Sun.May 21, 2023

article thumbnail

Future of Intercept’s NASH drug in doubt after FDA panel rejection

Bio Pharma Dive

The safety risks of obeticholic acid were too great for an advisory committee to recommend approval without clear proof of its benefits. But collecting that data may not be “economically feasible,” an executive said.

Drugs 195
article thumbnail

A Popular New Weight-Loss Drug May Help Prevent Dementia

AuroBlog - Aurous Healthcare Clinical Trials blog

Over 55 million people worldwide have dementia. This mind-robbing condition has a huge impact on society and the economy, so scientists are working hard to find ways to treat or prevent it. One of the avenues being explored is the new weight-loss jab, Wegovy.

Drugs 163
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease

BioSpace

Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease 5/22/2023

article thumbnail

Ayush ministry informs HC that it has instructed drug regulators against use of Unani label for Ayurveda drug

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]

Drugs 149
article thumbnail

Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

article thumbnail

Biopharma Targets the Untapped Potential of the Human Healthspan

BioSpace

Biopharma Targets the Untapped Potential of the Human Healthspan 5/22/2023

96
article thumbnail

FDA clears Vyjuvek as first topical gene therapy

pharmaphorum

FDA clears Vyjuvek as first topical gene therapy Phil.

More Trending

article thumbnail

Drug Patent Expirations for the Week of May 21, 2023

Drug Patent Watch

SELZENTRY (maraviroc) Viiv hlthcare Patent: 7,368,460 Expiration: May 25, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or… The post Drug Patent Expirations for the Week of May 21, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

Hepion Claims Phase II NASH Victory Following Intercept’s Adcomm Defeat

BioSpace

Hepion Claims Phase II NASH Victory Following Intercept’s Adcomm Defeat 5/22/2023

86
article thumbnail

Chronic Obstructive Pulmonary Disease and Pneumonia in New Users of Combination Maintenance Inhalers

JAMA Internal Medicine

This cohort study uses commercial insurance claims to compare the incidence of first moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation and first pneumonia hospitalization among patients with COPD who started using inhalers with long-acting muscarinic antagonists and long-acting β-agonists (LABAs) vs inhalers containing inhaled corticosteroids and LABAs.

article thumbnail

AbbVie, Genmab Score FDA Nod for DLBCL as Blood Cancer Space Heats Up

BioSpace

AbbVie, Genmab Score FDA Nod for DLBCL as Blood Cancer Space Heats Up 5/22/2023

86
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Comparative Effects of Glucose-Lowering Medications on Kidney Outcomes in Type 2 Diabetes

JAMA Internal Medicine

This randomized clinical trial evaluates kidney function with the use of medications added to metformin treatment in patients with type 2 diabetes.

article thumbnail

ReCode–a New Contestant in the mRNA Race

BioSpace

ReCode–a New Contestant in the mRNA Race 5/22/2023

99
article thumbnail

CD20 market heats up as FDA OKs AbbVie, Genmab bispecific

pharmaphorum

CD20 market heats up as FDA OKs AbbVie, Genmab bispecific Phil.

article thumbnail

Opinion: Sarepta Enters Uncharted Territory with Adcomm Approval

BioSpace

Opinion: Sarepta Enters Uncharted Territory with Adcomm Approval 5/22/2023

85
article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

article thumbnail

Which pharmaceutical drugs have the most drug patents in Philippines?

Drug Patent Watch

This chart shows the drugs with the most patents in Philippines. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Philippines? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

FDA Action Alert: Blueprint, Opiant and Lexicon

BioSpace

FDA Action Alert: Blueprint, Opiant and Lexicon 5/22/2023

90