Search Results for “Bayer” – Page 5 – media

What Are Its Treatment Prospects?

Recently, according to publicly available information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the technetium-99m ([99mTc]) hydrazinonicotinamide polyethylene glycol RGD peptide injection (referred to as “99mTc-3PRGD2”) developed by Ruidiao Pharmaceuticals has been included in the priority review list. This also applies to the injection of toluenesulfonate hydrazone nicotinamide polyethylene glycol RGD peptide. 99mTc-3PRGD2 is a radiolabeled drug conjugate (RDC) independently developed by Ruidiao Pharmaceuticals. It is the first class I new drug for radiologic diagnosis in nuclear medicine in China and the world’s first broad-spectrum tumor imaging agent for SPECT imaging. Notably, the success of this drug’s development will change the current technical status and conventional understanding that SPECT/CT imaging technology in nuclear medicine cannot be used for tumor diagnosis, staging, and efficacy evaluation. According to Ruidiao Pharmaceuticals, 99mTc-3PRGD2 targets integrin and specifically binds to the integrin αvβ3 receptor on tumor neovascularization, demonstrating high ...
- Source: drugdu
- 84
- September 30, 2024
Johnson & Johnson closes two business units

On September 25, according to foreign media Endpoints, Johnson & Johnson is closing the cardiovascular and metabolic drug unit of its pharmaceutical division. This is the second large-scale reorganization since Johnson & Johnson closed its infectious disease and vaccine units. Johnson & Johnson has gradually downplayed cardiopulmonary and metabolic work since last year. Under the change, Johnson & Johnson has narrowed its research and development focus to three therapeutic areas: oncology, immunology and neuroscience. This reorganization mainly affects the commercialization work of the cardiovascular department (sales, marketing and medical affairs teams), not research and development. At present, the cardiovascular department of Johnson & Johnson’s medical device department has not been affected, and its acquisitions are still ongoing. The core product of Johnson & Johnson’s cardiovascular and metabolic drug department is Xarelto (rivaroxaban), which was once one of the world’s best-selling anticoagulants and was jointly developed by Johnson & Johnson and ...
- Source: drugdu
- 68
- September 28, 2024
Focusing on the Frontiers of Biomedicine and Creating an Open Source Innovation Ecosystem.

Recently, a reporter from China Securities Journal visited the Shanghai Frontier Biomedical Innovation Center. Driving into the core area of the Zhangjiang Science City, a national-level biomedical base, one can see a modern, curved building from afar. Approaching closer, the open interior, visible through the yellow and white glass, creates a sense of freedom and positivity. “Currently, 10 resident companies and 11 ecological partners have signed cooperation agreements with Shanghai Frontier,” a representative from Shanghai Frontier stated. The center aims to create a “wall-less R&D center,” breaking down traditional barriers and promoting interaction and collaboration among experts, scholars, businesses, and investors from various fields and backgrounds, including industry, education, research, healthcare, and finance. Looking ahead, Shanghai Frontier will focus on cutting-edge biotechnologies such as gene and cell therapy, nucleic acid drugs, and conjugated drugs, hoping to discover and nurture highly innovative and competitive companies and projects while encouraging high-potential innovations ...
- Source: drugdu
- 112
- September 13, 2024
FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release. Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year. The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the ...
- Source: drugdu
- 86
- August 23, 2024
US judge denies initial attempt by Novartis to block generic Entresto launch

Novartis’s bid to block the launch of a biosimilar for its best-selling drug Entresto (sacubitril/valsartan) got off to a faltering start, as the drugmaker failed to convince a US court that MSN Pharmaceuticals’ (MSNPI) copycat infringed on a patent. Richard Andrews, district judge for the District of Delaware, ruled the likelihood that Novartis would win the lawsuit was not high enough, meaning a preliminary injunction was not granted. While Andrews stated that stopping MSNPI’s generic launch was not justified, he did order a temporary 72-hour halt while Novartis goes to the US Court of Appeal to seek an injunction, as per a 12 August court document first released by Reuters. The hearing is part of a lawsuit initiated by Novartis to fend off MSNPI’s generic – which received US Food and Drug Administration (FDA) approval last month – to protect sales for its heart failure blockbuster. Novartis’s reference drug was ...
- Source: drugdu
- 68
- August 15, 2024
FDA approves Sandoz’s Enzeevu as Eylea biosimilar saga continues

The US Food and Drug Administration (FDA) has approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD). Available as a 2mg vial kit and pre-filled syringe, the biosimilar– which references Regeneron and Bayer’s Eylea (aflibercept) – is indicated to improve and maintain visual acuity in patients with the eye disease. Enzeevu joins Biocon Biologics’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) in the list of FDA-approved biosimilars to Eylea. Yesafili and Opuviz were both greenlit by the agency as the first biosimilars in May this year. They were both designated as interchangeable products. The FDA has provisionally said Enzeevu would be interchangeable with Eylea as “it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products”, as per a 12 August press release. Interchangeable biosimilars are eligible for a year of market exclusivity if they are the first biosimilar of a given product ...
- Source: drugdu
- 91
- August 14, 2024
Kerendia Demonstrates Significant Efficacy Treating Heart Failure with Left Ventricular Ejection Fraction of 40% or More

By Don Tracy, Associate Editor The FINEARTS-HF study, which compared Kerendia to a placebo when added to standard therapy, met its primary endpoint by reducing cardiovascular death and total heart failure events. Results from the Phase III FINEARTS-HF study found that Bayer’s Kerendia (finerenone) demonstrated significant efficacy in treating heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or greater. According to the company, the study met its primary endpoint by significantly reducing the composite measure of cardiovascular death and total heart failure events, including both hospitalizations and urgent visits for heart failure.1 “We are very excited by the positive results from the FINEARTS-HF study,” said Christian Rommel, PhD, head of Research and Development, Bayer’s Pharmaceuticals Division. “With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and ...
- Source: drugdu
- 62
- August 8, 2024
NeuroSense Therapeutics shares positive results of lead candidate in ALS

The neurodegenerative disease currently affects more than 200,000 people worldwide NeuroSense Therapeutics has announced positive mid-stage results of its lead drug candidate, PrimeC, in people living with amyotrophic lateral sclerosis (ALS). The phase 2b PARADIGM study has been evaluating PrimeC, a fixed-dose combination of two US Food and Drug Administration (FDA)-approved drugs, Bayer’s ciprofloxacin, a well-known antibiotic, and Pfizer’s Celebrex (celecoxib), a COX inhibitor used to treat inflammation, in 68 people living with the neurodegenerative disease in Canada, Italy and Israel. Affecting more than 200,000 people globally, ALS is a neurological disorder that affects the motor neurons, the nerve cells in the brain and the spinal cord that control voluntary muscle movement and breathing. Previously granted Orphan Drug Designation by the FDA and the European Medicines Agency, PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic ...
- Source: drugdu
- 77
- July 9, 2024
Biotech fund Curie.Bio augments reserves with $380m to boost startups

Biotech startup incubator Curie.Bio has secured $380m in funding for its latest investment pool aimed at nurturing early-stage companies advancing towards clinical trials. The fundraising round – which boosts Curie.Bio’s total funds raised to nearly $1bn – specifically targets Series A investments in companies within its accelerator programme, focusing on advancing companies towards clinical proof-of-concept studies. The Massachusetts-based biotech investor launched with $520m in its pocket in February 2023, with investments from GV, ARCH Venture Partners, and Leaps by Bayer. The investor operates through two parts: one provides seed-stage funding to startups, while the other offers essential services to help advance scientific projects. Amid macroeconomic pressures, private biotech venture financing saw a significant downturn in 2022 and 2023. During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, as investors became more cautious and focused on existing portfolios. Curie.Bio was started by Alexis Borisy, Zach ...
- Source: drugdu
- 98
- July 1, 2024
Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease

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 ...
- Source: drugdu
- 100
- June 28, 2024

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