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FDA discontinue rare pediatric disease designation program despite increase in RPD approvals

Express Pharma

Between 2010 and 2013, annual FDA approvals for RPDs remained relatively low and stable, at an average of 6.5 In that same year, the FDA awarded 50 approvals for RPDs, at a five-fold increase from 2013. Jasper Morley, Pharma Analyst, GlobalData, comments, “In 2014, the FDA began awarding RPDDs. per cent.

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STAT+: Pharmalittle: We’re reading about a Roche deal for an obesity drug, a Gilead HIV drug and more

STAT

The agreement covering Zealand’s compound petrelintide, signals renewed efforts by Roche to catch up with obesity market leaders Novo Nordisk and Eli Lilly. billion in upfront cash , STAT writes.

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Actithera draws new investors to radiopharma drug pitch

BioPharma Dive

The technology works by attaching a radioisotope to a targeting compound via a specially engineered “linker” molecule. in 2013 — the field has taken off since the success of Novartis’ prostate cancer treatment Pluvicto. While radiopharmaceuticals have been around for years — Bayer’s Xofigo was approved in the U.S.

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Pharmacists Bridge the Gaps in Care Transitions

Pharmacy Times

February 2013. BMC Health Serv Res. 2024;24(1):576. doi:10.1186/s12913-024-11047-3 5. American Society of Health-System Pharmacists and American Pharmacists Association. ASHP-APhA Medication Management in Care Transitions Best Practices. Accessed July 7, 2025. Tasseff N, Axtell S, Nixon B.

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Lumateperone Submits Application for Schizophrenia Indication to FDA for Supplemental New Drug

Pharmacy Times

Factors associated with relapse in schizophrenia despite adherence to long-acting injectable antipsychotic therapy. International Clinical Psychopharmacology, 31 (4), 202–209. Lafeuille, M. Lefebvre, P., Fastenau, J., Doshi, D., & & Duh, M. Journal of Medical Economics, 16 (11), 1290–1299.

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NHC Submits Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients

Putting Patients First Blog

18 From the patient perspective, these compounded clinical, financial, and logistical burdens could mean the difference between continued disease management and devastating setbacks in health. 2 (2013): 1422, [link] 29 Trading Economics, United States Exports of Pharmaceutical Products, accessed May 5, 2025, [link] 30 U.S.

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Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

They have a team of highly skilled distribution professionals who can juggle efficacy and safety checks along with compounding as if they were conductors of a world-class symphony. Touchstone Books; 2013. We need people to coordinate and track prior authorizations, write persuasive appeal letters, and keep patients updated.