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- PMLiVE

GSK immunotherapy

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Roche reports positive phase 3 data for Tecentriq combination in liver cancer

More than 900,000 people are diagnosed with the disease globally each year

- PMLiVE

Merck KGaA’s MS drug put on partial clinical hold by FDA

Laboratory results suggested there were two cases of drug-induced liver injury during the phase 3 studies

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The draft guidance discusses the advantage of randomised clinical trials over single-arm studies

- PMLiVE

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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Roche and Eli Lilly to collaborate on Alzheimer’s disease blood test

If approved, the test could streamline the journey to diagnosis for more patients

- PMLiVE

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

GSK reports positive phase 3 results for five-in-one meningococcal vaccine candidate

There are currently no licensed vaccines offering simultaneous protection against all five serogroups

- 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

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

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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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