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STAT+: Pharmalittle: FDA approves Pfizer’s RSV vaccine for newborns; Boehringer sues over IRA

STAT

The Food and Drug Administration approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people, STAT tells us. The vaccine, marketed as Abrysvo, previously won approval for adults over the age of 60.

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STAT+: Pharmalittle: WHO pandemic accord may force pharma to disclose prices; FDA OKs first therapy to delay type 1 diabetes

STAT

Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord , Reuters reports.  A Or you may want to take stock of your life. But be safe. Enjoy, and see you soon.

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

For example, rising ambient temperatures and ingress of mould from items entering cleanrooms, has resulted in some vaccine and pharmaceutical companies in Europe experiencing increased contamination. The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.”

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Market cap growth surges for over half of the top biopharmaceutical companies in 2022

Pharmaceutical Technology

The 13 top players experienced significant growth over 2022 despite the decline in demand for COVID-19 vaccines and therapeutics, as well as uncertainty surrounding pricing due to the newly passed Inflation Reduction Act in the US. billion between Dec 31, 2021 and Dec 31, 2022, owing to expansion in its vaccine and oncology portfolio.

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Pfizer says COVID-19 jab could rake in $26bn this year

pharmaphorum

Pfizer expects revenues from its BioNTech-partnered COVID-19 vaccine to reach an eye-watering $26 billion this year, catapulting it to the top of the world’s biggest-selling medicines. . The vaccine made $3.5 The vaccine made $3.5 Spending and profit from the vaccine are split equally between Pfizer and BioNTech.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE). Covid-19 vaccines stay in the spotlight.

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2022 ISPE Annual Meeting: Transform, Collaborate, & Innovate for the Path Forward

ISPE

Applying what has been learned over the last three years to update pharmaceutical companies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. Pfizer “cleared runway to allow for large-scale vaccine manufacturing before we had a product!”