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FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option. By Frank Vinluan on August 21, 2024 Regeneron Pharmaceuticals already lags companies that have launched new multiple myeloma drugs, and it will have to wait a little bit longer to join them. The FDA turned down Regeneron’s application for its drug candidate, but not for any issues with the therapy itself. The regulator cited problems with the treatment’s third party manufacturer. The FDA rejection for the drug, linvoseltamab, is not a surprise. Regeneron foreshadowed that decision earlier this month during its conference call to discuss second quarter 2024 financial results, disclosing that that the FDA flagged unresolved findings with the contract manufacturer. Those problems centered on another company’s ...
- Source: drugdu
- 78
- August 23, 2024
CPhI Worldwide Milan -Discover the future of pharma in Europe

Organizer: Informa Markets Date: October 8-10, 2024 Venue: Strada Statale Sempione, 28, 20017 Rho MI Exhibition Hall: Fiera Milano Rho Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretics and Analgesics, Tetracyclines, Amino Acids and Their Derivatives, Chloramphenicols, Digestive System Drugs, Other Anti-Infective Agents Excipients and Dosage Forms: Excipients, Glidants, Enteric Materials Natural Extracts: Plant Extracts, Animal Extracts, Traditional Chinese Medicine Ingredients, Functional Food Ingredients, Health Product Ingredients Bioproducts and Reagents: Antibodies, Nucleic Acid/Protein Synthesis, Cell Biology Detection, Animal/Plant Proteins/Antigens/Peptides, Nucleic Acid Analysis, Libraries and Constructions, Biochemistry Technical Services: Project Design/Thesis Outsourcing, Cell Biology, Biochips, Instrument Testing/Maintenance, Molecular Biology, Microbiology Exhibition CPhI Worldwide Mila: CPhI Worldwide is the market leader in the global pharmaceutical ingredients industry. First held in 1990, it has been held annually in major developed cities in Europe. It is a trade exhibition with a large scale, high standard, and well-known reputation in the ...
- Source: drugdu
- 416
- August 23, 2024
Asia Pharma Expo

Organiser：Nexzen Solutions Pvt. Ltd. Time： February 12th – 14th, 2025 address：Plot# 66, Block#C, Umme Kulsum Road, Bashundhara R/A, Dhaka-1229, Dhaka Exhibition hall：International Convention City, Bashundhara Dhaka Product range: Pharmaceutical Processing Machinery (Tablets/Capsules/Liquids/Injections/Ointments/Dry Syrups) Packaging Machinery & Equipment, Packaging Materials, API Consumables, Pharmaceutical Additives, Excipients, Finished Pharmaceutical Products, Formulation Laboratory Reagents Glassware and Equipment Analysis, R&D Equipment, Biotechnology Instruments, Environmental Control Equipment Service Utilities Products, Turnkey Solutions Contractors, Project Consultancy About Asia Pharma Expo : Asia Pharma Expo Dhaka is the largest, most influential, and the only internationally recognized exhibition for pharmaceutical ingredients and equipment in Bangladesh. Endorsed by the Bangladesh Pharmaceutical Industry Association, it serves as a vital platform for pharmaceutical information exchange in Bangladesh and its neighboring regions.
- Source: drugdu
- 223
- August 23, 2024
【EXPERT Q&A】Can veterinary drug API companies succeed in CDMO transformation?

Drugdu.com expert’s response: I agree that the success of a veterinary API (Active Pharmaceutical Ingredient) company’s transition to CDMO (Contract Development and Manufacturing Organization) hinges on both the potential for success and the crucial factors that contribute to it. Here’s a translation of your points into English: I. Potential for Successful Transition Market Demand: With the rapid development of the global pharmaceutical industry, the veterinary drug market has also shown a steady growth trend. The transition of veterinary API companies to CDMO can cater to the outsourcing needs in veterinary drug R&D and production, particularly for those lacking in-house R&D and manufacturing capabilities, making CDMO services all the more crucial. Technical Accumulation: Veterinary API companies have accumulated substantial technical experience and production capabilities through their manufacturing processes, which can be effectively leveraged during the transition to CDMO. By enhancing their R&D capabilities and service standards, these companies can offer higher-quality, ...
- Source: drugdu
- 103
- August 23, 2024
POC Saliva Testing Device Predicts Heart Failure in 15 Minutes

Heart failure is a serious condition where the heart muscle is unable to pump sufficient oxygen-rich blood throughout the body. It ranks as a major cause of death globally and is particularly fatal for individuals without access to medical facilities. Traditionally, heart failure is monitored biannually through a blood test that measures B-type natriuretic peptide (BNP) levels, indicating excessive heart strain. Recently, advancements in point-of-care technology aim to revolutionize this approach by introducing simple, at-home saliva tests, allowing frequent monitoring of heart health more regularly than the current every six-month blood test. Until now, the widespread application of portable saliva tests has been hampered by complex production processes and the limited scope of data they can provide, usually restricted to a single biomarker. Now, a team of researchers at Colorado State University (Fort Collins, CO, USA) aims to bring heart failure screening from clinical settings to the home. The team ...
- Source: drugdu
- 71
- August 22, 2024
Rapid Diagnostic System to Deliver Same-Shift Antibiotic Susceptibility Test Results

The World Health Organization estimates that sepsis impacts around 49 million people worldwide each year, resulting in roughly 11 million deaths, with about 1.32 million of these deaths directly linked to bacterial antimicrobial resistance. Given the urgency, there’s a growing need for rapid antimicrobial susceptibility testing (AST) that can guide the use of targeted antimicrobial therapies. Such testing is crucial for enhancing patient outcomes, reducing hospital costs, and curbing the rise of antimicrobial resistance. Now, a rapid AST system aims to deliver same-shift results, significantly aiding antimicrobial stewardship teams and clinicians in promptly customizing treatments for patients with severe infections. The WAVE system from Accelerate Diagnostics (Tucson, AZ, US) is designed to deliver rapid AST results from positive blood culture (PBC) bottles and isolated bacterial colonies (isolates), delivering precise results in approximately 4.5 hours. Utilizing cutting-edge holographic imaging technology, the WAVE system tracks bacterial growth and morphology changes in real-time, ...
- Source: drugdu
- 86
- August 22, 2024
Johnson & Johnson Set to Acquire V-Wave Ltd

By Don Tracy, Associate Editor The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.Johnson & Johnson (J&J) has reached a definitive agreement to acquire V-Wave Ltd., a private company specializing in cardiovascular implants for heart failure patients. The acquisition is expected to integrate V-Wave into Johnson & Johnson MedTech. V-Wave was recently granted FDA Breakthrough Device Designation and CE mark approval for the Ventura Interatrial Shunt technology, which treats heart failure with reduced ejection fraction (HFrEF). The deal is expected to close by the end of this year.1 “We are excited to welcome V-Wave to Johnson & Johnson MedTech and to take another meaningful step toward transforming the standard of care for cardiovascular disease. We recognize the importance of identifying more diverse and effective treatments for heart failure, and our recent ...
- Source: drugdu
- 73
- August 22, 2024
Eli Lilly Drug Reduces Risk of Diabetes Onset, Building Case for Broader Use of the Therapy

In a Phase 3 study, Eli Lilly’s tirzepatide led to a 94% reduction in the risk that obese or overweight prediabetes patients progress to type 2 diabetes. Lilly was already planning to expand use of the blockbuster metabolic disorders drug to sleep apnea and heart failure. By Frank Vinluan The longest clinical trial to date for a blockbuster Eli Lilly metabolic disorder drug now has data showing the treatment delayed progression to type 2 diabetes in patients who are obese or overweight, results that continue to build the case of broader health benefits for the therapy. The preliminary results announced Tuesday come from a clinical trial designed to test once-weekly injections of tirzepatide in prediabetes participants. In addition to being overweight or obese, participants also had at least one weight-related complication, excluding diabetes. The main goal of the placebo-controlled study is assessing tirzepatide’s effect on weight. At the highest of three ...
- Source: drugdu
- 75
- August 22, 2024
J&Js Rybrevant plus Lazcluze combination gets FDA approval in NSCLC

Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) has secured US Food and Drug Administration (FDA) approval as a first-line treatment for patients with some types of non-small cell lung cancer (NSCLC). The indication covers patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. The approval is based on data from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Lazcluze combination to AstraZeneca’s Tagrisso (osimertinib). Data showed that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso alone. Additionally, the median duration of response was nine months longer with the combination therapy compared to Tagrisso. The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, including participant race, type of EGFR mutation, and history of brain metastasis. These ...
- Source: drugdu
- 84
- August 22, 2024
Adcendo and Multitude ink ADC deal potentially worth $1bn

The antibody drug conjugate (ADC) dealmaking trend has seen yet another example as Adcendo has signed a licencing agreement potentially worth over $1bn with China-based Multitude for its tissue factor-targeting ADC candidate. The Danish company will acquire the global rights for the development and commercialisation rights for ADCE-T02, except in the Greater China region, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan. The companies were light on financial details noting that upfront and milestone payments will “total over $1bn”. The deal also has the option for “single digit to low double digit” tiered royalties. “We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024,” said Adcendo CEO, Michael Pehl. “The highly ...
- Source: drugdu
- 78
- August 22, 2024

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