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

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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FDA Approval Reagent RNA Genome 90

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. Narayanan A, Narwal M, Majowicz SA et al.

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FDA Approval Drugs Protein In-Vitro 52

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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FDA Approval Trials 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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FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

XTalks

OCTOBER 7, 2020

LabCorp – a leading global life sciences company based in Burlington, North Carolina that focuses on advancing health and guiding patient care decisions – announced that it is the first commercial laboratory to receive an EUA from the FDA for the new, innovative, high-speed test.

Reagent 98

Reagent RNA Life Science FDA Approval 98

XTalks

DECEMBER 22, 2021

If the past year is anything to go by, then 2022 will also be a year marked by continued innovations in the life sciences. Here is a look at some life science trends to expect in the coming year, including key themes and topics in the pharmaceutical, biotechnology and medical device industries to keep an eye out for in 2022.

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Life Science RNA Vaccination Vaccine 98

Drug Discovery World

AUGUST 9, 2023

The life sciences sector has seen significant M&A activity over the last few weeks. The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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Drugs Drug Delivery Systems Drug Delivery Life Science 52

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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Gene Silencing Drug Delivery FDA Approval RNA 97

The Pharma Data

DECEMBER 8, 2020

December is bringing frost in the North and plenty of cold hard cash for these life sciences companies. . European venture capital firm Forbion rounded up $545 million for its fifth life sciences fund. Laying down a new track for RNA processing, Remix launched with $81 million in financing. Pear Therapeutics.

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RNA Antibody Life Science Protein 52

XTalks

MAY 29, 2024

The multiple myeloma drug recently received US Food and Drug Administration (FDA) approval in earlier treatment settings. Roche also expressed hope for its two CD20xCD3 bispecific T-cell engager immunotherapies Columvi and Lunsumio that received FDA approval in 2023 and 2022, respectively. billion, an increase of 10.8

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Pharma Companies Sales FDA Approval Vaccination 52

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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Clinical Trials Clinical Trials Trials FDA Approval 98

Roots Analysis

DECEMBER 18, 2023

In 2018, the French-based Advanced Accelerator Applications, a subsidiary of Novartis, achieved a significant milestone by obtaining the FDA approval for its product Lutathera®, a next-generation drug conjugate designed for GEP-NET (Gastroenteropancreatic Neuroendocrine Tumors).

Drugs 40

Drugs FDA Approval Antibody Development 40

XTalks

AUGUST 12, 2020

The results of persistent, underlying HIV infection include heightened immune activation and inflammation (leading to a number of diseases), ongoing damage to multiple organ systems and reduced life expectancy. Related: FDA Approves Rukobia for HIV Patients with Limited Treatment Options.

RNA 52

RNA Protein DNA In-Vivo 52

pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. It was the third approval from Alnylam’s pipeline of RNA interference therapeutics to make it to market. months, compared with 6.7 Neurology on the march.

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Marketing Gene Silencing Gene Drugs 94

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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Vaccination Vaccine FDA Approval Protein 98

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). The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry. The UK Government is behind this effort.

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Manufacturing Vaccination Vaccine RNA 130

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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Vaccination Vaccine FDA Approval Development 105

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

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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Vaccination Vaccine RNA Manufacturing 105

XTalks

AUGUST 30, 2022

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. Targeting the CNS directly has been successful in modern medicine.

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Trials Drug Delivery Drugs Gene 83

XTalks

DECEMBER 24, 2020

The pandemic propelled the life science and healthcare sectors onto center stage, and they rose to the occasion against the most unprecedented health challenge in recent times. While COVID-19 has undoubtedly been the biggest story in the life science industry in 2020, it was a busy and positive year in many other areas.

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Life Science Vaccination Vaccine Gene 111

Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. CAR T cells are T cells that have been trained to attack tumours.

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Manufacturing Gene Genome Genomics 98