Translation

MAY 28, 2022

The company received proposals from over fifty institutions, including 40 universities and 10 government labs, surfacing licensing candidates from diverse partners. The post R&D Partnering Testimonials from Bayer, Oldcastle and Joyn Bio appeared first on Translation | Halo Blog.

Testimonials 52

Testimonials Science Engineering Production 52

FDA Law Blog: Biosimilars

MARCH 24, 2025

In January a public hearing began to receive factual evidence and testimony on whether marijuana should be rescheduled. Dispensing marijuana to patients, as required for other schedule III substances, would require a prescription issued for legitimate medical purpose by a DEA-registered and state licensed practitioner.

Regulations 71

Regulations Testimonials Licensing Licensing 71

FDA Law Blog: Biosimilars

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however.

Laboratories 64

Laboratories DNA Testimonials Biosimilars 64

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. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. They excluded bogus expert testimony under Fed. Bonta , 85 F.4th Monsanto Co. ,

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Wyeth Laboratories, Inc. ,

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. emphasis added). 3d at 1286.

Testimonials 59

Testimonials Licensing Licensing FDA 59

Drug & Device Law

JUNE 1, 2022

co-DDL blog founder Mark Herrmann offers all sorts of good advice. Our favorite part of the plaintiff’s case was the reliance on unsworn affidavits and prior testimony by a Dr. Kory, who stated that he is “generally considered the foremost expert” on the proposed Covid treatment. None of those arguments passed muster.

Doctors 124

Doctors Treatment Hospitals Testimonials 124