scholarly journals Biotechnology and pharmaceutical R&D and licensing trends: You pays your money and takes your chances

10.5912/jcb55 ◽  
1969 ◽  
Vol 10 (1) ◽  
Author(s):  
Alan Ratliff
Keyword(s):  
Consumer Choice ◽  
Federal Trade Commission ◽  
Pharmaceutical Product ◽  
New Drugs ◽  
Success Rates ◽  
Department Of Justice ◽  
Upward Trend ◽  
Public Agency ◽  
Royalty Rates ◽  
Pharmaceutical Industries

R&D costs in the biotechnology and pharmaceutical industries continue to rocket, as do royalty rates for the relatively few new drugs and technology that successfully complete clinical testing. Several of the issues that led to last year's joint Department of Justice/Federal Trade Commission (DOJ/FTC) hearings are significant within those industries, including (1) recent court decisions reaching inconsistent results or at odds with public agency positions; (2) proliferation of new patent filings; (3) efforts to expand the scope of patents; (4) mergers and acquisitions reducing competition and consumer choice; (5) more restrictive, licenser-oriented licences; (6) patent blocking; and (7) patent settlements with reverse payments. This article discusses the results of studies evaluating the rising costs and declining success rates of new biotechnology and pharmaceutical product offerings, the upward trend in royalty rates and litigation awards, and the implications of the DOJ/FTC hearings.

Medical Tourism in India- A Paradigm Shift

2015 ◽  
Vol 8 (2) ◽  
Author(s):  
Ajay Kumar Dogra ◽  
Pooja Dogra
Keyword(s):  
Paradigm Shift ◽  
Medical Tourism ◽  
Tourism Industry ◽  
Success Rates ◽  
Indian Government ◽  
Service Levels ◽  
Healthcare Facilities ◽  
Treatment Facilities ◽  
World Class ◽  
Pharmaceutical Industries

The health tourism Industry is witnessing a sudden paradigm shift in last five years. India has become a home of traditional medicine that has been practiced for several thousand years as a part of manav dharma to give relief to the needy and mostly free of cost. With modern diagnostic and treatment facilities, experienced surgeons, one of the largest pharmaceutical industries in world, and a tradition of caring, India provides world class surgical and healthcare facilities, with comparable success rates and prompt service levels. The potential of medical tourism is such that it can even surpass the revenue earned from IT sector. Recognizing the pivotal contribution of medical tourism to the economic development, the Indian Government has initiated numerous measures to promote this vary young industry to attract international tourism. This has motivated to identify recent trends and opportunities in India for the medical and healthcare tourism, and to explore the critical factors which can lead to success of initiatives taken by ministry of tourism for the development of medical tourism in India. Finally paper suggests measures to enhance medical tourism in the country.

scholarly journals Night Landings on an Aircraft Carrier: Hospital Mergers and Antitrust Law

1997 ◽  
Vol 23 (2-3) ◽  
pp. 191-220
Author(s):  
Thomas L. Greaney
Keyword(s):  
Federal Trade Commission ◽  
Federal Courts ◽  
Antitrust Law ◽  
Department Of Justice ◽  
Aircraft Carrier ◽  
Hospital Mergers ◽  
The Past ◽  
Consent Decrees ◽  
The Government ◽  
Administrative Proceedings

Justice Stewart’s 1966 dictum about the inevitability of government success in challenging mergers under Section 7 of the Clayton Act held true for another fifteen years or so. In the early 1980s, however, federal enforcement agencies, the Department of Justice (DOJ) and the Federal Trade Commission (FTC), began to find the federal courts less hospitable to antitrust merger cases as more sophisticated economic inquiries and changing proof burdens complicated the task of identifying anticompetitive mergers. Indeed, since the early 1980s, the government has lost more litigated merger cases than it has won and has come under criticism from some quarters for becoming gun shy and not adequately policing the wave of consolidations that have occurred over the past decade.Hospital mergers, however, are a different story. Until two years ago, the government rode a streak of important victories in federal courts and FTC administrative proceedings, and had obtained consent decrees from scores of hospitals that had announced plans to merge.

scholarly journals Access to information supporting availability of medicines for patients suffering from rare diseases looking for possible treatments: the EuOrphan Service

Medicina ◽  
2007 ◽  
Vol 43 (6) ◽  
pp. 441 ◽  
Author(s):  
Donatas Stakišaitis ◽  
Indrė Špokienė ◽  
Jonas Juškevičius ◽  
Konstantinas Valuckas ◽  
Paola Baiardi
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Rare Diseases ◽  
Health Care Professionals ◽  
Large Population ◽  
New Drugs ◽  
Public Health Care ◽  
Quality Information ◽  
Care Providers ◽  
Pharmaceutical Industries

Currently in Europe, approximately 30 million people suffer from rare diseases, and a major problem is that many patients do not have access to quality healthcare for their disorders. Moreover, there is also a lack of quality information and a networking system aimed at supporting interaction among patients, clinicians, researchers, pharmaceutical industries, and governmental bodies. The purpose of this article is to inform physicians, public health care professionals, and other health care providers about EuOrphan service, the aim of which is to ensure easier access to quality information on rare diseases and their treatment. A set of web-based services is available at www.euorphan.com where information for target-users on treatments and products available worldwide for rare disease care as well as indications about healthcare centers are provided. Moreover, the service aims at providing consultancies for pharmaceutical companies to ultimately support the European legislation in bringing new drugs of a high ethical standard to the market and to exert a positive impact on the large population of patients suffering from rare diseases in Europe. The services provided by EuOrphan can facilitate concrete networking among patients, patient associations, doctors, and companies and also support the organization of clinical trials. In this perspective, EuOrphan could become a very valuable tool for globalizing the information about the availability of treatment (authorized or under development) of orphan patients.

Survey of Machine Learning Techniques in Drug Discovery

2019 ◽  
Vol 20 (3) ◽  
pp. 185-193 ◽  
Author(s):  
Natalie Stephenson ◽  
Emily Shane ◽  
Jessica Chase ◽  
Jason Rowland ◽  
David Ries ◽  
...  
Keyword(s):  
Machine Learning ◽  
Drug Discovery ◽  
Large Scale ◽  
State Of The Art ◽  
New Drugs ◽  
Machine Learning Techniques ◽  
Current Status ◽  
Learning Techniques ◽  
Pharmaceutical Industries ◽  
Current Stage

Background:Drug discovery, which is the process of discovering new candidate medications, is very important for pharmaceutical industries. At its current stage, discovering new drugs is still a very expensive and time-consuming process, requiring Phases I, II and III for clinical trials. Recently, machine learning techniques in Artificial Intelligence (AI), especially the deep learning techniques which allow a computational model to generate multiple layers, have been widely applied and achieved state-of-the-art performance in different fields, such as speech recognition, image classification, bioinformatics, etc. One very important application of these AI techniques is in the field of drug discovery.Methods:We did a large-scale literature search on existing scientific websites (e.g, ScienceDirect, Arxiv) and startup companies to understand current status of machine learning techniques in drug discovery.Results:Our experiments demonstrated that there are different patterns in machine learning fields and drug discovery fields. For example, keywords like prediction, brain, discovery, and treatment are usually in drug discovery fields. Also, the total number of papers published in drug discovery fields with machine learning techniques is increasing every year.Conclusion:The main focus of this survey is to understand the current status of machine learning techniques in the drug discovery field within both academic and industrial settings, and discuss its potential future applications. Several interesting patterns for machine learning techniques in drug discovery fields are discussed in this survey.

scholarly journals Judicial Response to the 2010 Horizontal Merger Guidelines

2021 ◽  
Vol 58 (1) ◽  
pp. 51-79
Author(s):  
Carl Shapiro ◽  
Howard Shelanski
Keyword(s):  
Federal Trade Commission ◽  
Case Law ◽  
Market Concentration ◽  
Horizontal Merger ◽  
Average Increase ◽  
Department Of Justice ◽  
Merger Guidelines ◽  
Direct Competition ◽  
The Government ◽  
The U.S

AbstractWe study how the courts have responded to the 2010 Horizontal Merger Guidelines issued by the U.S. Department of Justice and the Federal Trade Commission. Looking at decided cases, we find that both the government and merging parties rely on the 2010 Guidelines in presenting their cases, each side respectively arguing that it should win if the court properly follows them . The 2010 Guidelines had the strongest effect on the case law in the area of unilateral effects, where a number of courts have embraced them in ways that clearly depart from earlier decisions. The case law now exhibits much greater receptivity to a government showing that the merger will lead to higher prices simply due to the loss of direct competition between the two merging firms. The courts also have followed the 2010 Guidelines by more willingly defining markets around targeted customers. We do not detect any effect on decided cases of the higher concentration thresholds found in the 2010 Guidelines. Both the average pre-merger level of market concentration and the average increase in market concentration alleged by the government in litigated cases to date declined after 2010 .

scholarly journals From Off-Label to Repurposed Drug in Non-Oncological Rare Diseases: Definition and State of the Art in Selected EU Countries

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000016 ◽  
Author(s):  
Paola Minghetti ◽  
Elena P. Lanati ◽  
Josie Godfrey ◽  
Oriol Solà-Morales ◽  
Olivier Wong ◽  
...  
Keyword(s):  
Rare Diseases ◽  
Drug Repurposing ◽  
Orphan Drugs ◽  
New Drugs ◽  
Success Rates ◽  
Great Opportunity ◽  
Off Label ◽  
Research Activities ◽  
Oncological Diseases ◽  
Repurposed Drugs

Introduction Almost 8,000 rare diseases exist worldwide, affecting approximately 350 million people. Nevertheless, only 5% receive a specific authorized or licensed treatment. The need for effective and rapidly available therapies is still unmet for many patients. Objective The objective is to define repurposing versus off-label drugs, and to evaluate pathways of repurposed drugs for rare non-oncological diseases in Italy, France, England, and Spain (the EU4 countries). Methods This original paper is based on 3 research activities: (i) a nonsystematic literature research; (ii) a questionnaire-based survey to regulatory experts; and (iii) research on approval timelines and therapy prices of repurposed non-oncology orphan drugs. Official approval dates in England are not available if the National Institute for Health and Care Excellence does not appraise the products. Results Only France provides a specific adaptive pathway from off-label to repurposed drugs. Pricing and reimbursement assessment for the drug samples varied across the EU4 countries: time-to-market for repurposed drugs versus new drugs is longer in all analyzed countries; that is, 979 days versus 462 days in Italy, 502 days versus 350 days in France, and 624 versus 378 days in Spain. Repurposed drugs have higher success rates from development to approval than novel drugs (30% vs. 11%). Small- and medium-sized enterprises owned 9 of 12 repurposed non-oncology orphan drugs, of which only 4 were reimbursed in all EU4 countries. Prices were more homogeneous across EU4 although the reimbursement rates were different. Conclusions Drug repurposing represents a great opportunity to treat rare non-oncological diseases. However, a more homogenous assessment across EU4 could ensure reimbursement and prices high enough to reward organizations investing in this field.

The Federal Trade Commission: The Development of the Law which led to its Establishment

1915 ◽  
Vol 9 (1) ◽  
pp. 57-67
Author(s):  
James A. Fayne
Keyword(s):  
Federal Trade Commission ◽  
Executive Branch ◽  
Department Of Justice ◽  
Private Business ◽  
Administrative Work ◽  
Regulate Competition ◽  
Corporation Law ◽  
The Supreme Court ◽  
The Government ◽  
Circuit Courts

It was Munn vs. Illinois that first interpreted the constitutional provision empowering Congress to regulate commerce in such a way as to charge private business with a public interest. Since that epochal finding our courts have made comparatively swift progress, reaching ultimately (through the Standard Oil and tobacco decisions) a federal trade commission to regulate competition in trade and to restrain illegal combinations. All of this has been done during the professional life of many lawyers of today, for Munn vs. Illinois was decided in 1876.Writers upon the trend of legislation and of court decisions had clearly predicted this last development of corporation law. The incident of climax importance however, was the remanding of the oil and tobacco cases to the circuit courts where the decrees of dissolution were to be worked out in conjunction with the department of justice. This was administrative work, and a department of the executive branch of the government should do it. Hence the creation of the trade commission, empowered to investigate the carrying out of the decrees of the supreme court and to prepare the form of decree in certain cases referred to it by the circuit courts.

scholarly journals Partial Purification and Characterization of Albain 1, a Triterpene with Antimicrobial Activity, from the Wood Extract of Avicennia alba Blume

2020 ◽  
pp. 38-48
Author(s):  
Moumita Choudhury ◽  
Kalishankar Mukherjee ◽  
Arnab De ◽  
Amalesh Samanta ◽  
Amit Roy
Keyword(s):  
Antimicrobial Activity ◽  
Secondary Metabolites ◽  
1H Nmr ◽  
Biological Activities ◽  
New Drugs ◽  
Partial Purification ◽  
Molecular Formula ◽  
Pharmaceutical Industries ◽  
Wood Extract ◽  
Avicennia Alba

Secondary metabolites of plants are important resources for development of new drugs. Mangrove plants are very well known sources of wide variety of secondary metabolites. Many of these secondary metabolites from mangroves have been found to possess significant biological activities where human health is concerned. Avicennia alba Blume is one such mangrove plant with reports of having many such secondary metabolites of clinical and commercial interests. Aim: To evaluate antimicrobial activity potential of A. alba wood extract and to isolate new bioactive constituent(s) responsible for such biological activity. Methodology: Preliminary screenings of antimicrobial activities in different organic solvent extracts of A. alba wood tissue were done by TLC-bioautography method and phytochemical nature of the antimicrobial constituent(s) in the extracts have been studied. One compound exhibiting significant antimicrobial activity, named as Albain 1, has been isolated. MIC value has been determined for Albain 1. The purity and structure of Albain 1 have been determined by HPLC, 1H NMR, FTIR and HRMS etc. analysis. Results: 1H NMR, FTIR and HRMS analysis have found out that the isolated compound Albain 1 is a triterpene and the molecular formula is C30H48O4. It has exhibited remarkable antimicrobial activity against Bacillus cereus, Bacillus polymyxa, Bacillus pumilas (MIC 125 μg / ml). Conclusion: The observed antimicrobial activity of the isolated fraction of A. alba offer great potentials in pharmaceutical industries.

scholarly journals Efficacy of Spironolactone Treatment in Murine Models of Cutaneous and Visceral Leishmaniasis

2021 ◽  
Vol 12 ◽  
Author(s):  
Valter Viana Andrade-Neto ◽  
Juliana da Silva Pacheco ◽  
Job Domingos Inácio ◽  
Elmo Eduardo Almeida-Amaral ◽  
Eduardo Caio Torres-Santos ◽  
...  
Keyword(s):  
Visceral Leishmaniasis ◽  
Cutaneous Lesion ◽  
Parasite Burden ◽  
Parasite Load ◽  
New Drugs ◽  
Drug Candidate ◽  
Success Rates ◽  
Meglumine Antimoniate ◽  
Future Possibility

Translational studies involving the reuse and association of drugs are approaches that can result in higher success rates in the discovery and development of drugs for serious public health problems, including leishmaniasis. If we consider the number of pathogenic species in relation to therapeutic options, this arsenal is still small, and each drug possesses a disadvantage in terms of toxicity, efficacy, price, or treatment regimen. In the search for new drugs, we performed a drug screening of L. amazonensis promastigotes and intracellular amastigotes of fifty available drugs belonging to several classes according to their pharmacophoric group. Spironolactone, a potassium-sparing diuretic, proved to be the most promising drug candidate. After demonstrating the in vitro antileishmanial activity, we evaluated the efficacy on a murine experimental model with L. amazonensis and L. infantum. The treatment controlled the cutaneous lesion and reduced the parasite burden of L. amazonensis significantly, as effectively as meglumine antimoniate. The treatment of experimental visceral leishmaniasis was effective in reducing the parasite load on the main affected organs (spleen and liver) via high doses of spironolactone. The association between spironolactone and meglumine antimoniate promoted better control of the parasite load in the spleen and liver compared to the group treated with meglumine antimoniate alone. These results reveal a possible benefit of the concomitant use of spironolactone and meglumine antimoniate that should be studied more in depth for the future possibility of repositioning for leishmaniasis co-therapy.

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