XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Compared to Vaxneuvance’s targeting of 15 different strains of the bacterium, Pfizer’s shot protects against 20.

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 89

XTalks

JULY 25, 2023

Anthrax is a rare, yet severe disease caused by the bacterium B. Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. What Is Anthrax? anthracis , primarily affecting livestock and wild game.

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

Pharmaceutical Technology

MAY 18, 2023

Biotechnology company Lumen Bioscience has secured fast track designation from the US Food and Drug Administration (FDA) for LMN-201 for the treatment and prevention of C difficile infection (CDI). It is compatible with standard-of-care antibiotics.

Bacterium 130

Bacterium Bacteria FDA Approval Trials 130

pharmaphorum

DECEMBER 1, 2021

The French group said that ORI-001, a vaccine based on recombinant proteins from the Cutibacterium acnes (formerly Propionibacterium acnes ) bacterium that is often found in acne lesions, could be the first ever vaccine for the condition.

Vaccination 105

Vaccination Vaccine Development Hormones 105

pharmaphorum

JULY 2, 2021

Under the terms of the new deal, Nestle’s Health Sciences unit will pay Seres another $125 million if the FDA approves the drug – called SER-109 – and is also line for up to $225 million in commercial milestones tied to sales targets. Nestle and Seres have been working together on the microbiome project since 2016, focusing on C.

Bacterium 69

Bacterium Drugs Bacteria FDA Approval 69

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pharmaceutical Technology

OCTOBER 28, 2022

In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Merck, known outside of the US and Canada as MSD, is developing its portfolio of pneumococcal vaccines , and has secured an FDA approval for the paediatric use of its 15-serotype vaccine Vaxneuvance in June.

Vaccination 162

Vaccination Vaccine Marketing Bacteria 162