FDA will restrict bulk drug compounding, Gottlieb says | Pharmacy jobs among the best in 2018 | Rare pediatric disease status granted to Orphazyme's Niemann-Pick disease drug
January 19, 2018
Specialty Pharmacy SmartBrief
News for the specialty pharmacy industry
Leading News
FDA will restrict bulk drug compounding, Gottlieb says
FDA Commissioner Scott Gottlieb said the agency would issue guidance in March about what drugs can be compounded in bulk for physicians' offices and hospitals without individual prescriptions. "Ultimately, there's no question that the framework we will be laying out will place more restrictions on what they can do," Gottlieb said.
Reuters (1/18) 
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Specialty Pharmacy Update
Pharmacy jobs among the best in 2018
An analysis of the best jobs of 2018 by US News & World Report ranked pharmacists 45th among the 100 professions selected by the magazine, scoring 6.5 of 10 overall, 8.7 for salary, 6 for job market, 4 for work-life balance and 4 for stress. Pharmacists were ranked 21st of the 100 most highly compensated jobs for 2018.
Pharmacy Times online (1/18) 
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Legislation & Regulation
Rare pediatric disease status granted to Orphazyme's Niemann-Pick disease drug
The FDA has given Orphazyme's Arimoclomol a rare pediatric disease designation for the treatment of Niemann-Pick disease type C.
Seeking Alpha (free registration) (1/19) 
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Gilotrif gains new indication
Oral Gilotrif, or afatinib, was approved to treat metastatic non-small cell lung cancer with nonresistant epidermal growth factor receptor gene mutations. The drug, produced by Boehringer Ingelheim, was previously approved as a second-line treatment for advanced squamous cell lung cancer.
Specialty Pharmacy Continuum (1/18) 
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Trisonex combo approved for certain leukemias
Teva Pharmaceutical Industries' Trisenox, or arsenic trioxide injection, was approved in combination with tretinoin for treatment-naive patients with low-risk acute promyelocytic leukemia with the t(15;17) translocation or PML/RAR-alpha gene expression.
Specialty Pharmacy Continuum (1/18) 
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FDA orphan status given to Celgene's pediatric ulcerative colitis drug
Celgene's Otezla, or apremilast, which is being developed as a treatment for pediatric patients with ulcerative colitis, was granted orphan status by the FDA. The drug was previously approved for psoriatic arthritis and plaque psoriasis and is in a midstage study for the treatment of adult patients with UC.
Seeking Alpha (free registration) (1/18) 
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Clinical & Research News
Dosing initiated for VBI Vaccines' glioblastoma immunotherapy candidate
The first segment of a two-part early-stage trial to assess VBI Vaccines' immunotherapy candidate VBI-1901 has begun with the dosage of its first participant. The treatment targets cytomegalovirus antigens in patients with recurrent glioblastoma multiforme.
Seeking Alpha (free registration) (1/17) 
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Federal budget proposals underfund biomedical research infrastructure
The 2018 federal budget will set funding levels for critical medical research infrastructure, determining whether promising research is supported at levels that produce breakthroughs and maintain US leadership in innovation, writes Claire Pomeroy, president of the Albert and Mary Lasker Foundation. Current proposals leave the NIH's purchasing power below prior levels and fail to adequately support other institutions on which biomedical innovation depends, including the CDC, National Science Foundation and Agency for Healthcare Research and Quality, Pomeroy writes.
The Hill (1/16) 
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Trends & Technology
Md. coalition seeks affordable specialty, branded drugs
The Maryland Health Care for ALL! Coalition is asking the state General Assembly to support its proposal to increase affordability of specialty and brand-name drugs. Maryland passed a law last year banning price gouging for off-patent and generic drugs.
WBOC-TV (Salisbury, Md.)/The Associated Press/Capital News Service (1/16) 
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