XTalks

DECEMBER 2, 2024

The approval is grounded in data from five randomized, double-blind, placebo-controlled trials involving 317 adults. He expressed optimism about the therapy’s potential to enhance outcomes for patients in the US.

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XTalks

NOVEMBER 26, 2024

The FDA’s decision follows compelling data from the ATTRibute-CM Phase III study, which enrolled 632 symptomatic patients with either wild-type or hereditary ATTR-CM. Notably, acoramidis delivered measurable benefits as early as three months into treatment, making it the most rapid response observed in Phase III trials for ATTR-CM to date.

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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

SEPTEMBER 4, 2024

Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). While HELIOS-A focused on nerve damage, HELIOS-B expands vutrisiran’s use to cardiomyopathy.

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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

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

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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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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.

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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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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.,

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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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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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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 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

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.

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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.

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Sales Cardiology FDA Approval Trials 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.

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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.

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

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Cardiology Sales Marketing FDA Approval 52

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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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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XTalks

JUNE 11, 2024

The FDA’s approval is based on positive results from the AGENT IDE trial , a multicenter, prospective, randomized controlled study, which demonstrated the statistical superiority of Agent DCB over uncoated balloon angioplasty in preventing target lesion failure (TLF) at 12 months.

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Drugs Drug Delivery Cardiology Marketing 52

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”.

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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.

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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

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.

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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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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.

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Sales Production Marketing Cardiology 40

XTalks

OCTOBER 25, 2024

Abbott has announced the commencement of a new clinical trial for its advanced left ventricular assist device (LVAD), the HeartMate 3, to determine the benefits of early implantation of the device in patients with advanced heart failure. The device tracks PAP changes over time.

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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). 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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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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