Search Results for “EC” – Page 311 – media

Nexletol partners Esperion and Daiichi Sankyo patch up milestone dispute with $125M settlement

After a dispute over milestone payments derailed a 2019 heart med collaboration, Daiichi Sankyo and Esperion Therapeutics have mended fences with a $125 million settlement. Under the new agreement, Daiichi will pay Esperion $100 million in the coming weeks before an anticipated label expansion in Europe for their bempedoic acid products Nilemdo and Nustendi, which are branded as Nexletol and Nexlizet, respectively, in the U.S. The company will pay a further $25 million in the quarter following the European Medicines Agency’s (EMA) decision on whether to add language about a cardiovascular risk reduction to the drug’s label. Meanwhile, European manufacturing and supply responsibilities will change hands from Esperion to Daiichi, which will deliver “significant cost savings and efficiencies” to both companies, the partners said in a joint press release. Going forward, the two companies will expand their collaboration to potentially work on a triple-formulation product using bempedoic acid. Daiichi will ...
- Source: drugdu
- 79
- January 5, 2024
Pfizer rings in New Year with hemophilia B gene therapy nod in Canada

After a pair of high-profile approvals for sickle cell disease gene therapies in the U.S. last month, Pfizer is ushering in the New Year with a regulatory endorsement for its hemophilia B gene therapy north of the border. Health Canada has approved Pfizer’s adeno-associated viral (AAV) vector-based gene therapy, Beqvez, for the treatment of certain adults with hemophilia B, the company said Wednesday. Specifically, the agency endorsed the drug to treat patients with moderate to severe disease who are negative for neutralizing antibodies to variant AAV serotype Rh74. The approval is based on an open-label, single-arm study called BENEGENE-2, which enrolled 45 patients and met its primary goal. In the study, Pfizer’s drug demonstrated noninferiority and superiority to the standard of care, a recurrent Factor IX regimen, on the measure of annualized bleeding rates. Traditionally, patients with hemophilia B have needed to receive routine infusions of Factor IX treatment to ...
- Source: drugdu
- 114
- January 5, 2024
New Protein Risk Predicts Mortality Risk in Heart Failure Patients

Heart failure (HF) is a complex clinical condition characterized by high mortality rates. Existing methods for assessing the biological complexity of HF and determining clinical strategies are somewhat inadequate. High-throughput proteomics has the potential to enhance risk prediction; however, its practical application in managing HF patients requires robust validation and proven clinical advantages. Now, researchers have developed a new protein risk score that offers improved calibration and the potential to assist healthcare providers in more accurately determining the mortality risk in individuals with HF. Researchers from the National Institutes of Health (NIH, Bethesda, MD, USA) have developed and validated a protein risk score to stratify mortality risk in persons with heart failure using a community-based cohort of 7,289 plasma proteins in 1,351 patients with HF using the SomaScan Assay from SomaLogic (Boulder, CO, USA). In the development cohort, the team chose 38 unique proteins for inclusion in the protein risk ...
- Source: drugdu
- 146
- January 4, 2024
Novartis Returns to Voyager Therapeutics to Reach New Gene Therapy Destinations

Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
- Source: drugdu
- 187
- January 4, 2024
Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%. By FRANK VINLUAN Longboard Pharmaceuticals is chasing much bigger companies already in the market with therapies for rare forms of epilepsy. The biotech has gone from saying its drug could be differentiated to claiming it has best-in-class potential. Longboard now has some early clinical data to help build that case. Longboard drug bexicaserin, formerly known as LP352, was tested in a placebo-controlled Phase 1b/2a study whose main goal is measuring the change in seizure frequency. Preliminary results released Tuesday show the bexicaserin group achieved a median 53.3% reduction in seizure frequency in the 75-day treatment period compared to a 20.8% median decrease in seizure frequency in ...
- Source: drugdu
- 127
- January 4, 2024
MediLink Therapeutics and Roche reach exclusive global license agreement to collaborate on the development of next-generation antibody drug conjugates for cancer treatment

Suzhou, China, January 2, 2024 – Suzhou MediLink Therapeutics (“MediLink”) announced today that it has reached a global cooperation and licensing agreement with Roche. The two parties will collaborate to develop a next-generation antibody-drug conjugate product candidate YL211 (“c-MET ADC”) targeting mesenchymal epidermal transforming factor (c-MET) for the treatment of solid tumors. Under the terms of the agreement, Roche will obtain exclusive rights to the global development, manufacturing and commercialization of YL211. MediLink will work with the China Innovation Center of Roche (CICoR) to promote the YL211 project into phase I clinical trials, and Roche will be responsible for further development and commercialization work on a global scale. Roche will pay MediLink an upfront payment and near-term milestone payments of US$50 million, in addition to nearly US$1 billion in potential milestone payments for development, registration and commercialization, as well as future gradient royalties based on global annual net sales. About ...
- Source: drugdu
- 123
- January 4, 2024
After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In 2022, fueled by its powerhouse COVID products, Pfizer became the first company in the history of the biopharma industry to top $100 billion in annual revenue. What would the New York drugmaker do for an encore? In 2023, Pfizer went from generating the most sales in the industry to gaining the most approvals. With seven FDA nods in 2023, Pfizer had more than double that of any other company. It’s also more than twice as many as every drugmaker over each of the last three years. You need to go back to 2019, when Novartis scored six approvals, to find a company that approached what Pfizer accomplished in 2023. Pfizer’s splurge included four approvals in a dizzying five weeks in May and June. And all but one of the seven products has been pegged by analysts as a potential blockbuster. Two of the newly approved Pfizer treatments were acquired ...
- Source: drugdu
- 212
- January 4, 2024
Inside AbbVie’s $10B buyout of ImmunoGen—and the bidding war it swooped in on

AbbVie is entering 2024 with a foothold in the antibody-drug conjugate (ADC) field thanks to its late-2023 buyout of ImmunoGen worth more than $10 billion. But according to a new securities filing, AbbVie didn’t pursue the cancer drugmaker until other suitors were already at the negotiating table. ImmunoGen’s recent round of M&A deliberations began in April, according to the filing, when a company only identified as “Party A” reached out to CEO Mark Enyedy expressing interest in a potential transaction. Before that, ImmunoGen had been routinely evaluating potential opportunities for deals of various types, but the interest from Party A struck up a round of talks that ultimately led to the sale. However, Party A’s note of interest came without a proposed purchase price, a move that the company’s advisors at Goldman Sachs and Lazard called “unusual but not unprecedented.” Before the talks moved along, ImmunoGen presented its first-quarter earnings ...
- Source: drugdu
- 171
- January 4, 2024
Cancer Test Could Allow More Patients to Benefit from Immunotherapy

Millions of people across the world are diagnosed with colorectal cancer and endometrial cancer each year. A significant number of patients with these cancers exhibit mismatch repair deficiency, a genetic anomaly characterized by errors in DNA due to the absence of specific repair proteins. This deficiency hampers DNA repair capabilities, potentially leading to various cancer types. Prior studies have indicated that patients with this condition often show positive responses to immunotherapy, which leverages the body’s immune system to combat cancer. Now, a new study has broadened the scope of patients who might benefit from this treatment approach. A research team from Brigham and Women’s Hospital (Boston, MA, USA) conducted an analysis involving 1,655 patients with either colorectal or endometrial cancer. These patients underwent both immunohistochemistry, the prevailing standard test for this genetic state, and next-generation sequencing tests. Immunohistochemistry detects mutations impacting the antigen, while next-generation sequencing provides a more comprehensive ...
- Source: drugdu
- 192
- January 3, 2024
Making the Most of Real-World Data in Clinical Trials

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies. By DAVID BLACKMAN Clinical research is in the midst of a data explosion, and that’s a good thing. Technological advances are enabling access to secure and de-identified data sources for researchers, and the optimization of this data holds enormous potential for conducting clinical trials more efficiently, both from a cost and timeline perspective. The incorporation of real-world data (RWD), data gathered from actual patient experiences, in many ways represents an important step toward a fundamentally better understanding of states of disease and health. Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for ...
- Source: drugdu
- 171
- January 3, 2024

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