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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
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
Octapharma announced the results from the Phase III (LEX-209) study on the efficacy and safety of Balfaxar (prothrombin complex concentrate, human-lans) have been published by the American peer-reviewed journal JAMA Network Open. 13 August 2024
Shares in Actinogen Medical, an Australian biotech developing a novel therapy for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol, closed 58% lower on Monday. 13 August 2024
Connecticut, USA-based biotech start-up Halda Therapeutics announced that it has raised new financing of $126 million in a Series B extension. 13 August 2024
Crown Laboratories, a privately held skincare company, and Nashville, USA-based Revance Therapeutics have entered into an agreement whereby the companies seek to merge the two complementary organizations. 13 August 2024
German drug discovery company Evotec has announced the latest progress of its strategic partnership with US pharma major Bristol Myers Squibb relating to building a molecular glue-based pipeline. 13 August 2024
Swiss drugmaker Santhera Pharmaceuticals today announced the closing of two financing agreements that provided the company with gross funding totaling around 69 million francs ($80.2 million). 13 August 2024
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
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.