MedCity News
MARCH 18, 2024
Generic drugs are the pharmaceutical products mainly affected by the missile attacks disrupting shipping in the Red Sea. While the extra costs borne by drug companies aren’t causing an immediate spike in product prices, experts say they’ll eventually be factored into prices if the attacks become a long-term problem.
MedCity News
AUGUST 7, 2023
Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy. The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticals product.
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pharmaphorum
SEPTEMBER 9, 2022
As one of the world’s biggest contributors to climate change, pharma is morally obliged to adapt its processes and operations – and doing so will open up new opportunities for growth. Pharma’s reliance on global supply chains and its need for vast quantities of water make it particularly vulnerable to climate change. Responsibility .
MedCity News
JUNE 29, 2023
The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder. The FDA approved Roctavian for treating hemophilia A.
MedCity News
JUNE 20, 2022
In other drug decision news, the Rhythm Pharmaceuticals product Imcivree added the rare disease Bardet-Beidl syndrome as a new approved indication. AbbVie drug Skyrizi is now approved for Crohn’s disease, making it the first treatment for the disorder that addresses a particular protein associated with inflammation.
Clarivate
NOVEMBER 17, 2021
They’re here to ensure that their company meets the regulatory requirements in the different activities of the organization, whether they are from the submission, to the manufacturing or even the advertising of the given drugs or other pharmaceutical products. And this is why regulatory intelligence may be a challenge for these people.
Clarivate
MARCH 14, 2024
With the introduction of a new CMC Intelligence entitlement to address post-approval changes, Clarivate now covers a broader range of the lifecycle of pharmaceutical products. Cortellis CMC Intelligence changes the way we work in reviewing regional regulatory requirements by making complex content available in a simplistic view.
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