Drug Discovery World

MAY 3, 2023

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

Cardiology 52

Cardiology Trials FDA Approval Drug Trials 52

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 […].

Trials 41

Trials FDA Approval Clinical Trials Clinical Trials 41

XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

Sales 52

Sales Insulin FDA Approval Drugs 52

The Pharma Data

JULY 12, 2021

Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of the FIDELIO-DKD trial. The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th.

FDA Approval 52

FDA Approval Cardiology Medicine Trials 52

Drug Discovery World

APRIL 6, 2023

AF-130 is soon to be FDA approved for a different indication, paving the way for human trials. Over recent decades there have been several classes of drugs that have improved the prognosis of heart failure,” said Cardiology Consultant and Associate Professor, Martin Stiles.

Drugs 52

Drugs Cardiology FDA Approval Scientist 52

pharmaphorum

JULY 7, 2021

The results of the much-anticipated EMPEROR-Preserved trial found that SGLT2 inhibitor Jardiance (empagliflozin) reduced the risk of cardiovascular death or hospitalisation for heart failure in adults with HFpEF, which accounts for around half of all heart failure cases.

Sales 52

Sales Cardiology FDA Approval Trials 52

pharmaphorum

AUGUST 31, 2021

SGLT2 inhibitor Jardiance (empagliflozin) reduced a composite of cardiovascular (CV) death or hospitalisations for heart failure by a significant 21% compared to placebo in HFpEF, regardless of diabetes status, according to results presented at the European Society of Cardiology (ESC) meeting over the weekend.

Cardiology 52

Cardiology FDA Approval Trials Sales 52

XTalks

JULY 7, 2023

a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinical trial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). It received FDA approval in 1998. Milestone Pharmaceuticals Inc.,

Clinical Trials 98

Clinical Trials Clinical Trials Trials Drugs 98

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 post Jardiance gets parity with Farxiga in US as FDA clears use in heart failure appeared first on.

Cardiology 52

Cardiology Sales Marketing FDA Approval 52

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. The Phase II trial evaluated IMU-838, against placebo in 209 patients.

Cardiology 55

Cardiology Antibody FDA Approval Trials 55

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.

Sales 74

Sales FDA Approval Trials Marketing 74

XTalks

FEBRUARY 16, 2024

“This approval provides patients with the first-ever treatment option for severe frostbite,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research (CDER).

Cardiology 59

Cardiology Gene Therapy Drugs Branding 59

pharmaphorum

JUNE 22, 2021

That was followed by another first-in-class FDA approval for Farxiga in CKD in April, leaving Boehringer/Lilly playing catch-up with Jardiance once again. Now, the approval of Jardiance for HFrEF in Europe – with an FDA decision due in the coming weeks – gives them a chance to reset the playing field.

Sales 98

Sales Marketing FDA Approval Regulation 98

pharmaphorum

JULY 19, 2021

Cytokinetics estimates there are somewhere between 100,000 and 280,000 individuals with the disease in the US, and notes there are currently no therapies that are specifically approved for the disease, which is one of the most common reasons for sudden cardiac death in people who are younger than 35.

FDA Approval 98

FDA Approval Drugs Trials Regulation 98

XTalks

APRIL 7, 2022

Abbott Laboratories announced on Monday that the US Food and Drug Administration (FDA) approved its Aveir™ single-chamber (VR) leadless pacemaker system. The Illinois-based company received the FDA nod for its new pacemaker to treat patients with bradycardia (slow heart rhythms).

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Cardiology 105

XTalks

FEBRUARY 9, 2024

Eliquis (Apixaban) Eliquis sales in 2022: $11.789 billion Company/Developer: Bristol Myers Squibb (BMS) and Pfizer Date of first FDA approval: December 28, 2012 Indications Eliquis is FDA-approved for: Eliquis is primarily prescribed to prevent blood clots in individuals with certain medical conditions.

Sales 59

Sales FDA Approval Drugs Marketing 59

The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. The benefit was independent of ejection fraction or diabetes status.

Medicine 52

Medicine Insulin FDA Approval Trials 52

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).

FDA Approval 98

FDA Approval Marketing Cardiology Production 98

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

NOVEMBER 4, 2020

In the process of hiring select people with extensive commercial experience in Europe and preparing for post-approval market access negotiations. 7 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019. commercial team. “In 500 mg/dL) hypertriglyceridemia.

Sales 40

Sales Production Cardiology Marketing 40

XTalks

JANUARY 19, 2024

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.

DNA 66

DNA Radiology FDA Approval Development 66

pharmaphorum

JANUARY 5, 2021

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. “The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent”.

Sales 104

Sales Marketing Production Vaccination 104

The Pharma Data

OCTOBER 29, 2020

In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson , Ph.D., FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS.

Sales 40

Sales Clinical Trials Clinical Trials Production 40

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.

Sales 40

Sales Medicine Production Manufacturing 40