Policy
Last month, the agency hired a new director for the Office of Therapeutic Products, but both leadership and support staff positions remain open.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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Intercept Pharmaceuticals, Annovis Bio and Biohaven Pharma are moving forward with late-stage Phase III clinical trials.
A Senate Finance Committee report shows the majority of AbbVie’s income is taxed through foreign subsidiaries, allowing the company to pay less than half the U.S. corporate tax rate.
As the global life sciences industry slows down, companies are gathering money through means other than VC funding. BioSpace shines a light on some of these recent transactions.
Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.
Emory University’s Ken Thorpe told BioSpace that the average Medicaid spending on drugs approved under the accelerated pathway in relation to total Medicaid spending is.2%.
A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.
CureVac has filed a lawsuit against BioNTech and two of its subsidiaries for allegedly infringing on its intellectual property rights over mRNA technology used in the COVID-19 vaccine.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.
Even though the COVID-19 pandemic appears to be under control, it’s clear that it’s not over, with the rise of more subvariants. Read on for more details.