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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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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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The biotech company is collaborating with Israel’s NeuroSense to study how the latter’s amyotrophic lateral sclerosis candidate affects plasma neurofilament levels in patients.
The company announced Monday with its second-quarter earnings that the regulator has officially halted the Phase I study after a child with acute myeloid leukemia died following treatment.
The pendulum has swung back in favor of employees, and employers are struggling to retain employees as workers become less engaged.
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
The initial public offering on the Nasdaq is a last-ditch effort by the biotech as there is “substantial doubt” as to the company’s “ability to continue as a going concern” without the IPO, according to its SEC filing.
Data from a Phase II trial showed that Adcetris, used in a combination approach, is effective in early-stage classical Hodgkin lymphoma patients.
Valneva’s chikungunya vaccine candidate VLA1553 showed that the shot safely and rapidly induced high rates of seroprotection. Merck earlier in 2023 discontinued its chikungunya program.
Following a May 2023 settlement with Amgen, J&J has also signed an agreement with Teva and Alvotech, allowing their Stelara biosimilar to enter the U.S. no later than February 21, 2025.
The company announced Monday its shareholders elected Susan Langer, current president of Souffle Therapeutics, to its board of directors, replacing her reputed romantic partner Alex Denner.
After multiple delays, the contract manufacturer presents its earnings report for the third quarter of fiscal 2023, bumping its stock by more than 10%.