Remove 2024 Remove FDA Approval Remove Regulations
article thumbnail

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

article thumbnail

Bile acids and the microbiome: revolutionising disease approaches

Drug Target Review

Bile acids are crucial signalling molecules that aid the regulation of the immune system and have essential metabolic functions, like controlling lipid and glucose metabolism. The team debuted a novel tool to instantly match microbes to the metabolites they produce earlier in 2024. 2023 February 5 [2024 March 11]; 15(1).

Disease 111
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog: Biosimilars

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. On June 10, 2024, the District Court of New Jersey issued its Opinion in the case, finding that Teva’s patents were improperly listed.

FDA 116
article thumbnail

Another Attack on the Carve-Out: Novartis Seeks a TRO Enjoining ENTRESTO Generic

FDA Law Blog: Biosimilars

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.”

article thumbnail

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law Blog: Biosimilars

3558 ) on January 25, 2024. The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” House of Representatives ( H.B. 7085 ) and Senate ( S.B.

article thumbnail

ACI’s Advanced Legal, Regulatory and Compliance Forum on OTC Drugs, January 23?–?24, 2024, New York, NY — Featuring HPMer and Former FDAer Deborah Livornese

FDA Law Blog: Biosimilars

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

article thumbnail

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.