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Jefferies analysts envision a steady launch curve that could ultimately drive meaningful sales from people who are dissatisfied with existing treatments.
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A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.
Of all the stories we published this year, these deep dives by BioSpace editors stand out as relevant re-reads going into the New Year.
The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?
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Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Six weeks after HHS Secretary RFK Jr. cited unexplained conflicts of interest in dismissing all 17 members of the CDC’s vaccine advisory committee, Democrats are asking for details.
While some analysts forecast the tariffs could mean billions in additional industry expenditure, others expect the overall impact to be “manageable.”
In a post on X, Health Secretary Robert F. Kennedy Jr. alleged that the Vaccine Injury Compensation Program has “devolved into a morass of inefficiency, favoritism, and outright corruption.”
BMS is spinning out a new company with five immunology assets, including oral drugs being developed for systemic lupus erythematosus and plaque psoriasis, and $300 million in funds from Bain Capital.
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday.
In a Phase Ib/IIa trial, 91% of patients receiving the highest dose of trontinemab were amyloid negative after seven months of treatment, representing what B. Riley Securities called a “paradigm shift” to first-generation FDA-approved antibodies.
The German giant is looking to develop new drugs for undisclosed eye diseases using Re-Vana’s extended-release injectable platform to supply drugs to the eye for months at a time.
The star of GSK’s Hengrui partnership is the COPD candidate HRS-9821, which will complement the pharma’s respiratory pipeline that’s anchored by the anti-asthma drug Nucala.
Health Secretary Robert F. Kennedy Jr. wants to remove all members of the USPSTF for being too “woke,” according to reporting by the Wall Street Journal. An HHS spokesperson, however, says no final decision has been made about the panel.
Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe infection exacerbated by immunosuppression.