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Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
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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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Biogen announced that after 23 years with the company, Alfred W. Sandrock Jr. will retire on Dec. 31. Sandrock had his hand in the development of multiple treatments for neurological diseases.
Los Angeles-based ACELYRIN, Inc. announced a quarter-million dollars in Series B financing Tuesday morning, along with a splashy licensing deal.
Flagship Pioneering Founder and CEO Noubar Afeyan has been behind the launch of dozens of companies, some of which, such as Moderna, have become a household name across the globe.
Between the numerous COVID-19 vaccines and several new antiviral drugs, it would appear that the tools to end the COVID-19 pandemic are within reach. Here’s a look at some of the top stories.
Recludix launches with a mission to develop Three SH2 domain inhibitor programs targeting STAT3, STAT6, and an undisclosed non-STAT target for cancer and inflammatory disease targets.
Thanks partly to Biogen’s pricey new Alzheimer’s drug, Medicare enrollees will be burdened with higher monthly premiums for their Part B coverage.
FDA
The research showed that 61% of patients with PV experienced a complete hematological response after 7.5 years of treatment with BESREMi. Here’s more about it.
If bentracimab continues to yield the desired results through the rest of the Phase III study, PhaseBio will be on track to file a Biologics License Application in mid-2022.
The investigational drug directs a patient’s own IL-2 toward immune activation while simultaneously preventing IL-2’s immune suppression activities.
President Joe Biden has nominated former U.S. Food and Drug Administration Commissioner Robert Califf to reprise his role at the agency’s helm.