Jill Wechsler, Pharm Exec’s Washington Correspondent

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.

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.

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.

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.

Lapse spotlights wider actions to ensure data accuracy.

The Center for Drug Evaluation and Research has finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.

Market consolidation limits sales, while legal challenges offset regulatory gains.

As part of the legislation expanding the federal Open Payments program, drug and medical device manufacturers will have to report payments and other “transfers of value” to a broader range of health professionals.

Jill Wechsler casts her eye over the multitude of health reform measures emerging on Capitol Hill.

HHS, FDA back Trump back cheaper foreign drugs to cut pharma costs. Jill Wechsler reports.