World of DTC Marketing
APRIL 12, 2021
We can’t continue to develop drugs the same way as we have done before. A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. The question that I kept asking was why?
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.
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Camargo
MAY 10, 2021
the Center’s chief of medical oncology, In it, they laid out their analysis of accelerated approvals for 35 oncology indications for anti-programmed death ligand 1 antibodies and reported that for 10 of the 35 indications, the confirmatory trials failed to show a benefit. Drug Product. Indication. Triple-negative breast cancer.
XTalks
FEBRUARY 8, 2021
In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.
Drug Discovery World
MARCH 29, 2023
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.
Druggist
SEPTEMBER 30, 2020
Both products contain the same drug – hyoscine butylbromide. The only difference comes in licensing of both products, which are reflected, for example by the broader availability of Buscopan IBS Relief and more stringent age restrictions for the product. Mebeverine is generally well tolerated with no common side effects listed.
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.
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