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GSK is carving out a niche for Blenrep in the second-line multiple myeloma setting, for which it projects multi-blockbuster potential for the antibody-drug conjugate.
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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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Takeda announced that the European Commission has granted Marketing Authorization for LIVTENCITYTM for the treatment of cytomegalovirus infection and/or disease that are refractory to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet, in adult patients who have undergone a haematopoietic stem cell transplant or solid organ transplant.
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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.
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In addition to missing the mark in overall survival, Gilead reported Thursday a higher number of deaths in the Trodelvy arm of the confirmatory metastatic urothelial cancer study.
Novartis’ Scemblix posted stronger results with fewer discontinuation rates than both its own Gleevec and a stronger second-generation TKI, positioning it for a potential first-line indication in chronic myeloid leukemia.
As evidenced by this week’s buyouts by J&J and Merck, Big Pharma appears to have found a sweet spot favoring smaller deals over megabillion-dollar acquisitions.
The American Society of Clinical Oncology annual meeting kicks off today in Chicago, with highly anticipated presentations that include reports on a bispecific antibody, an ADC and a BCMA-targeted CAR-T cell therapy.
The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.
Tempting as it may be to turn to full automation to meet burdensome requirements, the potential for hallucination and other issues means biopharma companies must proceed with caution.
Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.
As BioNTech struggles to establish its footing in a post-pandemic world, the biotech has secured $145 million from the Coalition for Epidemic Preparedness Innovations to expand its mRNA operations in Rwanda.
Despite Biohaven’s bispecific protein degrader cutting autoantibody IgG levels by up to 37% in an early-stage study, investors saw it as “below the high bar” of 60%, according to William Blair analysts.
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.