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Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. who intend to evaluate a drug, biologic, medical device, or food for medical purposes that targets a rare disease in a clinical trial. By Sarah Wicks & James E.
The FDA has set a prescription drug user fee act (PDUFA) target action date of December 12, 2025, and currently does not plan to hold an advisory committee meeting regarding the application. We look forward to working with regulators to make lerodalcibep available to patients around the world.
Unger has joined the firm as a Principal Drug Regulatory Expert. Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). He completed his cardiology training at The Johns Hopkins Hospital in 1987.
Ionis Pharmaceuticals recently announced that its drug, Tryngolza (olezarsen), has been approved as an adjunct to diet for the reduction of triglyceride levels in FCS patients, who have long faced a condition with no existing pharmacological solutions. In the Balance study, patients who received the drug showed a 42.5
Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. Novartis added inclisiran to its pipeline after buying The Medicines Company, which had licensed the drug from Alnylam, for $9.7
The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. All three studies are looking at the drug on its own and in combination with anti-platelet therapies like aspirin and clopidogrel.
The US Food and Drug Administration (FDA) recently approved Boston Scientific’s Agent drug-coated balloon (DCB) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease (CAD). Key Features of the Agent Drug-Coated Balloon One of the standout features of the Agent DCB is its TransPax Coating Technology.
This meeting brings together industry, regulators, academics, and patients to discuss global and local challenges in the life sciences industry. Patient-Focused Drug Development: Reflecting on a Decade of Insights (June 21, 11am-12pm Central). Hyman, Phelps & McNamara, P.C.’s More information can be found here.
Patients will also receive a dose of tacrolimus, an immune-suppressing drug, to guard against any immune reaction to the transplanted cells. The hope is that the spheroids will help to replenish damaged cardiomyocytes in the heart, restoring some of its ability to pump blood around the body. Other readouts give grounds for optimism.
Unlike CETP inhibitors, PCSK9 inhibitors block a protein that regulates cholesterol levels. Amgens Repatha (evolocumab) and Novartis Leqvio (inclisiran) are injectable proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, with Leqvio offering a twice-yearly injection option.
The key lies in personalization, strategic segmentation, and strict adherence to industry regulations. Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. oncology, diabetes, cardiology). Therapeutic area focus (e.g.,
The decision gave Bayer complete control of BlueRock’s cell therapy pipeline, headed by DA01 and spanning various diseases in the neurology , cardiology , and immunology categories. It looks to carry on with a new class of oral, once-daily, small molecule drugs called Controlled Metabolic Accelerators (CMAs).
Food and Drug Administration (FDA) in January 2021 and was recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) in the EU in May 2021. Verquvo (vericiguat) was approved by the U.S. About Vericiguat Vericiguat 2.5 MSD has the commercial rights to vericiguat in the U.S.
Creating content that is informative, engaging, and compliant with industry regulations. Scientific Articles & Whitepapers HCPs rely on credible, research-backed content to stay informed about new treatments, drug efficacy, and emerging medical trends. Behind-the-scenes research lab videos showcasing drug development.
Food and Drug Administration] has only approved CBD for one rare childhood condition for epilepsy,” giving its stamp to a CBD medication called Epidiolex , said study co-author Erik Hendrickson, a research associate at the Center for Data Driven Health at the Qualcomm Institute at the University of California, San Diego. Source link.
It plays a crucial role in many inflammatory and autoimmune diseases across multiple therapy areas, including haematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. 5% have US Food and Drug Administration -approved treatments. The complement cascade is pivotal to the innate immune system.
Michael Felker, MD, MHS, FACC, FAHA, FHFSA is Professor of Medicine with tenure in the Division of Cardiology at Duke University School of Medicine. He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. About Dr. Udelson
James E.
Xtalks spoke with Kaushik Gune, Head of Healthcare (US) at Huma, a global digital health technology company, to learn more about SaMD and what it looks like to create a regulated health app. What are some examples of software as a medical device (SaMD) and how is this software regulated? Tier one devices represent the low risk.
Amarin’s Vazkepa cardiologydrug has been backed by the UK’s drugsregulator, following approval in Europe at the end of March. . Amarin said that Vazkepa is one of the first drugs filed and licensed through the MHRA’s new “Reliance” route following the end of the Brexit transition period.
The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”
The Clinical Trial Approval (CTA) scheme for ALXN1820 (bi-specific anti-properdin mini-body) and the Investigational New Drug (IND) application for ALXN1850 (next generation asfotase alfa) have been accepted, in Australia and the U.S. respectively, with Phase 1 studies expected to begin in the first half of 2021.
AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. mg tablet) to treat cardiovascular disease.
The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5
Pending collection of 12-month safety and drug-device combination data, Alexion plans to file for approval in the U.S. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care.
While the aim in many cases is to use biomarkers to assess a patient’s quantitative response to a study drug, it is important to ascertain a link between the drug’s mechanism of action and an ensuing biological effect in order for it to be a reliable readout of drug response. The Double-Edged Sword of Cardiac Biomarkers.
Bristol-Myers Squibb has new data backing up the value of mavacamten for obstructive hypertrophic cardiomyopathy (HCM), as it waits for a delayed verdict on its marketing application for the drug, acquired as part of its $13.1 billion takeover of MyoKardia in 2020.
Shares in Cytokinetics surged after it reported positive mid-stage results for CK-274, a drug for hypertrophic cardiomyopathy (HCM) that could tread on the toes of Bristol-Myers Squibb’s mavacamten – acquired as part of its $13.1 billion takeover of MyoKardia last October.
The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.
Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Invokana was the first mover among the SGLT2 drugs in the kidney area, winning FDA approval towards the end of 2019 for diabetic kidney disease.
The US regulator has cleared a 10mg daily dose of Jardiance (empagliflozin) to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with HFrEF, also known as systolic heart failure, which accounts for more than half of all heart failure cases. billion in the first half of 2021.
Lehan Chair in Cardiovascular Research, and professor and president of the department of drug at the University of Mississippi Medical Center. The cardiology ballot at Bayer formerly includes a number of products and several other composites are in colorful stages of preclinical and clinical development. Javed Butler, the PatrickH.
Now, detailed findings presented at the European Society of Cardiology (ESC) meeting over the weekend showed just how well the drug performed, and have the potential to “transform the standard of care” in patients with CKD, according to the trial investigators.
Related: IPV Therapy Device Recall: Phasitron 5 Breathing Circuits Withdrawn In the safety communication for the recall, the US Food and Drug Administration (FDA) said it is closely working with Boston Scientific to investigate the potential risks. The FDA has not issued a classification for the recall yet.
CAEL-101 has received Orphan Drug Designation from both the U.S. Food and Drug Administration and European Medicine Agency as a potential therapy for patients with AL amyloidosis. About AL Amyloidosis. AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow.
Food and Drug Administration (FDA) supported the positive results of the FIDELIO-DKD phase III clinical trial study for patients with CKD and T2D. They also control how much water and electrolytes are in the body, regulating blood pressure. In July, finerenone was approved under the name Kerendia® by the us (U.S.)
Presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, the analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran) from the Phase III trials.
Results were presented at the ESC Congress 2021, organized by the European Society of Cardiology (ESC). Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “As Food and Drug Administration (FDA) and other health authorities. It is currently under review by the U.S.
District Court ruling in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to VASCEPA capsules in its initial triglyceride lowering indication. Securities and Exchange Commission Regulation G. .
Reaffirmed strategy to continue increasing U.S.
Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. billion the drug generated in 2021. billion in 2022. billion, a 26.55
Following a topline presentation at the ESC Heart Failure Congress in June, the updated European Society of Cardiology and Heart Failure Association Guidelines on Acute and Chronic Heart Failure will also be presented during the ESC Congress and made available for use. About Vericiguat Verquvo 2.5
Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. Today, the U.S. Related Information. Source link: [link].
An IQVIA survey to Neurology, Cardiology, Rheumatology, Dermatology and Ophthalmologists in June 2020 across the lead five European countries showed an average of 30% of patients either “no shows” or still waiting for treatment that was delayed.
Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. Andrew Hull brings his expertise to the firms enforcement, compliance, and litigation practice. Director Karla L.
At present, drug development operations are continuing with manageable disruptions (see the Innovation Review Section of the Condensed Interim Financial Report for further information), with our range of digital technologies allowing us to proactively manage our clinical trials portfolio and rapidly mitigate any disruptions. Financials.
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