XTalks

JUNE 21, 2024

The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older.

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FDA Approval Vaccination Vaccine Life Science 108

XTalks

OCTOBER 29, 2024

It also marks the first US approval for an oral penem antibiotic (a class of beta-lactam antibiotics with wide-ranging antibacterial activity). Orlynvah is also only the second uUTI treatment approved in the past two decades. uUTIs affect millions in the US each year and primarily affect women.

FDA Approval 105

FDA Approval Bacteria Clinical Trials Clinical Trials 105

XTalks

OCTOBER 29, 2024

It also marks the first US approval for an oral penem antibiotic (a class of beta-lactam antibiotics with wide-ranging antibacterial activity). Orlynvah is also only the second uUTI treatment approved in the past two decades. uUTIs affect millions in the US each year and primarily affect women.

FDA Approval 98

FDA Approval Bacteria Clinical Trials Clinical Trials 98

XTalks

DECEMBER 2, 2022

According to the FDA, the infection causes about 500,000 illnesses and is associated with 15,000 to 30,000 deaths annually in the US. difficile as certain antibiotics can disrupt the balance of bacteria in the gut, allowing bacteria like C. Last year, the company partnered with Nestlé to market the drug once approved.

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FDA Approval Bacteria Clinical Trials Clinical Trials 59

XTalks

AUGUST 2, 2022

The autoantibodies do not fight actual infection or bacteria, but rather the normal tissue in the body. In those affected by lupus, autoreactive B cells (those that react against the body), remain in the body long after the “threat” to the immune system is gone. When this behaviour is prolonged, it results in inflammation.

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FDA Approval Antibody Bacteria Protein 94

Pharmaceutical Technology

FEBRUARY 26, 2023

The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI.

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Bacteria Trials Research Medicine 278

Pharmaceutical Technology

MAY 18, 2023

The drug is GMP-manufactured by Lumen Bioscience in Seattle, US, and is intended to be given concomitantly with normal antibiotics and for eight weeks thereafter, offering protection from re-infection while commensal bacteria recolonise the gastrointestinal tract. Pivotal trials on LMN-201 are expected to commence in 2023.

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Bacterium Bacteria FDA Approval Trials 130

XTalks

MAY 31, 2022

Tapinarof was discovered as an outcome of investigations into the secondary metabolites of Photorhabdus luminescens, a bioluminescent, Gram-negative bacteria. There is 10 mg of tapinarof per gram of Vtama cream. XTALKS WEBINAR: All Means All: The Road to Inclusivity in Clinical Trials.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

FDA Approval 52

FDA Approval Bacteria Medicine Cardiology 52

XTalks

MAY 31, 2024

This novel combination antibiotic treatment is approved for complicated urinary tract infections (cUTIs), including pyelonephritis (a urinary tract infection when one or both kidneys become infected). cUTIs often require broad-spectrum antibiotics to effectively eradicate bacteria in the urinary tract. What are cUTIs? and Candida spp.

Bacteria 52

Bacteria FDA Approval Trials Drugs 52

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

FDA Approval 52

FDA Approval Bacteria Clinical Trials Clinical Trials 52

XTalks

AUGUST 9, 2023

By focusing on the removal of excess bacteria, biofilm and bacterial toxins — the chief culprits behind eyelid symptoms — BlephEx presents a potent solution for those looking for symptom relief. This procedure, which takes just a few minutes, is crafted to address blepharitis and alleviate symptoms of dry eyes.

FDA Approval 98

FDA Approval In-Vitro Trials Bacteria 98

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. SILVER SPRING, Md. , 14, 2020 /PRNewswire/ — Today, the U.S.

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FDA Approval Genome Genomics Production 52

XTalks

JUNE 1, 2022

BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. Osteomyelitis is a bone infection caused by fungi or bacteria. What was special about this latest FDA approval from the company’s (BONESUPPORT’s) commercial perspective?

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Filler FDA Approval Production Marketing 98

The Pharma Data

JULY 29, 2021

BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. In children being treated for urinary incontinence, other side effects include urinary tract infection and bacteria in the urine. About BOTOX ®.

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Botox FDA Approval Doctor Doctors 52

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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Sales FDA Approval Pharmacy Production 52

XTalks

AUGUST 28, 2020

Egorov told Xtalks that, “many studies being carried out right now show that one of the major ways that people get infected with COVID or any other virus or bacteria is not by sharing the bacteria [directly] by sneezing or coughing, but by [touching surfaces], holding hands and then rubbing the nose and eyes.

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Containment Bacteria Marketing Production 111

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.

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Bacterium Drugs Bacteria FDA Approval 69

pharmaphorum

AUGUST 28, 2020

Shares in dermatology specialist Cassiopea, which is listed on the SWX exchange in Switzerland, rose almost 17% after news of the FDA approval emerged. Retinoids can help unclog pores, while antibiotics can limit the growth of bacteria.

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Dermatology Drugs Hormones FDA Approval 52

pharmaphorum

APRIL 26, 2022

The biotech is eligible to receive a further $125 million if the FDA approves the drug and could receive another $225 million in commercial milestones. If approved by the FDA, the treatment would become the first microbiome-based treatment to receive approval.

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Delveinsight

NOVEMBER 26, 2020

However, Urovant progressed quickly for filing for FDA approval earlier this year in a bid to set vibegron as a rival to beta-3 agonist Myrbetriq of Astellas. The latter can usually resist Pseudomonas infections, but as they target a broad spectrum of bacteria, can also contribute to the increase of antibiotic-resistant bugs.

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Antibody Trials Drugs Engineer 79

XTalks

NOVEMBER 7, 2024

Research suggests that certain bacteria, particularly those associated with Demodex mites (tiny mites that naturally live on human skin) like Bacillus oleronius , could contribute to rosacea in some individuals. Other studies suggest that Helicobacter pylori bacteria infections may also cause rosacea.

FDA Approval 105

FDA Approval Dermatology Bacteria Clinical Trials 105

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic.

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Bacteria FDA Approval Licensing Licensing 45

XTalks

DECEMBER 22, 2021

Sarepta Therapeutics has been focused on developing AOS for the treatment of DMD and has received FDA approvals for three of its compounds — EXONDYS 51 (eteplirsen), VYONDYS 53 (golodirsen) and AMONDYS 45 (Casimersen), which are based on exon skipping. Minimally Invasive Devices.

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Life Science RNA Vaccination Vaccine 98

Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. Examples of prominent microbial expression systems are bacteria, fungi, and yeast. coli is relatively easy compared to other strains of bacteria.

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Contract Manufacturing Protein Manufacturing Production 40

The Pharma Data

JULY 12, 2021

online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses machine learning to hunt for disease targets and then predicts whether a drug is likely to receive FDA approval. “Academic labs and pharmaceutical and?

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XTalks

NOVEMBER 28, 2023

This liquid formulation of metronidazole is the sole FDA-approved liquid option, offering a groundbreaking prescribing alternative for patients encountering difficulties in swallowing or facing taste-related obstacles. With a 24-month shelf life and no need for refrigeration, Likmez provides a convenient option for patients.

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FDA Approval Bacteria DNA Drugs 103

The Pharma Data

JUNE 28, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Medicine 52

Medicine Drugs Bacteria FDA Approval 52

The Pharma Data

APRIL 3, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Drugs 52

Drugs Medicine Bacteria FDA Approval 52

XTalks

DECEMBER 17, 2021

Developing a highly effective vaccine against malaria has been technically challenging because malaria has a large and complex genome, and it’s why it’s generally more difficult to develop a vaccine against parasites than smaller viruses and bacteria.

Life Science 98

Life Science Vaccination Vaccine Trials 98

XTalks

APRIL 12, 2021

Research suggests that some gut bacteria can increase levels of ?-synuclein Cala Trio is an FDA-approved device that’s worn on the wrist and that has been shown to reduce tremor power by 50 percent in patients using the device. synuclein in the brain through the production of amyloids.

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Gene Therapy Gene Trials Development 96

Delveinsight

DECEMBER 18, 2020

Brain infection from parasites (malaria, neurocysticercosis), viruses (influenza, dengue, Zika), and bacteria. Xcorpi (cenobamate) is an FDA-approved AED for the treatment of partial-onset seizures in adults. Severe Head Injury. Lack/ loss of oxygen to the brain (especially during birth). Drug or alcohol abuse. Pharmaceuticals.

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Doctor Doctors Drugs Development 52

The Pharma Data

APRIL 1, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Medicine 52

Medicine Doctor Doctors Bacteria 52

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.

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

JUNE 30, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Medicine 52

Medicine Bacteria Vaccine Vaccination 52

The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Medicine 40

Medicine Production Development Trials 40

Pharmaceutical Technology

OCTOBER 28, 2022

The company says that these four serotypes represent roughly 10–15% of bacteria causing pneumococcal disease in adults. While the first pneumococcal polysaccharide vaccine was approved in the US in 1977, the first conjugate shot Prevnar was greenlighted only in 2000.

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Vaccination Vaccine Marketing Bacteria 162