At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

A story is told that after first obtaining approval for marketing Premarin in 1942, Wyeth Laboratories didn’t lock up the secret recipe for making the hormonal drug in a company safe, to be guarded by patent lawyers.

January 23, 2026

Vol.52 No.03

By Claire Marie Porter

Capitol Hill

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

The U.S. House of Representatives Jan. 22 passed a three-bill minibus package that is expected to be the grand finale of the drama of the fiscal year 2026 appropriations process. The package, which funds the HHS as well as the departments of Defense, Transportation, Housing and Urban Development, Labor, and Education, gives NIH and NCI modest raises over FY25, and nullifies several aggressive cuts the White House had proposed for NIH.

NIH ends fetal tissue research—again

NIH will no longer fund scientific research that uses human fetal tissue from elective abortions, a practice that has contributed to the study of cancer, the development of vaccines, and the treatment of other diseases.

Trodelvy + Keytruda show potential as new standard of care in first-line PD-L1+ metastatic TNBC, phase III trial finds

Patients saw a 35% reduced risk of disease progression or death for Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) (n=221) versus standard of care Keytruda plus chemotherapy (n=222), according to the positive phase III ASCENT-04/KEYNOTE-D19 study evaluating the combination of Trodelvy plus Keytruda in first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer.

January 23, 2026

Vol.52 No.03

Clinical Roundup

Sylvester-led study focuses on rate of failure in head and neck cancer trials

Researchers from Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and collaborators analyzed 692 clinical trials launched between 2000 and 2024.

January 23, 2026

Vol.52 No.03

Drugs & Targets

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

FDA has issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease and complete response as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.

January 23, 2026

Vol.52 No.03

At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

YOU MAY BE INTERESTED IN

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

NIH ends fetal tissue research—again

Trodelvy + Keytruda show potential as new standard of care in first-line PD-L1+ metastatic TNBC, phase III trial finds

Sylvester-led study focuses on rate of failure in head and neck cancer trials

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

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At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

YOU MAY BE INTERESTED IN

Premarin’s 84-year hold on the market ends as FDA approves a generic versionTrade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Spending bill passed by the House gives NIH $415M raise, NCI gets $128MLegislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched

NIH ends fetal tissue research—again

Trodelvy + Keytruda show potential as new standard of care in first-line PD-L1+ metastatic TNBC, phase III trial finds

Sylvester-led study focuses on rate of failure in head and neck cancer trials

FDA issues draft guidance on MRD and CR as primary endpoints in MM drug trials to support accelerated approval

Never miss an issue!

Login

Premarin’s 84-year hold on the market ends as FDA approves a generic version
Trade secret protections helped the hormone drug resist generic entry and outlast safety controversies—including link to cancer

Spending bill passed by the House gives NIH $415M raise, NCI gets $128M
Legislation caps proportion of NIH grants to receive multiyear funding; indirect costs remain untouched