Drug Discovery World

APRIL 17, 2023

DDW’s Megan Thomas rounds up highlights from Monday 16 April at AACR 2023, from promising trial results for colorectal cancer patients to updates on Biden’s Cancer Moonshot initiative. Read more here. overall response rate. The survey also showed low awareness that HPV can cause anal, oral, and penile cancer. Read more here.

Research 130

Research FDA Approval Therapies Treatment 130

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Daratumumab already is approved for the treatment of multiple myeloma. Scientists at Charité, University Medicine Berlin , have been able to use daratumumab to successfully treat two female patients who have systemic lupus erythematosus.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

Codon

JUNE 18, 2024

For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. By 2016, Shapiro had set up a research laboratory at the California Institute of Technology in Pasadena and began to devote his attention entirely to gas vesicles.

Engineering 66

Engineering Laboratories International Clinical Trials 66

Codon

MARCH 24, 2024

by the time Bancel made it over to Flagship, where Afeyan delivered his pitch: He wanted Bancel to work on a startup that had so far hired only a single staff scientist and conducted just one mouse trial. In response to this hysteria, regulation was aggressively tightened. . “It was about 6 p.m.

Engineering 85

Engineering Vaccine Production RNA 85

The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA ® was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

FDA Approval 40

FDA Approval Treatment FDA Therapies 40

Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. FDA , 727 F.

FDA 59

FDA FDA Approval Pharmaceuticals Clinical Trials 59

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. Bonta , 85 F.4th

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JANUARY 30, 2023

280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Jones , 225 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

FDA 59

FDA Regulations FDA Approval Production 59