Remove 2021 Remove Clinical Development Remove Trials
article thumbnail

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. More information at www.algotx.com. View source version on businesswire.com: [link].

article thumbnail

News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Cytel

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Most of these post-approval changes have been overall decreases in dose.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

article thumbnail

Sanofi, GSK launch early trial for COVID-19 vaccine

The Pharma Data

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

Vaccine 52
article thumbnail

Gilead Sciences Announces Second Quarter 2021 Financial Results

The Pharma Data

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

Science 52
article thumbnail

Accelerated Approval and Confirmatory Trials: Timing is Everything

The Premier Consulting Blog

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials 52
article thumbnail

2021 Biotech IPOs Get Off to a Roaring Start

The Pharma Data

With this kind of a start, 2021 may be scorching. The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. It is now in a Phase I/IIa trial for adult NSCLC with EGFRex20ins mutations.