Tag: FDA

FDA Advice to Developers Makes a Pre-Election Covid Vaccine Unlikely

October 7, 2020
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An engineer works in the general laboratory during a media tour of a new factory built to produce a COVID-19 coronavirus vaccine


WANG ZHAO/AFP/Getty Images

A briefing document published today by the U.S. Food and Drug Administration makes it clear that President Trump won’t be able to push through a Covid-19 vaccine before November’s election.

The FDA posted the 38-page briefing on its website, ahead of an Oct. 22 meeting of the agency’s outside scientific advisors on development and authorization of Covid vaccines. Inside, the agency reports that it has advised vaccine developers not to apply for an emergency use authorization until they’ve followed-up on clinical trial participants for an average of two months after the last shot.

A two month follow-up would make it late November for the vaccine being tested by

Pfizer

(ticker: PFE) and

BioNTech

(BNTX), writes Raymond James analyst Steven Seedhouse in a Tuesday

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FDA Broadly Supports Oragenics’ Pre-IND Development Program for its SARS-CoV-2 Vaccine

October 6, 2020
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Re-Affirms Plan to File IND Application by the End of 1Q21, Begin Phase 1 Study in Early 2Q21

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration (“FDA”) that it is in broad agreement with the Company’s planned approach to clinical development of its SARS-CoV-2 vaccine, Terra CoV-2. As a result, the Company believes its timelines for both filing an Investigational New Drug (“IND”) application and the commencement of the Phase 1 study will proceed on schedule. Oragenics expects to file the IND by the end of the first quarter of 2021 and commence patient enrollment in the Phase 1 clinical study early in the second quarter of 2021.

“We are very pleased with the FDA’s response to our Type B Pre-IND meeting request as it permits us to maintain an aggressive

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Inovio Coronavirus Vaccine Candidate Trial Halted Due To FDA Inquiry

September 29, 2020
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Inovio Pharmaceuticals (NASDAQ:INO) stock was really taking it on the chin Monday, following a very discouraging revelation from the company.

The biotech announced that morning that the clinical trials for its INO-4800 COVID-19 vaccine candidate have been halted. This was because the Food and Drug Administration (FDA) served notice that it has additional questions about the phase 2/3 trial of INO-4800, in particular, the company’s proprietary CELLECTRA 2000 injection device that will be used in the testing.

Inovio said it is laboring to answer the regulator’s questions; the company plans to respond in October. After its responses are submitted, the FDA will have up to 30 days to render a decision about whether the clinical trials can proceed.

The company stressed that the FDA’s decision was not based upon, and does not impact, the expanded phase 1 trial of the vaccine candidate, which is ongoing. It also does not affect

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GNFT Soars On LabCorp Deal, INO’s COVID-19 Vaccine Trial On Partial Hold, FDA Expands Xeljanz Label

September 29, 2020
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(RTTNews) – Today’s Daily Dose brings you news about Abeaona’s leadership and Board transitions, GENFIT’s deal with LabCorp., FDA hold on Inovio’s planned Phase 2/3 Covid-19 vaccine trial, the new CEO of Merck KGaA, and label expansion of Pfizer’s blockbuster drug Xeljanz.

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1. Abeona Plunges as CEO, Directors Resign

Abeona Therapeutics Inc. (ABEO) announced that João Siffert resigned from his positions as CEO, Head of Research and Development, and Chief Medical Officer, as well as member of the Board of Directors, on September 23, 2020.

The company added that on September 27, 2020, Brian Pereira, Stefano Buono, Stephen Howell, George Migausky and Shawn Tomasello had all stepped down from the Board, effective immediately.

Abeona is reviewing and exploring all strategic options and alternatives to maximize stakeholder value, including its sale.

ABEO touched a new 52-week low of $1.07 in intraday trading Monday, before closing at $1.09, down 41.40%.

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