Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

Development 242

Development Bioequivalency Generic Drugs Production 242

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. A 351(K) application must include information explaining that the biosimilarity is completely based on the data related to animal studies, clinical studies, and analytical studies.

Development 161

Development Production Immune Response Licensing 161

Druggist

MARCH 25, 2021

This, however, does not come as a surprise since one of the requirements for licensing of generic medication is to provide the same products information leaflet as the branded drug’s leaflet. . Generic medicines are usually much cheaper because they do not go through the same process of marketing authorisation. Cerazette**.

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months. SOUTH SAN FRANCISCO, Calif.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

XTalks

FEBRUARY 8, 2021

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

Production 78

Production Insulin Branding Generic Drugs 78

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. J Neurol Sci.

Trials 52

Trials Medicine Production Containment 52