XTalks

AUGUST 18, 2020

An important feature of the test that contributes to its reduced cost is the fact that sample processing does not require a separate nucleic acid (RNA) extraction step. This is significant because shortages of RNA extraction kits have been a recurrent issue since the beginning of the pandemic. And now it’s getting approval.

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XTalks

NOVEMBER 15, 2024

XTALKS WEBINAR: Solutions for Vaccine Innovation and Gene Therapy: Unlocking the Power of RNA Live and On-Demand: Tuesday, December 17, 2024 , at 9am EST (3pm CET / EU-Central) Register for this free webinar to explore how next-generation RNA technologies can provide effective solutions for vaccine innovation and gene therapy.

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XTalks

JANUARY 9, 2023

log10 copies/mL reduction in HIV-1 RNA from baseline at the end of the functional monotherapy period. Thirty-six participants were randomly allocated to receive either oral lenacapavir or placebo in a 2:1 ratio for 14 days, while continuing their failing regimen (functional monotherapy).

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XTalks

JANUARY 3, 2025

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. In clinical trials, it showed up to an 86 percent reduction in triglyceride levels.

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XTalks

DECEMBER 22, 2021

The RNA Revolution: From mRNA Vaccines to RNA Editing. The age of RNA is officially here, and it’s here to stay as more than a passing life science trend. RNA technology is not new nor has its potential been surprising. RNA in the Making. So why did this perceived RNA ‘revolution’ take so long?

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BioTech 365

MAY 24, 2021

Scopus BioPharma Announces FDA Approval of IND Application for Lead Drug Candidate Scopus BioPharma Announces FDA Approval of IND Application for Lead Drug Candidate CpG-STAT3siRNA is a Distinctive RNA Therapy and Immunotherapy Developed at City of Hope A Phase 1 … Continue reading →

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pharmaphorum

NOVEMBER 24, 2020

The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder. The Swiss pharma’s bet looks to have paid off as inclisiran is likely to be approved in Europe in the coming weeks after backing from CHMP regulators last month.

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FDA Approval Gene Silencing Drugs RNA 52

XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Avacincaptad pegol combines an RNA aptamer with a roughly 43-kiloDalton (kDa) branched polyethylene glycol (PEG) molecule. How Does Izervay Work?

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pharmaphorum

JANUARY 10, 2022

Previously, messenger RNA (mRNA) therapies were a niche part of the global R&D pipeline, now a wide section of the public is at least familiar with the name of this type of therapy. Pfizer already has a head start on competitors in the field, having achieved the first US FDA approval for an mRNA vaccine, alongside BioNTech.

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The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. “Not At the same time, the FDA approved ViiV’s New Drug Application (NDA) for Vocabria (cabotegravir) 30 mg oral tablets.

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XTalks

OCTOBER 7, 2020

While the new test is based on RT-PCR molecular detection, it utilizes a high-throughput technique involving a new heat-based extraction method and enhanced technology to extract RNA from samples for COVID-19 testing. LabCorp was given the green light for the test by the FDA last week, which is set to be rolled out soon.

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Reagent RNA Life Science FDA Approval 98

XTalks

JANUARY 25, 2021

Patients in the studies were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) prior to initiation of treatment with Cabenuva. Cabenuva was actually expected to win FDA approval towards the end of 2019; however, manufacturing issues garnered rejection from the FDA at the time. Opening up Options.

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The Pharma Data

JANUARY 22, 2021

Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults. Before initiating Cabenuva treatment, study participants were virologically suppressed (HIV-1 RNA <50 copies/mL).

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FDA Approval RNA Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). Messenger RNA vaccines contain nucleic acids that code for a specific protein, or target antigen, related to a virus or disease. million in funding to support this work.

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The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” The findings published today (Feb.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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XTalks

JUNE 5, 2023

RSV belongs to the family of negative-strand RNA viruses and was first identified in 1955. Today’s FDA approval of Abrysvo recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease,” said Edward E.

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The Pharma Data

NOVEMBER 18, 2020

Food and Drug Administration has said that coronavirus vaccines should be at least 50 percent effective to be approved. Both vaccine makers used a synthetic version of coronavirus genetic material called messenger RNA to program a person’s cells to churn out copies of a fragment of the virus, the Times said.

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The Pharma Data

JANUARY 21, 2021

In the ATLAS study, CABENUVA met the primary endpoint for noninferiority (the proportion of participants with plasma HIV-1 RNA ?50 50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ?50

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pharmaphorum

MARCH 4, 2021

billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche. Sylentis, part of PharmaMar Group, has just announced FDA approval of a phase 3 trial for eye drops containing tivanisiran, in dry eye disease associated with Sjogren’s Syndrome.

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XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). RSV is a negative-strand RNA virus that was first identified in 1955.

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XTalks

SEPTEMBER 4, 2024

Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). As of March 2024, the FDA has approved six small interfering RNA (siRNA) therapies.

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Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Moderna brings up the rear after announcing Phase III results with its own messenger RNA (mRNA) RSV vaccine earlier this month. per 100,000.

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XTalks

JUNE 14, 2023

More Drugs for Dry Eye Disease Are on the Way Several other drugs have recently gained FDA approval or are currently in advanced stages of clinical development for the treatment of dry eye disease. One such approved medication is Miebo , an ophthalmic solution developed by Bausch + Lomb and Novaliq.

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pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Novartis resubmitted its marketing application in the US earlier this year, after swapping fill-and-finish production to one of its own facilities in Schaftenau, Austria.

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XTalks

JULY 10, 2024

Unlike traditional testing methods that require samples to be sent to central laboratories, this test utilizes a blood sample from the fingertip to detect HCV RNA, delivering results in approximately one hour. “This is the first HCV RNA detection technology sensitive enough for active case finding at the point of care.

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The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Combines confirmatory HIV testing and HIV-1/HIV-2 differentiation into one single test. Basel, 1 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S.

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FDA Approval In-Vitro Antibody Medicine 52

XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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Worldwide Clinical Trials

MAY 30, 2024

From drugs previously FDA-approved for gallstone diseases, Parkinson’s disease, and even cancer, researchers are working tirelessly to test and establish whether these pharmacotherapies with well-defined safety profiles may have any potential for efficacy in treating ALS.

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XTalks

MAY 10, 2023

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. Ayesha and the team also discussed the FDA approval of Qalsody (tofersen), a novel, first-of-its-kind treatment for ALS.

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Life Science Vaccine Vaccination FDA Approval 40

pharmaphorum

DECEMBER 23, 2020

There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class. It was the third approval from Alnylam’s pipeline of RNA interference therapeutics to make it to market. months, compared with 6.7

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The Pharma Data

DECEMBER 8, 2020

Laying down a new track for RNA processing, Remix launched with $81 million in financing. Funds will be used to support development of the REMaster technology platform and advance the company’s pipeline of RNA processing targeted therapeutics as well. “As Pear Therapeutics.

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The Pharma Data

FEBRUARY 12, 2022

Veklury was approved by the FDA on October 22, 2020 for grown-ups and pediatric cases 12 times of age and aged and importing at least 40 kg for the treatment of COVID-19 taking hospitalization. Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase.

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pharmaphorum

APRIL 5, 2022

.” Strong efficacy data is likely to be the key to carving out a role for the antisense drug in the PCSK9 inhibitor class, particularly as it is up against some heavyweight competition – notably Novartis’ small interfering RNA (siRNA) therapy Leqvio (inclisiran), which only needs to be administered twice a year.

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Drugs Antibody Sales FDA Approval 52

pharmaphorum

JULY 19, 2021

Drugs harnessing the potential of modified RNA, antisense and siRNA oligonucleotides, antibody–drug conjugates and nanomedicines will become as important as today’s ‘small molecule’ drugs, reaching potential market values into the hundreds of billions – if the potential can be realised through innovation support and industry collaboration.

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