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INSANE: 4 | Vintage Vibes

FDA Extends Review Period For Regeneron's COVID-19 Antibody Therapy

The FDA has extended its review of Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) marketing application of REGEN-COV (casirivimab and imdevimab) for non-hospitalized COVID-19 patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use. Regeneron has submitted additional data from its completed prophylaxis trial that the…

Regeneron Builds On Retinal Disease Expertise Via Gene Therapy Pact With ViGeneron

Regeneron Builds On Retinal Disease Expertise Via Gene Therapy Pact With ViGeneron

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) beefed up its gene therapy capabilities after signing a new deal with the German biotech ViGeneron. The companies did not specify their target but noted it would be some inherited retinal disease. It's an area where Regeneron has much expertise. One of its best-selling products, Eylea, is approved to treat…

Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

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Buy the Dip in 3 Top-Rated Large-Cap Stocks

The increasing economic sanctions on Russia and consequent surge in oil prices and supply-chain disruptions will surely keep the stock market under pressure. Therefore, we think it could be wise to buy the price dip in quality large-cap stocks Regeneron Pharmaceuticals (REGN), Telefonaktiebolaget LM Ericsson (ERIC), and PPG Industries (PPG)…

BioNTech, Regeneron To Evaluate FixVac-Based Cancer Vaccine/Libtayo Combo In NSCLC

BioNTech SE (NASDAQ:BNTX) has expanded its strategic collaboration with Regeneron Pharmaceuticals Inc (NASDAQ:REGN) to its FixVac candidate BNT116 combined with Libtayo (cemiplimab) in advanced non-small-cell lung cancer (NSCLC). Under the terms of the agreement, the companies plan to jointly conduct clinical trials to evaluate the combination in different patient populations with advanced NSCLC and share…

The Daily Biotech Pulse: Regeneron-Sanofi Halt Late-Stage Dupixent Study, Agios Gets FDA Nod, Safety Scare For GSK's RSV Vaccine, Shockwave Jumps On Earnings

Here's a roundup of top developments in the biotech space over the last 24 hours.

Sanofi - Regeneron's Dupixent Under FDA Priority Review For Children Under 5 Years With Atopic Dermatitis

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Regeneron's Q4 Sales, Profits More Than Double With Boost From COVID-19 Treatment Sales

Regeneron's Q4 Sales, Profits More Than Double With Boost From COVID-19 Treatment Sales

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) earned

Regeneron, Sanofi Withdraw FDA Application For Libtayo's Expanded Use

Regeneron, Sanofi Withdraw FDA Application For Libtayo's Expanded Use

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and its partner Sanofi SA (NASDAQ: SNY) have

FDA limits use of Regeneron and Lilly COVID antibody treatments

FDA limits use of Regeneron and Lilly COVID antibody treatments

The FDA said "data show these treatments are highly unlikely to be active" against Omicron.

FDA Rescinds Authorization For Regeneron, Eli Lilly COVID-19 Antibody Treatments: Here's Why

FDA Rescinds Authorization For Regeneron, Eli Lilly COVID-19 Antibody Treatments: Here's Why

Antibody treatments made by Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Eli Lilly And Co (NYSE: LLY) are not likely to work against the Omicron variant of COVID-19 and their emergency use authorization has been rescin

FDA halts use of 2 treatments found to be ineffective against omicron

WASHINGTON — U.S. regulators restricted the use of a pair of COVID-19 monoclonal antibody therapies after scientific evidence suggested they are unlikely to be effective against the omicron variant.

Tribune News Service

FDA halts use of antibody drugs that don't work vs. omicron

FDA halts use of antibody drugs that don't work vs. omicron

U.S. health officials say COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don't work against the omicron variant

The Independent UK

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