Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir. If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting. […]
Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant
Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I […]
Baxter bolsters fill-finish capabilities with $100M investment in Germany
Baxter International (NYSE:BAX) plans to invest roughly $100 million to expand a sterile fill-finish manufacturing plant in Halle/Westfalen, Germany. BioPharma Solutions (BPS), a subsidiary of Deerfield, Illinois–based Baxter, will manage the new facility. BPS supports pharmaceutical companies through a range of offerings, including scientific support, sterile contract manufacturing and parenteral delivery systems. Get the full […]
Johnson & Johnson to spin off consumer segment
Recently, General Electric (NYSE:GE), Zimmer Biomet (NYSE: ZBH) and Toshiba (TYO:6502) announced their plans to slim down by spinning out core businesses. Now, Johnson & Johnson (NYSE:JNJ) is following a similar approach by making its consumer health business a standalone company. J&J will retain its pharmaceutical and medical device segments. The company said in an […]
FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents
The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine. Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine. Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine […]
Antivirals could be a vital weapon in the COVID-19 pandemic endgame
Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could […]
Early safety concerns accompanied Merck’s molnupiravir, the first potential oral COVID-19 therapy
The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%. One potential hurdle for the drug is whether unvaccinated individuals […]
Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children
Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11. The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA. The companies last week announced that the […]
Gottlieb: Delta wave could burn out by Thanksgiving
Pfizer board member Dr. Scott Gottlieb has predicted that the COVID-19 Delta surge could mark a high-water mark of the pandemic. “This may be the last major wave of infection,” said Gottlieb, who served as the FDA commissioner from 2017 to 2019. In an interview with CNN, Gottlieb predicted that the pandemic in the U.S. […]
FDA advisory panel recommends boosters only for older and high-risk individuals
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals […]
COVID-19 vaccine booster tensions mount between White House, CDC and FDA
Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. Two departing senior FDA vaccine officials recently co-wrote […]