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.

Drugs 40

Drugs Cardiology FDA Approval Doctors 40

XTalks

JULY 19, 2021

Phosphorus, a leading preventative genomics company, has developed the first comprehensive preventative genetic test for consumers. 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.

Genetics 98

Genetics Genome Genomics Gene 98

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). Many companies have already developed their own DCBs, each with unique features supported by varying levels of clinical evidence.

Drugs 52

Drugs Drug Delivery Cardiology Marketing 52

XTalks

FEBRUARY 16, 2024

Aurlumyn injection is approved for the treatment of adults with severe frostbite to reduce the risk of finger or toe amputation. Originally developed by California-based CoTherix, the drug was first approved in 2004 for the treatment of pulmonary arterial hypertension (PAH) under the brand name Ventavis.

Cardiology 59

Cardiology Gene Therapy Drugs Branding 59

Delveinsight

AUGUST 4, 2020

MorphoSys and Incyte announced the US FDA approval under accelerated approval for their treatment Monjuvi in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) – the most common form of non-Hodgkin lymphoma. Billion deal in a thirst to grow in the cancer market.

Cardiology 55

Cardiology Antibody FDA Approval Trials 55

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. Price of Eliquis: Approximately $635 for a supply of 60 oral 2.5 However, sales of Eliquis fell from $16.73 billion in 2021 to $11.79

Sales 59

Sales FDA Approval Drugs Marketing 59

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.

Sales 97

Sales Marketing FDA Approval Regulation 97

XTalks

JULY 7, 2023

It occurs when a rapid, short-circuit rhythm develops in the heart’s upper chamber. It is currently being developed for self-administration by patients without medical supervision, specifically for the acute conversion of atrioventricular-nodal-dependent PSVT. It received FDA approval in 1998.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Drugs 98

XTalks

AUGUST 4, 2022

It is important to consider how the US racial and ethnic populations may change in the future because on average, an investigational product can take five to seven years to undergo Phase I to Phase III development, and this is ideally followed by at least 10 to 15 years of commercial value. or greater than 1.2

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 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. vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.

Medicine 52

Medicine Insulin FDA Approval Trials 52

The Pharma Data

OCTOBER 25, 2020

Furthermore, we will advance the field of native lung recovery and improve patient outcomes by collecting critical research data and developing and teaching best practices.”. The authorized Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. ABOUT IMPELLA HEART PUMPS. The Impella 2.5®,

Cardiology 52

Cardiology FDA Approval Production Engineer 52

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc. billion.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

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

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 million and $30.5 million, respectively, compared to $8.9 million and $23.3

Sales 40

Sales Production Cardiology Marketing 40

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. One bright spot in an otherwise dreadful year: the pharmaceutical industry has discovered it can do things it never dreamed possible.

Sales 105

Sales Marketing Production Vaccination 105

The Pharma Data

OCTOBER 29, 2020

Research and Development. 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. ULTOMIRIS – 100 mg/mL: In October 2020 , the U.S.

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