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. Orlynvah was generally well tolerated in both SURE 1 and REASSURE clinical trials.

FDA Approval 98

FDA Approval Bacteria Clinical Trials Clinical Trials 98

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. XTALKS WEBINAR: All Means All: The Road to Inclusivity in Clinical Trials. Clinical Trials of Vtama. There is 10 mg of tapinarof per gram of Vtama cream.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials 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. The featured speakers will discuss how to facilitate trial participation in rare disease. Before Benlysta was approved, the treatment options for LN were limited to non-selective immunosuppressants and corticosteroids.

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FDA Approval Antibody Bacteria Protein 94

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

XTalks

JULY 6, 2021

CDIs usually develop after treatments with antibiotics as they can kill off healthy bacteria in the gut in the process of targeting the pathogenic bacteria. As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDA approval of the drug.

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Marketing Drugs Bacteria FDA Approval 105

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

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

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

This endorsement stems from data acquired from two comprehensive, randomized, multicenter, double-masked and vehicle-controlled trials: Saturn-1 and Saturn-2. In both Saturn-1 and Saturn-2 trials, Xdemvy showcased significant efficacy. This was evident through marked improvements in the eyelids of participants.

FDA Approval 98

FDA Approval In-Vitro Trials Bacteria 98

Delveinsight

NOVEMBER 26, 2020

Urovant’s vibegron fails Irritable bowel syndrome phase 2 trial. A phase 2a clinical trial of vibegron of Urovant in Irritable bowel syndrome (IBS) patients has flunked primary endpoint. The drug did not do any better than a generic control in a phase 3 trial in overactive bladder patients.

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Antibody Trials Drugs Engineer 79

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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Vaccination Vaccine FDA Approval Containment 52

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. Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX ® compared to 2 of the 542 treated with placebo.

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Botox FDA Approval Doctors Doctor 52

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. diff coming through clinical trials, some of which also have deep-pocketed partners.

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Bacterium Drugs Bacteria FDA Approval 69

pharmaphorum

APRIL 26, 2022

The treatment has been granted US FDA breakthrough therapy designation and orphan drug designation, and has also completed a phase 3 clinical study. In the trial, Seres announced that the product candidate had met its primary endpoint, showing a statistically significant 30.2% difficile infection (CDI). Compelling advantages.

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Containment Development Production Drugs 115

XTalks

APRIL 12, 2021

Like other neurodegenerative disorders, such as Alzheimer’s disease and dementias, Parkinson’s disease research has been immensely challenging for biotechs, with a high rate of late-stage attrition in trials leading to a lack of disease-modifying therapies being approved. Axovant Gene Therapies. After closing a $74.7

Gene Therapy 96

Gene Therapy Gene Trials Development 96

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.

Dermatology 52

Dermatology Drugs Hormones FDA Approval 52

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

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Immune Response Vaccination Vaccine FDA Approval 52

XTalks

DECEMBER 17, 2021

And in healthcare and health research, trends towards increased digitization continued, including remote monitoring in clinical trials, use of wearable technologies and AI-based approaches to data collection, management and analysis. The results are promising and Moderna is set to go ahead with its planned Phase II trial for the vaccine.

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Life Science Vaccination Vaccine Trials 98

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

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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Drugs Gene Expression Big Data Gene 52

XTalks

DECEMBER 22, 2021

We talked about the emergence of dozens of CRISPR biotechs last year and the growing number of CRISPR-based therapies in clinical trials for conditions ranging from Duchenne muscular dystrophy (DMD) and sickle cell disease (SCD). As with other RNA technologies, RNA editing also makes use of endogenous cellular components and processes.

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Life Science RNA Vaccination Vaccine 98

The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. Small Molecule Inhibitors. The maximum achievable ACR CRISS score is 1.0.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

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. The approved dose for RINVOQ in these indications is 15 mg. In August 2019, RINVOQ received U.S. Some people have died from these infections.

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. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. In August 2019 , RINVOQ received U.S. Some people have died from these infections.

Drugs 52

Drugs Medicine Bacteria FDA Approval 52

The Pharma Data

SEPTEMBER 8, 2021

–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.

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Botox Doctors Doctor Medicine 52

The Pharma Data

APRIL 1, 2021

” Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. . ” The safety profile of upadacitinib was generally similar to results reported previously in rheumatoid arthritis trials. The long-term extension of the trial is ongoing. About RINVOQ (upadacitinib).

Medicine 52

Medicine Doctor Doctors Bacteria 52

The Pharma Data

SEPTEMBER 10, 2021

Levodopa/Carbidopa Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On Without Troublesome Dyskinesia in Advanced Parkinson’s Disease: Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% versus 0.4%, respectively).

Botox 52

Botox Doctors Doctor Medicine 52

The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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Medicine Production Development Trials 40

The Pharma Data

JUNE 30, 2021

More information on these trials can be found at www.clinicaltrials.gov (NCT02819635, NCT03653026, NCT03006068). FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ is 15 mg.

Medicine 52

Medicine Bacteria Vaccination Vaccine 52

XTalks

DECEMBER 24, 2020

As of November, the WHO has discouraged the use of the drug as the agency’s review of data from four different clinical trials yielded no worthy effect on mortality, need for mechanical ventilation, time to clinical improvement or any other important patient outcomes.

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Life Science Vaccination Vaccine Gene 111

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

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FDA Approval Bacteria Contamination Pharma Companies 130

XTalks

FEBRUARY 11, 2025

By exploring key metrics from sales figures and pricing structures to clinical trial outcomes and regulatory milestones this analysis provides a snapshot of how these drugs are meeting both patient needs and business objectives. Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) Biktarvy 2023 sales: $11.85

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Sales FDA Approval Vaccination Vaccine 66

XTalks

MARCH 24, 2025

Due to a risk of serious infections from encapsulated bacteria, its use is limited to a Risk Evaluation and Mitigation Strategy requiring specific vaccinations. This latest approval marks Fabhaltas third milestone. It was first approved for PNH and later for IgAN. The company plans to expand these trials to include IgAN.

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Bioavailability Immune Response Protein Bacteria 71