Drug Discovery World
SEPTEMBER 26, 2022
According to MarketWatch, the drug repurposing sector was thought to be worth $25,280 in 2021 and is expected to grow to $30,620 million by 2028 with a CAGR of 2.8%. Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Benefits and barriers .
Agency IQ
JUNE 28, 2024
New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. This would entail review of the CER and orphan device status.
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Drug Discovery World
SEPTEMBER 28, 2022
In fact, the market research firm, Bekryl, predicts that AI has the potential to offer over $70 billion in savings for the drug discovery process by 2028. . The significance of these predictions has not been lost on investors in the health and technology space. billion in 2021, an increase of 79% from 2020.
The Premier Consulting Blog
NOVEMBER 20, 2023
The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Agency IQ
MAY 28, 2024
regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).
Drug Discovery World
AUGUST 10, 2022
And now, with more than 600 CAR T trials recruiting or ongoing, these cells represent a majority of the cellular immunotherapies in development today. For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks. Plus, regulators are promoting this growth.
The Pharma Data
JANUARY 9, 2021
RECONCILIATION OF NON-GAAP MEASURES (unaudited) This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules and regulations.
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