FDA Law Blog: Biosimilars

MAY 11, 2023

If an FDA-approved carve-out could support an intent to induce infringement claim, the use of the “section viii pathway would be substantially deterred.” Plainly, the Government brief states “The decision below is incorrect. The Government’s brief puts a lot of faith in the existing regulatory system rather than the patent system.

Government 72

Government FDA FDA Approval Doctors 72

Broad Institute

OCTOBER 11, 2023

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. The drugs work by blocking a protein, PD-1 — which helps keep immune responses in check — and stimulating the immune system to attack tumors.

Research 137

Research Immune Response Clinical Trials Therapies 137

The Pharma Data

OCTOBER 25, 2020

FDA approval. Patients are advised to call their doctor for medical advice about side effects. Side effects can be reported to the FDA at 1-800-FDA-1088. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder.

Treatment 40

Treatment Disease FDA FDA Approval 40

The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. Do not stop taking XARELTO ® without talking to the doctor who prescribes it for you.

Doctors 52

Doctors Treatment Hospitals Clinical Trials 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. In short, all studies found no significant difference between phenylephrine and placebo.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Broad Institute

NOVEMBER 6, 2024

Kerry Reynolds: The first immune checkpoint inhibitor was FDA-approved in 2011 to treat melanoma, with nearly a dozen more ICIs approved for various cancers since then. The longer patients wait to inform their doctor, the more complex it can become.

Research 131

Research Immune Response Hospitals Therapies 131

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Same result – no causation. Zydus Pharms USA, Inc. 2023 WL 4700651 (3d Cir.

Testimonials 105

Testimonials FDA Drugs Vaccine 105