Search Results for “EC” – Page 301 – media

Gilead Drug Fails Pivotal Lung Cancer Study, But Still Might Have Path Forward

Gilead Sciences said even though Trodelvy missed the main goal of its Phase 3 test in non-small cell lung cancer, the drug’s preliminary results show numerical improvement in patients whose disease did not respond to prior treatment with immunotherapy. The company plans to discuss with regulators a possible path forward in these patients. By FRANK VINLUAN Sales for Gilead Sciences cancer drug Trodelvy are growing, but the company is counting on additional approvals to boost the product to blockbuster status and justify the premium price it paid to acquire the therapy. The drug’s failure in a pivotal lung cancer study is a setback to that strategy. Treatment with Trodelvy, an antibody drug conjugate (ADC), fell short of a Phase 3 study’s main goal of showing statistically significant improvement in overall survival in patients with advanced cases of non-small cell lung cancer (NSCLC), Gilead announced Monday. Nevertheless, the company pointed to numerical ...
- Source: https://medcitynews.com/author/fvinluan/
- 182
- January 24, 2024
NHS catch up campaign launched for missed MMR vaccines

Approximately one in five children will be hospitalised to treat measles The NHS has announced the launch of its new catch up campaign to get millions of children booked in for their missed measles, mumps and rubella (MMR) vaccine. The new campaign aligns with the health services efforts to protect children from becoming seriously ill as cases of measles rise across the UK. MMR are highly infectious illnesses that can lead to blindness, deafness and swelling of the brain. Considered more infectious than COVID-19, NHS analysis has shown that one infected child in a classroom can infect up to nine other unvaccinated children. In total, more than 3.4 million children under the age of 16 are currently unprotected and are at risk of catching MMR. The new campaign will assure that all parents of children from the age of six to 11 years are contacted to book an appointment with ...
- Source: https://pharmatimes.com/news/nhs-catch-up-campaign-launched-for-missed-mmr-vaccines/
- 96
- January 24, 2024
FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma

Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy. The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.1 The regulatory action amends the accelerated approval granted by the FDA in April 2019 for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy. Balversa, a fibroblast growth factor (FGFR) inhibitor, is not recommended for patients who are eligible for, and were not previously administered, prior treatment with a PD-1 or PD-L1 inhibitor, according to the FDA.The FDA based the approval on data from Study BLC3001 cohort 1, which evaluated data from 266 patients with metastatic urothelial carcinoma harboring selected FGFR3 alterations and who previously received ...
- Source: drugdu
- 261
- January 23, 2024
January 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for blu PLUS+ brand e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action. On Thursday, the FDA and the Centers for Medicare & Medicaid Services (CMS) issued a joint statement reiterating mutual support of the FDA’s oversight of laboratory developed tests (LDTs), including the analytical and clinical validity of these tests. LDTs help physicians make critical decisions about their patients’ care. According to the Centers for Disease Control and Prevention, approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it ...
- Source: drugdu
- 111
- January 23, 2024
InnoCare Announces First Prescription of Tafasitamab in Combination with Lenalidomide for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Under Greater Bay Area’s Early Access Program

BEIJING, China. Jan. 22, 2024 – InnoCare (HKEX: 09969; SSE:688428) today announced that tafasitamab (Minjuvi®) in combination with lenalidomide has been recently approved by the Medical Products Administration of Guangdong Province, under the early access program in Guangdong-Hong Kong-Macao Greater Bay Area (“Greater Bay Area” for short), for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient. The early access program of the Greater Bay Area allows designated medical institutions in the area to access drugs and medical devices that have been approved by regulatory authorities for marketing in Hong Kong or Macao.Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “We are pleased to provide eligible patients access ...
- Source: drugdu
- 154
- January 23, 2024
World’s First Perioperative Immunization Phase III Study Results in Esophageal Cancer Presented at 2024 ASCO GI

The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) was held in San Francisco from January 18 to 20, local time. As an academic event in the field of gastrointestinal tumors, ASCO GI showcased several heavyweight and innovative scientific advances in the field, especially the release of the Late-breaking Abstract (LBA) study, which will lead the way to a new direction in clinical treatment. Phase III study (ESCORT-NEO/NCCES01), led by Prof. Li Yin of Cancer Hospital, Chinese Academy of Medical Sciences, with the participation of 24 centers across China, was selected as LBA. Professor Li Yin reported the results of the study, which is the world’s first perioperative immunization Phase III study in esophageal cancer. Neoadjuvant carelizumab in combination with chemotherapy showed a significantly better pCR rate than that of neoadjuvant chemotherapy, achieving the primary endpoint without increasing the risk of surgery and with a manageable safety profile. ...
- Source: drugdu
- 82
- January 23, 2024
FDA Fast Tracks Nurix Therapeutics, Inc’s Novel BTK Inhibitor for CLL, SLL

Pharmaceutical Executive Editorial Staff NX-5948 is under evaluation for for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor. The FDA has granted Fast Track Designation to Nurix Therapeutics, Inc’s investigational Bruton’s tyrosine kinase (BTK) inhibitor NX-5948 for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) following at least two lines of therapy that includes a BTK inhibitor and a BCL2 inhibitor.1 NX-5948 has previously demonstrated that it is highly potent across a range of tumor cell lines with BTK inhibitor–resistance, which is an important treatment consideration for heavily pretreated patients with CLL and SLL, according to Nurix. “Fast Track designation for NX-5948 is an important recognition of the unmet patient need in CLL, particularly in the growing number of patients whose cancer has progressed ...
- Source: drugdu
- 118
- January 22, 2024
AI Governance Alliance calls for stronger global collaboration

As global leaders and industry power players gather in Davos to address the world’s most pressing problems, the World Economic Forum’s (WEF) AI Governance Alliance (AIGA) has called for stronger collaboration to create a framework for advanced AI. In a series of three new reports, AIGA has focused on unlocking the value and creating a framework for generative AI (GenAI) usage. AIGA said a global effort is needed to create equitable access to AI. According to Cathy Li, head of AI, data and metaverse at the WEF: “The AI Governance Alliance is uniquely positioned to play a crucial role in furthering greater access to AI-related resources, thereby contributing to a more equitable and responsible AI ecosystem globally.” “We must collaborate among governments, the private sector and local communities to ensure the future of AI benefits all,” she added. AIGA has called for experts in various sectors to address key areas ...
- Source: drugdu
- 93
- January 22, 2024
Synendos set to study endocannabinoid inhibitor for neuropsychiatric conditions

Swiss company Synendos therapeutics has been given the go-ahead from the European Medicines Agency (EMA) to advance its lead candidate, SYT-510, into a Phase I clinical trial to treat neuropsychiatric disorders. The first-in-class inhibitor targets endocannabinoids—naturally occurring, lipid-based neurotransmitters that help to maintain homeostasis. SYT-510 is said to inhibit endocannabinoid reuptake, which raises the amount of those neurotransmitters available in the synaptic cleft and increases neurotransmission. In the upcoming planned Phase I first-in-human trial, the focus will be on assessing the safety, tolerability and pharmacokinetics in healthy patients receiving increasing single doses of SYT-510. Basel headquartered-Synendos was spun out of the University of Bern in 2019, raising $27.8m in two Series A funding rounds in 2020 and 2021, co-led by Kurma Partners, Sunstone Life Science Ventures, and Ysios Capital. The company secured a two-year Eurostars grant in 2021, a European Union (EU) funding scheme, named the EndoCARE programme, to propel ...
- Source: drugdu
- 82
- January 22, 2024
Announcement of Tonghua Dongbao on the Achievement of Primary Endpoint in Phase IIa Clinical Trial of URAT1 Inhibitor (THDBH130 Tablets)

Tonghua Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd (“Dongbao Zixing”), a wholly-owned subsidiary of Tonghua Dongbao Pharmaceuticals Co., Ltd. (“Tonghua Dongbao”), has completed a pivotal Phase IIa clinical trial and obtained the summary report of the trial. The results of the study showed that the primary endpoints were achieved. The relevant information is announced as follows: I. Basic information of the drug 1、Name: THDBH130 Tablets 2、Indications：Hyperuricemia and gout 3、Dosage form: Tablet 4、Specification：2.5mg、20mg 5、Registration Classification: Chemical 1 6、Applicant: Dongbao Zixing (Hangzhou) Biomedical Co. 7, drug clinical trial approval: State Drug Administration approved the issuance of drug clinical trial approval notice (2021LP02020). The State Drug Administration approved the issuance of a notice of approval for clinical trial of the drug (2021LP02022; 2021LP02023), agreeing to carry out clinical trials. II. R&D Investment As at the date of this announcement, the Company has invested approximately RMB79.39 million in research and development in the Project. III. ...
- Source: drugdu
- 104
- January 22, 2024

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