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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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SIGA Technologies’ TPOXX did not outperform placebo at resolving lesions in patients with clade I mpox, the new strain that has spread through parts of Africa and is reaching beyond the continent.
The unit’s closure comes as Genentech’s parent Roche rethinks its cancer business, an effort that has included the discontinuation of three early-stage candidates and a T-cell partnership with Adaptimmune.
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Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
Regeneron, Akouos and Mass Eye and Ear are testing therapies that can reverse genetic protein deficiency to restore hearing, with promising early results.
The entry of new players and new approaches into the ATTR-CM space could help bring down the cost of treatment, experts say.
For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous.
Lykos will lay off approximately three-quarters of its staff amidst a reorganization aimed at helping the company complete a regulatory resubmission for its MDMA-assisted therapy.
The companies’ late-stage stumble could allow Moderna to widen its lead, with its mRNA-based combination vaccine eliciting superior immune responses against COVID-19 and three influenza strains.
Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.