News and Trends 3 Jan 2023 Legend Biotech new drug application approved in China Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its new drug application (NDA) for ciltacabtagene autoleucel (cilta-cel). This submission is based on data from the confirmatory phase 2 clinical study CARTIFAN-1, conducted in China, which evaluated the efficacy and safety of cilta-cel in adult patients with relapsed or […] January 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 19 Dec 2022 Jacobio’s cancer treatment given breakthrough therapy designations by China CDE Jacobio Pharma’s in-house KRAS G12C inhibitor JAB-21822 has been granted breakthrough therapy designations in China. The designations are for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation. The designations were granted by the Center for Drug Evaluation (CDE) of the National Medical Products […] December 19, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 5 Dec 2022 First subject dosed in inflammation phase I study Innovent Biologics, Inc. and UNION therapeutics A/S have announced that the first Chinese healthy volunteer has been successfully dosed in the phase I study of orismilast, a potential best-in-class PDE4 inhibitor in global clinical phase II stage. This study is a multiple dose escalation phase I study in healthy volunteers aiming to evaluate the pharmacokinetic […] December 5, 2022 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 2 Dec 2022 Tris Pharma and Pediatrix Therapeutics extend partnership for ADHD portfolio Tris Pharma, Inc announced today (December 2) that they have expanded their partnership allowing Pediatrix Therapeutics to receive exclusive rights to commercialize its entire FDA-approved ADHD portfolio as well as ADHD pipeline products in China. Tris says it has a robust portfolio of FDA-approached products for the treatment of attention deficit/hyperactivity disorder (ADHD) and a pipeline of treatments […] December 2, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 2 Dec 2022 Full-Life Technologies acquiring Focus-X Therapeutics Full-Life Technologies, a global radiotherapeutics company, is acquiring New Jersey-based Focus-X Therapeutics, a company developing targeted radiopharmaceuticals to treat cancer based on peptide engineering technology. The acquisition expands Full-Life’s pipeline, including two compounds nearing clinical trials, provides a second innovative peptide focused discovery platform, and leverages its radiotechnology manufacturing and logistics platforms to advance compounds […] December 2, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 25 Nov 2022 XtalPi and CK Life Sciences partner on tumor vaccine R&D XtalPi has entered into a strategic collaboration with CK Life Sciences, a member of the CK Hutchison Group. The goal is to jointly develop a novel artificial intelligence (AI) tumor vaccine R&D platform. This will improve the discovery and design capabilities of tumor vaccines and accelerate development of more vaccine types. According to public information, […] November 25, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 24 Nov 2022 FDA gives IND approval for Ascletis Covid drug Ascletis Pharma Inc. has revealed that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for Covid-19. The FDA has approved Ascletis to study the safety, tolerability and pharmacokinetics of ASC11 at various doses in healthy subjects […] November 24, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
More News! 18 Nov 2022 Triastek cleared for 3D printed medicine treatment of ulcerative colitis Triastek, Inc. has received clearance for its Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) to initiate clinical studies of the 3D printed medicine, T21, a potential treatment for ulcerative colitis. “We are excited to receive IND clearance to begin clinical trials of this potentially transformative treatment for patients,” […] November 18, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 17 Nov 2022 Ascletis announces IND approval for treatment of advanced solid tumors Ascletis Pharma has announced the approval of the investigational new drug (IND) application by China National Medical Products Administration (NMPA). The approval is for an in-house developed oral PD-L1 small molecule inhibitor prodrug, ASC61, for the treatment of advanced solid tumors. The ASC61 phase 1 dose escalation study is ongoing in the U.S. IND approval […] November 17, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 17 Nov 2022 VISEN growth hormone deficiency trial results announced VISEN Pharmaceuticals has published detailed clinical data from its pivotal phase 3 study of lonapegsomatropin, a long-acting prodrug of unmodified somatropin being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China. The data showed that lonapegsomatropin demonstrated an annualized height velocity (AHV) of 10.66 cm/year compared to 9.75 cm/year for […] November 17, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 16 Nov 2022 Ascletis’ monkeypox tablet receives IND approval from the FDA A drug to treat monkeypox from Ascletis Pharma has had its investigational new drug (IND) application approved by the U.S Food and Drug Administration (FDA). The FDA made its decision based on the available data, which was 800 mg ASC10 taken twice a day, and Ascletis can now go ahead with a phase 1b clinical […] November 16, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 15 Nov 2022 Biotheus enters agreement with Hansoh Pharma for bispecific antibody Biotheus Inc., a clinical-stage biotech company focused on the discovery and development of biologics for oncology and inflammatory diseases, has entered into a collaboration agreement with Hansoh Pharmaceuticals, for Biotheus’ EGFR/MET bispecific antibody (also known as PM1080) in China, Hong Kong, Macao and Taiwan. Under the terms of the agreement, Hansoh will be granted by […] November 15, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email