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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.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
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Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, a polymerase chain reaction (PCR) test designed to detect non-variola Orthopoxviruses, including monkeypox virus, in approximately three-and-a-half hours.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
Johnson & Johnson and Legend Biotech’s Carvykti cell therapy significantly improved survival in patients with multiple myeloma when used in the second-line setting, the companies announced on Tuesday.
GSK on Wednesday restructured its contract with CureVac to gain access to the biotech’s influenza and COVID-19 programs for $430 million upfront and up to $1.13 billion in future payments.
Despite an uncertain legislative path to becoming law, the BIOSECURE Act has already impacted the biopharma industry’s confidence in Chinese service providers and prompted efforts to diversify manufacturing partners.
Taysha Gene Therapies looks to move past its pipeline culls and staff reductions by moving its lead asset into a possible billion-dollar market.
As congressional pressure increases on WuXi AppTec and other China-based companies over alleged ties to the Chinese government, India’s contract development and manufacturing organization sector could benefit.
Moderna on Tuesday announced it has been awarded $176 million by a consortium funded by the Biomedical Advanced Research and Development Authority to develop an mRNA-based vaccine to counter H5N1 avian influenza.
Donanemab, which will be marketed as Kisunla, will compete with Biogen and Eisai’s Leqembi.
Eli Lilly is expanding its radiopharmaceutical portfolio with a $140 million upfront payment to Radionetics Oncology and the exclusive future right to acquire the biotech for $1 billion.
This week on Denatured, Head of Insights Lori Ellis and guests discuss the implications of not addressing the DE&I data gaps for the future.
Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S.