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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.
FDA
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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Read our takes on the biggest stories happening in the industry.
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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AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.
Intellia’s first-quarter financial conference call and report focused on the ongoing Phase I trial of NTLA-2001 in transthyretin (ATTR) amyloidosis with polyneuropathy patients.
Two biologic therapeutic candidates have met their primary endpoints in phase III trials, including AstraZeneca’s Champion-NMOSD trial and Argenx’s Advance trial.
AstraZeneca’s proposed treatment for heart disease delivered positive high-level results from its Phase III DELIVER trial of Farxiga. Here’s more about this drug.
The FDA’s reaction came after Pfizer CEO Albert Bourla said that physicians may give a second five-day course of Paxlovid if patients see a spike in their SARS-CoV-2 viral load.
After the market closed on Wednesday, Allogene reported its first-quarter financial results, along with updates to its research programs. The report marked Allogene’s fourth anniversary.
Jazz’s Q1 included a key licensing deal with Werewolf Therapeutics and another announced Wednesday with Japan’s Sumitomo Pharma Co. for a narcolepsy treatment.
Awakn researches and develops drug-assisted psychotherapy treatments, focusing on psychedelic drugs to treat addiction.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Context Therapeutics’ lead candidate ONA-XR prevents interaction between progesterone and its receptor, downregulates cancer stem cell mobilization and blocks immune evasion.