BioPharma Reporter

JULY 11, 2024

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

Antibody 98

Antibody Drug Trials Clinical Research Trials 98

Outsourcing Pharma

NOVEMBER 1, 2021

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.

Trials 95

Trials Drug Trials Clinical Research Drugs 95

The Pharma Data

JANUARY 20, 2021

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.

Drug Trials 52

Drug Trials Drugs Trials Compliance 52

pharmaphorum

AUGUST 4, 2020

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier.

Drugs 122

Drugs Manufacturing Marketing Regulation 122

pharmaphorum

JANUARY 18, 2021

The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. Fundamental barriers and deeply rooted mistrust of medical research motives among communities of colour require a more thoughtful and deliberate approach to participant outreach.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drug Trials 52

Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

Placebo Control

JULY 31, 2013

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. Pharma: breaking the law in broad daylight? It would be more than a bit ironic otherwise.

Pharma Companies 40

Pharma Companies Trials Compliance Clinical Trials 40