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- PMLiVE

Accelerated approval

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Incyte and Biotheryx collaborate to develop protein degraders for oncology targets

Biotheryx will receive up to $347m in potential milestone payments

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BioNTech and Duality Biologics partner in deal worth over $1.5bn

The companies will co-develop two antibody-drug conjugates for solid tumours

- PMLiVE

Boehringer Ingelheim and Covant to collaborate on cancer immunotherapies

The deal to develop a small-molecule inhibitor could be worth over $480m

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The draft guidance discusses the advantage of randomised clinical trials over single-arm studies

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AbbVie’s Parkinson’s disease therapy application rejected by FDA

The regulator has requested more information on the pump used to administer ABBV-95

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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

- PMLiVE

Roche’s Polivy backed by FDA Advisory Committee for lymphoma therapy

Around 160,000 people worldwide are estimated to be diagnosed with DLBCL each year

- PMLiVE

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

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Eli Lilly/Boehringer’s Jardiance for children with type 2 diabetes accepted by FDA

The incidence of type 2 diabetes in children has nearly doubled over the past two decades

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Eli Lilly’s Verzenio label expanded by FDA for early breast cancer patients

The decision removes the previous 20% Ki-67 score requirement for patient selection

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FDA approves intramuscular administration of Merck’s MMRV vaccines

Until now, the vaccines have only been administered via subcutaneous injection

- PMLiVE

FDA grants priority review for traditional approval of Biogen and Eisai’s Alzheimer’s drug

Leqembi was granted accelerated approval in the US earlier this year

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