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PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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While AstraZeneca discontinued its Phase IIb trial for tozorakimab, the pharma’s zibotentan—if approved—could be “an optimal treatment of choice” for patients with diabetic kidney disease, finds a new report from GlobalData.
The European Commission granted marketing authorization in the EU to treat patients 16 years of age and older with moderately to severely active ulcerative colitis.
With the investment in the plant, Daiichi Sankyo is looking to create new laboratories for its antibody-drug conjugates used to develop and manufacture therapies for breast, lung and stomach cancers.
In a late-stage study, Tagrisso induced a “statistically significant and highly clinically meaningful improvement” in progression-free survival in patients with unresectable stage III, EGFR-mutated non-small cell lung cancer.
A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.
The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.
Almirall will have exclusive global rights to develop and commercialize the anti-IL-21 monoclonal antibody NN-8828 in several fields, including immune inflammatory dermatological indications.
In a Phase II study, Sanofi and Denali’s RIPK1 inhibitor SAR443820/DNL788 failed to meet the primary endpoint of improved functional performance in amyotrophic lateral sclerosis patients.
The regulator’s approval means AstraZeneca’s Tagrisso can now be used in combination with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer patients.
The Icelandic biotech Thursday said that it has settled its grievances with Johnson & Johnson regarding its Stelara biosimilar in markets with regulatory approval.