Markets & Regulations

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Oramed inks deal to commercialize oral insulin in South Korea

By Jane Byrne

Oramed Pharmaceuticals, a company focused on the development of oral drug delivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate....

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FDA expected to make decision on GSK’s RSV vaccine in May

By Rachel Arthur

The US Food and Drug Administration (FDA) has granted Priority Review to GSK’s respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.

© GettyImages/Chee Siong Teh

Earnings miss, lowered outlook for Catalent

By Jane Byrne

Shares of Catalent Inc plunged yesterday after the contract development and manufacturing organization (CDMO) reported fiscal first-quarter profit and revenue that missed expectations. The company also scaled back its full-year outlook.

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CPHI Pharma Award finalists announced

The awards cover innovations spanning the full pharmaceutical supply chain and feature many of pharma’s biggest names and breakthrough companies.

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Pfizer to raise COVID-19 vaccine price in US

By Jane Byrne

As the US government stops buying COVID-19 shots, Pfizer said the vaccine it developed with BioNTech will be sold for US$110 to US$130 per dose, from as early as the first quarter 2023.

Pic:getty/MG

EMA pilot to provide regulatory support to selected ATMP developers

By Rachel Arthur

The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.

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