Drug Target Review

JANUARY 31, 2024

Since joining Allergan Aesthetics in 2001, my role in medical affairs has always focused, in one way or another, on supporting the journey of a drug/device from bench to bedside. One of the biggest obstacles I faced early in my career was the perception that women often quit their career to achieve a work-life balance.

Clinical Trials 97

Clinical Trials Production Science Research 97

The Pharma Data

DECEMBER 20, 2020

They are one of the top pharmaceutical firms in China and are considered a market leader in the antibiotics space. There is an urgent need in China, and indeed, globally, to bring new antibiotics to the market that can address critical resistance issues. and EU based on these results.

Licensing 40

Licensing Licensing Pharmaceuticals Pharmaceutical Companies 40

The Pharma Data

DECEMBER 15, 2020

As the world’s first PPAR pan agonist that completed two confirmatory phase III clinical trials, Chiglitazar Sodium has shown significant and long-lasting hypoglycemic effects in a series of clinical studies, as well as other comprehensive effects including significant insulin sensitization and blood lipid regulation.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Clinical Trials Production 40

Drug & Device Law

JULY 24, 2023

341 (2001). The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. Plaintiffs Legal Committee , 531 U.S. You can see where this is going.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

MARCH 31, 2022

Nor was a mere trial court free to invent new causes of action. “[I]t is not this Court’s role to adopt novel causes of action. 1995) (“the deceptive practice must occur in the sale or offer for sale to consumers,” not “entirely during the marketing of the [product]”); Penn-Plax, Inc. Osmose Wood Preserving , 667 A.2d 906, 909 (D.

Government 52

Government Production FDA Approval FDA 52

Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. One prescriber “testified that based on her review of all the post-approval data, at the time of trial, she believed the [risk] was still rare.”

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

Drug & Device Law

NOVEMBER 9, 2023

341 (2001)), calls “off-label use,” so we go with the majority naming convention. Beyond such gold-plated research: [O]ther well-designed and well-conducted trials are also able to generate scientifically sound and clinically relevant information. . . . Plaintiffs Legal Committee , 531 U.S.

FDA 64

FDA Nurses Production Regulations 64