pharmaceutical

Danish Pharmaceutical Novo Nordisk to Pay $25 Million to Resolve Allegations of Off-Label Promotion of Novoseven

Novo Nordisk Inc., a Danish pharmaceutical manufacturer, has agreed to pay $25 million to resolve its civil liability arising from the illegal promotion of its hemostasis management drug, NovoSeven.



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pharmaceutical

FDA Chemist Pleads Guilty to Using Insider Information to Trade on Pharmaceutical Stocks Resulting in Almost $4 Million in Profits

A Food and Drug Administration (FDA) chemist pleaded guilty today before U.S. District Court Judge Deborah K. Chasanow in the District of Maryland to one count of securities fraud and one count of making false statements, related to a $3.7 million insider trading scheme that spanned nearly five years.



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pharmaceutical

Assistant Attorney General Tony West Speaks at the 12th Annual Pharmaceutical Regulatory and Compliance Congress

"The work of the Justice Department on health care fraud is part of a comprehensive approach this Administration has taken toward improving the Nation’s overall health care delivery system; an approach that aims to secure better, quality coverage at lower costs for all of us," said Assistant Attorney General West.




pharmaceutical

U.S. Pharmaceutical Company Merck Sharp &

American pharmaceutical company Merck, Sharp &.



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pharmaceutical

St. Louis-Based KV Pharmaceutical to Pay $17 Million to Settle False Claims Allegations

KV Pharmaceutical Company, which was the St. Louis-based parent company of now-defunct Ethex Corporation, will pay $17 million to resolve False Claims Act allegations that Ethex failed to advise the Centers for Medicare and Medicaid Services (CMS) that two unapproved products did not qualify for coverage under federal health care programs, the Justice Department announced today.



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pharmaceutical

U.S. Files Consent Decree for Permanent Injunction Against Pharmaceutical Ranbaxy Laboratories

The United States has filed a consent decree for permanent injunction against the generic drug manufacturer Ranbaxy Laboratories Ltd., an Indian corporation, in the U.S. District Court for the District of Maryland, the Department of Justice announced today.



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pharmaceutical

Dava Pharmaceuticals to Pay U.S. $11 Million to Settle False Claims Act Allegations

Dava Pharmaceuticals Inc. has agreed to pay the United States $11 million to settle allegations that it violated the False Claims Act by misreporting drug prices in order to reduce its Medicaid Drug Rebate obligations, the Justice Department announced today.



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pharmaceutical

Mississippi Pharmaceutical Firm and CEO to Pay $2.8 Million to Resolve Allegations of Illegal Marketing of Unapproved Drugs

Mississippi-based Cypress Pharmaceutical Inc., its subsidiary Hawthorn Pharmaceuticals Inc. and its CEO, Max Draughn, have agreed to pay $2.8 million to resolve civil allegations under the False Claims Act, the Justice Department announced today.



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pharmaceutical

U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx

American pharmaceutical company Merck, Sharp & Dohme was sentenced by U.S. District Court Judge Patti B. Saris in Boston to pay a criminal fine in the amount of $321,636,000 in connection with its guilty plea related to its promotion and marketing of the painkiller Vioxx (rofecoxib), the Justice Department announced today.



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pharmaceutical

South Carolina Pharmaceutical Distribution Company Pleads Guilty in Multi-Million Dollar Scheme to Purchase and Sell Drugs in the Grey Market

The Department of Justice announced the guilty plea and sentencing of Easley, S.C.-based Aletec Medical for engaging in a multi-million dollar prescription drug scheme. Altec Medical pleaded guilty in U.S. District Court in Miami to one count of conspiring to defraud the U.S. Food and Drug Administration (FDA) and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.



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pharmaceutical

Canadian Citizen Pleads Guilty in Scheme to Defraud Consumers Purchasing Pharmaceuticals Online

Andrew Strempler, a Canadian citizen, pleaded guilty today in the Southern District of Florida for his role in a scheme to defraud consumers purchasing pharmaceuticals online, the Justice Department announced. Strempler faces up to five years in prison, a forfeiture of $300,000, a fine and restitution.



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pharmaceutical

Two Pakistani Nationals Indicted for Conspiring to Illegally Ship Pharmaceuticals into the US

Two Pakistani nationals have been indicted by a federal grand jury in the District of Columbia on charges alleging that they operated Internet sites that illegally shipped pharmaceuticals from Pakistan and the United Kingdom to customers in the United States.



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pharmaceutical

Canadian Citizen Sentenced in Scheme to Defraud Consumers Purchasing Pharmaceuticals Online

A Canadian citizen was sentenced to 48 months in prison today for his role in a scheme to defraud consumers purchasing pharmaceuticals online, the Justice Department announced. Andrew J. Strempler was also ordered to pay a forfeiture of $300,000, a fine of $25,000 and restitution.



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pharmaceutical

Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing

New Jersey-based Par Pharmaceutical Companies Inc. pleaded guilty in federal court today and agreed to pay $45 million to resolve its criminal and civil liability in the company’s promotion of its prescription drug Megace ES for uses not approved as safe and effective by the Food and Drug Administration and not covered by federal health care programs.



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pharmaceutical

Teva Pharmaceuticals USA to Pay $2.25 Million Civil Penalty for Air, Water and Hazardous Waste Violations at Missouri Facility

Teva Pharmaceuticals USA Inc. has agreed to pay a $2.25 million civil penalty to settle alleged violations of the federal Clean Air Act (CAA), Clean Water Act (CWA), and the Resource Conservation and Recovery Act (RCRA), as well as the Missouri Air Conservation Law, Clean Water Law and Hazardous Waste Management Law at its facility in Mexico, Mo.



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pharmaceutical

United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs

The Justice Department announced today that the United States has filed a second civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers.



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pharmaceutical

ISTA Pharmaceuticals Inc. Pleads Guilty to Federal Felony Charges; Will Pay $33.5 Million to Resolve Criminal Liability and False Claims Act Allegations

Pharmaceutical company ISTA Pharmaceuticals, Inc. pled guilty earlier today to conspiracy to introduce a misbranded drug into interstate commerce and conspiracy to pay illegal remuneration in violation of the Federal Anti-Kickback Statute.



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pharmaceutical

The Department of Justice Files Suit Against Louisiana Pharmaceutical Company for Distributing Unapproved and Misbranded Prescription and Over-the-counter Drugs

Acting Assistant Attorney General Stuart F. Delery announced today that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals.



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pharmaceutical

United States and Tennessee Reach Agreement with King Pharmaceuticals LLC to Resolve Allegations of Clean Air Act Violations

King Pharmaceuticals LLC (King) will pay $2.2 million and take measures to comply with the Clean Air Act to resolve alleged violations of the Clean Air Act (CAA) at its pharmaceutical manufacturing facility located in Bristol, Tenn.



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pharmaceutical

Wyeth Pharmaceuticals Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses

Wyeth Pharmaceuticals Inc., a pharmaceutical company acquired by Pfizer, Inc. in 2009, has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by the U.S. Food and Drug Administration (FDA).



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pharmaceutical

Assistant Attorney General Stuart F. Delery Delivers the Keynote Address at the CBI Pharmaceutical Compliance Congress

"Why is health care enforcement so important? A major reason is the importance of the health care industry itself. From compliance officers to physicians, from corporate executives to nurses and researchers, you contribute to producing the drugs and medical devices on which we and our loved ones rely. Your efforts help to ensure that, when we are sick, the medicines we take will heal us effectively; that when we are in pain, we can obtain relief safely," said Assistant Attorney General Delery




pharmaceutical

Endo Pharmaceuticals and Endo Health Solutions to Pay $192.7 Million to Resolve Criminal and Civil Liability Relating to Marketing of Prescription Drug Lidoderm for Unapproved Uses

Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. (Endo) have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration.



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pharmaceutical

Pharmaceutical Company to Pay $27.6 Million to Settle Allegations Involving False Billings to Federal Health Care Programs

Pharmaceutical manufacturer Teva Pharmaceuticals USA Inc. and a subsidiary, IVAX LLC, have agreed to pay the government and the state of Illinois $27.6 million for allegedly violating the False Claims Act by making payments to induce prescriptions of an anti-psychotic drug for Medicare and Medicaid beneficiaries.



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pharmaceutical

Justice Department Sues Los Angeles Pharmaceutical Company Over Feminine Health Drug Products

The Department of Justice today announced the filing of a civil lawsuit against Laclede Inc. and its president, Michael A. Pellico, seeking to stop the distribution of over-the-counter vaginal drug products that the company makes and sells nationwide



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pharmaceutical

Wisconsin Pharmacist and Nevada Pharmacologist Charged with Smuggling Counterfeit Pharmaceuticals Using a Costa Rican Internet Pharmacy

A Wisconsin pharmacist and a Nevada pharmacologist were arraigned on an indictment today in Federal Court in Central Islip, New York, before United States Magistrate Judge Gary Brown. The defendants are charged with conspiring to supply at least four million misbranded and counterfeit pharmaceuticals to an illegal Internet pharmacy based in Costa Rica that catered to U.S. customers.



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pharmaceutical

Draft 2020 Chinese pharmacopeia includes hundreds of new pharmaceuticals

From : Communities>>Regulatory Open Forum
Hi everyone, As currently drafted,  the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug legally marketed in China is published by the Chinese Pharmacopoeia Commission. It is designed [More]




pharmaceutical

The Pharmaceutical-Biotech-Devices Industries Face a New World Post-Pandemic

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading




pharmaceutical

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading




pharmaceutical

Effect of non-pharmaceutical interventions to contain COVID-19 in China




pharmaceutical

Improving productivity in pharmaceutical research and development


Event Information

July 28, 2015
8:30 AM - 5:00 PM EDT

Ambassador Ball Room
Embassy Row Hotel
2015 Massachusetts Avenue
Washington, DC 20036

Register for the Event

The role of clinical pharmacology and experimental medicine



The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the outsize amount of time and resources necessary to develop new drugs. Advances in clinical pharmacology and experimental medicine have the potential to rebalance these trends by providing researchers with the tools to more efficiently and systematically identify promising targets and compounds, appropriate patient populations, and adequate doses for study much earlier in development. 

On July 28, the Center for Health Policy at Brookings, in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA), hosted a public meeting to tackle these issues. Through presentations and case studies, leading experts from industry, academia, and government agencies explored the evolving role of clinical pharmacology tools in pre-clinical and clinical development, existing gaps in the application of those tools, and how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments. Discussion at this event will potentially be harnessed to inform downstream guidance documents, to establish best practices for the application of emerging clinical pharmacology tools, or to support academic publications. Speakers will convene privately to discuss such downstream deliverables and key takeaways from the conference.

Click here to access the full event agenda.

Video

Event Materials

       




pharmaceutical

Promoting continuous manufacturing in the pharmaceutical sector


Event Information

October 19, 2015
9:00 AM - 4:00 PM EDT

The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

Over the past decade, drug shortages and product recalls in the U.S. have occurred at unprecedented rates, limiting patient access to critical medicines and undermining health care. A majority of these shortages and recalls have been due to manufacturing quality issues. In response to these problems, and as part of its ongoing efforts to ensure a continuous supply of high-quality pharmaceuticals in the U.S., the U.S. Food and Drug Administration (FDA) is pursuing a range of strategies designed to improve the flexibility, reliability, and quality of pharmaceutical manufacturing. Among these strategies is the promotion of new manufacturing technologies, including continuous manufacturing. Continuous manufacturing offers several important advantages over current approaches to manufacturing and has the potential to significantly mitigate the risks of quality failures. At present, however, these technologies and processes are not widely used by the pharmaceutical industry, and there remain a number of barriers to their broader adoption. In collaboration with a range of stakeholders, FDA is currently exploring ways in which it can help to address these barriers and facilitate the uptake of new manufacturing technologies.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held a workshop on October 19 entitled “Promoting Continuous Manufacturing in the Pharmaceutical Sector.” This workshop provided an opportunity for industry, academia, and government partners to identify the major barriers to the adoption of continuous manufacturing, discuss regulatory policies and strategies that could help to address those barriers, and explore approaches to improving public and private sector alignment and collaboration to promote the adoption of continuous manufacturing.

Event Materials

       




pharmaceutical

Water 3.0 solves problem of microplastics and pharmaceuticals in wastewater

Current water treatment can't remove these wastes that are increasingly implicated in serious environmental effects




pharmaceutical

The world's rivers are clogged with pharmaceutical waste

Scientists say levels are dangerously high, affecting wildlife and ecosystems.




pharmaceutical

National Sports Commentator, Dr. Jerry Punch, Together with Men's Health Network and Endo Pharmaceuticals, Encourages Men with Peyronie's Disease to Ask About the Curve - Ask About the Curve Public Service Announcement

Ask About the Curve Public Service Announcement





pharmaceutical

West Pharmaceutical Services, Inc. and HealthPrize Technologies Announce Self-Reporting and Barcoding Capabilities for Self-Injection Technology - West and HealthPrize Collaboration

West and HealthPrize are collaborating to provide an end to end connected health solution for pharmaceutical companies and the patients they serve.




pharmaceutical

National Sports Commentator, Dr. Jerry Punch, Together with Men's Health Network and Endo Pharmaceuticals, Encourages Men with Peyronie's Disease to Ask About the Curve - Ask About the Curve Public Service Announcement

Ask About the Curve Public Service Announcement




pharmaceutical

Watch CNBC's full interview with Teva Pharmaceuticals CEO Kare Schultz

Kare Schultz, CEO of Teva Pharmaceuticals, joins "Squawk on the Street" to discuss the coronavirus pandemic and treatment.




pharmaceutical

Profiting from the Pandemic: Will Pharmaceutical Giants Use Patents to Limit Access to COVID Drugs?

As the number of confirmed COVID-19 cases worldwide approaches 4 million and the pandemic could be with us for months or years, we look at who can access drugs like remdesivir, being developed by pharmaceutical giant Gilead, which has the patent for the drug and is poised to make massive profits. We look at how much drugs like remdesivir will cost, and who can access them, with writer Achal Prabhala, coordinator of the AccessIBSA project, which campaigns for access to medicines in India, Brazil and South Africa.




pharmaceutical

Hiring for Medical Representative pharmaceutical

Company: Confidential
Qualification: Bachelor Of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm)
Experience: 4 to 8
Salary: 3.20 to 4.70
location: Delhi
Ref: 24798194
Summary: Urgent Opening for the profile of Medical Representative pharmaceutical in Sanitizer Co.




pharmaceutical

On Pharmaceutical Products, Health Care Products Packaging Theoretical

Of pharmaceutical products, health care products packaging theory , there are several aspects of the law we need to , inter alia: 1 , generate new theory of pharmaceutical products , not only to consider the psychological factors of...




pharmaceutical

Canada Imports Pharmaceutical And Medicinal Products

Imports (Bop) - Pharmaceutical And Medicinal Products in Canada increased to 1826.70 CAD Million in March from 1786.80 CAD Million in February of 2020. Imports (Bop) - Pharmaceutical And Medicinal Produ in Canada averaged 772.14 CAD Million from 1988 until 2020, reaching an all time high of 2084 CAD Million in December of 2019 and a record low of 80.90 CAD Million in April of 1989. This page includes a chart with historical data for Canada Imports of (bop) - Pharmaceutical And Medicinal P.




pharmaceutical

Pharmaceutical Expenditure and Policies: Past Trends and Future Challenges

This paper looks at recent trends in pharmaceutical spending across OECD countries. It examines the drivers of recent spending trends, highlighting differences across therapeutic classes, and then looks at emerging challenges for policy makers in the management of pharmaceutical spending.




pharmaceutical

United Kingdom Imports of Intra EU - Pharmaceutical Products

Imports of Intra EU - Pharmaceutical Products in the United Kingdom decreased to 1002.66 GBP Million in February from 1303.57 GBP Million in January of 2020. Imports of Intra EU - Pharmaceutical Products in the United Kingdom averaged 746.54 GBP Million from 1996 until 2020, reaching an all time high of 2706.48 GBP Million in March of 2019 and a record low of 119.69 GBP Million in April of 1996. This page includes a chart with historical data for the United Kingdom Imports of Intra EU - Pharmaceutical Products.




pharmaceutical

France Exports of Pharmaceuticals

Exports of Pharmaceuticals in France increased to 3874 EUR Million in March from 2668 EUR Million in February of 2020. Exports of Pharmaceuticals in France averaged 2022.39 EUR Million from 2000 until 2020, reaching an all time high of 3874 EUR Million in March of 2020 and a record low of 918 EUR Million in April of 2000. This page includes a chart with historical data for France Export: Pharmaceuticals.




pharmaceutical

Switzerland Exports - Pharmaceuticals, Vitamin, Diagnostic Product

Exports - Pharmaceuticals, Vitamin, Diagnostic Product in Switzerland increased to 10314.12 CHF Million in March from 7828.12 CHF Million in February of 2020. Exports - Pharmaceuticals, Vitamin, Diagnostic Pro in Switzerland averaged 6977.56 CHF Million from 2014 until 2020, reaching an all time high of 10314.12 CHF Million in March of 2020 and a record low of 4831.40 CHF Million in December of 2014. This page includes a chart with historical data for Switzerland Exports of Pharmaceuticals, Vitamin, Diagnostic P.




pharmaceutical

China Imports of Pharmaceuticals

Imports of Pharmaceuticals in China decreased to 3138000 USD THO in April from 3840100 USD THO in March of 2020. Imports of Pharmaceuticals in China averaged 2209862.09 USD THO from 2014 until 2020, reaching an all time high of 5043700 USD THO in February of 2020 and a record low of 1078115 USD THO in February of 2015. This page includes a chart with historical data for China Imports of Pharmaceuticals.




pharmaceutical

SkyCell raises $62M for smart containers and analytics to transport pharmaceuticals

While human travel has become severely restricted in recent months, the movement of goods has remained a constant priority — and in some cases, has become even more urgent. Today, a startup out of Switzerland that builds hardware and operates a logistics network designed to transport one item in particular — pharmaceuticals — is announcing […]




pharmaceutical

Dexter Blackstock has no regrets over quitting football as ex-striker turns hand to pharmaceuticals

Dexter Blackstock has gone from football to pharmaceuticals - and hopes to save lives, slash the cost of healthcare and even help change the perception of professional players.




pharmaceutical

Practical statistics for pharmaceutical analysis : with Minitab applications [Electronic book] / Jaames E. De Muth.

Cham : Springer, [2019]