Alys Pharmaceuticals has announced its launch with a research and development (R&D) immuno-dermatology focused pipeline backed by a $100m financing from Medicxi. Co-founded by Medicxi and a team of dermatology and scientific specialists, Alys Pharmaceuticals is led by co-founder and COO Thibaud Portal, with Medicxi’s Francesco De Rubertis serving as board chairman. The company’s pipeline is powered by multiple platform technologies, targeting a range of dermatological ailments. Its goal is to transform the dermatological treatment landscape, focusing on conditions such as atopic dermatitis, vitiligo, alopecia areata and chronic spontaneous urticaria. Alys Pharmaceuticals’ pipeline also includes programmes for less common ailments such as mastocytosis and cutaneous T-cell lymphoma, and therapies to prevent skin side effects from cancer treatments. The company is partnering with establishments including the Institut Gustave Roussy and UMass Chan Medical School to advance its collaborative R&D. Alys Pharmaceuticals integrates the platforms and assets from six Medicxi companies: Aldena ...
Tumours with high mtDNA mutations more likely to respond to Opdivo Scientists from the Cancer Research UK Scotland Institute and Memorial Sloan Kettering Cancer Centre have discovered a cancer treatment that can identify patients who are more likely to respond to cancer drugs. Funded by Cancer Research UK and published in Nature Cancer, the study reveals new ways to identify patients who could benefit most from immunotherapy testing for mitochondrial DNA mutations (mtDNA). Researchers rewired the DNA of the mitochondria – energy factories found in living cells – to determine cancer responses to treatments that harness the body’s natural defences to attack cancer cells. Found in up to 50% of all cancers, mtDNA mutations cause mitochondrial dysfunction, which affects adenosine triphosphate levels – the source of energy for use and storage at the cellular level – as well as other cellular processes, leading to neuronal loss. Researchers found that tumours with ...
AnaMar has received orphan drug designations for its systemic sclerosis candidate AM1476 from the FDA and the EMA. The Swedish biotech is now eligible for several incentives in the two regions, according to the designations. Both agencies will provide regular feedback during the application process and waive certain fees. The FDA also offers seven years of market exclusivity while the EMA promises ten years of protection from competition. AnaMar’s AM1476 is an oral antagonist of the 5-hydroxytryptamine receptor (5-HT2B) receptor, which is also known as a serotonin receptor. The company says its candidate halts key signalling pathways associated with fibrosis in a 5 February press release. Systemic sclerosis, also known as scleroderma, is a progressive autoimmune disease characterised by inflammation and fibrosis. Not only is skin hardened in this condition, but internal organs can be affected too. Interstitial lung disease (ILD) is one of the most common disease consequences, occurring ...
Recently, Hengrui Pharmaceutical received the “Drug Registration Certificate” approved and issued by the State Drug Administration, approving the launch of the company’s independently developed Tagelidine Fumarate Injection (Asut®) for the treatment of moderate to severe pain after abdominal surgery. This product is China’s first independently developed innovative Class 1 opioid analgesic drug and will provide new treatment options for patients suffering from postoperative pain. So far, Hengrui has got marketing approval for 16 innovative drugs. Postoperative pain is one of the most common forms of acute pain. It is reported that in China the prevalence of moderate to severe acute pain after surgery in patients is as high as 48.7%. At the same time, patients with moderate to severe pain are not satisfied with analgesic treatment, with 28.5% of patients expressing a need for more efficient analgesic therapy1. Taglidine Fumarate Injection is Hengrui’s key milestone product in the field of ...
Recently, CanSinoBio’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197, TT vector) (hereinafter referred to as “PCV13i”) has obtained the summary report of the Phase III clinical trial. The report shows that the vaccine has good safety and immunogenicity, and the clinical study has reached the predefined clinical endpoints in the target population. CanSinoBio’s PCV13i adopts the covalent combination of polysaccharide antigen and protein carrier. After the polysaccharide antigen connects to the carrier protein, the polysaccharide can be transformed into T-cell-dependent antigen, which not only induces high specific antibody levels in infants and young children under the age of 2 years, but also generates memory B-cells and produces immune memory. At the same time, the company adopts dual-carrier technology, which can reduce the immunosuppression on immunogenicity caused by co-injection with other vaccines. In terms of production process, CanSinoBio adopts a safer production process, and the fermentation medium adopts medium of no animal ...
Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company’s tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022. Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and ...
At the kick-off meeting held at the Center for Disease Control and Prevention in Pu’er City, Yunnan Province, regarding the REC610 China Phase I clinical trial project, the investigator introduced the background of the disease, information about the REC610 product, and gave a detailed introduction of the overall design of the clinical trial, the trial process, and the precautions and other aspects of the clinical trial. After the meeting, the research team sorted out the trial process to support the smooth development of the subsequent trial. REC610 carries a novel adjuvant, BFA01, developed by the Company, which promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies, and is intended to be used for the prevention of herpes zoster in adults aged 40 years and above. Previously, data from an interim analysis of the FIH clinical trial of REC610 in the Philippines using GlaxoSmithKline ...
Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceuticals Co., Ltd. has received notification from the U.S. Food and Drug Administration (FDA) that the company’s abbreviated new drug application (ANDA, i.e., U.S. generic application) for the filing of tacrolimus extended-release capsule has been approved for production and marketing in the U.S. market. The product is indicated for use in combination with other immunosuppressive agents for the prevention of graft rejection following kidney transplantation in adults. The Company’s tacrolimus extended-release capsule is the first generic of this product approved for marketing by the U.S. FDA, and is also the first generic product approved for marketing in China. Tacrolimus is the core basic immunosuppressant after transplantation, which belongs to calmodulin neural phosphatase inhibitor (CNI), and its mechanism of action is to inhibit the expression and/or production of various cytokines, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., by inhibiting the activity of calmodulin phosphatase, and ...
January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
Shenzhen Biokangtai Pharmaceutical Co., Ltd. (hereinafter referred to as “BIOKANGTAI”), a wholly-owned subsidiary of BIOKANGTAI (hereinafter referred to as “the Company”), has recently received a notification of acceptance from the State Drug Administration, agreeing to accept the application for clinical trial of 20-valent Pneumococcal Sugar Conjugate Vaccine (hereinafter referred to as “20-valent Pneumococcal Conjugate Vaccine”) developed by BIOKANGTAI. (hereinafter referred to as “Minhai Biotechnology”), a wholly-owned subsidiary of the Company, has recently received a notification of acceptance issued by the State Drug Administration, agreeing to accept the application for clinical trial of the 20-valent Pneumococcal Polysaccharide Conjugate Vaccine developed by Minhai Biotechnology: I. Main contents of the acceptance notice Product Name: 20-valent pneumococcal polysaccharide conjugate vaccine Application: domestic production of drugs registered for clinical trials Applicant: Beijing Minhai Biotechnology Co. Ltd. Acceptance No.: CXSL2400053 According to the “People’s Republic of China Administrative License Law”, Article 32 of the provisions of ...
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