Drug Discovery World

NOVEMBER 17, 2022

billion by 2027. . However, the development of drugs takes decades which is too long for most biotech start- ups looking for fast-track drug development programs. It shows that the synthetic biology market was valued at US$9.5 billion in 2020, and it is expected to reach a value of US$38.7

Engineering 130

Engineering Molecular Biology Synthetic Chemistry DNA 130

Drug Discovery World

AUGUST 3, 2023

Michael Sassano, CEO at SOMAÍ Pharmaceuticals, shared with DDW that it is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estimated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 5.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

Drug Discovery World

NOVEMBER 15, 2022

Synthetic libraries for antibody drug discovery . Developing therapeutic antibodies, one of the most successful approaches in drug development, involves identifying and characterising antibodies to be used as treatment against different types of cancers as well as autoimmune and cardiovascular diseases.

DNA 246

DNA Engineering Drugs Vaccine 246

Drug Discovery World

JANUARY 11, 2023

The annual ‘Drugs to Watch’ report identifies drugs entering the market or launching key indications in 2023 which are predicted to achieve blockbuster status by 2027 or be clinical game changers for millions of patients worldwide. .

Drugs 130

Drugs Pharmaceuticals Trials Treatment 130

Drug Discovery World

JANUARY 17, 2024

Challenges in the Oncology Clinical Trials Space The oncology market is a key growth driver for the pharma industry, with global drug revenues expected to reach US$390 billion by 2027 and the annual number of new cancer cases set to grow from 18 to 27 million by 2040 1,2. 21 In a recent publication, Silvestri et al., Narayan, P.

DNA 148

DNA Clinical Trials RNA Treatment 148

FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several drug, biological product, and medical device user fee provisions that were scheduled to sunset on September 30, 2022, FUFRA reauthorizes—but only through December 16, 2022—several other statutory provisions that were scheduled to expire.

FDA 59

FDA Regulations Production Drugs 59

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

NOVEMBER 3, 2023

October 1, 2027) in order to align with the next iteration of the device user fee program, the QS compliance requirement for LDTs could theoretically be in place by FY2027. The system as proposed could have compounding implications across the life sciences industry, including for drug development.

FDA 40

FDA Laboratories Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

FDA 40

FDA Regulations Laboratories Production 40

Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” The workshop will solicit and include industry and public feedback.

FDA 40

FDA Science Biosimilars Regulations 40