XTalks

DECEMBER 18, 2024

Related: Arrowhead Pharmas New Rare Disease Campaign for FCS Highlights Importance of Lowering Triglycerides The FDAs approval of Crenessity was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. Crenessity marks the third approved drug for Neurocrine.

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XTalks

OCTOBER 16, 2024

Stelara Price Reductions and Expanding Biosimilar Competition Imuldosa’s approval joins a wave of Stelara biosimilars. In October 2023, Amgen’s Wezlana (ustekinumab-auub) became an interchangeable biosimilar approved by the FDA, eligible for pharmacy-level substitution.

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XTalks

JUNE 3, 2024

Yesafili and Opuviz are approved to treat the same conditions as Regeneron’s vascular endothelial growth factor (VEGF) inhibitor Eylea — neovascular (wet) age-related macular degeneration (AMD), diabetic retinopathy, macular edema following retinal vein occlusion (RVO) and diabetic macular edema (DME). According to Biocon, there are 19.8

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XTalks

MAY 25, 2022

On Thursday, the FDA granted De Novo authorization for NeuroMetrix to market the Quell® wearable neuromodulation device for treating fibromyalgia. This approval is significant because prior to Quell, there were no FDA-approved medical devices for fibromyalgia treatment.

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Pharmaceutical Technology

MAY 24, 2023

In a statement announcing the approval , the FDA stated that the lower doses offer a new and accessible route to treatment for patients in recovery who usually might struggle to adhere to treatment regimens. Braeburn submitted data from a 24-week Phase III trial (NCT02651584) to support approval.

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FDA Approval Pharmacy Pharma Companies Containment 147

XTalks

JANUARY 29, 2025

This translates to an average weight loss of 21%, which was demonstrated in clinical trials (over a period of 72 weeks) that supported Zepbounds FDA approval. This month, Zepbound won FDA approval for obstructive sleep apnea (OSA) , making it the first approved drug for the condition.

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Pharmaceutical Technology

SEPTEMBER 2, 2022

The company plans to make Konvomep available commercially in pharmacies across the country in the first quarter of next year. Azurity Pharmaceuticals CEO Richard Blackburn said: “We are very pleased that patients will soon have access to this FDA-approved oral liquid formulation option of a commonly prescribed proton pump inhibitor.

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Pharmaceutical Technology

JUNE 9, 2023

The drug performed “extraordinarily well” in a variety of cohorts, said Nimish Patel, PharmD, professor of clinical pharmacy at University of California San Diego. Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease.

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FDA Approval Antibody Allergies Packaging 147

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

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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.

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FDA Approval Bacteria Clinical Trials Clinical Trials 105

XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration. This will help healthcare providers seamlessly incorporate this ready-to-use solution into their clinical practice.

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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.

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FDA Approval Bacteria Clinical Trials Clinical Trials 98

XTalks

MARCH 10, 2025

Pricing data indicate that the price of TNKase is around $8,672 for a 50 mg IV injection for cash-paying customers, though prices can vary based on pharmacy and location. TNKase is already approved for treating acute ST-elevation myocardial infarction, another critical cardiovascular emergency.

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XTalks

AUGUST 2, 2023

Eichenfield serves on Verrica Pharmaceuticals’ Board of Directors and spoke to Xtalks about the company’s recent approval of YCANTH (cantharidin) topical solution as the first FDA approved treatment for pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.

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Life Science FDA Approval Dermatology Pharmacy 52

XTalks

SEPTEMBER 25, 2024

However, it still requires a prescription, and those choosing the self-administration option will complete a screening process through an online pharmacy before receiving the vaccine. The FDA’s approval came after comprehensive studies, which included human factors and usability evaluations.

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FDA Approval Vaccination Vaccine Pharmacy 52

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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XTalks

JULY 3, 2024

Verona Pharma has received US Food and Drug Administration (FDA) approval for Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disorder (COPD). After Jack, Verona was established to take on ensifentrine and 19 years and almost 20 clinical trials later, the drug has finally received its approval.

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Drugs Clinical Trials Clinical Trials FDA Approval 105

Pharmaceutical Technology

JUNE 12, 2023

The addition of a topical gel to pharmacy shelves expands treatment options available to those with ED. The Guildford, UK-based Futura used data from two clinical studies to enable approval. A US confirmatory trial (FM71) investigated the gel compared to oral tadalafil (5mg) in 96 male patients with ED.

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Pharmacy Checkers

MAY 8, 2020

A good portion of this blog takes on Big Pharma for their funding of misleading public information campaigns and programs against drug importation and the practice of safe international online pharmacies. Longer and more involved clinical trials are still necessary for the drug to obtain full approval. We all want to stop them.

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Pharmacy Clinical Trials Clinical Trials FDA Approval 73

pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. This initial approval was only for treatment of excessive daytime sleepiness. Wake up and go to sleep.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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XTalks

NOVEMBER 1, 2024

Why it sold so well: Botox is FDA-approved for the treatment of chronic migraines and that is currently the only chronic condition for which it has received approval. mL, depending on the pharmacy. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1. mL) is around $620 for a supply of 0.25

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FDA Approval Drugs Botox Sales 85

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?

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Trials Drug Delivery Drugs Gene 83

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

Pharma Mirror

FEBRUARY 11, 2021

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS)

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Pharmaceutical Technology

JUNE 30, 2022

The pandemic resulted in research efforts and resources being pulled from the NTD space to Covid-19 treatments, says Eugene Muratov, PhD, Associate Professor at the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. Two of these are in the Phase II trials, and potential vaccines are also being studied.

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The Pharma Data

MAY 13, 2021

NIH trial seeks answers. ( Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef ( Endpoints ). Amgen, AstraZeneca bolster their case for breakthrough asthma program as FDA considers taking up a review ( Endpoints ). In Focus: International. Purdue’s Ch.

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Bioengineer

JULY 23, 2021

MUSC Hollings Cancer Center part of promising clinical trial for aggressive lymphoma. MUSC Hollings Cancer Center was one of 28 clinical sites around the world that participated in the LOTIS-2 trial to test the efficacy of Loncastuximab tesirine, a promising new treatment for aggressive B-cell lymphoma. sponsored the trial.

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Trials Antibody Drugs Clinical Trials 52

XTalks

NOVEMBER 26, 2020

As the second wave of the pandemic continues to grip much of the world, the study is part of efforts to identify existing FDA-approved drugs that can be repurposed to treat or prevent COVID-19 as it is the most efficient and inexpensive approach. The list also included melatonin.

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XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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FDA Approval Clinical Trials Clinical Trials Nurses 64

XTalks

SEPTEMBER 22, 2023

In time for respiratory virus season this fall and winter, the US Food and Drug Administration (FDA) approved updated COVID vaccines from Pfizer/BioNTech and Moderna last week, followed by an endorsement from the Centers for Disease Control and Prevention (CDC) a day later.

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. Verdiperstat also failed a phase 3 trial in multiple system atrophy last year.

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XTalks

MARCH 7, 2023

With the FDA approval, it’s become the first and only treatment for the debilitating condition. Pegcetacoplan Trial Results Syfovre is a C3 therapy designed to regulate the over activation of the complement cascade. The vision loss caused by geographic atrophy has a severely negative impact on quality of life.

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FDA Approval Drugs Sales Trials 98

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity. The larger of the two trials enrolled adults without diabetes.

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FDA Approval Manufacturing Drugs Pharmacy 59

pharmaphorum

APRIL 29, 2022

Bristol-Myers Squibb’s has become the first company to bring a cardiac myosin inhibitor through to FDA approval, claiming a green light from the US regulator for mavacamten as a therapy for obstructive hypertrophic cardiomyopathy (HCM). The FDA approval was delayed b three months while the RENS was drawn up.

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Drugs FDA Approval Trials Pharmacy 52