XTalks

AUGUST 14, 2024

He serves as director of Atlantic Health System Sports Cardiology and director of the Chanin T. Dr. Martinez also serves as a cardiology consultant for elite and professional athletes, including acting as the League cardiologist for Major League Soccer, team cardiologist for the New York Jets and cardiac consultant for the NFL and NHL.

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Life Science Cardiology FDA Approval Medicine 72

The Pharma Data

NOVEMBER 2, 2020

FDA Approves 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.

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XTalks

DECEMBER 2, 2024

The US Food and Drug Administration (FDA) has approved AOP Health’s landiolol injection, marketed as Rapiblyk, for the treatment of atrial fibrillation (Afib) and atrial flutter in critical care settings.

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The Pharma Data

FEBRUARY 24, 2022

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.

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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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FDA Law Blog

NOVEMBER 10, 2024

Interestingly, based on a review of the 709 Orphan Products Clinical Trials Grants awarded since 1983 that are listed in FDA’s public database , as of October 1, 2024, only 48 Phase 3 trials have been granted an award (eight of which were Phase 2/3 trials). Relative to other areas of medicine (e.g.,

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Production Clinical Development Development Regulation 69

The Pharma Data

JULY 12, 2021

The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. The study met its primary endpoint.

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XTalks

JULY 19, 2021

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 FDA approval.

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Genetics Genome Genomics Gene 98

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.

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Sales FDA Approval Drugs Marketing 59

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

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.

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Sales Insulin FDA Approval Drugs 52

XTalks

SEPTEMBER 9, 2024

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.

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pharmaphorum

JANUARY 12, 2021

The new FDA review – covering Jardiance as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) in patients with and without diabetes – is Lilly and Boehringer’s first chance to fight back. AZ picked up EU approval for the same indication the following November.

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Sales FDA Approval Trials Marketing 76

FDA Law Blog

FEBRUARY 21, 2022

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. “I

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Drugs Cardiology FDA Approval Doctor 40

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.

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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.

Trials 52

Trials RNA Protein Gene Editing 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. Billion deal in a thirst to grow in the cancer market.

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Cardiology Antibody FDA Approval Trials 55

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

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.

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Cardiology Sales Marketing FDA Approval 52

pharmaphorum

JULY 19, 2021

BMS filed for FDA approval of the drug on the strength of that data, and a verdict from the US regulator is due by 28 January next year.

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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

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., Engagement history (active vs. inactive subscribers).

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Compliance Marketing Branding Regulation 72

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.

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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).

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Cardiology Gene Therapy Drugs Branding 59

XTalks

JULY 7, 2023

It received FDA approval in 1998. Adenosine is typically administered through a rapid intravenous (IV) bolus injection into a vein or an IV line and requires a prescription. Another prescribed drug for PSVT is Verapamil, a calcium antagonist or slow-channel inhibitor.

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Clinical Trials Clinical Trials Trials Drugs 98

XTalks

JUNE 11, 2024

Treatment options like it not only have the potential to improve patient care but also to influence future research directions and treatment strategies in interventional cardiology.

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Drugs Drug Delivery Cardiology Marketing 52

XTalks

AUGUST 4, 2022

During the webinar, Dr. Shreenivas gave examples from cardiology and oncology which show that race and ethnicity do matter for medical problems. During the study period, the FDA approved 24 novel cardiovascular drugs and 11 novel diabetes mellitus drugs, and the median number of participants supporting each drug was 5930 individuals.

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Clinical Trials Clinical Trials Trials Clinical Research 52

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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The Pharma Data

OCTOBER 25, 2020

The European Journal of Heart Failure , ASAIO , and the Journal of the American College of Cardiology have published studies that conclude use of ECpella was associated with increased survival rates, as compared to patients who were treated with ECMO only. Department of Health and Human Services (HHS). ABOUT IMPELLA HEART PUMPS.

Cardiology 52

Cardiology FDA Approval Development Engineer 52

The Pharma Data

SEPTEMBER 11, 2021

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. ” The FDA previously granted Fast Track designation for the development of Jardiance to reduce the risk of cardiovascular death and hospitalization for heart failure.

Medicine 52

Medicine Insulin FDA Approval Trials 52

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.

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DNA Radiology FDA Approval Development 66

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. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. 500 mg/dL) hypertriglyceridemia.

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The Pharma Data

APRIL 26, 2021

New approvals. Topline results will be presented at the American College of Cardiology 70th Annual Scientific Session. Exjade/Jadenu. Top 20 products total. R&D update – key developments from the first quarter. Entresto. . The safety profile of Entresto was confirmed. Novartis will continue to evaluate the data.

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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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Sales Clinical Trials Clinical Trials Production 40

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). In August, the FDA approved Janssen Biotechs EGFR kinase inhibitor Lazcluze in combination with Rybrevant as a first-line treatment for NSCLC with EGFR exon 20 insertion mutations.

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Sales FDA Approval Licensing Licensing 97

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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