A Year in Review: FDA 2015 New Drug Approvals
The approval of first-of-a-kind drugs rose last year to forty-one, resulting in the highest level of newly approved U.S. drugs in nineteen years. The total number of new drugs approved last year was even higher at sixty-nine. The rising figures reflect an industry-wide desire to research and develop drugs for rare and hard-to-treat diseases. The newly approved drugs serve to advance medical care and the health of patients suffering from many ailments, including various forms of cancer, heart failure, and cystic fibrosis. Additionally, more than 40% of the new therapies were approved for treatment of rare or "orphan" diseases that affect less than 200,000 Americans. Those suffering from orphan diseases often have few or no drug treatment options; these approvals will provide great help to their treatment regimen. This trend of increasing numbers of new drugs is beneficial for both industry and patients. Between 2007 and 2011, only one in nineteen drugs that entered early-stage testing made it to market, compared to one in thirteen drugs today. While more drugs may be making it to market, the development time for drugs is increasing, likely due to the complexity of drug trials and demands for more data from health insurers. However, for 2015 new drug approvals, 60% were designated in one or more categories of Fast Track, Breakthrough, Priority Review, or Accelerated Approval. A therapy with one of those designations is helped along the process at a more rapid pace...
Conclusions: Our report is the first study to examine the distant metastatic breast cancer proteome using FFPE tissues. The depth of our dataset allowed us to discover a novel biomarker candidate and a proteomic characteristics of distant metastatic breast cancer. Distinct molecular features of various breast cancer subtypes were also established. Our proteomic data constitute a valuable resource for research on distant metastatic breast cancer. PMID: 32489334 [PubMed]
Publication date: May 2020Source: Membrane Technology, Volume 2020, Issue 5Author(s):
In 2019, the Congressional Black Caucus convened an emergency Taskforce to examine Black Youth Suicide and Mental Health. The Taskforce released its report in December 2019, highlighting several recommendations for increased research, intervention development, and community engagement. In collaboration with the Office of Behavioral Health Equity at SAMHSA, this 90-minute interactive roundtable webinar featured co-authors of the Taskforce report, including the leader of the Taskforce, answering our most pressing questions about Black youth suicide.
Authors: Słomiak-Wąsik A, Jałowska M, Iwanik K, Żaba R, Adamski Z PMID: 32489368 [PubMed]
Authors: Kaminska-Winciorek G, Zalaudek I, Wozniak Z, Baglaj M PMID: 32489367 [PubMed]
Authors: Chlebicka I, Stefaniak A, Bieniek A, Szepietowski J PMID: 32489366 [PubMed]
Conclusions: The results of the study show that the size of the scar can depend on the incision technique used. Larger scars after laser therapy limit the lymphatic flow of the skin, which may have an adverse effect on mapping sentinel lymph nodes. However, this hypothesis requires further research. PMID: 32489365 [PubMed]
Conclusions: The obtained data indicate that TNF-α, TNFR1, and TNFR2 may be useful markers of the efficacy of anti-TNF therapy, thus complementing clinical parameters. PMID: 32489364 [PubMed]
Conclusions: Keeping a dog at home before and during pregnancy decreased the risk of food allergy in 1-year-old children. This effect was eliminated in case of having a cat, hamster, guinea pig, or rabbit. PMID: 32489363 [PubMed]
Conclusions: Serum periostin production is significantly associated with treatment modality (omalizumab vs. conventional) and presence of CRSwNP. These variables need to be taken into account to interpret periostin levels accurately. PMID: 32489361 [PubMed]
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