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nilotinib

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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

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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

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NICE recommends Novartis’ Adakveo for sickle cell disease

The treatment for sickle cell disease is the first in more than 20 years

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Strong five-year survival data for Kisqali in breast cancer

Novartis’ Kisqali plus letrozole offers more than a year survival benefit for postmenopausal women with HR+/HER2 advanced breast cancer

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

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Boehringer Ingelheim to boost antibody discovery with partner Twist

The biotech company will use Twist’s proprietary antibody libraries to discover therapeutic antibodies against multiple targets

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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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UK’s NICE recommends anti-cholesterol Leqvio for high-risk patients

The approval for the Novartis drug by the NHS gatekeeper could save 30,000 lives over 10 years

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NICE recommends Novartis’ Rydapt for advanced SM treatment

The twice-daily, oral drug improves overall survival of people with the rare blood disorder

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CureVac to push ahead with first- and second-generation COVID-19 vaccines

The biotech will seek EMA approval for first-generation jab while trials are due to start for second-generation jabs in Q4

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EMA to evaluate Roche arthritis drug RoActemra for severe COVID-19

FDA approval has already been granted following positive phase 3 trials

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