Jill Wechsler, Pharm Exec’s Washington Correspondent

Biopharma companies have been working overtime to supply billions of doses of any safe and effective preventive. But the tight timeframe means they can't wait for final clinical test results to begin preparing large-scale manufacturing operations and to address critical supply chain issues.

Proposals around the globe seek to ensure access to any promising treatments.

Under pressure amid the COVID-19 panic, FDA has issued more than 100 Emergency Use Authorizations since early February, compared to less than 75 over the ten previous years.

The next version of the Cures Act will include provisions to advance research related to the COVID-19 crisis, writes Jill Wechsler.

With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.

Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.

Emergency funds for research, public health, and economic disaster raise access issues.

Jill Wechsler reports on the healthcare and regulatory provisions of the $2 trillion Coronovirus Aid, Relief, and Economic Security Act.

FDA officials are rolling out guidance and support for researchers striving to assess potential treatments for COVID-19 while the agency tries to object to premature optimism and regain public credibility.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

Now officially a worldwide pandemic, the biomedical research community is rushing to develop treatments and preventives to halt the spread and severity of the COVID-19 virus.

Now officially a worldwide pandemic, the biomedical research community is rushing to develop treatments and preventives to halt the spread and severity of the COVID-19 virus.

Initiatives aim to limit the gamesmanship that can inhibit prescribing of follow-on biologics.

The continued COVID-19 outbreak has fueled fears of drug shortages, primarily for active pharmaceutical ingredients produced in China.

Weighing new strategies to accelerate biomedical product development.

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

New FDA commissioner Stephen Hahn announced his priorities at an “all hands” staff meeting last week. Jill Wechsler reports.

Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.

Challenges will mount to established models for researching, developing, and marketing new therapies.

In a a new report penned by CEOs, more than 200 biopharma leaders acknowledge that out-of-pocket costs for individuals must be limited to sustain support for fiscal and patent policies key to advancing innovation.

While not setting any records for the rapid approval of new drugs in 2019, FDA did speed a number of important new therapies to patients, writes Jill Wechsler.

FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.

Sponsors developed important new therapies amidst ongoing concerns over drug quality and costs.

While labor and tariff reforms in the revised North American trade agreement may have more visible impacts on the United States economy, the final document levels a major blow to exclusivity and patent protections important to innovator biotech and pharma companies.

Jill Wechsler looks at the CDER Office of New Drugs' new structure, which features more operational support for review functions and closer alignment of review offices to therapeutic categories.

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

Measure would cut drug costs, slash revenues, curb R&D.

CDER's Rare Disease Cures Accelerator initiative looks to foster a coordinated research approach and methods that can expedite development of drugs to treat some of the 7,000 rare diseases.

A new drug shortages report from FDA revives the call for a rating system to help drug purchasers, hospital buying groups and consumers identify quality products that warrant higher prices. Jill Wechsler reports.