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.

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Drugs Cardiology FDA Approval Scientist 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

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.

Drugs 52

Drugs Drug Delivery Cardiology Marketing 52

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

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).

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FDA Approval Clinical Trials Clinical Trials Cardiology 105

XTalks

FEBRUARY 9, 2024

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. Marketing in both cardiac and hematological indications has contributed to its success, which continues to grow in emerging markets globally.

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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).

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FDA Approval Marketing Cardiology Production 98

XTalks

AUGUST 2, 2023

We delve into the driving forces behind their successes and shed light on the groundbreaking research that has earned them a place among the elite in the pharmaceutical arena. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023.

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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. Research and development (R&D) expense for the three and nine months ended September 30, 2020 were $10.2 commercial team. “In million and $30.5 million and $23.3

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”.

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Sales Marketing Production Vaccination 105

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., Research and Development. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS.

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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.

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Sales Medicine Production Manufacturing 40