Market Access News | pharmaphorum

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'UK Only' red stamp on manufacturing facility

Deadline looms for post-Brexit label changes for UK meds

The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements.

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BMS files legal challenge to HHS' 340B rebate decision

Bristol-Myers Squibb has become the latest pharma in the US to file a legal challenge to a block on a 340B drug rebate model opposed by HRSA.

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Sanofi opens $595m manufacturing facility in Singapore

Sanofi has officially opened a modular biologics manufacturing facility in Singapore that is designed to allow rapid switching between products

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Kelun's MSD-partnered TROP2 drug gets first okay in China

Kelun-Biotech has become the second drugmaker to bring a TROP2 ADC to regulatory approval, after its sac-TMT drug was cleared in China

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Applied Tx craters as FDA rejects lead product candidate

Applied Therapeutics plummets after the FDA turns down its marketing application for govorestat as a treatment for galactosaemia

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Court sides with EU on decision to revoke Ocaliva's license

Advanz Pharma's bid to keep its Ocaliva treatment for rare liver disease primary biliary cholangitis (PBC) on the EU market has ended in failure

Deadline looms for post-Brexit label changes for UK meds

BMS files legal challenge to HHS' 340B rebate decision

Sanofi opens $595m manufacturing facility in Singapore

Kelun's MSD-partnered TROP2 drug gets first okay in China

Applied Tx craters as FDA rejects lead product candidate

Court sides with EU on decision to revoke Ocaliva's license

UK MHRA green lights AbbVie’s ELAHERE for ovarian cancer

The value of a partner, globally and locally

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