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Clinical / R&D

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Latest From Research & Development

Yet Another Myeloma CAR-T Therapy Makes It Onto EMA’s PRIME

Only two of seven applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical need to patients faster were successful last month.

Research and Development Strategies Europe

US FDA Fulfills Annual Antibiotic Guidance Goal With Three Women’s Health Guidances

Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.

Drug Approval Standards Infectious Diseases

Austria Works On Method To Improve Price Transparency

Austria’s health technology appraisal institute aims to further discussion on public investments in R&D and medicines pricing transparency.

Europe Austria

One Patient, Many Questions: Milasen ‘N of 1’ Trial Provides Early Template For Individualized Genomic Medicine

Rapid development of patient-customized oligonucleotide at Boston Children’s Hospital suggests promise and hazards of new drug development model.

Drug Approval Standards Rare Diseases

BeyondSpring’s Pivotal NSCLC Trial For Plinabulin Designed To Avoid Bavencio’s JAVELIN 200 Failure

Lessons learned about blinding and stratification from Pfizer and Merck KGaA’s earlier Phase III disappointment shaped the design of BeyondSpring's ongoing Phase III trial of plinabulin in second- and third-line non-small cell lung cancer.

Clinical Trials Cancer

Woodcock Bemoans Lack Of 'Biobetter' Provision In BPCIA

CDER director lobbied for inclusion of a 505(b)(2)-like category for biologics, but it was ultimately not included in the 2010 legislation creating the biosimilar pathway; Woodcock urges patience on the development of the biosimilar marketplace and notes the agency will be keeping an eye on the development of biobetters, which are relatively new innovations.

Biologics Biosimilars
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