Remove 2028 Remove Marketing Remove Regulations Remove Trials
article thumbnail

Where are the global hotspots for biotech?

Drug Discovery World

According to data analysts Precedence Research, the global biotechnology market was estimated at $1.38 Following a subdued 2022 and 2023 for biotech investment, there is optimism that the market is heading to recovery in 2024. In 2021, the country had the seventh largest share of the global biotech market 2.

article thumbnail

Highs and lows of drug repurposing 

Drug Discovery World

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%. A report by the medical charity LifeArc 1 puts the timeframe for a therapy brought to market through repurposing methods at anywhere from one to three years.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

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.

Trials 40
article thumbnail

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

FDA 40
article thumbnail

How AI in pharma can live up to the hype 

Drug Discovery World

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. . According to Hampleton Patners’ latest Healthtech M&A market report2, digital health companies raised a total of $57.2 billion in 2021, an increase of 79% from 2020.

article thumbnail

FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals

The Premier Consulting Blog

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).

article thumbnail

Article EMA Thank You U.K. regulator lays out proposal for international device and diagnostics recognition

Agency IQ

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).