News
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Amgen held its earnings conference call on Wednesday for Q1 of 2022. Most notably, the company provided updates on its ongoing litigation with the Internal Revenue Service.
The Q1 results for Voxzogo gave BioMarin the confidence to raise its 2022 full-year guidance to between $100 million to $125 million (net product revenue) for the drug.
Bryostatin-1 increases antigen expression on the surface of cancer cells, enabling them to be seen and killed by IO agents.
Zentalis Pharmaceuticals announced that Pfizer made a $25 million equity investment in the company.
Exogene nets $2 million to propel the development of its AI platform for T-cell receptor discovery and Healome spins out to deploy a ‘pro-healing’ platform with a focus on ocular surface diseases.
AviadoBio is celebrating orphan drug designations from both the U.S. FDA and the European Commission for AVB-101, a gene therapy intended to treat frontotemporal dementia (FTD).
BeiGene’s candidate drug tislelizumab for cancer succeeded in meeting the primary endpoint of overall survival in a global Phase III trial. Learn more about it here.
Weeks after Gilead Sciences raised concern over counterfeit HIV drugs, Johnson & Johnson has taken similar action against the distribution of counterfeit prescription drugs.
Cytovia Holdings, a biopharma company focused on natural killer (NK) cells, merged with special purpose acquisition company (SPAC) Isleworth Healthcare Acquisition Corp. to go public.
The U.S. Congress is calling for the coronavirus management plan to deliberate on the timeline for the approval and release of vaccines for children under 5 years old.