Drug Development
After SPN-820’s failure, Supernus is relying on its non-stimulant ADHD drug Qelbree and the recently approved Parkinson’s therapy Onapgo to sustain the company.
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With Sarepta’s gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data.
Pfizer CEO Albert Bourla is in a tough spot as activist investor Starboard Value continues to call for a change in the company’s leadership. However, analysts are supportive of the embattled executive.
Pharmaceutical companies are combining antibodies with radioisotopes in a bid to more precisely deliver radiation to cancers and tumors.
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Incyte is abandoning its ALK2 blocker zilurgisertib, which it was trialing for myelofibrosis-associated anemia, while iTeos will deprioritize the development of inupadenant after it failed to meet the biotech’s clinical bar in a Phase II study of metastatic non-small cell lung cancer.
Ocaliva recently failed to secure the FDA’s traditional approval for primary biliary cholangitis due to safety concerns.
The EMA approved a kidney disease–related label expansion for the blockbuster GLP-1 drug after a study showed reduced risk of death by 20%.
Pfizer, facing increasing pressure from Novartis, is touting a Phase III win for Ibrance as the first clinical evidence supporting the CDK4/6 inhibitor class’ use in patients with a specific type of breast cancer.
Keros’ stock plummeted more than 70% premarket Thursday and Truist Securities analysts predict it will remain under pressure until the safety concerns for cibotercept are resolved.
Candel’s trial was conducted under the FDA’s Special Protocol Assessment program, meaning that its data could be used as a basis for a regulatory application.
The discontinuation caps off a turbulent development path for izokibep, which in September 2023 produced disappointing results from Phase IIb/III study in hidradenitis suppurativa that was found to have had dosing errors.
Ending the diagnostic journey for patients, particularly those with rare diseases, improves patients’ quality of life while reducing costs to healthcare systems.
With nearly 90% of patients showing no detectable cancer cells after treatment, J&J and Legend’s Carvykti could stave off competition from emerging CAR T therapies such as Gilead and Arcellx’s anito-cel.
BNT327, now in early-phase trials, is part of a class of drugs that could one day challenge Keytruda’s dominance. BioNTech obtained the candidate when it bought Biotheus last month in an acquisition deal that could reach up to $950 million.