XTalks

JUNE 11, 2024

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). Repeat PCI: For patients experiencing restenosis, a repeat PCI procedure can be performed.

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Scienmag

NOVEMBER 16, 2020

ET, Monday, November 16, 2020, Cleveland: Cleveland Clinic researchers leading a global clinical trial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of […].

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Trials FDA Approval Clinical Trials Clinical Trials 41

Delveinsight

AUGUST 3, 2021

Nevro Received FDA Approval of its 10 kHz High-Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy. received approval for its Senza System, Nevro’s unique 10 kHz stimulation, to treat chronic pain associated with Painful Diabetic Neuropathy (PDN).

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XTalks

JULY 7, 2023

This substantial achievement paves the way for Milestone Pharmaceuticals to proceed with a New Drug Application (NDA) submission in late 2023. “We believe that self-administered etripamil could serve as the first approved supraventricular tachycardia treatment for use outside of the healthcare setting.

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Delveinsight

AUGUST 4, 2020

MorphoSys, Incyte gets an early FDA nod for Monjuvi, an alternative to CAR-T for B-cell malignancies. Siemens Healthineers, formed as a result of spin-off in 2018, plans to increase its presence in oncology, neurology as well as cardiology domain. Billion deal in a thirst to grow in the cancer market.

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Cardiology Antibody FDA Approval Trials 55

Pharma Marketing Network

FEBRUARY 19, 2025

oncology, diabetes, cardiology). FDA and Fair Balance Messaging All promotional emails must include fair balance messaging benefits and risks must be presented equally. Drug names and indications must align with FDA-approved labeling. Therapeutic area focus (e.g.,

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Compliance Marketing Branding Regulation 72

The Pharma Data

OCTOBER 25, 2020

–( BUSINESS WIRE )– The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System. Food and Drug Administration (FDA) to provide extracorporeal circulation.

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XTalks

JANUARY 22, 2025

From blockbuster anticoagulants like Eliquis (apixaban) and Xarelto (rivaroxaban) to life-saving treatments such as Entresto (sacubitril/valsartan) and Brilinta (ticagrelor), each of these drugs has made a significant impact in the cardiovascular space. Partnered with Pfizer, the drug continues to show strong market performance.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease.

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XTalks

JUNE 26, 2023

has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). The approval comes after the FDA made several requests for additional data, which lengthened the approval process that began in 2021.

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pharmaphorum

FEBRUARY 25, 2022

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients. . According to the FDA, heart disease impacts more than 650,000 people in the US each year.

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XTalks

FEBRUARY 8, 2024

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

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Pharmaceutical Technology

JUNE 14, 2023

All six treatments are US Food and Drug Administration (FDA) approved. Blue Water bought the FDA-approved benign prostatic hyperplasia treatment from Veru for a total cost of $100m in April 2023. “We Blue Water Biotech has expanded its commercial portfolio with the purchase agreement of six assets from WraSer.

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XTalks

FEBRUARY 9, 2024

As we delve into the top 15 cardiovascular disease drugs in 2023, guided by comprehensive 2022 sales data, we gain valuable insights into the market trends, drug efficacy and the evolving needs of patients worldwide. Read on to learn more about the top 15 cardiovascular disease drugs in 2023, based on 2022 sales statistics.

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XTalks

NOVEMBER 26, 2024

The US Food and Drug Administration (FDA) has approved Attruby (acoramidis) , marking a significant advancement for patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). This progressive disease occurs when misfolded transthyretin (TTR) proteins form amyloid deposits in the heart, leading to cardiac dysfunction.

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The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. A global Phase 3 study of ULTOMIRIS in children and adolescents with aHUS is underway.

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XTalks

SEPTEMBER 9, 2024

The da Vinci X and Xi systems also received a revised US Food and Drug Administration (FDA) clearance, validating their effectiveness in robotic-assisted radical prostatectomy. Billion Boston Scientific continues to shape the future of medical technology with innovations across cardiology, neuromodulation and interventional procedures.

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pharmaphorum

JULY 19, 2021

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.

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pharmaphorum

JANUARY 12, 2021

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. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

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pharmaphorum

JUNE 22, 2021

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.

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XTalks

AUGUST 4, 2022

The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. or greater than 1.2

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The Pharma Data

JULY 12, 2021

Food and Drug Administration (FDA) has approved finerenone, the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist, under the brand name Kerendia ®. The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th.

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pharmaphorum

JULY 7, 2021

The top-line data sets up a possible market clash with Novartis, which secured the first FDA approval for a drug treatment for HFpEF in February, although the label for its Entresto (sacubitril/valsartan) drug says that its benefits are more evident in patients with reduced ejection fraction.

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Sales Cardiology FDA Approval Trials 52

XTalks

SEPTEMBER 4, 2024

The data, presented at the European Society of Cardiology Congress 2024, suggest that vutrisiran could significantly reduce the risk of death and heart-related issues, marking a potential treatment breakthrough. These results suggest that vutrisiran may be more effective as a standalone treatment.

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Trials RNA Protein Gene Editing 52

XTalks

FEBRUARY 16, 2024

Eicos’ Aurlumyn (iloprost) received approval from the US Food and Drug Administration (FDA) for the treatment of severe frostbite, making it the first approved medication for the condition. Aurlumyn injection is approved for the treatment of adults with severe frostbite to reduce the risk of finger or toe amputation.

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Cardiology Gene Therapy Drugs Branding 59

pharmaphorum

AUGUST 31, 2021

The data is now in from the EMPEROR-Preserved study of Boehringer Ingelheim and Eli Lilly’s Jardiance in heart failure with preserved ejection fraction (HFpEF), and suggest the drug performs better than Novartis’ Entresto – currently the only approved option for these patients.

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Cardiology FDA Approval Trials Sales 52

XTalks

JANUARY 19, 2024

Over the last year, there have been new acquisitions, launches and deals for novel radiotherapeutics and newly created peptide-radioisotope drug conjugates. Relative Biological Effectiveness (RBE), RBE~3-7 but depends on AD, biological endpoint, tissue type as discussed by Donika Plyku, PhD (FDA) Dawson, Laura A.,

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DNA Radiology FDA Approval Development 66

pharmaphorum

AUGUST 18, 2021

Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. The drug also reduced the risk of first and recurrent hospitalisation for heart failure by 30% compared to control.

Cardiology 52

Cardiology Sales Marketing FDA Approval 52

The Pharma Data

SEPTEMBER 11, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Jardiance ® (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. vice president, Product Development, Lilly.

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Medicine Insulin FDA Approval Trials 52

The Pharma Data

NOVEMBER 4, 2020

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. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. promotion of VASCEPA : As reported, the U.S.

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XTalks

AUGUST 2, 2023

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. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Today, the U.S.

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pharmaphorum

JANUARY 5, 2021

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.

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XTalks

NOVEMBER 7, 2024

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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The Pharma Data

APRIL 26, 2021

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.

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XTalks

DECEMBER 19, 2024

The US Food and Drug Administration (FDA) has rejected Johnson & Johnsons (J&J) application for a subcutaneous formulation of Rybrevant (amivantamab). percent, including impacts from its 2023 acquisition of cardiology medtech company Laminar.

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XTalks

OCTOBER 25, 2024

Related: Surmodics and Abbott’s Drug-Coated Balloon for Peripheral Artery Disease Gets FDA Approval Heart failure affects about 6.5 In August, the US Food and Drug Administration (FDA) updated the label for the HeartMate 3 device, removing the requirement for routine aspirin use in patient management.

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