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1. Disclosure of payments by pharmaceutical companies to healthcare professionals in the UK: analysis of the Association of the British Pharmaceutical Industry's Disclosure UK database, 2015 and 2016 cohorts. (PubMed)

Disclosure of payments by pharmaceutical companies to healthcare professionals in the UK: analysis of the Association of the British Pharmaceutical Industry's Disclosure UK database, 2015 and 2016 cohorts. To analyse the section of Disclosure UK that pertains to healthcare professionals (HCPs) in order to provide insight into the database's structure and content and suggest ways to improve its transparency.Cohort study of drug companies and HCPs in the 2015 and 2016 versions of Disclosure (...) , firms and countries. If deficiencies remain unresolved, the UK should consider introducing legislation requiring mandatory disclosure to allow for adequate tracking of industry payments.© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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2018 BMJ open

2. Proposed changes to the reimbursement of pharmaceuticals and medical devices in Poland and their impact on market access and the pharmaceutical industry (PubMed)

Proposed changes to the reimbursement of pharmaceuticals and medical devices in Poland and their impact on market access and the pharmaceutical industry In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement (...) in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry

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2017 Journal of Market Access & Health Policy

3. Pharmaceutical Industry Support of US Patient Advocacy Organizations: An International Context. (PubMed)

Pharmaceutical Industry Support of US Patient Advocacy Organizations: An International Context. To examine whether the share of pharmaceutical industry funds allocated to patient advocacy organizations (PAOs) is disproportionately large in the United States relative to other industrialized countries and to compare pharmaceutical companies' disclosure practices across industrialized countries.We examined funding of PAOs among the 10 largest pharmaceutical companies in 2016. We compared funding (...) allocated to organizations across 8 large industrialized countries and pharmaceutical companies' disclosure practices in each country.Only 6 of the 10 largest pharmaceutical companies disclosed their financial transactions with PAOs in the United States. All 10 companies disclosed transactions in France, Germany, and the United Kingdom, with varying levels of disclosure in other countries. In 2016, the 6 companies that disclosed transactions in the United States allocated 74% of their patient advocacy

2019 American Journal of Public Health

4. America's Health Care System is Broken: What Went Wrong and How We Can Fix It. Part 4: The Pharmaceutical Industry. (PubMed)

America's Health Care System is Broken: What Went Wrong and How We Can Fix It. Part 4: The Pharmaceutical Industry. As is true for most aspects of the US health care system, we pay much more for medications than do patients in any other country. Not only are new "breakthrough" products expensive, but existing products see price increases that regularly outstrip general inflation, making the pharmaceutical industry very profitable and resulting in many patients skipping or cutting the doses

2019 American Journal of Medicine

5. Top 10 most read in October: Physician-pharmaceutical industry interactions, systematic reviews and unpublished data, and polypharmacy and falls in older adults

Top 10 most read in October: Physician-pharmaceutical industry interactions, systematic reviews and unpublished data, and polypharmacy and falls in older adults Top 10 most read in October: Physician-pharmaceutical industry interactions, systematic reviews and unpublished data, and polypharmacy and falls in older adults | BMJ Open by Four new entries, and two re-entries, made it into BMJ Open’s top 10 most read articles in October. Climbing back into the top position is a longitudinal cohort (...) study by Xie et al. , which examines the association between Proton Pump Inhibitors and the risk of all-cause mortality. New in at number five is a systematic review by Fickweiler et al. , exploring whether physicians’ interactions with pharmaceutical industry representatives impact on their attitude and prescribing habits. The researchers extracted and synthesised data from studies encompassing an assortment of study designs; they demonstrate that interactions with pharmaceutical industry

2017 BMJ Open Blog

6. Developing the latest framework to measure and incentivise pharmaceutical industry contributions to health research and development (PubMed)

Developing the latest framework to measure and incentivise pharmaceutical industry contributions to health research and development Major pharmaceutical companies contribute important expertise to health research and development (R&D), particularly in their ability to develop and bring pharmaceuticals to market. The Access to Medicine Index evaluates how 20 of the world's largest pharmaceutical companies are directing R&D efforts towards the needs of people living in low- and middle-income (...) countries. In dissemination of its findings, the Index stimulates pharmaceutical companies to expand R&D activities in this direction. The Index methodology is reviewed every 2 years, most recently for the 2018 Index, to ensure their R&D activity is benchmarked against current health R&D priorities as defined by the global health community. The review is based on consensus-building processes involving global health stakeholders. In the latest review, two main changes to the methodology were made

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2018 Health Research Policy and Systems

7. Responding to Unsolicited Medical Requests from Health Care Professionals on Pharmaceutical Industry-Owned Social Media Sites: Three Pilot Studies. (PubMed)

Responding to Unsolicited Medical Requests from Health Care Professionals on Pharmaceutical Industry-Owned Social Media Sites: Three Pilot Studies. The use of social media has risen tremendously over the past decade with usage rates spanning from 5% American adults in 2005 up to 69% in 2016. A 2011 survey of 4033 clinicians found that 65% physicians use social media for professional purposes. To meet the changing needs and preferences of their customers, medical information departments within (...) the pharmaceutical industry must continue to assess new digital channels such as social media and evolve their medical information services.The objective of the study was to pilot the use of social media as an additional channel to respond to unsolicited medical requests from health care professionals (HCP RUR) directed toward the pharmaceutical industry.From November 2016 to June 2017, 3 pilots were conducted during 3 professional congresses: the 2016 American College of Rheumatology Annual Meeting, the 2017

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2018 Journal of medical Internet research

8. Preclinical QSP Modeling in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape (PubMed)

Preclinical QSP Modeling in the Pharmaceutical Industry: An IQ Consortium Survey Examining the Current Landscape A cross-industry survey was conducted to assess the landscape of preclinical quantitative systems pharmacology (QSP) modeling within pharmaceutical companies. This article presents the survey results, which provide insights on the current state of preclinical QSP modeling in addition to future opportunities. Our results call attention to the need for an aligned definition

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2018 CPT: pharmacometrics & systems pharmacology

9. Assessment of primary labeling of medicines manufactured by Nepalese pharmaceutical industries (PubMed)

Assessment of primary labeling of medicines manufactured by Nepalese pharmaceutical industries Appropriate labeling of marketed medicines is necessary to fulfill the regulatory provisions and ensure patient medication safety. This study aimed to assess the primary labeling of medicines manufactured and marketed by Nepalese pharmaceutical industries.We assessed the primary labeling of all medicines available at the pharmacy of Chitwan Medical College Teaching Hospital (CMCTH), Chitwan, Nepal (...) , between November 2017 to December 2017. Medicines were assessed as required by Drug Standard Regulation, 2043 (1986 AD) of Nepal. Appropriate classification of all the medicines and content of over-the-counter (OTC) medicines (where certain information should be in Nepali language) was also assessed. Descriptive statistics was performed.Seven hundred fifty-nine medicines manufactured by 37 Nepalese pharmaceutical industries were assessed. While all pharmaceutical products had the name of the drug

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2018 Journal of pharmaceutical policy and practice

10. The Holo-Transcriptome of the Zoantharian Protopalythoa variabilis (Cnidaria: Anthozoa): A Plentiful Source of Enzymes for Potential Application in Green Chemistry, Industrial and Pharmaceutical Biotechnology (PubMed)

The Holo-Transcriptome of the Zoantharian Protopalythoa variabilis (Cnidaria: Anthozoa): A Plentiful Source of Enzymes for Potential Application in Green Chemistry, Industrial and Pharmaceutical Biotechnology Marine invertebrates, such as sponges, tunicates and cnidarians (zoantharians and scleractinian corals), form functional assemblages, known as holobionts, with numerous microbes. This type of species-specific symbiotic association can be a repository of myriad valuable low molecular weight (...) . These predicted enzyme structures and activities can prospectively be harnessed for applications in diverse areas of industrial and pharmaceutical biotechnology.

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2018 Marine drugs

11. A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)

A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have (...) reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03528577

2018 Clinical Trials

12. EUPATI Guidance for Patient Involvement in Medicines Research and Development (R&D); Guidance for Pharmaceutical Industry-Led Medicines R&D (PubMed)

EUPATI Guidance for Patient Involvement in Medicines Research and Development (R&D); Guidance for Pharmaceutical Industry-Led Medicines R&D The importance and merits of greater patient involvement in medicines research and development (R&D) are commonly acknowledged and are thought to offer benefits for all involved parties. It helps to improve discovery, development, and evaluation of new effective medicines, based on the collaborative identification and understanding of unmet needs, research (...) for selected stakeholders. Four separate guidance documents were developed, incorporating the results from comprehensive internal and external consultation. They cover patient involvement in: pharmaceutical industry-led medicines R&D; ethics committees; regulatory authorities; HTA. Each guidance suggests where patient involvement could be adopted or strengthened. The EUPATI guidance document for patient involvement in industry-led medicines research and development covers the interaction between patients

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2018 Frontiers in medicine

13. Physician-Scientist Careers in the Biotechnology and Pharmaceutical Industries. (PubMed)

Physician-Scientist Careers in the Biotechnology and Pharmaceutical Industries. Many careers are open to physician-scientists in the biotechnology and pharmaceutical sectors. However, research is structured very differently in these environments compared to academic medicine. This article highlights these differences and the reasons for them, then outlines the different career paths available to physician-scientists in the variegated worlds of biotechnology and pharmaceutical companies.

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2018 Journal of Infectious Diseases

14. The Pharmaceutical Industry in 2017. An Analysis of FDA Drug Approvals from the Perspective of Molecules (PubMed)

The Pharmaceutical Industry in 2017. An Analysis of FDA Drug Approvals from the Perspective of Molecules This is an analysis from a chemical point of view of the 46 drugs (34 New Chemical Entities and 12 Biologics) approved by the FDA during 2017. The drugs included in the 2017 "harvest" have been classified on the basis of their chemical structure: biologics (antibodies and proteins); peptides; amino acids and natural products; drug combinations; and small molecules.

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2018 Molecules : A Journal of Synthetic Chemistry and Natural Product Chemistry

15. Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries (PubMed)

Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries (...) concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we collected information from each disclosure policy/code on: target industries, categories of healthcare professionals covered, scope of payments included, location and searchability of the disclosed data. Our analysis shows that although important improvements have been put in place in the past few years, significant gaps remain in disclosure requirements

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2018 International journal of health policy and management

16. Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability. (PubMed)

Data sharing from pharmaceutical industry sponsored clinical studies: audit of data availability. Clinical trial transparency is important to participants, trialists, publishers, and regulators, and there have been recent major policy changes by the pharmaceutical industry regarding clinical study data sharing. However, it is unknown if these changes are enabling independent researchers to access participant-level data from prominent contemporary clinical trials sponsored by the pharmaceutical (...) industry 2 years after publication of the primary results.PubMed and ClinicalTrials.gov were searched to identify clinical trials of medicines sponsored by the pharmaceutical industry and first published between 1 July 2015 and 31 December 2015 in the top 10 general and internal medical journals by impact factor. For each clinical trial, the eligibility of independent researchers to request participant-level data was identified via the sponsor having a data sharing policy/process and a positive

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2018 BMC Medicine

17. Medical Device and Pharmaceutical Industry Employees as Medical Research Publication Authors. (PubMed)

Medical Device and Pharmaceutical Industry Employees as Medical Research Publication Authors. As an editorial policy, medical device and pharmaceutical industry employees are generally permitted to publish original scientific research in Arthroscopy journal but are not permitted to publish systematic reviews. All authors complete the International Committee of Medical Journal Editors Form for Disclosure of Potential Conflicts of Interest, which are thoughtfully considered by our reviewers (...) but not limited to commercial bias in the interpretation of scientific research data. In the end, our goal is to publish the best science, and as above, industry plays "an important role in…(t)his collaborative effort."Copyright © 2018 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

2018 Arthroscopy

18. Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany)

Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany) Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer (...) to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Bioequivalence Study of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: Bayer Healthcare, Germany) The safety and scientific validity of this study is the responsibility

2017 Clinical Trials

19. Melding regulatory, pharmaceutical industry, and U.S. payer perspectives on improving approaches to heterogeneity of treatment effect in research and practice. (PubMed)

Melding regulatory, pharmaceutical industry, and U.S. payer perspectives on improving approaches to heterogeneity of treatment effect in research and practice. Effective pursuit of the science and management of heterogeneity of treatment effect (HTE) relies on the mutual understanding of the perspectives of, and collaboration among, the various stakeholders in health care. In this article, we compare, contrast, and endeavor to find areas of alignment across the perspectives of three (...) such stakeholders -regulators, the biopharmaceutical and device industry, and U.S. payers. First, we discuss how evidence of HTE is generated and could be improved upon. For pharmaceuticals, much of the initial research is conducted by the pharmaceutical industry, guided by basic science but also delimited by potential markets, regulatory approval requirements, trial size considerations, and payer expectations for evidence of value. Once a drug is marketed, further evidence can be generated via combining trial

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2017 Value in Health

20. Critical Analysis of Valuation and Strategical Orientation of Merger and Acquisition Deals in the Pharmaceutical Industry. (PubMed)

Critical Analysis of Valuation and Strategical Orientation of Merger and Acquisition Deals in the Pharmaceutical Industry. The pharmaceutical industry is undergoing major shifts due to changing macro and micro factors. As the industry is highly capital intensive and patents are expiring, the outlook is on generating inorganic growth, mainly through M&A. Using the income valuation approach, one analyses two completed deals in 2016 above 1bn USD. Thereafter one outlines the main motives behind M (...) &A deals and concluded by discussing whether M&A harms medical innovations.The paper is based on empirical study questioning existing literature in order to critically analyse valuation and the strategical orientation of pharmaceutical companies.Pharmaceutical companies understand the changing market conditions and favour their expertise. The restructuring of the industry moves to small niche companies (I.e. Biopharma or biotech companies) researching key innovations and big companies purchasing them

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2017 Expert review of pharmacoeconomics & outcomes research

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