The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes.

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WCG Clinical

MAY 28, 2024

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies. The currently approved CD-19 CAR products are autologous, ex vivo cellular therapies.

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STAT News

MARCH 6, 2023

Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. But more work remains before personalized vaccines  can be greenlighted.

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The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

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Vaccination Vaccine Immune Response FDA Approval 52

pharmaphorum

DECEMBER 23, 2020

The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1

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The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. The assumption is SciNeuro will start with Parkinson’s disease and pain in addition to rare genetic diseases, after scaling up staffing. . Laying down a new track for RNA processing, Remix launched with $81 million in financing.

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The Pharma Data

NOVEMBER 29, 2020

The submission was based on the safety and efficacy data of the pivotal Phase II trials 201 and 12-230. The FDA approved the drug on November 24. It is an RNA interference (RNAi) therapeutic. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

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Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Initial approval in 1994: FDA, U.S.

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Drug Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Though some genetic mutations are harmful, others can be protective.

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RNA Drugs Gene Silencing Vaccination 52

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. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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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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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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The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine was 94.1%

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The Pharma Data

OCTOBER 21, 2020

The pooled analysis examined 1,744 participants across 16 countries currently taking long-acting cabotegravir and rilpivirine as part of the regimen’s ongoing global clinical development programme of six studies, which includes the phase IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE clinical trials. Source: GSK .

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XTalks

JUNE 5, 2023

RSV belongs to the family of negative-strand RNA viruses and was first identified in 1955. The genetic material of RSV (respiratory syncytial virus) encodes 11 proteins. The Global RSV Vaccine Market Multiple RSV vaccines have received FDA approval or are in advanced stages of clinical trials. billion by 2028.

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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

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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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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The Pharma Data

DECEMBER 31, 2020

Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis .

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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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Drug Discovery World

FEBRUARY 22, 2024

For example, it can take up to it three years to recruit enough participants for a dementia clinical trial. years it takes to complete an entire cancer clinical trial. The organisation also notes that only 1% of the people that can take part in dementia clinical trials actually do so. This compares to the 2.3

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XTalks

DECEMBER 24, 2020

However, for virologists like Lori Frappier, PhD, professor in the department of molecular genetics at the University of Toronto, the outbreak of SARS-CoV-2 was less of a surprise and more of an inevitability. Authorizations/approvals, vaccine shipments and the world’s first inoculations followed shortly thereafter.

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