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COVID-19 Pfizer/BioNTech booster approved by FDA and CDC

FDA new

The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC

FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer

FDA newThe drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment

New data for Tecentriq in early-stage lung cancer

Roche Basel SwitzerlandRoche’s PD-L1 blocker reduced the risk of disease recurrence and death for patients with stage 2-3a non-small cell lung cancer following surgery

Strong five-year survival data for Kisqali in breast cancer

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

Biogen’s Vumerity recommended by CHMP in MS

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

Orphan status in Europe for lymphoma drug Zynlonta

European Commission HQ.jpgThe ADC Therapeutics antibody-drug conjugate is licensed to treat patients with a common form of non-Hodgkin lymphoma.

Valneva shares fall as UK cancels COVID-19 vaccine order

LondonThe UK government has cancelled a supply agreement for French vaccine maker Valneva’s COVID candidate VLA2001 over an alleged breach of obligations.

Green light for Amgen’s KRAS inhibitor in the UK

Amgen flagLumakras – known as Lumykras in the UK – will be available to 600 lung cancer patients in England through an early access scheme.

Future of MHRA uncertain amid Brexit-fuelled shake up

LondonTrade 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

Brexit‘Post-Brexit landscape for EU-wide IP Rights: The Story So Far’

Brexit means pharma must review its intellectual property rights across Europe

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