Policy
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
FEATURED STORIES
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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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.
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Adverum Biotechnologies is cutting 78 jobs after announcing it had successfully amended its Investigational New Drug application for ADVM-022.to treat wet age-related macular degeneration.
DiaMedica Therapeutics’ Phase II/III ReMEDy2 trial is on hold by the FDA because patients were experiencing severe drops in blood pressure.
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.