhalta (iptacopan), a first-in-class complement inhibitor for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. 8 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
CytoReason’s $80 million venture round may not have been the biggest in July, but it is one of a growing number of investor bets on AI powered drug discovery this year. 7 August 2024
Finland-based Faron Pharmaceuticals, a biopharma reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, has announced that its chief executive Markku Jalkanen is to retire. 7 August 2024
Denmark US oncology-based Pharmacosmos today revealed it has entered a definitive agreement to acquire US cancer-focused company G1 Therapeutics. 7 August 2024
Shares of US therapeutic gene editing company Sangamo Therapeutics leapt as much as 46% to $1.11 yesterday on the news of a licensing deal. 7 August 2024
Danish pharma major Novo Nordisk was trading nearly 4% lower on Wednesday afternoon after earlier presenting its latest quarterly financial results and guidance for the rest of 2024. 7 August 2024
The US Food and Drug Administration approved French privately-held drug major Servier’s vorasidenib, now trade named Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for certain types of brain tumors. 7 August 2024
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Company Spotlight
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of first-in-class biological therapeutics for the treatment of rare disorders.