Allakos’s lirentelimab did not beat a placebo in separate Phase 2 tests in atopic dermatitis and spontaneous chronic urticaria. A restructuring now turns the biotech’s focus to an early-stage drug candidate also designed to treat inflammation. By FRANK VINLUAN The lead therapeutic candidate of Allakos has failed in two mid-stage clinical trials for inflammatory skin disorders, leading the biotech to halt work on the drug. Allakos is shifting its focus to an earlier-stage program in its pipeline but will do so with fewer staff. A corporate shakeup is shaving about half of the company’s workforce. San Carlos, California-based Allakos aims to treat allergic, inflammatory, and proliferative diseases with antibodies that target receptors on cells that create immune responses in the body. By activating inhibitory receptors, these drugs are intended to stop inflammation. Its most advanced drug candidate was lirentelimab, which was designed to target an inhibitory receptor on mast cells ...
Recently, according to the public information on the NMPA official website, the KL003 cell injection independently developed by Kanglin Biotechnology (Hangzhou) Co., Ltd. successfully obtained the NMPA’s implicit clinical trial license, with the acceptance number CXSL2300699, and is clinically used to treat transfusion-dependent beta in adults or children. -Thalassemia. The microspectrum biosafety service platform provides cell bank testing and strain library testing services for this product. β-thalassemia is a hemolytic anemia caused by defects or mutations in the β-globin gene (Hemoglobin β, HBB) on chromosome 11, resulting in partial or complete loss of β-globin-related functions, which brings great consequences to the patient’s life and health. The patients is more common in children and adolescents. Traditional treatments for thalassemia (blood transfusion, hematopoietic stem cell transplantation, etc.) are accompanied by side effects that cannot be ignored. The vast majority of patients lack the opportunity for radical cure, and there are obvious unmet ...
Pharmaceutical Executive Editorial Staff Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. The FDA has granted Fast Track designation to ProfoundBio’s rinatabart sesutecan (Rina-S; PRO1184) to treat patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.1 The novel folate receptor alpha (FRα)–targeted antibody-drug conjugate (ADC) is comprised of an FRα-directed antibody linked to sesutecan, which is an investigational, cleavable hydrophilic linker, and the topoisomerase 1 inhibitor payload exatecan. “Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,” said Naomi Hunder, chief medical officer of ProfoundBio, in a press release.1 “FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in ...
The era of medical insurance access management has arrived, the catalog of consumables has been dynamically adjusted, and many places have clearly supported the entry of new technologies and new consumables into medical insurance. 1. Original, patented and centralized purchasing consumables will be included in the medical insurance catalog with priority Recently, the Shaanxi Provincial Medical Insurance Bureau issued the “Notice of the Shaanxi Provincial Medical Insurance Bureau on Further Improving the Payment Management of Medical Insurance Medical Consumables” (hereinafter referred to as the “Notice”). It is clarified that the implementation of the access management of the medical insurance medical consumables catalog will be promoted and the province’s unified catalog of medical insurance medical consumables will be steadily formulated. According to the “Notice”, the payment management of medical insurance medical consumables must follow four principles: first, ensuring basics, second, encouraging innovation, third, being fair and open, and fourth, dynamic adjustment. ...
Detecting cancer in the body or monitoring it during therapy is typically a time-consuming process, often conducted in later phases when signs become obvious. Researchers engaged in cancer research are continuously seeking reliable and sensitive techniques to detect a developing tumor at a very early stage and to closely monitor the success or failure of cancer therapy. Therefore, a breakthrough in early cancer diagnosis is a significant advancement. Researchers have now achieved a breakthrough with the development of a test for early diagnosis of cancer. Researchers at the Paul Scherrer Institute (Würenlingen, Switzerland) have demonstrated that changes in the organization of the cell nucleus of certain blood cells can reliably indicate the presence of a tumor in the body. Using fluorescence microscopy, the team examined the chromatin of these blood cells – DNA packaged into a complex structure. They analyzed about 200 different characteristics, including the external texture, the packing ...
Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland—BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235), a global biotechnology company, today announced that it has The commercialized products and new indications have been successfully entered into the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2023)” (“National Medical Insurance Drug Catalog”) issued by the National Medical Insurance Administration (“National Medical Insurance Administration”). Among them, the company’s independently developed anti-PD-1 antibody Zelzian® (tislelizumab injection) and BTK inhibitor Baiyezan® (zanubrutinib capsules) successfully renewed their contracts and added two new adaptations respectively. The disease was included in the national medical insurance drug catalog; the cooperative products introduced the long-acting goserelin microsphere preparation Bituowei® (goserelin microspheres for injection), the rare disease Castleman’s disease treatment drug Savinco® (stuximab for injection) ) was included for the first time, while the RANKL inhibitor Anjiavir® (desomasumab injection, 120 mg (1.7ml)/bottle) was ...
On December 13, the National Medical Insurance Administration announced that the adjustment of the national basic medical insurance, work injury insurance and maternity insurance drug catalogs in 2023 has been successfully completed. The new version of the catalog will be implemented on January 1, 2024. In this adjustment, a total of 126 drugs were newly added to the national medical insurance drug catalog, and 1 drug was removed from the catalog. 143 drugs outside the catalog participated in negotiations or bidding, of which 121 drugs were successfully negotiated or bid. The negotiation success rate was 84.6%, and the average price reduction was 61.7%. The success rate and price reduction were basically the same as in 2022. After this round of adjustments, the total number of drugs in the national medical insurance drug catalog has reached 3,088, including 1,698 Western medicines and 1,390 Chinese patent medicines; there are still 892 types ...
The commitments will make health systems faster, simpler and fairer for patients Health and social care secretary Victoria Atkins has set out new priorities to improve the health and social care system in the UK. The new commitments intend to make the health and social care system faster, simpler and fairer for patients. As healthcare systems approach the winter season, Atkins has committed to ensuring that health and social care services are faster for patients by making it easier to get treatment locally, improving A&E performance and cutting waiting lists. She commits to making systems simpler for patients and staff with joined-up integrated care and reducing bureaucracy by giving them the latest technology to free up their time to care for patients. Furthermore, Atkins committed to making systems fairer by ensuring that children are protected from health harms; health outcomes are not determined by where people live; the government supports ...
Dive Brief The Food and Drug Administration has authorized the first chlamydia and gonorrhea test with at-home sample collection. LetsGetChecked received de novo authorization for the Simple 2 Test, an over-the-counter kit that uses vaginal swabs or urine specimens to detect the bacteria that cause the two sexually transmitted diseases (STDs). The authorization will move sample collection from the doctor’s office to the home — potentially increasing testing of STDs, which are on the rise — and create a 510(k) pathway for rival diagnostics. Dive Insight Until this week, the FDA had only authorized at-home sample collection for one STD, HIV. Sample collection for all other STDs occurred at the point of care, for example, in a doctor’s office. People may be less likely to get tested at the point of care, particularly for frequently asymptomatic infections such as chlamydia and gonorrhea, because of concerns about confidentiality and convenience. The ...
Don Tracy, Associate Editor Company aims to receive approval on a Type II Variation application for Sirturo for patients with pulmonary tuberculosis. The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for bedaquiline (Sirturo), indicated as part of a combination therapy for adults and pediatric patients over the age of five with pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis. Back in August, a supplemental New Drug Application (sNDA) was also submitted to the FDA for the medication. According to data from the CDC, there was a report of approximately 8,300 cases of TB in 2022, up from 7,874 cases reported in 2021. The center also reports that TB cases in the United States are beginning to return to pre-pandemic levels, following a substantial decline in 2020, likely due to factors associated with ...
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