Search Results for “EC” – Page 300 – media

INNOCARE Pharmaceutical Co., Ltd. voluntarily discloses the announcement on the progress of ICP-723 clinical trial

INNOCARE Pharmaceuticals Limited (the “Company” or “INNOCARE”) is currently in the clinical phase of registration of its innovative drug zurletrectinib (ICP-723). zurletrectinib (ICP-723) has shown favorable safety and efficacy in adult and adolescent (12 to 18 years old) patients. zurletrectinib (ICP-723) has demonstrated a favorable safety and efficacy profile in adults and adolescents (12 to 18 years of age), and has recently completed the first case of administration in a pediatric patient (2 to 12 years of age), initiating the first clinical study in a pediatric patient. The main information is announced as follows: I. Introduction of ICP-723 Zurletrectinib (ICP-723) is INNOCARE’s proprietary second-generation pan TRK small molecule inhibitor for the treatment of patients with advanced or metastatic solid tumors harboring NTRK fusion genes who have not received TRK inhibitor therapy and who are resistant to first-generation TRK inhibitors. Zurletrectinib (ICP-723) can effectively inhibit not only TRKA, TRKB, and TRKC ...
- Source: drugdu
- 81
- January 26, 2024
Major update of the SME user guide

The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development, and has become a reference source of information for SME and academic developers, supporting them to navigate the system of medicine regulation in the EU. The new release incorporates significant updates to reflect major changes in the EU’s legal and regulatory framework for human and veterinary medicines: Veterinary Regulation: the document has been fully revised to align with the veterinary regulation Clinical Trials Regulation (new section 4.4): provides an overview of the clinical trial regulation and Clinical Trials Information System (CTIS) Medical Devices Regulation (new section 4.8): offers insights into the medical devices regulation for human medicines Other important new sections/subsections include: IT Systems (section 1.3): An overview of common platforms, systems, and databases ...
- Source: drugdu
- 84
- January 26, 2024
Reuters

Dangerously low levels of blood sugar—attributed to counterfeit versions of Novo Nordisk’s Ozempic—hospitalized three people in the United States last year, the American Association of Poison Control Centers (AAPCC) told Reuters. In all last year, the AAPCC revealed that there were 3,316 calls from users of semglutide, the active ingredient in Ozempic. It was more than double the number of calls from the previous year and a 15-fold increase from 2019, according to CNN. Most of the calls were for severe episodes of the commonly known side effects of semaglutide, which include nausea, vomiting and stomach pain. Most cases were resolved with intravenous fluids and nausea medications. Of the three dangerous U.S. cases of low blood sugar, also known as hypoglycemia, the AAPCC suspected the users were supplied with fake versions of semaglutide. All three cases were reported from the same regional poison control center, of which there are 55 ...
- Source: drugdu
- 147
- January 26, 2024
FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply. By FRANK VINLUAN Post a comment / at 7:04 PM Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers. The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the drugmakers last Friday instruct them to add additional language to the boxed warning stating that T cell malignancies have occurred following the treatment of ...
- Source: drugdu
- 91
- January 25, 2024
Gilead’s Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC

January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
- Source: drugdu
- 87
- January 25, 2024
AI Leverages Tumor Genetics to Predict Patient Response to Chemotherapy

Understanding tumor responses to drugs becomes challenging due to the complex nature of DNA replication, a critical target for many cancer treatments. All cells, including cancer ones, depend on a sophisticated system for DNA replication during cell division. Most chemotherapies aim to disrupt this replication process in rapidly multiplying tumor cells. Given the diverse genetic mutations in tumors, predicting drug resistance remains a formidable challenge. Now, scientists have developed a machine learning algorithm capable of predicting when cancer will resist chemotherapy. This model was specifically tested on cervical cancer, accurately predicting responses to cisplatin, a widely used chemotherapy drug. It efficiently identified tumors likely to resist treatment and shed light on the molecular mechanisms driving this resistance. Developed by the University of California San Diego School of Medicine (La Jolla, CA, USA; ), the algorithm assesses how various genetic mutations collectively impact a tumor’s response to DNA replication-inhibiting drugs. The ...
- Source: drugdu
- 86
- January 25, 2024
Deep Cooperation Agreement Between Beijing Hemophilia Association and Shanghai RAAS in Rare Disease Care

In January 2024, the Beijing Hemophilia Association Rare Disease Care Center and Shanghai RAAS Blood Products Co., Ltd., after negotiations, reached a deep cooperation agreement in the field of hemophilia charity and public welfare. They will work together to promote the development of charitable and public welfare activities related to hemophilia in China. Shanghai RAAS Blood Products Co., Ltd. was established in 1988 and went public on the Shenzhen Stock Exchange in June 2008. It is a leading domestic blood products enterprise that integrates the collection of raw plasma, research and development, production, and sales of blood products. Their main products include human albumin, intravenous human immunoglobulin (PH4), human coagulation factor VIII, human fibrinogen, human prothrombin complex, human thrombin, and human fibrin sealant. Shanghai RAAS is one of the few domestic blood product manufacturers capable of extracting six components from plasma and has the most comprehensive range of coagulation factor ...
- Source: drugdu
- 79
- January 25, 2024
Harbour BioMed Announces Positive Profit Alert

Cambridge, MA, Rotterdam, NL, Suzhou, CN – Jan 19, 2023 Harbour BioMed (the “Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces a positive profit alert for the year ended December 31, 2023. As disclosed before, there was a turnaround from a loss of US$73.1 million for the six months ended June 30, 2022 to a profit of US$2.9 million for the six months ended June 30, 2023. Based on the preliminary review of the unaudited consolidated management accounts, it is expected that there will be a profit of approximately US$18 million for the year ended December 31, 2023, as compared to a loss of approximately US$137 million for the year ended December 31, 2022. This is the first time that the Company has recorded a net profit on its annual financial statements. The anticipated ...
- Source: drugdu
- 134
- January 25, 2024
MHRA introduces new restrictions for fluoroquinolone antibiotics

From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. This means that fluoroquinolones should only be prescribed when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient. This is a strengthening of the previous regulations which stated that fluoroquinolones should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions.The MHRA conducted a thorough review into the effectiveness of current measures to reduce the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics and sought advice from the Commission on Human Medicines (CHM). The review process considered available evidence, including Yellow Card reports submitted by patients and healthcare professionals, and the experiences of people affected by these side effects. The restrictions have ...
- Source: drugdu
- 75
- January 25, 2024
Data from 11 studies of CHIATAI TIANQING’s class 1 innovator anilotinib, pembrolizumab, and bemosulbemab unveiled

The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) 2024 has been successfully concluded. CHIATAI TIANQING Pharmaceutical Group’s Class 1 innovative drugs Anrotinib (small molecule multi-targeted receptor tyrosine kinase inhibitor), Paianprilizumab (PD-1 inhibitor) and Behmosubaisumab (TQB2450, PD-L1 inhibitor) have been selected to be presented at the poster session this time with a total of 11 studies, which are related to the field of GI tumors with liver metastasis, esophageal cancer, hepatocellular carcinoma, tumors of the biliary tract system, and colorectal cancer. ALTER-G-001 is a multi-cohort, multi-center phase II study, and updated results from Cohort A were presented at this ASCO GI meeting. Patients in Cohort A were treated with 6 cycles (3 weeks each) of anilotinib (12 mg, po, qd, d1-14, q3w) + oxaliplatin (130 mg/m2, iv, d1, q3w) + capecitabine (850 mg/m2, po, bid, d1-14, q3w), and if liver metastases were not converted to resectable on ...
- Source: drugdu
- 159
- January 24, 2024

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