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Terrosa

- PMLiVE

Merck’s COVID-19 antiviral under review in Europe by EMA

Molnupiravir could be the first oral antiviral treatment for COVID-19 in Europe for patients at risk of severe disease

- PMLiVE

Real-world data highlights flu vaccine efficacy

Flu vaccinations prevented 7.5 million illnesses and 6,300 deaths from influenza in 2019/20

- PMLiVE

Biosimilars boosted by FDA’s landmark ruling for Boehringer’s Cyltezo

The FDA has approved Boehringer’s Cyltezo (adalimumab-adbm) as ‘interchangeable’ with Humira (adalimumab) in a landmark ruling

- PMLiVE

Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

regeneron headquarters

FDA accepts Regeneron’s REGEN-COV for priority review for treatment of COVID-19

In Europe, the EMA will review a Marketing Authorisation Application for the antibody cocktail

- PMLiVE

FDA approves Eli Lilly’s Verzenio in high risk early breast cancer

Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- early breast cancer

Sanofi reception

Sanofi’s tolebrutinib demonstrates favourable one-year tolerability in patients with relapsing forms of multiple sclerosis

New long-term data presented at ECTRIMS 2021 reinforces promising safety and efficacy profile

- PMLiVE

Sanofi refocuses COVID-19 efforts away from mRNA

Trial data validates Sanofi’s mRNA and lipid nanoparticle platform but the company will not pursue its own mRNA COVID-19 vaccine

- PMLiVE

Amgen’s Biosimilar Trends Report shows benefit of competition from biosimilars

Competition created by biosimilars has delivered $9.8bn in savings over five years and could reduce patients’ out-of-pocket costs by $238m

Biogen Idec building

Biogen’s Vumerity recommended by CHMP in MS

A thumbs up for Vumerity in the EU could ease the way for Biogen’s follow-up to Tecfidera in multiple sclerosis

- PMLiVE

Sanofi boosts transplant portfolio with newly approved Rezurock

Sanofi’s acquisition of Kadmon Holdings adds Rezurock to its transplant portfolio in a deal worth $1.9bn.

- PMLiVE

Future of MHRA uncertain amid Brexit-fuelled shake up

Trade unions and regulatory experts warn that budget and staff cuts may lead to drug approval delays or the UK regulator simply rubber-stamping EMA decisions

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