Pharma Rep Focus

Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Food and Drug Administration

Food and Drug Administration FDA Marketing Pharmaceutical

Versanis’ bimagrumab, first-in-class obesity therapy, enters Phase IIb of development

Pharmaceutical Technology

JANUARY 17, 2023

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. In addition to facilitating loss of fat, the Phase II trial also showed that a lean mass gain of 4.5% was observed in the study.

Marketing

Marketing Patients Safety Pharmaceutical

Axsome bounces back as FDA clears depression drug

pharmaphorum

AUGUST 21, 2022

In this product, bupropion is designed to increase levels of dextromethorphan in the blood and extend its half-life. Axsome’s drug was given a breakthrough designation from the FDA, reflecting the need for new treatment options in patients at increased risk of self harm or suicide, and was also given a priority review.

FDA

FDA Marketing Pharma Sales

Actualising the power of antibody-drug conjugates as cancer therapeutics

European Pharmaceutical Review

AUGUST 24, 2022

ANTIBODY-DRUG conjugates (ADCs) are therapeutic molecules designed as highly targeted medicines with the promise of changing the way we treat cancer and other diseases. In total, there are 14 approved ADCs on the global market, all for oncology indications, and over 140 ADCs currently in clinical development.

Engineering

Engineering Side effects Marketing Patients

CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

JULY 25, 2022

It showed an overall response rate with Tecvayli of 63%, including 39% complete responses which is a remarkable result given that the patient recruited into the trial were very ill and heavily pre-treated. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

Medicine

Medicine FDA Recruitment Patients

Pioneering the Path Pre- and Post-Launch Strategies

PM360

APRIL 22, 2024

From defining the target product profile to shaping clinical endpoints and devising asset strategies to crafting scientific narratives, the value of Medical Affairs permeates every aspect of product development. Today, teams are indispensable strategic partners, deeply involved in crafting the very foundation of a product’s journey.

Medical

Medical Healthcare Healthcare Education

Q&A: A decade on, what’s next for CAR-T therapies?

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

Food and Drug Administration

Food and Drug Administration Engineering Patients Education

CCC Adds Clinical Trial Registries to RightFind Navigate Data Sources

Copyright Clearance Center

NOVEMBER 7, 2023

. – CCC , a pioneer in voluntary collective licensing, advancing copyright, accelerating knowledge, and powering innovation, announces Clinical Trial Registries, a new data connector for customers of the cloud-based software solution RightFind Navigate. clinical trials through the connector to ClinicalTrials.gov.

Management

CCC Pilots AI-disambiguated Researcher and Institution Data in RightFind Navigate

Copyright Clearance Center

SEPTEMBER 28, 2023

RightFind Navigate’s machine-learning driven semantic enrichment and advanced personalization features help users locate the most relevant information in scientific literature, clinical trials, patents, and many other sources.

Management

Management Pharmaceutical

Unconventional Approaches Pharma Is Taking to Engage Patients

PM360

SEPTEMBER 7, 2023

A card game designed to help hemophilia patients exercise. Then onto Tuan Vu, MD, Professor of Neurology, Director, Neuromuscular Division, EMG Laboratories, and ALS Clinic, Department of Neurology University of South Florida, who discussed the global clinical trial. The “Kama Sutra” for Parkinson’s patients.

Patients

Patients Pharma Education Doctors

How to Become a Medical Sales Rep & Build a Successful Career As One

Map My Customers

AUGUST 2, 2022

These include: Medical Device Sales - In this role, medical device sales reps have a designated territory for selling medical devices for a manufacturer. Surgical Equipment Sales - This type of rep will be selling specialized surgery equipment that often comes with a high price tag.

Medical sales reps

Medical sales reps Medical sales Sales Medical

CEPI provides $30m to advance novel coronavirus vaccine

European Pharmaceutical Review

JULY 11, 2022

Funding of up to $30 million will support vaccine design, its development through Phase I trials and regulatory activities. . is designed to focus the immune response on parts of RBD shared by all viruses in the Severe Acute Respiratory Syndrome (SARS)-like Betacoronavirus family. 2 is the virus that causes COVID-19.).

Manufacturing

Manufacturing Engineering Leads Medicine

The Blogger, The Podcaster, The OR Nurse With Melanie Perry

Evolve Your Success

DECEMBER 27, 2022

They are inspecting and ensuring that all of these instruments that we use, whether we’re talking about using it in the OR, labor and delivery, wound care clinic, or anywhere where you might need an instrument that is clean or sterile, they are the ones making sure that instrument is exactly like it needs to be. They know everything about it.

Medical sales

Medical sales Medical sales reps Sales Medical

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5%

Medical

Medical Manufacturing Insurance Side effects

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5%

Medical

Medical Manufacturing Insurance Side effects

Pharma Rep Focus

Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Versanis’ bimagrumab, first-in-class obesity therapy, enters Phase IIb of development

Trending Sources

Axsome bounces back as FDA clears depression drug

Actualising the power of antibody-drug conjugates as cancer therapeutics

CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

Pioneering the Path Pre- and Post-Launch Strategies

Q&A: A decade on, what’s next for CAR-T therapies?

CCC Adds Clinical Trial Registries to RightFind Navigate Data Sources

CCC Pilots AI-disambiguated Researcher and Institution Data in RightFind Navigate

Unconventional Approaches Pharma Is Taking to Engage Patients

How to Become a Medical Sales Rep & Build a Successful Career As One

CEPI provides $30m to advance novel coronavirus vaccine

The Blogger, The Podcaster, The OR Nurse With Melanie Perry

The “Medical Bypass”: new drugs to strike obesity

The “Medical Bypass”: new drugs to strike obesity

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