PFIZER INC.

Pfizer is withdrawing Oxbryta, a sickle cell disease drug, due to safety concerns, leading to an imbalance of deaths and vaso-occlusive crises. The European Medicines Agency recommended suspending its clearance. Pfizer acquired Oxbryta through its purchase of Global Blood Therapeutics in 2022, with Oxbryta generating $92 million in revenue in Q2 2024. Pfizer continues to develop other sickle cell treatments, including inclacumab and osivelotor in Phase 3. Patients currently on Oxbryta should consult their doctors for alternatives.

Pfizer withdraws sickle cell drug Oxbryta from worldwide markets; Evotec partners with Novo Nordisk on stem cell therapy manufacturing.

The EU’s drug watchdog called for suspending Pfizer’s Oxbryta approval due to higher occurrence of vaso-occlusive crises and deaths. Pfizer voluntarily withdrew Oxbryta from global markets, citing the drug’s risks no longer outweighing its benefits.

Pfizer's withdrawal of Oxbryta, a sickle cell disease treatment due to safety concerns, could expedite trials for rival drugs like Agios' mitapivat and Fulcrum's pociredir. The removal of Oxbryta leaves mild-moderate patients reliant on hydroxyurea, while gene therapies Lyfgenia and Casgevy are reserved for severe cases. Pfizer's decision adds to its challenges, including declining COVID vaccine sales and disappointing clinical data.

Pfizer withdraws Oxbryta® due to 16 patient deaths in clinical trials, citing imbalance in vaso-occlusive crises and fatal events. The European Medicines Agency reports 18 deaths in two Phase III trials, with 16 linked to the drug. Pfizer halts all clinical trials and expanded access programs globally.

Pfizer withdraws voxelotor (Oxbryta) from markets worldwide due to increased risk of death, including malaria-related fatalities, outweighing benefits for sickle cell disease patients.

EMA recommended suspending Pfizer's Oxbryta marketing authorization due to safety concerns. Pfizer withdrew Oxbryta from all approved markets citing risks of painful complications and deaths.

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Pfizer Inc. is voluntarily withdrawing all lots of Oxbryta (voxelotor) for sickle cell disease due to clinical data indicating the drug's risks outweigh its benefits. The company is also discontinuing related clinical trials and expanded access programs globally. Pfizer has notified regulatory authorities and does not expect this to impact its 2024 financial guidance.

Tavapadon, a dopamine agonist, met its primary endpoint in the TEMPO-1 trial for Parkinson’s disease, showing significant reduction in MDS-UPDRS scores. This follows positive results from the TEMPO-3 trial, with the final TEMPO-2 trial expected to conclude this year. Tavapadon aims to offer effective treatment with minimal side effects.