Today, the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Screenshot source: CDE official website Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once a week as a replacement therapy for endogenous growth hormone in adult growth hormone ...
Today (September 5th), the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once a week as a replacement therapy for endogenous growth hormone in adult growth hormone deficiency (AGHD) patients. ...
Original Medicine Guanlan Medicine Guanlan September 5, 2024 08:35 Shanghai Reported by WuXi AppTec Content Team Today (September 5th), the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once ...
Novo Nordisk Education Foundation (NNEF), a non-profit organisation set up by Novo Nordisk India, signed a Memorandum of Understanding (MoU) with Rabindranath Tagore (RNT) Medical College, Udaipur to establish a ‘Sickle Cell Wellness Hub’ dedicated to people living with sickle cell disease (SCD). The MoU was signed between Dr Vipin Mathur – Principal & Controller, RNT Medical College and Vikrant Shrotriya – Managing Trustee, Novo Nordisk Education Foundation. Also present at the occasion were Dr R L Suman – Medical Superintendent, MB Government Hospital, Udaipur and Dr Lakhan Poswal – Senior Professor & HOD, Pediatrics and Nodal Officer, SCD Centre of Excellence, RNT medical College, Udaipur. This public-private partnership is aligned to the Government of India’s commitment of eradicating SCD from India by 2047 as part of its National Sickle Cell Anaemia Elimination Mission 2023 [1]. According to the statement released, the Sickle Cell Wellness Hub will offer holistic care ...
The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank VinluanA Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank Vinluan A Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
Amgen is confident its injectable obesity drug would have a differentiated profile compared to medications now on the market from Novo Nordisk and Eli Lilly and it’s now preparing for Phase 3 testing. But an oral obesity drug in Amgen’s pipeline will not advance beyond Phase 1. By Frank Vinluan Amgen aims to challenge the Novo Nordisk and Eli Lilly duopoly in the market for injectable obesity medications, and the company is now preparing for Phase 3 testing of an injectable drug candidate that would introduce new competition. While executives are not yet sharing specific details of the clinical data that support these plans, Amgen’s drug candidate could have dosing and manufacturing advantages. The update for the drug, maridebart cafraglutide or MariTide (known in earlier stages of development as AMG 133), came with Amgen’s report of financial results for the first quarter of 2024. CEO Robert Bradway said the company ...
The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
Don Tracy, Associate Editor Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure. Novo Nordisk announced that it has acquired Cardior Pharmaceuticals in hopes of improving its pipeline in cardiovascular disease management. The acquisition includes Cardior’s top drug candidate, CDR132L, which is currently in Phase II of clinical development for treating heart failure. Under terms of the agreement, Cardor has the potential to earn up to $1.112 billion, including an upfront payment and the opportunity for more payments pending the completion of certain development and commercial milestones.1 “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “We have been impressed by the scientific work carried out by the ...
An experimental Novo Nordisk obesity pill led to weight loss of 13.1% in a clinical trial, topping results posted in studies of the company’s approved injectable medication Wegovy. It’s early days and more testing is needed, but the preliminary data suggest that this pill has the potential to offer patients superior weight shedding in a more convenient oral formulation. Phase 1 data for the once-daily Novo Nordisk pill, amycretin, were presented Thursday during a company investor event. The study followed participants for 12 weeks. In that span, those who received a placebo lost 1.1% of their body weight. Wegovy, which is administered as a once-weekly injection, was not part of this clinical trial. Published clinical trial results for that drug show it led to weight loss of 5.9% measured at 12 weeks. Wegovy, whose main ingredient is the peptide semaglutide, offers one mechanism of action: activating the GLP-1 receptor to ...
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