Pharmaceutical Technology

JANUARY 30, 2023

In a Complete Response Letter to Eli Lilly in March 2022, the FDA indicated that the Oncologic Drug Advisory Committee voted overwhelmingly in favour of requiring more research to support the approval of sintilimab with pemetrexed and platinum-based chemotherapy for nonsquamous non-small cell lung cancer.

Drugs 130

Drugs Manufacturing Contract Manufacturing FDA Approval 130

pharmaphorum

JUNE 14, 2021

This can lead to metabolic abnormalities including insulin resistance, diabetes, and elevated levels of blood lipids (such as high cholesterol). Partial lipodystrophy results in a partial loss, but the fat that remains is redistributed in inappropriate places around the body.

Drugs 105

Drugs Pharma Companies Licensing Licensing 105

Pharmaceutical Technology

JANUARY 10, 2023

Hailed as a breakthrough, Tzield’s approval marks the first of its kind to be introduced since the discovery of insulin, which won the 1923 Nobel Prize in the category of Physiology or Medicine. These therapies work by reprogramming the immune system, preventing it from attacking and eradicating insulin-producing cells in the pancreas.

Insulin 246

Insulin FDA Approval Research Clinical Trials 246

The Pharma Data

MAY 13, 2021

Insulin Resistance and Cancer Risk: An Overview of the Pathogenetic Mechanisms. Experimental Diabetes Research. Ectopic lipid storage and insulin resistance: a harmful relationship. Relationship between disease severity, hyperinsulinemia, and impaired insulin clearance in patients with nonalcoholic steatohepatitis.

Insulin 52

Insulin Production Hormones Medicine 52

XTalks

SEPTEMBER 17, 2020

While the table lists acceptable surrogate endpoints for trials of more common conditions, such as asthma, type 2 diabetes and various cancer types, the document also provides key information to developers of certain rare disease therapies. Also known as Berardinelli-Seip syndrome, there are four subtypes of lipodystrophy.

Trials 98

Trials Gene Hormones Clinical Trials 98

The Pharma Data

DECEMBER 13, 2020

7.1%) levels were well controlled, and in this context, significant placebo-adjusted decreases were observed in both glycemic parameters along with improvements in commonly used fasting indexes of insulin sensitivity (HOMA-IR and QUICKI scores). Harrison, MD, Director, Summit Clinical Research. .

Trials 52

Trials In-Vitro Insulin Protein 52

The Pharma Data

APRIL 4, 2023

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40