Remove Clinical Trials Remove Containment Remove Generic Drugs Remove Licensing
article thumbnail

In the News: October Regulatory and Development Updates

Camargo

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.

article thumbnail

Buscopan vs Mebeverine | OTC IBS treatment

Druggist

Mebeverine, on the other hand, is a generic name of the drug, which is also known as Colofac (brand name). Both products contain the same active ingredients regardless of whether they are prescribed or purchased over the counter: Each Buscopan tablets contains 10mg of hyoscine butylbromide.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. However, stakeholders should be aware that the leaked review contains no such analysis.

article thumbnail

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. GSK’s Top 5 Best-Selling Drugs of 2022: 1) Shingrix (zoster vaccine recombinant, adjuvanted) Shingrix, with 2022 sales of £2.96

Sales 98
article thumbnail

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

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.

article thumbnail

Cerelle vs Cerazette: Are they really the same?

Druggist

Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). In terms of prescribing, both contraceptives are regarded as the same drug. . Cerelle vs Cerazette: are they the same?

article thumbnail

Truvada for PrEP: availability, cost and side effects

Druggist

Truvada (emtricitabine/tenofovir disoproxil) is an antiviral drug used in the treatment of HIV, alone or as part of antiviral combination therapy. Truvada is also licensed as pre-exposure prophylaxis (PrEP) medication. This post will cover the use of Truvada and its generic form for PrEP. Today, I am reviewing Truvada for PrEP.