pharmaphorum
SEPTEMBER 2, 2020
The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If
World of DTC Marketing
OCTOBER 4, 2021
SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. A year ago, Facebook was making a hard charge to get the pharma business.
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pharmaphorum
JANUARY 14, 2021
Healthcare technology firm Seqster has introduced a new version of its service that aims to help pharma companies work with patients’ data while on virtual clinical trials. The company adds that it has split data into two silos to prevent hackers from using it in the unlikely event of a breach. The new Seqster 7.1
Camargo
NOVEMBER 11, 2020
In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.
pharmaphorum
MARCH 26, 2021
The UK Government and EU Commission trumpeted their Brexit trade deal, struck at the end of December, as ‘comprehensive’, the ‘biggest yet’ But a closer inspection of the EU-UK Trade and Cooperation Agreement (TCA) renders these statements largely illusory for the pharma sector. The Medicinal Products Annex.
Advarra
JULY 19, 2022
The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,
Drug Discovery World
MARCH 29, 2023
The commission is looking to put more pressure on pharma companies to report such shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market. However, stakeholders should be aware that the leaked review contains no such analysis.
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