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Copanlisib (BAY 80-6946)
1032568-63-0, cas no
In oncology, Copanlisib (BAY 80-6946), a novel, oral phosphatidylinositol-3 kinases (PI3K) inhibitor, was selected for accelerated development. Copanlisib demonstrated a broad anti-tumor spectrum in preclinical tumor models and promising early clinical signals in a Phase I study in patients with follicular lymphoma. A Phase II study in patients with Non-Hodgkin’s lymphoma is currently ongoing.
PI3K inhibitor BAY 80-6946
A phosphoinositide 3-kinase (PI3K) inhibitor with potential antineoplastic activity. PI3K inhibitor BAY 80-6946 inhibits the activation of the PI3K signaling pathway, which may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis and dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.
Finerenone (BAY 94-8862), BAYER’S next generation oral, non-steroidal Mineralocorticoid Receptor antagonist which blocks the deleterious effects of aldosterone
CAS Number: 1050477-31-0, UNII-DE2O63YV8R
MW: 378.4298, C21-H22-N4-O3
Finerenone (BAY 94-8862) is a next generation oral, non-steroidal Mineralocorticoid Receptor antagonist which blocks the deleterious effects of aldosterone.
Currently available steroidal MR antagonists have proven to be effective in reducing cardiovascular mortality in patients with heart failure but have significant side effects that limit their utilization.
Finerenone is currently in clinical Phase IIb development for the treatment of worsening chronic heart failure, as well as diabetic nephropathy.
Bayer seeks EMA approval for marketing of regorafenib to treat GIST
Bayer HealthCare has submitted an application to the European Medicines Agency (EMA) for marketing authorisation regarding the oral multi-kinase inhibitor, regorafenib.
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Actavis submits ANDAs for two more generic version of Bayer’s Safyral and Fresenius Kabi’s Diprivan (propofol) injection
Actavis submits ANDAs for two more generic version of
Bayer’s Safyral and
Fresenius Kabi’s Diprivan (propofol) injection
Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.http://www.gabionline.net/Generics/News/Actavis-submits-ANDAs-for-two-more-generics
Bayer’s Eylea (aflibercept),
Ranibizumab (trade name Lucentis) is a monoclonal antibody fragment (Fab) derived from the same parent mouse antibody as bevacizumab (Avastin). It is much smaller than the parent molecule and has been affinity matured to provide stronger binding to VEGF-A. It is an anti-angiogenic that has been approved to treat the “wet” type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss.
Ranibizumab sells for $1,593 per dose, compared to bevacizumab, which can be prepared for macular degeneration treatment in doses that cost $42. Clinical trials have shown both to be equally effective; however there were some reports of infection after dividing bevacizumab into smaller doses.
The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs
Cl 223Ra Cl
is the structure
http://www.ama-assn.org/resources/doc/usan/radium-ra-223-dichloride.pdf check out yourself
FDA Approves Xofigo for Advanced Prostate Cancer
May 15, 2013 — The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.
Xofigo is being approved more than three months ahead of the product’s prescription drug user fee goal date of Aug. 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
“Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer.”
In August 2012, the FDA approved Xtandi to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients who have previously been treated the chemotherapy drug docetaxel.
Xofigo’s safety and effectiveness were evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Patients were randomly assigned to receive Xofigo or a placebo plus best standard of care.
The study was designed to measure overall survival. Results from a pre-planned interim analysis showed men receiving Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo. An exploratory updated analysis conducted later in the trial confirmed Xofigo’s ability to extend overall survival.
The most common side effects reported during clinical trials in men receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg, ankle or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).
Xofigo is marketed by Wayne, N.J.-based Bayer Pharmaceuticals. Xtandi is co-marketed by Astellas Pharma U.S., Inc. of Northbrook, Ill., and Medivation, Inc. of San Francisco, Calif.
NICE has given a provisional green light for Bayer’s blood thinner Xarelto for help patients with thrombotic events
NICE has given a provisional green light for Bayer’s blood thinner Xarelto for help patients with thrombotic events
Developing a series of national clinical guidelines to secure consistent, high quality, evidence based care for patients using the National Health Service in
April 22, 2013
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Rivaroxaban (BAY 59-7939) is an oral anticoagulant invented and manufactured by Bayer; in a number of countries it is marketed as Xarelto. In the United States, it is marketed by Janssen Pharmaceutica. It is the first available orally active direct factor Xa inhibitor. Rivaroxaban is well absorbed from the gut and maximum inhibition of factor Xa occurs four hours after a dose. The effects lasts 8–12 hours, but factor Xa activity does not return to normal within 24 hours so once-daily dosing is possible. There is no specific way to reverse the anticoagulant effect of rivaroxaban in the event of a major bleeding event, unlike warfarin
In September 2008, Health Canada granted marketing authorization for rivaroxaban as one 10 mg tablet taken once daily for the prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.
In September 2008, the European Commission granted marketing authorization of rivaroxaban for the prevention of venous thromboembolism in adult patients undergoing elective hip and knee replacement surgery. In December 2011 rivaroxaban has been approved by the European Commission for use in two new indications: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors and treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. On November 4, 2011, the U.S. FDA approved rivaroxaban for stroke prophylaxis in patients with non-valvular atrial fibrillation. On November 2, 2012, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for the treatment of patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) and for long-term treatment to prevent recurrence.
Bayer Initiates Phase III Trial of Investigational Inhaled Amikacin Solution (BAY41-6551T) in Mechanically Ventilated Patients with Gram-negative Pneumonia
April 16, 2013
Bayer HealthCare Pharmaceuticals Inc. announced today that patient enrollment is underway in its global Phase III trial program to evaluate the efficacy and safety of adjunctive aerosolized BAY41-6551 versus aerosolized placebo in the treatment of intubated and mechanically ventilated patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. BAY41-6551 consists of amikacin inhalation solution delivered by a Pulmonary Drug Delivery System (PDDS) developed by Nektar Therapeutics (NASDAQ: NKTR).
Amikacin is an aminoglycoside antibiotic used to treat different types of bacterialinfections. Amikacin works by binding to the bacterial 30S ribosomal subunit, causing misreading of mRNA and leaving the bacterium unable to synthesize proteins vital to its growth.
“Bayer continues to invest in research for potential treatment options for many difficult to treat diseases,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “This study is designed to evaluate the effectiveness of a solution of amikacin formulated for inhalation, delivered through a proprietary drug delivery system, as an adjunctive therapy for Gram-negative pneumonia in intubated and mechanically ventilated patients.”
About the Phase III INHALE Study Program
The global INHALE study program is comprised of two prospective, randomized, double-blind, placebo-controlled, multicenter studies to evaluate the safety and efficacy of BAY41-6551 as adjunctive therapy in intubated and mechanically-ventilated patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. The study will enroll patients age 18 or above that have microbiologically-confirmed pneumonia caused by Gram-negative organisms. INHALE will be a large multi-center global program involving centers in North America, South America, Europe, Japan, Australia and Asia. For more information about the trial, please visit www.clinicaltrials.gov
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
About Nektar Therapeutics
BAY41-6551 is being developed through a collaboration with Nektar Therapeutics (NASDAQ:NKTR). Nektar Therapeutics is a biopharmaceutical company developing therapeutics based on its proprietary technology platforms. Nektar has a robust R&D pipeline of therapeutic candidate in pain, oncology and other therapeutic areas. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at www.nektar.com.
BAYER® and the Bayer Cross® are registered trademarks of Bayer.
CAS NO 625115-55-1
Bayer has been boosted by the news that regulators in the USA are fast-tracking the German group’s investigational pulmonary arterial hypertension riociguat.
The US Food and Drug Administration has granted priority review to the New Drug Application for riociguat, which Bayer filed in February on both sides of the Atlantic for PAH and a related condition, inoperable chronic thromboembolic pulmonary hypertension (CTEPH). The FDA bestows a priority review on medicines that offer major advances in care or that provide a treatment where no adequate therapy exists. The agency aims to complete its assessment within eight months from the submission of the NDA, rather than the standard 12 months.
Riociguat (BAY 63-2521) is a novel drug that is currently in clinical development by Bayer. It is a stimulator of soluble guanylate cyclase (sGC). At the moment Phase III clinical trialsinvestigate the use of riociguat as a new approach to treat two forms of pulmonary hypertension (PH): chronic thromboembolic pulmonary hypertension (CTEPH) andpulmonary arterial hypertension (PAH). Riociguat constitutes the first drug of a novel class of sGC stimulators
The submissions are based on two Phase III studies and riociguat, the first member of a novel class of compounds called stimulators of soluble guanylate cyclase (sGC), met its primary endpoint in both trials, a change in exercise capacity after 12- or 16 weeks respectively. The drug was generally well tolerated, with a good safety profile.
If approved, riociguat would be going up against Actelion’s Tracleer (bosentan) and Gilead Sciences/GlaxoSmithKline’s Letairis/Volibris (ambrisentan). Actelion, which has dominated the PAH market, has already filed its follow-up to Tracleer, Opsumit (macitentan).