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Array Biopharma

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FDA proposes improvements for oncology clinical trials supporting accelerated approval

The draft guidance discusses the advantage of randomised clinical trials over single-arm studies

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Pfizer and Astellas’ Xtandi shows promise in phase 3 prostate cancer study

The treatment is already approved in the US for three disease states of prostate cancer

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Pfizer pays Royalty Pharma $475m following US approval of migraine nasal spray

Royalty Pharma signed a deal for the programme in 2020 with Biohaven, which Pfizer has since acquired

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Pfizer/BioNTech’s Omicron-adapted booster approved by FDA for young children

The companies have also submitted an application to the EMA for this age group

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Pfizer to acquire Seagen for $43bn in biggest pharma transaction since 2019

The deal includes four approved medicines and Seagen’s antibody-drug conjugate technology

Medscape Oncology: Delivering Impact at ASH

You can read more information on Medscape Oncology at ASH here, or please reach out to Chris Carey or Steve Dunn who can tell you more about how Medscape can help to...

Medscape Education Global

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Pfizer/BioNTech submit FDA application for Omicron-adapted booster for young children

The vaccine is already authorised as the third of a three-dose primary series in this age group

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Pfizer’s RSV vaccine candidate for older adults backed by FDA Advisory Committee

RSV infections in older adults account for 60,000 to 160,000 hospitalisations each year in the US

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Pfizer’s maternal RSV vaccine candidate accepted for FDA priority review

Globally, RSV infections cause over 100,000 child deaths annually

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Pfizer’s Talzenna combination shows promise in phase 3 prostate cancer study

10-20% of patients develop metastatic prostate cancer within five to seven years of diagnosis

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Ipsen to acquire worldwide rights to pre-clinical stage oncology programme

The company has an existing partnership with the Université de Montréal and IRICoR

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Pfizer/BioNTech initiate study of first mRNA shingles vaccine candidates

Around 95% of people over the age of 50 have been exposed to the virus that causes shingles

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