Athenex's angiosarcoma candidate gains FDA orphan designation | Greater pharmacist role decreases costs, increases safety, study shows | FDA developing more disease-specific guidance for drugmakers
April 20, 2018
Specialty Pharmacy SmartBrief
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Specialty Pharmacy Update
Athenex's angiosarcoma candidate gains FDA orphan designation
Athenex's oral therapy Oraxol, a combination of paclitaxel and a nonabsorbable gastrointestinal tract P-glycoprotein pump inhibitor, was given orphan drug status by the FDA. The candidate is being developed as a treatment for patients with angiosarcoma.
eMPR (4/19) 
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Greater pharmacist role decreases costs, increases safety, study shows
A new study published in the Annals of Pharmacology estimates a cost of $528.4 billion for nonoptimized medication use leading to treatment failure, new medication problems and even death. Clinical pharmacist and prescriber collaboration to deliver comprehensive medication management services may fix this problem.
Drug Topics (4/19) 
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Legislation & Regulation
FDA developing more disease-specific guidance for drugmakers
The FDA intends to release more guidance for drugmakers developing treatments for specific diseases, including ulcerative colitis, rare pediatric cancers, pediatric HIV and serious blood disorders, according to written testimony from FDA Commissioner Scott Gottlieb. The FDA is also considering opening a policy officeā€ˇ inside the Center for Drug Evaluation and Research's Office of New Drugs to harmonize regulatory, clinical and scientific review protocols across the agency and to promote policy transparency and consistency.
Regulatory Focus (4/17) 
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Rigel plans for May launch of new autoimmune drug Tavalisse
Patients with chronic immune thrombocytopenia will have a new option for treatment with the May release of San Francisco based Rigel Pharmaceuticals' autoimmune drug, Tavalisse. The drug prevents destruction of platelets by targeting the underlying cause of the disease and is considered the first in a new class of oral spleen tyrosine kinase inhibitors.
FiercePharma (4/20) 
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Clinical & Research News
Ribavirin plus DAA benefits hepatitis C patients with cryoglobulinemia
Italian investigators found that adding ribavirin to direct-acting antiviral therapies to treat hepatitis C virus infections with mixed cryoglobulinemia increased immunological response and reduced serum cryocrit among patients achieving sustained virologic response at 12 weeks. The research was published in the journal Archives of Virology.
MD Magazine online (4/19) 
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Study compares efficacy of treatment regimens for CLL
Venclexta, or venetoclax, was effective in 67% of patients with relapsed or refractory chronic lymphocytic leukemia who were previously treated with Zydelig, or idelalisib, and whose disease had progressed, according to data published in the journal Blood. The midstage, open-label trial evaluated venetoclax's efficacy after treatment with either idelalisib or Imbruvica, or ibrutinib.
Targeted Oncology (4/18) 
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Trends & Technology
FDA is partly to blame for high drug prices, Gottlieb says
FDA is partly to blame for high drug prices, Gottlieb says
Gottlieb (Zach Gibson/Getty Images)
FDA Commissioner Scott Gottlieb conceded that the agency is partly to blame for high drug prices because it could have done more to promote competition in the generic pharmaceutical market. Speaking at an event sponsored by pharmacy benefit managers, Gottlieb said improving the approval pathway for generic medicines and creating regulations to boost competition for complex brand-name drugs are some of the ways the agency could promote lower drug prices.
The Examiner (Washington, D.C.) (4/19) 
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Drug developer uses AI to identify new compounds
A financing round has pulled in $115 million for BenevolentAI, which uses artificial intelligence to identify new drug candidates and has more than 20 drug candidates in its pipeline for diseases including Parkinson's, glioblastoma and sarcopenia. The firm's technology analyzes scientific research and clinical studies to identify new drug candidates and new uses for existing drugs.
Reuters (4/18) 
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Be practical as well as generous in your ideals. Keep your eyes on the stars, but remember to keep your feet on the ground.
Theodore Roosevelt,
26th US president
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