Remove Containment Remove Regulation Remove RNA
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Discovery of MicroRNA Genetic Regulation Leads American Scientists to Win 2024 Nobel Prize

XTalks

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. A gene contains instructions within our DNA.

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Top 30 New Medical Devices of 2024

XTalks

The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers. The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer.

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UK faces “V-Day” and largest ever vaccination programme

pharmaphorum

On top of this is the requirement for the cutting-edge RNA-based vaccines to be stored at ultra-low temperatures. Pfizer’s vaccine needs to be stored at around -70C to retain its integrity, while its rival from Moderna that is under review by regulators needs to be stored at -20C.

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New RSV therapies may accelerate the emergence of resistant strains

Pharmaceutical Technology

As an RNA virus, like SARS-CoV-2, RSV is highly prone to mutations. However, caution must be taken, especially while bringing new mAbs to market, to avoid the potentially serious consequences of inducing novel viral mutations and further antibody-resistant strains of RSV.

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IN FOCUS: Solvias

Pharmaceutical Technology

Our laboratories operate to the highest quality standards under international organisation for standardisation (ISO), good manufacturing practice (GMP), good laboratory practice (GLP) and US Food and Drug Administration (FDA) regulations. However, messenger RNA (mRNA) based vaccines present particular analytical challenges.

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Two biotechs target dry eye disease after Novartis’ Xiidra problems

pharmaphorum

But with Novartis failing to convince European regulators about the merits of Xiidra last year, and Allergan’s ageing Restasis potentially facing generic competition, there’s a lot to play for and two biotechs are aiming to disrupt the market.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve. In the case of generics, the only concerns you might see is where the brand name and generic drug contain different excipients,” explained Dr Amiji. “A