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- PMLiVE

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FDA grants priority review for AZ, Amgen’s tezepelumab for asthma

Drug 'has the potential to transform treatment for a broad population of severe asthma patients'

- PMLiVE

CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

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bluebird bio’s CALD gene therapy Skysona gains positive opinion from CHMP

CHMP's marketing authorisation recommendation is a step towards gaining EU approval

- PMLiVE

US Supreme Court rebuffs Sandoz’s Enbrel biosimilar patent case

Amgen will retain market exclusivity on blockbuster arthritis drug until 2029

- PMLiVE

EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

- PMLiVE

AZ, Amgen file first-in-class asthma drug with the FDA

Submission is based on positive results from the companies’ PATHFINDER clinical programme

- PMLiVE

Gilead’s Q1 revenues lifted by COVID-19 med Veklury as HIV drugs take a hit

Total product sales excluding Veklury dropped by 11% to $4.9bn compared to Q1 2020

- PMLiVE

Amgen plans acquisition of Rodeo Therapeutics

Deal could be worth over $700m including potential future milestone payments

- PMLiVE

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

CHMP issues a positive opinion for S1P1 modulator based on positive phase 3 results

- PMLiVE

EMA starts rolling review of Lilly’s COVID-19 antibodies

CHMP will review the combination of bamlanivimab and etesemivab as well as bamlanivimab monotherapy

- PMLiVE

EMA recommends use of Lilly’s COVID-19 antibody cocktail

Agency concludes bamlanivimab and etesevimab can be used to treat certain COVID-19 patients

- PMLiVE

Amgen adds to oncology pipeline with $1.9bn Five Prime Therapeutics acquisition

Five Prime's pipeline includes potentially first-in-class anti-FGFR2b antibody bemarituzumab

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