Drug Patent Watch
DECEMBER 12, 2024
Encouraging Competition : The FDA should work to lift barriers to generic drug competition by addressing scientific and regulatory obstacles. This can help increase the availability of lower-cost, generic medicines and reduce the cost burden on patients and the healthcare system. Retrieved from [link] The Commonwealth Fund.
European Pharmaceutical Review
MAY 27, 2025
Generic medicine Emtricitabine/Tenofovir alafenamide Viatris (emtricitabine / tenofovir alafenamide), received a positive opinion to treat adults and adolescents with human immunodeficiency virus type 1 (HIV-1). Additionally, the treatment was recommended for adults and skeletally mature adolescents with giant cell tumour of bone.
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Express Pharma
AUGUST 4, 2024
.” Dr Chandrashekar Ranga, Joint Drugs Controller, India, will discuss the obstacles regulators face in the digital era; Dr Stewart Geary, Global Safety Officer, Eisai and a Fellow of DIA, will provide updates on behalf of the Council for International Organizations of Medical Sciences (CIOMS) Working Group XII on Benefit-Risk Balance for Medicinal (..)
pharmaphorum
JULY 4, 2022
At Teva , he replaces Hafrun Fridriksdottir, a 25-year Teva veteran who was named R&D chief almost immediately after Kare Schultz took over the reins of Teva in 2017 with the task of turning around the fortunes of the ailing generics giant. ” The post Teva poaches Vertex exec as new head of R&D appeared first on.
Pharmaceutical Technology
MAY 3, 2023
In recent years, first generics have improved patient access to essential treatments and offered affordable treatment options for patients with multiple sclerosis, asthma, heart disease, diabetes, and even the flu. In 2017, FDA announced the Drug Competition Action Plan (DCAP) to allow consumers to get access to medicines.
Quality Matters
JUNE 26, 2023
Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age. link] (accessed on June 12, 2023) 2 Daan J.A. Crommelin, Vinod P. Shah, et al.
Quality Matters
APRIL 26, 2023
Essential elements of a strong, global medicines supply chain The U.S. Pharmacopeia (USP) has long been recognized as an international leader in medicines quality and supply chain integrity. in a platform that assesses the vulnerability of specific medicines to supply chain disruptions.
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