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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
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.
Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.
The FDA lifted its clinical hold on Vertex Pharmaceuticals’ Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).
Provention Bio announced the FDA extended its review period by three months for the Biologics License Application (BLA) of its diabetes prevention drug, teplizumab to Nov. 17.
Citing an unnamed FDA insider, the regulator is in the process of devising a plan to enable clinical testing on a larger scale.
Companies are still developing and refining treatments and preventions for COVID-19, but not all of them are approved or authorized. Here’s a look at the latest COVID-19 news.
There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.
The FDA’s decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
As the nation reacts to the overturning of Roe v. Wade, pharma companies must address the changes in demand for drugs and services, all while navigating increasingly muddy legal waters.