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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. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. Investigational drug plozasiran , developed by Arrowhead Pharmaceuticals, is under review for FCS treatment. In clinical trials, it showed up to an 86 percent reduction in triglyceride levels.
FDAApproves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.
Phosphorus, a leading preventative genomics company, has developed the first comprehensive preventative genetic test for consumers. Phosphorus may be a familiar name as it was one of the first to develop an FDA-authorized at-home test for COVID-19 ; it was also the first test to have received an asymptomatic, direct-to-consumer FDAapproval.
He completed his cardiology training at The Johns Hopkins Hospital in 1987. While at Johns Hopkins, and as a Senior Investigator in the Cardiology Branch of the NIH National Heart, Lung, and Blood Institute, Dr. Unger led a translational research program on promotion of angiogenesis.
MorphoSys and Incyte announced the US FDAapproval under accelerated approval for their treatment Monjuvi in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) – the most common form of non-Hodgkin lymphoma. Billion deal in a thirst to grow in the cancer market.
It occurs when a rapid, short-circuit rhythm develops in the heart’s upper chamber. It is currently being developed for self-administration by patients without medical supervision, specifically for the acute conversion of atrioventricular-nodal-dependent PSVT. It received FDAapproval in 1998.
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). Many companies have already developed their own DCBs, each with unique features supported by varying levels of clinical evidence.
Furthermore, we will advance the field of native lung recovery and improve patient outcomes by collecting critical research data and developing and teaching best practices.”. The authorized Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. ABOUT IMPELLA HEART PUMPS. The Impella 2.5®,
Participants treated with LODOCO had a 31% reduction in the overall risk of cardiovascular death, spontaneous myocardial infarction or ischaemic stroke when added to statins and other cardiology prevention therapies, compared to those treated with placebo.
Their widespread adoption is driven by strong clinical evidence, broad FDA-approved indications and continued advancements in treatment protocols. Although the FDAapproved generic versions from Micro Labs Limited and Mylan Pharmaceuticals Inc. Eliquis (Apixaban) Eliquis 2023 sales :$12.21
Obtaining FDAapproval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics, in the company’s press release. “It SurVeil has an edge over IN.PACT as it is coated with a lower dose of the drug.
Research and Development. ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDAapproved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. ULTOMIRIS – 100 mg/mL: In October 2020 , the U.S.
BridgeBio’s leadership, including Neil Kumar, emphasizes the significance of Attruby’s approval as a cornerstone in their mission to develop therapies for genetic diseases. Looking ahead, the company plans to pursue regulatory approvals in Japan and Brazil, further expanding access to this life-changing treatment.
Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDAapproval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 mL subcutaneous solution (2 mg/1.5 billion in Q4 2022.
It’s about comprehending the clinical value they bring to patients’ lives, the research and development strides behind their success and their role in shaping future therapeutic pathways. Price of Eliquis: Approximately $635 for a supply of 60 oral 2.5 However, sales of Eliquis fell from $16.73 billion in 2021 to $11.79
Billion Boston Scientific continues to shape the future of medical technology with innovations across cardiology, neuromodulation and interventional procedures. billion in Q2 2024 , largely driven by the FARAPULSE Pulsed Field Ablation System, which earned National Medical Products Administration (NMPA) approval in China.
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.
Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.
Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th. Up to 40% of all patients with type 2 diabetes develop CKD. The study met its primary endpoint.
It is important to consider how the US racial and ethnic populations may change in the future because on average, an investigational product can take five to seven years to undergo Phase I to Phase III development, and this is ideally followed by at least 10 to 15 years of commercial value. or greater than 1.2
Aurlumyn injection is approved for the treatment of adults with severe frostbite to reduce the risk of finger or toe amputation. Originally developed by California-based CoTherix, the drug was first approved in 2004 for the treatment of pulmonary arterial hypertension (PAH) under the brand name Ventavis.
Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 on August 27 and published in The New England Journal of Medicine. vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.
In the process of hiring select people with extensive commercial experience in Europe and preparing for post-approval market access negotiations.
Research and development (R&D) expense for the three and nine months ended September 30, 2020 were $10.2 million and $30.5 million, respectively, compared to $8.9 million and $23.3
is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc. billion.
Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction. The FDA granted the approval of Jardiance to Boehringer Ingelheim.
Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at. One bright spot in an otherwise dreadful year: the pharmaceutical industry has discovered it can do things it never dreamed possible.
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. New approvals.
Johnson & Johnson (J&J) MedTech recently received US Food and Drug Administration (FDA) approval for its VARIPULSE pulsed field ablation (PFA) platform, making it the first PFA system in the US to be fully integrated with the CARTO 3 electro-anatomical mapping system for treating paroxysmal atrial fibrillation (AFib).
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