Novel Drugs and Biologics of 2016: A Boom for Neurodrugs in the Pipelin

2017 ◽  
Vol 10 (5) ◽  
pp. 3809-3814
Author(s):  
D Samba Reddy
Keyword(s):  
Muscular Atrophy ◽  
Clinical Care ◽  
New Drugs ◽  
Essential Medicines ◽  
High Demand ◽  
The Past ◽  
Novel Drugs ◽  
Innovative Products ◽  
Cns Drugs ◽  
The U.S

This article provides a brief overview of novel drugs approved by the U.S. FDA in 2016.  It also focuses on the emerging boom in the development of neurodrugs for central nervous system (CNS) disorders. These new drugs are innovative products that often help advance clinical care worldwide, and in 2016, twenty-two such drugs were approved by the FDA. The list includes the first new drug for disorders such as spinal muscular atrophy, Duchenne muscular dystrophy or hallucinations and delusions of Parkinson’s disease, among several others. Notably, nine of twenty-two (40%) were novel CNS drugs, indicating the industry shifting to neurodrugs. Neurodrugs are the top selling pharmaceuticals worldwide, especially in America and Europe. Therapeutic neurodrugs have proven their significance many times in the past few decades, and the CNS drug portfolio represents some of the most valuable agents in the current pipeline. Many neuroproducts are vital or essential medicines in the current therapeutic armamentarium, including dozens of “blockbuster drugs” (drugs with $1 billion sales potential).  These drugs include antidepressants, antimigraine medications, and anti-epilepsy medications. The rise in neurodrugs’ sales is predominantly due to increased diagnoses of CNS conditions. The boom for neuromedicines is evident from the recent rise in investment, production, and introduction of new CNS drugs.  There are many promising neurodrugs still in the pipeline, which are developed based on the validated “mechanism-based” strategy. Overall, disease-modifying neurodrugs that can prevent or cure serious diseases, such as multiple sclerosis, epilepsy, and Alzheimer’s disease, are in high demand. 

scholarly journals Recent advances in the development of protein–protein interactions modulators: mechanisms and clinical trials

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Haiying Lu ◽  
Qiaodan Zhou ◽  
Jun He ◽  
Zhongliang Jiang ◽  
Cheng Peng ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Discovery ◽  
Small Molecules ◽  
Protein Interactions ◽  
Clinical Studies ◽  
New Drugs ◽  
Protein Protein Interactions ◽  
The Past ◽  
Recent Advances ◽  
Novel Drugs

Abstract Protein–protein interactions (PPIs) have pivotal roles in life processes. The studies showed that aberrant PPIs are associated with various diseases, including cancer, infectious diseases, and neurodegenerative diseases. Therefore, targeting PPIs is a direction in treating diseases and an essential strategy for the development of new drugs. In the past few decades, the modulation of PPIs has been recognized as one of the most challenging drug discovery tasks. In recent years, some PPIs modulators have entered clinical studies, some of which been approved for marketing, indicating that the modulators targeting PPIs have broad prospects. Here, we summarize the recent advances in PPIs modulators, including small molecules, peptides, and antibodies, hoping to provide some guidance to the design of novel drugs targeting PPIs in the future.

The Novel Drugs of 2014 –Record Approvals for Niche Markets

2015 ◽  
Vol 8 (3) ◽  
pp. 2889-2893
Author(s):  
D Samba Reddy
Keyword(s):  
Prescription Drugs ◽  
New Drugs ◽  
The Novel ◽  
Niche Markets ◽  
Novel Drugs ◽  
Accelerated Approval ◽  
Pricing Power ◽  
Drug Approvals ◽  
Unique Mechanism ◽  
The U.S

In 2014, 41 new drugs were approved by the FDA, the highest approval in two decades. This number was 52% higher than the 27 approvals in 2013, indicating another year of excellent innovation and productivity. Seventeen drugs (41%) were First-in-Class with a new or unique mechanism of action for treating a disease. Moreover, 17 of 41 (41%) of these novel drugs were for the treatment of rare diseases, a testament to continued focus or shift to niche diseases. The U.S. FDA is the leading authority for drug approvals worldwide. Many schemes and tracks at the FDA have led to accelerated approval of novel drugs. Such reviews as fasttrack or breakthrough designation are established for meeting demand more quickly. Despite such historic drug approvals, there is continued productivity crisis in R & D due to steady cost escalation for drug discovery and development. The U.S. pharmaceutical market is forecasted to increase from an estimated value of $395 billion in 2014 to reach $548 billion by 2020. The prices appear to be increasing faster for branded prescription drugs. Overall, the current drug approvals and trends clearly reveal the pharma industry shift to niche diseases for pricing power and return on investment.   

Herbal Medicine: Clinical Perspective & Regulatory Status

2020 ◽  
Vol 23 ◽  
Author(s):  
Md Abul Barkat ◽  
Anjali Goyal ◽  
Harshita Abul Barkat ◽  
Mohammad Salauddin ◽  
Faheem Hyder Pottoo ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Herbal Medicines ◽  
New Drugs ◽  
Herbal Drugs ◽  
Clinical Perspective ◽  
Regulatory Status ◽  
Novel Drugs ◽  
History Of ◽  
Pros And Cons ◽  
Health Complications

Abstract:: Herbal medicines pays an important in treating the vaious diseases mainly due to the their potentially high therapeutic values and also due to the better acceptance of vaioruspatient under different health complications. The herbal medicine practice involves use of part of plant, entire plant or the selectctive isolated phytomedicineand the use and practices based on these has its pros and cons and has been greatly affected during the dawn. The search of new drugs during scientific era revives the interest in discovery of herbal drugs from different natural resources during 20th century. The present modern healthcare system invovlves utilization drugs and 50% of them are of ofnaural origin. Herbal drug disocovery found to be highly costly affair with low success rate and it hinders the further progress in utilizting the phytomedicine in treating the various deseases. But in recent years there is an increase in the search interest of herbal drugs mainly by the pharmaceutical industry and those invoves in the search of novel drugs from the herbs. Discovery of such new novel phytomedicines has to overcomes various challenges in indentification of active extracts and their toxicity, advereffects, herb drug interaction and importantly their regulatory requirments. The present review mainly focused on the history of herbal medicine, current clinical perspective, pharmaceutical, and regulatory challenges as well as its clinical presentation. Moreover, problems encountered in drug discovery from herbal resources and its possible solutions are delineated.

The Future of FBI Counterintelligence through the Lens of the Past Hundred Years

2010 ◽  
pp. 504-517
Author(s):  
Raymond J. Batvinis
Keyword(s):  
United States ◽  
The United States ◽  
Main Concern ◽  
Federal Bureau ◽  
The Past ◽  
Intelligence Services ◽  
Terrorist Groups ◽  
Foreign Intelligence ◽  
Key Events ◽  
The U.S

Counterintelligence is the business of identifying and dealing with foreign intelligence threats to a nation, such as the United States. Its main concern is the intelligence services of foreign states and similar organizations of non-state actors, such as transnational terrorist groups. Counterintelligence functions both as a defensive measure that protects the nation's secrets and assets against foreign intelligence penetration and as an offensive measure to find out what foreign intelligence organizations are planning to defeat better their aim. This article addresses the Federal Bureau of Investigation's (FBI) foreign counterintelligence function. It briefly traces its evolution by examining the key events and the issues that effected its growth as the principle civilian counterintelligence service of the U.S. government.

scholarly journals Evaluation of a Cryptococcal Antigen Lateral Flow Assay and Cryptococcal Antigen Positivity at a Large Public Hospital in Atlanta, Georgia

2021 ◽  
Author(s):  
Kristin R V Harrington ◽  
Yun F (Wayne) Wang ◽  
Paulina A Rebolledo ◽  
Zhiyong Liu ◽  
Qianting Yang ◽  
...  
Keyword(s):  
Public Hospital ◽  
Clinical Care ◽  
Latex Agglutination ◽  
Lateral Flow ◽  
Lateral Flow Assay ◽  
Clinical Implications ◽  
Cryptococcal Antigen ◽  
Cryptococcal Disease ◽  
Percent Positivity ◽  
The U.S

Abstract Background Cryptococcus neoformans is a major cause of morbidity and mortality among HIV-infected persons worldwide, and there is scarce recent data on cryptococcal antigen (CrAg) positivity in the U.S. We sought to determine the frequency of cryptococcal disease and compare the performance of a CrAg lateral flow assay (LFA) versus latex agglutination (LA) test. Methods All patients from Grady Health System in Atlanta who had a serum or cerebrospinal fluid (CSF) sample sent for CrAg testing as part of clinical care from November 2017 – July 2018 were included. Percent positivity and test agreement were calculated. Results Among 467 patients, 557 diagnostic tests were performed; 413 on serum and 144 on CSF. Mean age was 44 years, most were male (69%) and had HIV (79%). Twenty-four (6.4%, CI95% = 4.1, 9.4) patients were serum CrAg positive, and eight (5.8%, CI95% = 2.6, 11.2) individuals tested positive for CSF CrAg. While overall agreement between the LA and LFA was substantial to high for CSF (κ= 0.71, CI95% = 0.51, 0.91) and serum (κ= 0.93, CI95% = 0.86, 1.00), respectively, there were important discrepancies. Five patients had false-positive CSF LA tests which affected clinical care, and four patients had discordant serum tests. Conclusions We found a moderately high proportion of cryptococcal disease and important discrepancies between the LA test and LFA. Clinical implications of these findings include accurate detection of serum CrAg and averting unnecessary treatment of meningitis with costly medications associated with high rates of adverse events.

It’s Time to Talk to Prehospital Providers: Feedback Disparities among Ground-Based Emergency Medical Services Providers and its Impact on Job Satisfaction

2021 ◽  
pp. 1-9
Author(s):  
Sarayna S. McGuire ◽  
Anuradha Luke ◽  
Aaron B. Klassen ◽  
Lucas A. Myers ◽  
Aidan F. Mullan ◽  
...  
Keyword(s):  
Job Satisfaction ◽  
Patient Care ◽  
Emergency Medical Services ◽  
Performance Feedback ◽  
Life Support ◽  
Clinical Care ◽  
Medical Services ◽  
The Past ◽  
Emergency Medical ◽  
Overall Job Satisfaction

Abstract Objective: Performance feedback on clinical care and patient outcomes is a cornerstone of medical education, yet it remains lacking in the prehospital environment. Research seeking to establish the quantity of feedback provided to Emergency Medical Services (EMS) has been limited and studies focused on complimentary feedback or how feedback relates to EMS job satisfaction are lacking. The objectives of this study were to measure the frequency and nature of feedback received by EMS agencies and to identify the importance of receiving feedback as it relates to EMS job satisfaction. Methods: This was an anonymous, survey-based study of twenty-nine Basic Life Support (BLS) and fifteen Advanced Life Support (ALS) agencies located in Southeastern Minnesota (USA). Descriptive statistics and Fisher exact tests were used. The study was deemed exempt by the Mayo Clinic Institutional Review Board. Results: Ninety-four responses were included from nineteen different EMS agencies, including sixty-one (64.9%) paramedics and thirty-three (35.1%) emergency medical technicians (EMTs). One-half of all respondents reported that they had not received any type of feedback in the past 30 days, while another 43.6% of respondents indicated that they had only received feedback one to three times in the same time period. Twenty (60.6%) EMTs reported receiving no feedback in the past 30 days, compared with twenty-seven (44.3%) paramedics (P = .123). Of respondents receiving feedback, 65.9% reported never or rarely receiving positive reinforcing feedback and 60.6% reported never or rarely receiving constructive criticism or feedback regarding something that did not go well with patient care or transport. The majority of respondents were dissatisfied with the quantity (86.1%) and quality (73.4%) of feedback received. An overwhelming majority (93.6%) indicated that feedback on patient care or outcomes was important in influencing their overall job satisfaction. This high importance was maintained across all demographic groups. Conclusion: Within the cohort of survey respondents, a paucity of feedback received by EMS personnel is a source of dissatisfaction for EMS providers. Feedback on patient care strongly relates to overall job satisfaction. These findings suggest system-wide opportunities for structured feedback processes, focusing upon both quality and quantity of delivered feedback, to improve both patient care and staff satisfaction.

scholarly journals Evolution of Cancer Vaccines—Challenges, Achievements and Future Directions

Vaccines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 535
Author(s):  
Ban Qi Tay ◽  
Quentin Wright ◽  
Rahul Ladwa ◽  
Christopher Perry ◽  
Graham Leggatt ◽  
...  
Keyword(s):  
Cancer Vaccines ◽  
New Drugs ◽  
Delivery Methods ◽  
Future Directions ◽  
The Past ◽  
New Directions ◽  
Tumour Antigens ◽  
Target Characteristics ◽  
Toxic Responses ◽  
Shed Light

The development of cancer vaccines has been intensively pursued over the past 50 years with modest success. However, recent advancements in the fields of genetics, molecular biology, biochemistry, and immunology have renewed interest in these immunotherapies and allowed the development of promising cancer vaccine candidates. Numerous clinical trials testing the response evoked by tumour antigens, differing in origin and nature, have shed light on the desirable target characteristics capable of inducing strong tumour-specific non-toxic responses with increased potential to bring clinical benefit to patients. Novel delivery methods, ranging from a patient’s autologous dendritic cells to liposome nanoparticles, have exponentially increased the abundance and exposure of the antigenic payloads. Furthermore, growing knowledge of the mechanisms by which tumours evade the immune response has led to new approaches to reverse these roadblocks and to re-invigorate previously suppressed anti-tumour surveillance. The use of new drugs in combination with antigen-based therapies is highly targeted and may represent the future of cancer vaccines. In this review, we address the main antigens and delivery methods used to develop cancer vaccines, their clinical outcomes, and the new directions that the vaccine immunotherapy field is taking.

scholarly journals Immunizing the Flock: How the Pandemic Court Rewrote Religious Freedom

Laws ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 12
Author(s):  
Paul Baumgardner
Keyword(s):  
United States ◽  
Supreme Court ◽  
Legal System ◽  
Religious Freedom ◽  
The United States ◽  
Religious Practices ◽  
The Past ◽  
The U.S

When coronavirus began to descend upon the United States, religious freedom advocates across the country sounded the alarm that citizens’ religious practices and institutions were under threat. Although some of the most extreme arguments championed by these advocates were not validated by our legal system, many were. This article explores the underappreciated gains made by religious freedom advocates before the U.S. Supreme Court over the past year. As a result of the “Pandemic Court”, religious freedom in the United States has been rewritten. This promises to radically change the educational, employment, and health prospects of millions of Americans for the rest of the pandemic and long afterwards.

The past is prologue

2018 ◽  
Vol 17 (3) ◽  
pp. 366-385 ◽  
Author(s):  
David Cassels Johnson ◽  
Crissa Stephens ◽  
Stephanie Gugliemo Lynch
Keyword(s):  
Language Policy ◽  
Language Ideologies ◽  
Public Policies ◽  
Social Structures ◽  
New Latino Diaspora ◽  
Policy Initiatives ◽  
The Past ◽  
Historical Processes ◽  
The U.S

Abstract This article examines reactions to the changing linguistic ecology in the U.S. state of Iowa, which is experiencing a demographic phenomenon often referred to as the New Latino Diaspora (NLD) (Hamann et al., 2002). We first examine the historical processes and social structures that link current language policy initiatives within Iowa to local and national nativism. We then analyze public policies and texts to reveal how language ideologies circulate across diverse texts and contexts, forming discourses that shape the experiences of Latin@s in Iowa.

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