Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

Agency IQ

AUGUST 16, 2024

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. Importantly, midomafetamine was proposed for use in conjunction with psychotherapy.

FDA 40

FDA Trials Regulations Therapies 40

Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g.,

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FDA Science Regulations Biosimilars 40

Drug Discovery World

FEBRUARY 26, 2024

Reece Armstrong speaks to Kathryn Golden , SVP Technical Operations and Manufacturing, bit.bio, about novel technologies, and methods to manufacture human cells for therapies so more patients can access these treatments. Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas.

Therapies 130

Therapies Treatment Engineering Disease 130

Drug Discovery World

OCTOBER 13, 2022

Samsung Biologics’ Senior Vice President, James Park, explores the opportunities emerging for CDMOs to support mRNA developers as they explore new therapeutic areas for patients. . One aspect that makes mRNA technology popular with drug developers is that its proteins can be easily edited. Why mRNA has potential .

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Vaccine Therapies Drugs RNA 130

Drug Discovery World

JANUARY 24, 2024

Fibrocor is on track to complete all IND-enabling work to support IND filing and initiation of clinical trials in 2024. Phase I of the clinical program will dose healthy volunteers with single ascending doses of FIB992 before proceeding to a multiple ascending dose study where the drug is administered for a two-week period.

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Small Molecule Research Pharma Companies Disease 147

Codon

SEPTEMBER 29, 2024

It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life. The average pass rate of phase I trials went up by 5 percent. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either.

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Engineering Virus DNA Therapies 125