Search Results for “Clinical Trial” – Page 82 – media

FDA investigates ‘serious risk’ of secondary cancer following CAR-T treatment

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. The FDA unveiled the probe Tuesday. The agency said it has received reports of T-cell malignancies, including CAR-positive lymphoma, among patients who received BCMA- or CD19-directed CAR-T cell immunotherapies. Some patients involved have had to be hospitalized or died, according to the agency. The cases stem from clinical trials and postmarketing adverse event surveillance, the FDA said. The FDA has determined that the potential risk is applicable to all currently approved CAR-T therapies, as T-cell malignancies have occurred after patients received several different products. The FDA is now weighing potential regulatory action—even as the potential risk of developing secondary cancer is already included as a class warning on the labels of the CAR-T therapies. Currently marketed CD19 CAR-Ts include Yescarta and Tecartus from Gilead ...
- Source: drugdu
- 225
- November 30, 2023
FDA grants second orphan drug designation to Priothera’s mocravimod

The US Food and Drug Administration (FDA) has granted an orphan drug designation to Priothera’s mocravimod for leukaemia patients undergoing a stem cell transplant. The drug is indicated to help improve the outcome of patients with haematologic malignancies following a haematopoietic stem cell transplantation, according to a 27 November press release. Following the designation, the Dublin, Ireland-headquartered biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, have seven years of market exclusivity in the designated indication. Haematopoietic stem cell transplantation, also known as blood and bone marrow transplantation, is used to treat a wide range of blood cancers. There are nearly 60,000 new cases of leukaemia in the US each year. This is the second orphan drug designation for Priothera’s mocravimod. The first, granted in March 2022, was for the treatment of acute myeloid leukaemia (AML) in patients undergoing hematopoietic ...
- Source: drugdu
- 206
- November 29, 2023
AbbVie’s epcoritamab gets one step closer to follicular lymphoma approval

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to the investigational therapy epcoritamab to treat follicular lymphoma. The European Medicines Agency (EMA) has validated a Type II application for epcoritamab for the same indication. Co-developed by AbbVie and Genmab, the subcutaneous IgG1-bispecific antibody, marketed as Epkinly in the US and Tepkinly in the EU, is being evaluated as a new therapy for follicular lymphoma. It has regulatory approval for treating certain large B-cell lymphomas (LBCL). AbbVie had entered into the $750m cancer therapeutics deal with Genmab to develop and commercialise antibody therapies back in 2020. In May 2023, the FDA granted an accelerated approval to Epkinly to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. Epkinly has generated $14m in sales so far this year, according to AbbVie’s Q3 2023 financial results. According to GlobalData’s Pharma Intelligence Center, the drug ...
- Source: drugdu
- 94
- November 29, 2023
EirGenix’s Breast Cancer Biosimilar Receives Marketing Authorization by EC

TAIPEI, Nov. 22, 2023 /PRNewswire/ — EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®. Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). Breast and gastric cancers are among the most frequently occurring in Europe, and combined, are responsible for nearly 200,000 deaths ...
- Source: drugdu
- 108
- November 28, 2023
Health Canada approves Jazz’s cannabis derived seizure therapy

Health Canada has approved Jazz Pharmaceuticals’s Epidiolex (cannabidiol oral solution) as an adjunct therapy in patients aged two years and older for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC). Epidiolex is a plant-based oral cannabidiol solution. It was developed by GW Pharmaceuticals and was added to Jazz’s portfolio following GW’s acquisition in 2021. The therapy was first approved in the US as an adjunct therapy in patients aged two years and older for the treatment of seizures associated with LGS and Dravet syndrome in June 2018. The approval in TSC came in July 2020. All three indications causes different types of serizure. LGS and Dravet syndrome are types of epileptic encephalopathy, that cause seizures. LGS is managed by two or more seizure medications whilst Dravet is treatment-resistant. TCS is a rare genetic condition that causes benign tumours to develop in different ...
- Source: drugdu
- 98
- November 28, 2023
Simcere and Connect sign licensing agreement for anti IL-4Rα AD drug

Simcere has entered a licensing agreement with Connect Biopharma for the development of a monoclonal antibody (MAb) candidate rademikibart (CBP-201) against allergic inflammation in autoimmune conditions such as atopic dermatitis (AD) and asthma. Under the deal, the Nanjing, China-headquartered company will have a licence for the development and commercialisation of rademikibart in mainland China, Macau, Taiwan, and Hong Kong. Connect retains its rights to the MAb outside Greater China. Rademikibart is a humanIgG4 MAb that binds to IL-4Rα, which can be administered as a subcutaneous or intravenous (IV) injection. Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has dominated the AD drug market since it first gained a US Food and Drug Administration (FDA) approval in March 2017. Dupixent had generated $6.4bn in US sales up until 30 September, according to Regeneron’s Q3 2023 report. It is forecast to make over $11bn in global sales for all indications by the end of ...
- Source: drugdu
- 188
- November 26, 2023
Levofloxacin revealed as first effective treatment for multi-drug resistant TB

Two landmark clinical trials involving researchers at University College London (UCL) have demonstrated that levofloxacin is the first effective treatment to prevent multidrug-resistant tuberculosis (MDR-TB). Results from both trials were announced at the Union World Conference on Lung Health in Paris, France. Annually, around 500,000 people develop tuberculosis (TB), an infectious disease caused by a type of bacteria that affects the lungs, that is resistant to multiple antibiotics. Led by Stellenbosch University in South Africa, with the MRC Clinical Trials Unit (CTU) at UCL responsible for trial management and statistical analysis, the TB-CHAMP trial involved 922 children and adolescents exposed to an adult with MDR-TB in their household. Results showed that levofloxacin reduced the risk of MDR-TB disease by 56%, with very few side effects reported. Additionally, after one year, only 1.1% of children developed TB, compared to 2.6% who received a placebo. The second trial, VQUIN, led by the ...
- Source: drugdu
- 125
- November 25, 2023
AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy. The FDA approved the new drug, capivastertib, for use in combination with fulvestrant, an older AstraZeneca breast cancer therapy. The new drug will be marketed under the brand name Truqap. Approval of Truqap covers the treatment of adults with advanced cases of breast cancer classified as HR positive and HER2 negative. Those patients must also have disease that has either progressed after treatment with a hormone therapy or has come back after adjuvant therapy. Truqap joins a group of therapies already available for HR positive, HER2 negative breast cancer, including products from AstraZeneca. Truqap stands apart from them as the first AKT inhibitor. AKT ...
- Source: drugdu
- 110
- November 20, 2023
Q&A With Dr. Mike McCullar, CEO of RegCell

Mike Hollan McCullar discusses his new role as CEO of RegCell. Dr. Mike McCullar CEO RegCell Pharmaceutical Executive: How did you end up as CEO? Dr. Mike McCullar: Prior to joining RegCell as CEO and president, I was a toxicologist by training. I was fortunate to work in multiple operating roles over the years. I ended up working in Japan for a decade, and I was approached by a leading Japanese venture fund and asked if could help them start to migrate leading Japanese companies to the US. RegCell was one of those companies, and I felt it had the potential to have the best-in-class platform in terms of how we think about treating autoimmune disorders. It’s been an interesting journey so far. PE: What are the companies plans for the coming year? McCullar: What we’re focused on right now is launching a first in-human clinical trial. That takes quite ...
- Source: drugdu
- 109
- November 20, 2023
World’s first CRISPR-based gene therapy approved for sickle cell anaemia

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel), marking the world’s first approval of a CRISPR-based gene editing therapy. Casgevy has been approved to treat patients with sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent beta-thalassemia aged 12 years or older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available. Also known as exa-cel, Casgevy is currently being evaluated by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for the drug is set for 8 December in severe sickle cell disease and 30 March 2024 in beta-thalassemia, as per a 16 November press release. Casgevy is a genetically modified autologous CD34+ cell population that contains clustered regularly interspaced short palindromic repeats (CRISPR) edited human haematopoietic stem and progenitor ...
- Source: drugdu
- 102
- November 20, 2023

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