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Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
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German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its drug candidate survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate or advanced fibrosis (stages 2 or…
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China’s NHSA and MOF Issue Notices to Enhance Cross-Regional Medical Treatment Direct Settlement
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The National Healthcare Security Administration (NHSA) and the Ministry of Finance (MOF) have issued two key notices aimed at enhancing the healthcare system in China. The first, ‘Notice on Further Strengthening the Management Service of Direct Settlement for Medical Treatment Incurred in Other Regions,’ outlines several measures to improve the…
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Bayer’s Finerenone Shows Promise in Heart Failure Treatment, Outperforms Placebo in Phase III Trial
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FRANKFURT—Bayer AG (FRA: BAYN) has announced positive results from the Phase III FINEARTS-HF study for its mineralocorticoid receptor (MR) antagonist, finerenone. Originally approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes, finerenone is now being developed for heart failure, a condition with significant market potential.…
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Suzhou Sanegene Bio Receives NMPA Approval for Clinical Trial of Antihypertensive siRNA Drug
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Suzhou Sanegene Bio Inc., a leading RNAi specialist with research and development centers in both the US and China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug SGB-3908. This antihypertensive siRNA drug has been co-developed with Innovent Biologics,…
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Novo Nordisk to Pump USD 4.1 Billion into U.S. Manufacturing Expansion
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Novo Nordisk (NYSE: NVO), a Danish biopharmaceutical company, has announced plans to invest USD 4.1 billion in expanding its manufacturing capacity in the United States. This strategic move is aimed at bolstering the company’s ability to supply obesity medications along with other treatments for chronic diseases. The decision suggests that…
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Eli Lilly’s Tirzepatide Hits Primary Endpoint in MASH Trial, Outperforming Placebo
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Eli Lilly and Company (NYSE: LLY), a global healthcare conglomerate, has announced positive outcomes from a Phase II clinical trial of tirzepatide, a novel GIP/GLP-1 receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. The study successfully achieved its primary endpoint, demonstrating resolution of MASH without exacerbation of…
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Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
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Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase IIa proof-of-concept trial for its anti-thymic stromal lymphopoietin (TSLP) biologic, Tezspire (tezepelumab), in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The trial indicated that Tezspire reduced the annualized rate of moderate or severe exacerbations…
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AbbVie’s Aquipta/Qulipta Shows Promise in Migraine Prevention Trial
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, last week released interim results from a Phase III open-label trial of its CGRP receptor antagonist, Aquipta/Qulipta (atogepant), for the prevention of migraines in patients with chronic or episodic migraine. The data, collected between weeks 13 to 16, indicated that the average…
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Teva’s Ajovy Achieves Positive Results in Phase III Migraine Prevention Trial in China
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Teva Pharmaceutical Industries Ltd (NYSE: TEVA), headquartered in Israel, has announced positive results from a Phase III study for Ajovy (fremanezumab) as a preventive treatment for migraine in adult Chinese patients. The study met its primary and all secondary endpoints, demonstrating Ajovy’s efficacy in reducing the number of migraine days…
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Hinova Pharmaceuticals Receives NMPA Greenlight for HP501 Clinical Trial in Gout Patients
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Shanghai-based Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HP501 in combination with febuxostat for the treatment of primary gout with hyperuricemia. This marks a significant step forward in addressing…
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Boehringer Ingelheim to Shut Down Consanas Rehabilitation Unit in China Amid Disappointing Performance
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Boehringer Ingelheim (BI), the Germany-based pharmaceutical firm, is set to close its Consanas Rehabilitation stroke care unit in China, despite ongoing efforts to develop innovative treatments for the disease. This move follows disappointing performance metrics, with only 11.5% of stroke patients in China receiving rehabilitative treatment within a week and…
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Novo Nordisk Acquires Cardior for €1.025 Billion to Strengthen Cardiovascular Portfolio
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Denmark-based Novo Nordisk (CPH: NOVO-B) has announced a significant agreement to acquire Germany’s Cardior, a leading expert in RNA biology focused on the prevention, repair, and reversal of cardiovascular diseases (CVDs). The deal, valued at EUR 1.025 billion, which includes upfront and milestone payments, is anticipated to finalize in the…
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AstraZeneca Caps Monthly Costs for US Patients with Asthma and COPD Inhalers
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced an expansion of its accessibility program for inhaled respiratory drugs in the US. The initiative will cap monthly expenses at USD 35 for eligible patients suffering from asthma and chronic obstructive pulmonary disease (COPD). The savings program includes coverage…
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Novo Nordisk’s Ozempic Meets Phase III Endpoints in Type 2 Diabetes and Chronic Kidney Disease Study
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Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical company, has this week published results from a Phase III study assessing the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). Following the trial’s discontinuation…
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Shanghai Pharmaceuticals’ MediTrust Health Teams Up with Eisai to Enhance Alzheimer’s Prevention and Treatment
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Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607, HKG: 2607)’s subsidiary MediTrust Health, which specializes in insurance, financing, and direct-to-patient pharmacy services, has entered into a partnership with Japan’s Eisai to jointly address the prevention, control, and security of Alzheimer’s disease (AD). The collaboration aims to develop a comprehensive health management…
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Sanofi’s Dupixent Receives FDA Priority Review for COPD Indication Extension
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Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food and Drug Administration (FDA) has accepted for priority review an indication extension filing for its interleukin blocker Dupixent (dupilumab). The drug is proposed as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD),…
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Sanofi Secures Rights to Graviton’s ROCK2 Inhibitor Candidates in Strategic Biotechnology Investment
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has made an undisclosed investment in biotechnology firm Graviton Bioscience, securing a right of first negotiation for Graviton’s clinical-stage ROCK2 inhibitor candidates in immunological and metabolic syndrome indications. Graviton’s lead program, GV101, is a potential best-in-class ROCK2 inhibitor capable of crossing the…
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Eisai’s Alzheimer’s Drug Leqembi Earns Marketing Approval in China
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Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This…
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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
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China-based Jiangxi Jemincare Group (SHA: 603222) has announced receiving clinical trial approvals for six of its Category 1 chemical drugs in China and the United States, with indications spanning cancer, kidney diseases, and infectious diseases. JMKX003801, approved for study in China for severe infections caused by Gram-negative bacteria, has demonstrated…
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Sanofi Partners with Minapharm for Local Production of Anticoagulant Clexane in Egypt
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Sanofi (NASDAQ: SNY) has entered into a partnership with Egyptian biotechnology company Minapharm to locally manufacture and supply its leading anticoagulant, Clexane (enoxaparin). The technology transfer agreement is aimed at enabling the French pharmaceutical giant to navigate “changing market dynamics,” as stated in a press release. Production of the medication…
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AstraZeneca Halts Late-Stage Trials for Lokelma in Hyperkalemia Due to Timing and Event Rate Issues
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, has announced the termination of two late-stage trials for its commercial-stage potassium binder, Lokelma (sodium zirconium cyclosilicate), in hyperkalemia (HK) across the cardiorenal spectrum. The company has clarified that the decision is not due to safety concerns and does not affect…
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Dupixent Trial Success Reinforces Potential in Moderate-to-Severe COPD Treatment
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Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) have announced that a late-stage replicate trial for their interleukin blocker Dupixent (dupilumab) has successfully met its primary endpoint during an interim analysis. The trial demonstrated a significant reduction in exacerbations over 52 weeks in patients with chronic obstructive pulmonary disease (COPD)…
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Novo Nordisk Invests DKK 16 Billion to Expand French Production Facility
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Denmark-based pharmaceutical giant Novo Nordisk (CPH: NOVO-B) has initiated an expansion of its production facility in France with an investment of DKK 16 billion (USD 2.3 billion). This strategic move aims to accommodate future demand for its portfolio of serious chronic diseases, including GLP-1 products. The investment will be directed…
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Bayer Halts Late-Stage Trial for Asundexian After Underperformance
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Germany-headquartered Bayer (ETR: BAYN) announced the termination of a late-stage trial for its antithrombotic candidate asundexian. Asundexian, once considered a potential blockbuster, was outperformed by the standard of care in preventing stroke and systemic embolism in patients with atrial fibrillation, the most lucrative indication for the drug, with an estimated…
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Gilead Announces Low-Carbon Bronchodilator Study for H1 2024
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Gilead Sciences Inc. (NASDAQ: GILD) has announced plans for a Phase III study in the first half of 2024 for a new iteration of its bronchodilator Ventolin (salbutamol). This version utilizes a low-carbon propellant, which could potentially reduce the greenhouse gas emissions from the associated metered dose inhaler (MDI) by…
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SanegeneBio Partners with Huadong Medicine to Develop RNAi Therapeutics for Metabolic Diseases
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Suzhou-based RNA interference (RNAi) therapeutics developer SanegeneBio has entered into a partnership with compatriot firm Huadong Medicine Co., Ltd (SHE: 000963). The collaboration will utilize SanegeneBio’s Ligand and Enhancer Assisted Delivery (LEAD) technology platform to develop small interfering RNA (siRNA) drugs targeting chronic metabolic diseases, with the potential to expand…
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Novartis’ Remibrutinib Meets Milestones in Late-Stage Chronic Spontaneous Urticaria Studies
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that two late-stage studies for its Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib, used in the treatment of chronic spontaneous urticaria (CSU), have successfully met all primary and secondary endpoints at the 12-week mark of a 52-week trial. After three months of treatment…
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Boehringer Ingelheim’s Aldosterone Synthase Inhibitor BI 690517 Shows Promise in CKD Phase II Trial
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Germany-based Boehringer Ingelheim (BI) has published the results of a Phase II trial for its aldosterone synthase inhibitor (ASi) BI 690517, used alone or in combination with the antidiabetic Jardiance (empagliflozin), in patients with chronic kidney disease (CKD), with or without type 2 diabetes (T2D). The trial aimed to evaluate…
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Bayer Unveils Real-World Insights on Kerendia for CKD and T2D Management
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Germany-headquartered Bayer (ETR: BAYN) recently published interim insights from a significant real-world observational study focusing on the clinical characteristics and treatment patterns associated with its mineralocorticoid receptor antagonist (MRA), Kerendia (finerenone). This medication has received global approvals aimed at reducing cardiorenal risk in patients suffering from chronic kidney disease (CKD)…
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AstraZeneca Announces Positive Phase IIb Results for CKD Treatment Combination
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UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced last week that its combination therapy of ETA receptor antagonist zibotentan and SGLT2 inhibitor dapagliflozin achieved dose-dependent reductions in urinary albumin-to-creatinine ratio (UACR) during a Phase IIb trial for chronic kidney disease (CKD). This development marks a significant step forward in the…
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Novo Nordisk Acquires Global License for Vect-Horus Molecular Cargo Delivery Platform
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Novo Nordisk (NYSE: NVO), a leading pharmaceutical company based in Denmark, has obtained an exclusive global license to a molecular cargo delivery platform from Vect-Horus, a French specialist in targeted drug delivery. This strategic move is aimed at addressing unmet needs within the treatment of serious chronic diseases. Terms of…
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J&J MedTech Partners with CED Medical for Neurointerventional Solutions
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Johnson & Johnson MedTech’s (J&J, NYSE: JNJ) Shanghai-based subsidiary, Johnson Johnson Medical Equipment Co., Ltd, has entered into a strategic partnership with CED Medical, a neuroscience device marker headquartered in Nantong, near Shanghai. The collaboration aims to expand market reach, promote technology, and foster innovation in the field of neurointerventional…
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Novo Nordisk Strikes $1.3 Billion Deal for KBP Biosciences’ Ocedurenone
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) announced a significant deal this week, valued at up to USD 1.3 billion, for the acquisition of the potential best-in-class antihypertensive drug ocedurenone from Singapore’s KBP Biosciences. The transaction, anticipated to close by the end of the year, is subject to meeting customary…
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Mabwell Bioscience Enters Licensing Agreement with Laboratorios Legrand for Biosimilars in Colombia and Ecuador
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China-based Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced a strategic licensing agreement with Colombia-headquartered Laboratorios Legrand S.A. Under this agreement, Laboratorios Legrand will manage the regulatory filing and commercialization of Mabwell’s biosimilars, MAILISHU and 9MW0321, which are both biosimilars of denosumab. This deal specifically covers the territories of…
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Novo Nordisk Partners with Valo Health to Develop Cardiometabolic Disease Therapies
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has announced a strategic partnership with US company Valo Health. The collaboration aims to leverage Valo Health’s patient genetic database, artificial intelligence (AI) capabilities, and tissue modelling platform for the target identification, discovery, and development of novel treatments for cardiometabolic diseases. Additionally, Novo…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US Food and Drug Administration (FDA) for their SGLT2 inhibitor, Jardiance (empagliflozin), marking a significant advancement in the treatment of chronic kidney disease (CKD). The drug is now approved for the prevention of kidney function decline,…
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Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
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US-based Organon (NYSE: OGN) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Liptruzet (ezetimibe, atorvastatin), which is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) in China. DYSIS China Study and Liptruzet’s ImpactThe DYSIS China study reveals…
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MSD’s Sotatercept Demonstrates Positive Interim Results in Phase III PAH Studies
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has presented interim data from Phase III and extension studies for its potential first-in-class biologic sotatercept, which is being investigated for the treatment of pulmonary arterial hypertension (PAH). The late-stage trial indicated that the activin signaling inhibitor led to a reduction in right…
