Regulatory

In today’s Pharmaceutical Executive Daily, we cover the FDA lifting its clinical hold on Neurizon Therapeutics’ lead program Nuz-001, the agency’s export ban on Sun Pharma’s Halol facility, and new insights on how small biotechs can better navigate regulatory and market complexities.

CDC introduces shared-decision making for COVID-19 vaccinations, emphasizing informed consent and individual consultation with healthcare providers.

Products tested and manufactured exclusively from domestic materials will be eligible for the program.

This marks the latest change in the President’s strategy.

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

The FDA has expanded Johnson & Johnson’s Tremfya (guselkumab) approval to children six years and older weighing at least 40 kilograms with moderate to severe plaque psoriasis or active psoriatic arthritis, marking the first pediatric approval of an IL-23 inhibitor for these conditions.

Companies that have broken ground or begun construction on US manufacturing sites will be exempt from these tariffs.

FDA approves Eli Lilly’s Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after endocrine therapy.

Aside from pricing changes, the impacts that MFN could have on the US market could have global reverberations.

In order to enforce MFN, regulatory agencies must navigate the complex process of determining a drug’s true value.

The President announced FDA will no longer recommend the use of the common painkiller during pregnancy, despite a casual link between the medication and autism not being established.

Alongside regulations from the IRA, oncology R&D is set to face unique challenges when MFN is enforced.

Peter Rubin discusses how the industry is an ecosystem and each of the parts will feel the impact differently.

The FDA has expanded the indication of Incyte’s Opzelura (ruxolitinib) cream to include children aged two to 11 years with mild to moderate atopic dermatitis, making it the first steroid-free topical treatment option for this age group.

FDA warns major pharmaceutical companies to improve transparency in drug advertising, addressing misleading claims and enforcing stricter regulations.

R-DXd has previously shown promising clinical results in platinum-resistant ovarian, peritoneal, and fallopian tube cancers.

The new administration has a different perspective of vaccines than the previous administration, causing confusion with the public.

The pause follows a patient death in the SYNRGY trial evaluating the novel therapy for STXBP1-related disorders, as the company prioritizes safety and transparency with the community.

The designation supports expedited development of SAR402663, Sanofi’s one-time gene therapy designed to reduce treatment burden and slow vision loss in patients with wet age-related macular degeneration.

Key points from our recent webinar on the President’s MFN order.

Approval was based on data from the Phase IIb SunRISe-1 trial (NCT04640623), in which Inlexzo demonstrated an 82% complete response rate in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

The agency noted ongoing safety violations at the location.

The company says addressing the issues raised in the CRL could take years.

The list prevents the import of ingredients from potentially dangerous facilities.

Wayrilz is the first Bruton’s tyrosine kinase inhibitor to be approved for adults with persistent or chronic immune thrombocytopenia who have not responded adequately to prior therapy.