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Having secured deals with AstraZeneca and Novartis, Niowave is constructing a second facility to meet rising demand for actinium-225, which can be used to develop next-generation radiopharmaceuticals.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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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.
Pfizer plans to settle a lawsuit filed 12 years ago by distributors of Lipitor for $93 million. The pharma giant was accused of colluding with Ranbaxy Laboratories to delay generic versions of the drug.
Alnylam Pharmaceuticals is modifying the primary and secondary endpoints of the Helios-B Phase III trial investigating its next-generation RNA interference therapy in patients with ATTR amyloidosis with cardiomyopathy.
The regulator has granted a priority review of the efficacy supplement for Sarepta Therapeutics’ gene therapy Elevidys with a target decision date of June 21, 2024.
Novo Nordisk seems to believe it can do a better job managing troubled Catalent than the contract manufacturer. However, the Danish drugmaker has its work cut out for it.
Following a patient case of severe liver enzyme elevations, Inventiva is suspending its Phase III NATiV3 study in non-alcoholic steatohepatitis as Madrigal Pharmaceuticals awaits a March 14 PDUFA date.
The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.