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AstraZeneca invests in RNA tech platform

AstraZeneca will support research using VaxEquity’s RNA platform then pay at least $195m for each candidate that enters its pipeline

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

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

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AstraZeneca chooses Ireland for $360m manufacturing site

The next-generation facility will make small molecule active ingredients, future-proofing the company’s supply chain and boosting the Irish life sciences sector

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AstraZeneca’s Imfinzi provides sustained survival benefit for lung cancer patients

The drug tripled patient survival after three years in the longest-ever follow-up in extensive-stage small cell lung cancer

Biogen Idec building

Embattled Biogen talks up Aduhelm

Biogen CEO admitted the company was experiencing “near-term challenges” after the controversial approval of Alzheimer’s drug, Aduhelm

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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.

Biomarin

FDA pauses BioMarin gene therapy trial

The study for BMN 307 in genetic disease phenylketonuria will be paused while malignancies in mice are explored

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Congress “concerned by apparent anomalies” around FDA’s approval of Aduhelm

Congress demands more information from the FDA on its controversial approval of Biogen’s Alzheimer’s drug and its dealings with the company.

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New data advances AstraZeneca’s “revolution in oncology”

In a busy few weeks for AstraZeneca, the company will present data on 14 approved and potential drugs in lung and breast cancer

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FDA experts to evaluate Pfizer-BioNTech COVID-19 booster

As Moderna announces it has submitted COVID-19 vaccine booster data, the FDA advisory committee of outside experts will convene in two weeks’ time

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FDA nod for Janssen schizophrenia treatment Invega Hafyera

The phase 3 study results showed that 92% of patients were relapse-free after 12 months

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FDA’s director and deputy director of its Office of Vaccines Research & Review resign

The departure of director Marion Gruber and deputy director Philip Krause is unexpected

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