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GreenLight and US NIH partner to develop Covid-19 vaccine for variants

Pharmaceutical Technology

The company will jointly design and analyse messenger ribonucleic acid (mRNA) Covid-19 vaccines in partnership with the NIH unit National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC). They intend to develop vaccines that provide lasting immune responses compared to existing vaccines.

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FDA committee recommends AstraZeneca and Sanofi’s RSV prophylactic nirsevimab

Pharmaceutical Technology

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. Marketed under the name Beyfortus in the EU, nirsevimab is a long-acting human recombinant monoclonal antibody. Although AdCom verdicts are considered by the FDA when it comes to approvals, they are not binding.

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NEW FEXOFENADINE over the counter – Allevia tablets

Druggist

First-generation antihistamines can also be used to help manage allergies. Allevia tablets will be licensed as General Sale Item (GSL), which means it will be available over the counter in shops and supermarkets and not only in pharmacies. Once Allevia reaches the market, I will update this post accordingly.

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Valneva eyes first place in chikungunya vaccine race

pharmaphorum

That sets up a rolling Biologics License Application (BLA) with the FDA by the end of the year, setting Valneva on course to bring the first chikungunya vaccine to market anywhere in the world. Valneva estimates that the global market for vaccines against chikungunya could exceed $500 million annually by 2032.

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Oxford Nanopore makes stellar debut on UK stock market

pharmaphorum

The debut – raising upwards of £350 million from new shares – is the largest IPO for a UK biotech company since allergy drug specialist Circassia in 2014. It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.

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Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union. Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5

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Glenmark and Lotus partner on allergic rhinitis spray 

pharmaphorum

The Swiss subsidiary of Glenmark Pharmaceuticals and Lotus International have signed a licensing agreement whereby Glenmark will handle the manufacture and supply of Ryaltris and Lotus will take charge of commercialising the drug, subject to approval. with allergic rhinitis.