Altus Drug Development

JUNE 28, 2022

Ensuring access to safe and effective treatments is the main challenge faced by pharmaceutical companies big and small. The purpose of research and development in the pharmaceutical industry is the incremental innovation of medicinal products and treatments. What is a value-added medicine? To comply with the law.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Doctors Treatment 52

Advarra

JULY 19, 2022

Q: If an emergency use authorization (EUA) is granted, once there is an approved treatment, does that mean that the EUA is no longer valid? The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. A: Yes, the EUA is just temporary. is this acceptable to the FDA?

Packaging 52

Packaging FDA Trials Regulations 52

The Pharma Data

DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. AB2 Bio – Swiss pharma company AB2 Bio Ltd. Immune Regulation – U.K.-based

Small Molecule 52

Small Molecule Clinical Development Engineering Pharmaceuticals 52

The Pharma Data

NOVEMBER 5, 2020

The demand for an effective drug for nail fungus is high and MOB-015 can achieve a unique market position through its high antifungal effect,” says Anna Ljung, CEO of Moberg Pharma. MOB-015 is the next-generation nail fungus treatment targeting both OTC and prescription markets worldwide. CET on November 6, 2020.

Marketing 40

Marketing Production Regulations Pharma Companies 40

Drug Target Review

MAY 26, 2025

For example, cell therapies use living cells as treatments, allowing for the combination of multiple biologically active molecules into complex, hybrid drugs. “Regulators are also much more interested in the manufacturing process, especially when it comes to stability.”

Drug Development 52

Drug Development Drugs Therapies Pharmaceuticals 52

Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

Therapies 137

Therapies Virus DNA Clinical Trials 137

The Anticancer Fund

JUNE 7, 2022

Treatment with DFMO aka eflornithine, already a high-profile repurposing candidate in neuroblastoma, decreased intracellular pH in TAMCs and was associated with improved survival, more so when combined with immunotherapy or radiotherapy. Patients were randomised to treatment or observation groups and followed for six months.

Drugs 40

Drugs Clinical Trials Trials Treatment 40

Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

FDA 40

FDA Regulations Production Science 40

The Pharma Data

MAY 13, 2021

In this special report, I’m going to show you why researchers at Harvard University and the Massachusetts General Hospital in Boston are now praising a strange new pain treatment originally discovered on the International Space Station. Unfortunately, I learned the hard way that the “Big Pharma” companies don’t care about their patients.

Pharmacy 52

Pharmacy Doctors Production Therapies 52

Drug Target Review

MARCH 13, 2025

The journey from distrust to collaboration among industry, academia and regulators will expedite integration, minimise clinical failures and enhance economic sustainability. Techbio companies have initiated this approach. FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.

Drug Development 59

Drug Development Science Clinical Trials Drugs 59

The Pharma Data

DECEMBER 30, 2020

The reason for this is still not understood and many regulators may want it to be explained before authorizing it for broader use. It is also being developed for GIST in other treatment settings and has several pipeline compounds for oncology. Johnson & Johnson’s COVID-19 vaccine. Deciphera has a market cap of $3.2

Vaccine 52

Vaccine FDA Trials Therapies 52

The Pharma Data

DECEMBER 16, 2020

The goal will be to develop anti-SARS-CoV-2-specific dMAbs which could offer versatile capabilities to function as both a therapeutic and preventive treatment for COVID-19. Recombinant monoclonal antibodies are designed to enhance the immune system’s ability to regulate cell functions. The research is being supported by a $37.6

Vaccine 52

Vaccine DNA Government Pharma Companies 52

Drug & Device Law

APRIL 7, 2023

So the company sued, and the district judge ruled that the FDA had no valid basis to withhold the requested information. The plaintiff pharma company marketed a drug for sleep disorders and wanted to add a new approved use—treatment for jet lag. Here is what happened.

FDA 64

FDA Government Pharma Companies Regulations 64