Norton Scientific By Brad Kepler: PRESENTATIONpeterchung65
A fire at a drug manufacturing plant in Quebec led to shortages of important injectable drugs for cancer patients and hospitals across Canada. The Canadian Cancer Society criticized the lack of oversight and warning systems to prevent or mitigate such shortages. Hospitals have been holding daily calls to manage supplies and doctors are prioritizing patients who can take oral forms of medications when possible. The manufacturer aims to restore previous supply levels as soon as possible.
Thomas Weisel Partners Healthcare Conference Presentationfinance2
This document summarizes Jeff Campbell's presentation at the 2006 Thomas Weisel Healthcare Conference. It provides an overview of McKesson Corporation, including its three business segments, key market positions, and factors driving sustained value creation. McKesson generated $88 billion in revenues in FY06 across pharmaceutical, medical-surgical, and provider technology solutions. It aims to create shareholder value through its leading market positions, growth opportunities beyond core distribution, and experienced management team.
Special Challenges in Clinical Trials: Case Study: the Dying child and the ...Michael Swit
A review of a case study involving whether it would be proper to authorize the use of a drug whose approval had been withdrawn when it is believed to be the only hope for a dying child.
Top 5 IVD Market News Stories - January 2017Bruce Carlson
The document provides a summary of the top 5 news stories from the in vitro diagnostics field in January 2017 from the website www.kaloramainformation.com. The stories discuss 1) partnerships between Illumina and IBM Watson Health and between Illumina and Royal Philips to advance cancer genetics using sequencing data, 2) Guardant Health announcing a partnership to develop the largest commercially available liquid biopsy panel of over 500 genes, 3) researchers creating a low-cost paper centrifuge that could enable point-of-care diagnostics in resource-poor areas, 4) the FDA warning of potential false positives in a Zika virus test, and 5) CMS beginning to collect market data from laboratories to set new reimbursement rates for 2018
Globalization is driving changes in healthcare through factors like changing demographics, integrated economies, technology, and geopolitical changes. This is impacting India through opportunities in areas like clinical process outsourcing, medical tourism, and IT services for healthcare organizations in other countries. Managing healthcare delivery and IT across geographic and cultural boundaries presents challenges around privacy, security, productivity and control.
The document discusses several key aspects of globalization and its impact on health. It defines economic globalization as the extension of markets across national boundaries through reduced trade barriers and increased competition. While economic globalization may increase trade opportunities, issues can arise when markets are poorly regulated, leading to financial crises and marginalization of poorer countries. Globalization influences health through its economic, social, and cultural effects. Specific health impacts mentioned include growth in the refugee population and increased availability of toxic goods like tobacco.
Educación según socrates, platón y aristótelesHugo Herminio
Este documento resume las perspectivas educativas de Sócrates, Platón y Aristóteles. Sócrates utilizó el método mayéutico de preguntas para guiar a los estudiantes a descubrir la verdad por sí mismos. Platón creía que la educación debía guiar al alma hacia la razón y propuso una educación pública y obligatoria que incluyera gimnasia, música y ciencias. Aristóteles promovió una educación liberal basada en la experimentación y razonamiento inductivo que durara toda la vida.
Norton Scientific By Brad Kepler: PRESENTATIONpeterchung65
A fire at a drug manufacturing plant in Quebec led to shortages of important injectable drugs for cancer patients and hospitals across Canada. The Canadian Cancer Society criticized the lack of oversight and warning systems to prevent or mitigate such shortages. Hospitals have been holding daily calls to manage supplies and doctors are prioritizing patients who can take oral forms of medications when possible. The manufacturer aims to restore previous supply levels as soon as possible.
Thomas Weisel Partners Healthcare Conference Presentationfinance2
This document summarizes Jeff Campbell's presentation at the 2006 Thomas Weisel Healthcare Conference. It provides an overview of McKesson Corporation, including its three business segments, key market positions, and factors driving sustained value creation. McKesson generated $88 billion in revenues in FY06 across pharmaceutical, medical-surgical, and provider technology solutions. It aims to create shareholder value through its leading market positions, growth opportunities beyond core distribution, and experienced management team.
Special Challenges in Clinical Trials: Case Study: the Dying child and the ...Michael Swit
A review of a case study involving whether it would be proper to authorize the use of a drug whose approval had been withdrawn when it is believed to be the only hope for a dying child.
Top 5 IVD Market News Stories - January 2017Bruce Carlson
The document provides a summary of the top 5 news stories from the in vitro diagnostics field in January 2017 from the website www.kaloramainformation.com. The stories discuss 1) partnerships between Illumina and IBM Watson Health and between Illumina and Royal Philips to advance cancer genetics using sequencing data, 2) Guardant Health announcing a partnership to develop the largest commercially available liquid biopsy panel of over 500 genes, 3) researchers creating a low-cost paper centrifuge that could enable point-of-care diagnostics in resource-poor areas, 4) the FDA warning of potential false positives in a Zika virus test, and 5) CMS beginning to collect market data from laboratories to set new reimbursement rates for 2018
Globalization is driving changes in healthcare through factors like changing demographics, integrated economies, technology, and geopolitical changes. This is impacting India through opportunities in areas like clinical process outsourcing, medical tourism, and IT services for healthcare organizations in other countries. Managing healthcare delivery and IT across geographic and cultural boundaries presents challenges around privacy, security, productivity and control.
The document discusses several key aspects of globalization and its impact on health. It defines economic globalization as the extension of markets across national boundaries through reduced trade barriers and increased competition. While economic globalization may increase trade opportunities, issues can arise when markets are poorly regulated, leading to financial crises and marginalization of poorer countries. Globalization influences health through its economic, social, and cultural effects. Specific health impacts mentioned include growth in the refugee population and increased availability of toxic goods like tobacco.
Educación según socrates, platón y aristótelesHugo Herminio
Este documento resume las perspectivas educativas de Sócrates, Platón y Aristóteles. Sócrates utilizó el método mayéutico de preguntas para guiar a los estudiantes a descubrir la verdad por sí mismos. Platón creía que la educación debía guiar al alma hacia la razón y propuso una educación pública y obligatoria que incluyera gimnasia, música y ciencias. Aristóteles promovió una educación liberal basada en la experimentación y razonamiento inductivo que durara toda la vida.
FDA Promotes Transparency, Collaboration for 2018Georgia_Bull
The Food and Drug Administration (FDA) prepares to shake up its traditional processes in the hopes of improving quality patient care and driving down the costs of drugs.
The FDA has delayed finalizing a proposed rule requiring generic drug companies to unilaterally update labels when new safety information emerges from December 2014 to September 2015. This delay provides more time for the generic drug industry, represented by the Generic Pharmaceutical Association (GPhA), to continue fighting the rule, which they allege would impose huge costs. However, public health advocates view the rule as important for drug safety and informing consumers. The debate around the economic impact of the rule on the generic drug industry versus the improved safety it could provide is expected to continue into next year.
This document discusses regulatory inefficiencies surrounding companion diagnostics and laboratory developed tests (LDTs) in the United States. It uses the case study of Genentech's drug MPDL3280A and its companion diagnostic to show that the FDA thoroughly regulates companion diagnostics but provides no oversight of clinical validity for LDTs. This allows multiple competing diagnostic tests to be used without proof of efficacy. The document also compares healthcare systems and technology assessment processes in the US, UK, and France to illustrate decentralized decision making in the US compared to centralized bodies in other countries.
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
14 crucial disease drugs are hard to find. It's arrived at an 'emergency level' in N.J.
One health institution in New Jersey has weekly meetings to talk about its severe prescription shortages.
Another was compelled to interact "regularly."
Additionally, one doctor claims that she now has adequate life-saving cancer medications for her patients. Oncologist Dr. Eleonora Teplinsky of Valley-Mount Sinai Comprehensive Cancer Care in Paramus stated, "It is really at crisis level."
The US Food and Drug Administration has declared that there is a countrywide shortage of 14 cancer medications. Among these are the crucial chemotherapeutic drugs cisplatin and carboplatin. Weekly meetings are held at one medical facility in New Jersey to discuss the acute prescription shortages there.
A few oncologists across the US have been compelled to defer treatment for patients and even proportion drugs because of the deficiencies.
"Just from what I've heard and have perused in the news, a few patients have had their treatment changed, and they've needed to totally switch conventions," Teplinsky said. "A few patients in the nation have not had the option to get their medication by any means. Certain individuals are holding on to get medication.
"Thus it truly is influencing patients on an everyday level."Dr. Julie Gralow, the central clinical official and leader VP of the American Culture of Clinical Oncology, has seen nothing like this. She told NBC News, "I don't know of a time that's worse than this." "What's different about this shortage is simply the wide applicability of these drugs and how crucial they are globally and in the U.S. in the treatment of many diseases," the author says.
Several New Jersey health systems report that their cancer medication supplies are now adequate. However, they change according to the facility. And nobody seemed to be fully at peace. Teplinsky cited carboplatin and cisplatin shortages as "the big ones" that hospitals have been experiencing.
"I don't think there's anyone right now who's swimming in drugs," she remarked. For patients wanting to obtain therapy without having to worry about a medicine becoming abruptly unavailable, it's a terrifying reality.
Teplinsky claims that Valley, the state-ranked top hospital in Ridgewood, has kept a supply for its clients. And in recent weeks, those supplies have marginally increased.
The hospital is "still being very careful" with its supply, she added, adding that "we're definitely not out of the woods."
Teplinsky noted that "other places are completely out."
Because carboplatin and cisplatin are used to treat a range of cancers and tumur types, specialists believe the shortages of these drugs are particularly alarming.
If a patient needs carboplatin to treat uterine cancer, for example, they might not be able to obtain it, according to Teplinsky. "Unfortunately, switching out one medicine for another is not always an option.
"The other medications might not work as well ag
Accountability in Healthcare: Collaboration and Analytics are KeyBukmarker
This document discusses accountability in the healthcare industry. Key points include:
- Healthcare providers, insurers, life sciences companies, and other stakeholders face increasing demands for cost control while improving quality of care and making the system more patient-centric.
- The Affordable Care Act aims to provide affordable healthcare to more Americans and represents an irreversible trend toward greater accountability in the industry.
- All players must find new business models using collaboration and data analytics to navigate this changing environment focused on evidence-based and patient-centric care.
The life sciences industry is a key contributor to the Canadian and global economies. In the pursuit of competitive advantage, participants in the pharmaceutical, biotech, medical device and diagnostic, and health-careservices sectors have seen significant growth attributed to major leaps in technology and an unprecedented demand for health-related goods and services. This growth has paralleled the expansion and imposition of more stringent regulatory requirements, improvement of market access, aggressive patent acquisition and enforcement, strategic M&A activity, and increased product liability claims and other litigation.
This report highlights insights and developments relating to a wide range of legal, business and consumer issues currently impacting the life sciences industry in Canada and abroad. These highlights were prepared by Blakes based on non-confidential information gathered in our practices, as well as through a review of publicly available information. Through
a series of articles, we examine the implications of some of the recent legal developments impacting the sector, including the Supreme Court of Canada’s decision to uphold Ontario’s ban on private-label generic drugs, the enforcement of prohibitions on pharmacy-related loyalty points in B.C., the Competition Bureau’s ongoing consideration of competition among pharmaceutical companies, and recent trends in Canadian litigation. We also discuss issues relating to the navigation of transfer-pricing rules, protecting intellectual property in the development of combination products, and obtaining financing for new product development and business expansion efforts. Supplementing our discussion of these matters are snapshots of consumer-facing and market trends, including integrated patient care and direct-to-consumer sales.
Third-party administrators (TPAs), employers and employees are increasingly concerned about the growing cost of specialty drugs. Relief, WellDyneRx believes, will come to those employers and TPAs that (1) encourage specific public policy changes and (2) partner with pharmacy benefit managers (PBMs) that own best-of-breed specialty pharmacies.
3 News Uptoday
22 New Guidance
28 Audit Findings
483 Observations
- Caraco Pharmaceutical Laboratories
- Hospira Inc
- Novartis Consumer Health
- McNeil Consumer Healthcare
Warning Letters
- Hikma Farmaceutica, (Portugal) S.A.
- Cadila Pharmaceuticals Limited
- Sharp Global Limited
- Wells Pharmacy Network LLC
EMA Non-Compliance Reports
- Taishan City Chemical Pharmaceutical Co. Ltd., China
- Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd., China
- MANUEL RIESGO S.A., Spain
- Ranbaxy Laboratories Limited, Dewas, India
36 Regulations of the Month
§ 211.186 Master production and control records
§ 211.188 Batch production and control records
This document discusses why importing prescription drugs from Canada is not a viable solution to high drug costs in the US. It notes that previous state-level importation programs failed due to lack of savings and inability to adequately regulate foreign pharmacies. Proper testing of imported drugs is very expensive and would consume any savings. There are also safety concerns, as importation would undermine track-and-trace systems and Canada's drug supply is already limited. Law enforcement experts warn that importation could exacerbate the opioid crisis and organized crime may exploit regulatory loopholes. The document argues policymakers should focus on real solutions rather than unrealistic importation proposals.
Lawmakers call on nih to reduce price of cancer drug by Floyd Arthur (PPT)Floyd Arthur
A group of Democratic lawmakers urged the National Institutes of Health and Department of Health and Human Services to hold hearings on the high price of the prostate cancer drug Xtandi. Xtandi was developed with public funds from UCLA research but sells for $129,000 per year in the US, while being cheaper in other countries. The lawmakers want the agencies to revoke the patent and make the drug available at a lower price, since taxpayers funded its development. Drugmakers are increasingly under fire for soaring drug prices in the US.
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
The chemotherapy drugs that are used to treat cancer patients can themselves cause cancer in health care workers who handle them. A 2004 alert from NIOSH warned of this risk but more study is still needed. A proposed study of health care worker exposures has been delayed after the OMB raised questions about the study design twice. Proponents say the study is important to better understand the risks to workers from exposure to chemo drugs through inhalation, skin contact, or contact with contaminated surfaces and waste. Many countries in Europe have done more to control exposures and reduce risks to health care workers compared to the US.
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 8 has been released with the following content.
3 News Uptoday
14 New Guidance
30 Audit Findings
483 Observations
- Exemplar Lab, MA
- Genentech Inc
- Celltex Therapeutics Corporation
- APP Pharmaceuticals, LLC
- Reganeron Pharmaceuticals, Inc.
Warning Letters
- Hospira, Austarlia
- Sanjiu Medical and Pharmaceutical Co.,
- Beacon Hill Medical Pharmacy
EMA Non-Compliance Reports
- Wockhardt Limited, Nani Daman
- Fujian South Pharmaceutical, China
40 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
§ 211.186 Master production and control records
ASCP Commends CMS Decision on Medicare's Six Protected ClassesTravis Leonardi
The American Society of Consultant Pharmacists (ASCP) commended the Centers for Medicare and Medicaid Services' (CMS) decision not to revise Medicare's Six Protected Classes policy. The policy ensures that Medicare patients can access needed treatments. ASCP joined over 20 patient advocacy organizations in advocating for this position. However, ASCP was disappointed that CMS did not reform direct and indirect remuneration fees, which can still unfairly increase medication costs for seniors through a loophole.
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
washingtonpost.com
> Health
Correction to This Article
Previous versions of this article misspelled the name of Tito Fojo, of the National Cancer Institute. This version has been corrected.
Review of prostate cancer drug Provenge renews medical cost-benefit debate
TOOLBOX
Resize
PrintE-mailReprints
By Rob Stein
Washington Post Staff Writer
Monday, November 8, 2010; 7:52 AM
Federal officials are conducting an unusual review to determine whether the government should pay for an expensive new vaccine for treating prostate cancer, rekindling debate over whether some therapies are too costly.
The Centers for Medicare & Medicaid Services, which dictate what treatments the massive federal health-insurance program for the elderly will cover, is running a "national coverage analysis" of Provenge, the first vaccine approved for treating any cancer. The treatment costs $93,000 a patient and has been shown to extend patients' lives by about four months.
Although Medicare is not supposed to take cost into consideration when making such rulings, the decision to launch a formal examination has raised concerns among cancer experts, drug companies, lawmakers, prostate cancer patients and advocacy groups.
Provenge, which was approved for advanced prostate cancer in April, is the latest in a series of new high-priced cancer treatments that appear to eke out only a few more months of life, prompting alarm about their cost.
"This absolutely is the opening salvo in the drive to save money in the health-care system," said Skip Lockwood, who heads Zero - the Project to End Prostate Cancer, a Washington-based lobbying group. "If the cost wasn't a consideration, this wouldn't even be under discussion."
Those concerns have been heightened because the review comes after the bitter health-care reform debate, which was marked by accusations about rationing and "death panels." The appointment of Donald M. Berwick to head Medicare only intensified anxieties. President Obama sidestepped a Senate battle by naming Berwick, who has advocated for scrutinizing costs, when Congress was in recess in July.
Because men tend to be elderly when they get diagnoses of advanced prostate cancer, Medicare's decision will have a major effect on Provenge's availability. Regional Medicare providers paying for Provenge would have to stop. Private insurers also tend to follow Medicare's lead.
Medicare officials, who are convening a panel of outside advisers to vet the issue at a public hearing Nov. 17, say Provenge's price tag isn't an issue. But Berwick and other officials declined to discuss the rationale for the review.
"Certainly no one in the Medicare program would publicly state that the price tag would have anything to do with Medicare looking at it. But they are human beings, too. They notice things like that," said Sean Tunis, director of the Center for Medical Technology Policy and a former chief medical officer at Medicare. ...
A Pennsylvania pharmacist testified that only generic drug makers are benefiting from large price increases for generic medications. The pharmacist cited drug shortages, industry consolidation, and fewer manufacturers as reasons for the price hikes, with some generics increasing in price by as much as 8,000%. A government investigation into the sudden price increases was announced. An analysis found that more than 12,000 generic drugs have seen dramatic price rises in the last 18 months, hardest hit being patients paying out of pocket for prescriptions.
The document summarizes 10 health stories from the past week, including Ontario increasing efforts to reduce smoking by banning flavored tobacco and prohibiting smoking in certain public places. It also discusses Health Canada's inability to recall drugs on its own and a legal challenge launched in British Columbia to the federal ban on prescription heroin. Concerns were also raised regarding increased powers proposed for naturopaths in Ontario.
FDA Promotes Transparency, Collaboration for 2018Georgia_Bull
The Food and Drug Administration (FDA) prepares to shake up its traditional processes in the hopes of improving quality patient care and driving down the costs of drugs.
The FDA has delayed finalizing a proposed rule requiring generic drug companies to unilaterally update labels when new safety information emerges from December 2014 to September 2015. This delay provides more time for the generic drug industry, represented by the Generic Pharmaceutical Association (GPhA), to continue fighting the rule, which they allege would impose huge costs. However, public health advocates view the rule as important for drug safety and informing consumers. The debate around the economic impact of the rule on the generic drug industry versus the improved safety it could provide is expected to continue into next year.
This document discusses regulatory inefficiencies surrounding companion diagnostics and laboratory developed tests (LDTs) in the United States. It uses the case study of Genentech's drug MPDL3280A and its companion diagnostic to show that the FDA thoroughly regulates companion diagnostics but provides no oversight of clinical validity for LDTs. This allows multiple competing diagnostic tests to be used without proof of efficacy. The document also compares healthcare systems and technology assessment processes in the US, UK, and France to illustrate decentralized decision making in the US compared to centralized bodies in other countries.
To recap the previous month's pharma highlights to Pharma Uptoday followers, Monthly magazine Volume 17 has been released with the following content.
News Uptoday
New Guidance
Audit Findings
483 Observations
EU Non Compliance Report
- INTEGRA LIFE SCIENCES CORP, United States
- JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD., China
- WUXI JIDA PHARMACEUTICAL CO., LTD, China
- PARABOLIC DRUGS LIMITED, India
Warning Letters
- Mahendra Chemicals, India
Regulations of the Month
- Sec. 211.25 Personnel qualifications
- Sec. 211.28 Personnel responsibilities
14 crucial disease drugs are hard to find. It's arrived at an 'emergency level' in N.J.
One health institution in New Jersey has weekly meetings to talk about its severe prescription shortages.
Another was compelled to interact "regularly."
Additionally, one doctor claims that she now has adequate life-saving cancer medications for her patients. Oncologist Dr. Eleonora Teplinsky of Valley-Mount Sinai Comprehensive Cancer Care in Paramus stated, "It is really at crisis level."
The US Food and Drug Administration has declared that there is a countrywide shortage of 14 cancer medications. Among these are the crucial chemotherapeutic drugs cisplatin and carboplatin. Weekly meetings are held at one medical facility in New Jersey to discuss the acute prescription shortages there.
A few oncologists across the US have been compelled to defer treatment for patients and even proportion drugs because of the deficiencies.
"Just from what I've heard and have perused in the news, a few patients have had their treatment changed, and they've needed to totally switch conventions," Teplinsky said. "A few patients in the nation have not had the option to get their medication by any means. Certain individuals are holding on to get medication.
"Thus it truly is influencing patients on an everyday level."Dr. Julie Gralow, the central clinical official and leader VP of the American Culture of Clinical Oncology, has seen nothing like this. She told NBC News, "I don't know of a time that's worse than this." "What's different about this shortage is simply the wide applicability of these drugs and how crucial they are globally and in the U.S. in the treatment of many diseases," the author says.
Several New Jersey health systems report that their cancer medication supplies are now adequate. However, they change according to the facility. And nobody seemed to be fully at peace. Teplinsky cited carboplatin and cisplatin shortages as "the big ones" that hospitals have been experiencing.
"I don't think there's anyone right now who's swimming in drugs," she remarked. For patients wanting to obtain therapy without having to worry about a medicine becoming abruptly unavailable, it's a terrifying reality.
Teplinsky claims that Valley, the state-ranked top hospital in Ridgewood, has kept a supply for its clients. And in recent weeks, those supplies have marginally increased.
The hospital is "still being very careful" with its supply, she added, adding that "we're definitely not out of the woods."
Teplinsky noted that "other places are completely out."
Because carboplatin and cisplatin are used to treat a range of cancers and tumur types, specialists believe the shortages of these drugs are particularly alarming.
If a patient needs carboplatin to treat uterine cancer, for example, they might not be able to obtain it, according to Teplinsky. "Unfortunately, switching out one medicine for another is not always an option.
"The other medications might not work as well ag
Accountability in Healthcare: Collaboration and Analytics are KeyBukmarker
This document discusses accountability in the healthcare industry. Key points include:
- Healthcare providers, insurers, life sciences companies, and other stakeholders face increasing demands for cost control while improving quality of care and making the system more patient-centric.
- The Affordable Care Act aims to provide affordable healthcare to more Americans and represents an irreversible trend toward greater accountability in the industry.
- All players must find new business models using collaboration and data analytics to navigate this changing environment focused on evidence-based and patient-centric care.
The life sciences industry is a key contributor to the Canadian and global economies. In the pursuit of competitive advantage, participants in the pharmaceutical, biotech, medical device and diagnostic, and health-careservices sectors have seen significant growth attributed to major leaps in technology and an unprecedented demand for health-related goods and services. This growth has paralleled the expansion and imposition of more stringent regulatory requirements, improvement of market access, aggressive patent acquisition and enforcement, strategic M&A activity, and increased product liability claims and other litigation.
This report highlights insights and developments relating to a wide range of legal, business and consumer issues currently impacting the life sciences industry in Canada and abroad. These highlights were prepared by Blakes based on non-confidential information gathered in our practices, as well as through a review of publicly available information. Through
a series of articles, we examine the implications of some of the recent legal developments impacting the sector, including the Supreme Court of Canada’s decision to uphold Ontario’s ban on private-label generic drugs, the enforcement of prohibitions on pharmacy-related loyalty points in B.C., the Competition Bureau’s ongoing consideration of competition among pharmaceutical companies, and recent trends in Canadian litigation. We also discuss issues relating to the navigation of transfer-pricing rules, protecting intellectual property in the development of combination products, and obtaining financing for new product development and business expansion efforts. Supplementing our discussion of these matters are snapshots of consumer-facing and market trends, including integrated patient care and direct-to-consumer sales.
Third-party administrators (TPAs), employers and employees are increasingly concerned about the growing cost of specialty drugs. Relief, WellDyneRx believes, will come to those employers and TPAs that (1) encourage specific public policy changes and (2) partner with pharmacy benefit managers (PBMs) that own best-of-breed specialty pharmacies.
3 News Uptoday
22 New Guidance
28 Audit Findings
483 Observations
- Caraco Pharmaceutical Laboratories
- Hospira Inc
- Novartis Consumer Health
- McNeil Consumer Healthcare
Warning Letters
- Hikma Farmaceutica, (Portugal) S.A.
- Cadila Pharmaceuticals Limited
- Sharp Global Limited
- Wells Pharmacy Network LLC
EMA Non-Compliance Reports
- Taishan City Chemical Pharmaceutical Co. Ltd., China
- Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd., China
- MANUEL RIESGO S.A., Spain
- Ranbaxy Laboratories Limited, Dewas, India
36 Regulations of the Month
§ 211.186 Master production and control records
§ 211.188 Batch production and control records
This document discusses why importing prescription drugs from Canada is not a viable solution to high drug costs in the US. It notes that previous state-level importation programs failed due to lack of savings and inability to adequately regulate foreign pharmacies. Proper testing of imported drugs is very expensive and would consume any savings. There are also safety concerns, as importation would undermine track-and-trace systems and Canada's drug supply is already limited. Law enforcement experts warn that importation could exacerbate the opioid crisis and organized crime may exploit regulatory loopholes. The document argues policymakers should focus on real solutions rather than unrealistic importation proposals.
Lawmakers call on nih to reduce price of cancer drug by Floyd Arthur (PPT)Floyd Arthur
A group of Democratic lawmakers urged the National Institutes of Health and Department of Health and Human Services to hold hearings on the high price of the prostate cancer drug Xtandi. Xtandi was developed with public funds from UCLA research but sells for $129,000 per year in the US, while being cheaper in other countries. The lawmakers want the agencies to revoke the patent and make the drug available at a lower price, since taxpayers funded its development. Drugmakers are increasingly under fire for soaring drug prices in the US.
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
The chemotherapy drugs that are used to treat cancer patients can themselves cause cancer in health care workers who handle them. A 2004 alert from NIOSH warned of this risk but more study is still needed. A proposed study of health care worker exposures has been delayed after the OMB raised questions about the study design twice. Proponents say the study is important to better understand the risks to workers from exposure to chemo drugs through inhalation, skin contact, or contact with contaminated surfaces and waste. Many countries in Europe have done more to control exposures and reduce risks to health care workers compared to the US.
Pharma Uptoday Monthly Magazine Volume 8 issue Nov 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 8 has been released with the following content.
3 News Uptoday
14 New Guidance
30 Audit Findings
483 Observations
- Exemplar Lab, MA
- Genentech Inc
- Celltex Therapeutics Corporation
- APP Pharmaceuticals, LLC
- Reganeron Pharmaceuticals, Inc.
Warning Letters
- Hospira, Austarlia
- Sanjiu Medical and Pharmaceutical Co.,
- Beacon Hill Medical Pharmacy
EMA Non-Compliance Reports
- Wockhardt Limited, Nani Daman
- Fujian South Pharmaceutical, China
40 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
§ 211.186 Master production and control records
ASCP Commends CMS Decision on Medicare's Six Protected ClassesTravis Leonardi
The American Society of Consultant Pharmacists (ASCP) commended the Centers for Medicare and Medicaid Services' (CMS) decision not to revise Medicare's Six Protected Classes policy. The policy ensures that Medicare patients can access needed treatments. ASCP joined over 20 patient advocacy organizations in advocating for this position. However, ASCP was disappointed that CMS did not reform direct and indirect remuneration fees, which can still unfairly increase medication costs for seniors through a loophole.
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
washingtonpost.com
> Health
Correction to This Article
Previous versions of this article misspelled the name of Tito Fojo, of the National Cancer Institute. This version has been corrected.
Review of prostate cancer drug Provenge renews medical cost-benefit debate
TOOLBOX
Resize
PrintE-mailReprints
By Rob Stein
Washington Post Staff Writer
Monday, November 8, 2010; 7:52 AM
Federal officials are conducting an unusual review to determine whether the government should pay for an expensive new vaccine for treating prostate cancer, rekindling debate over whether some therapies are too costly.
The Centers for Medicare & Medicaid Services, which dictate what treatments the massive federal health-insurance program for the elderly will cover, is running a "national coverage analysis" of Provenge, the first vaccine approved for treating any cancer. The treatment costs $93,000 a patient and has been shown to extend patients' lives by about four months.
Although Medicare is not supposed to take cost into consideration when making such rulings, the decision to launch a formal examination has raised concerns among cancer experts, drug companies, lawmakers, prostate cancer patients and advocacy groups.
Provenge, which was approved for advanced prostate cancer in April, is the latest in a series of new high-priced cancer treatments that appear to eke out only a few more months of life, prompting alarm about their cost.
"This absolutely is the opening salvo in the drive to save money in the health-care system," said Skip Lockwood, who heads Zero - the Project to End Prostate Cancer, a Washington-based lobbying group. "If the cost wasn't a consideration, this wouldn't even be under discussion."
Those concerns have been heightened because the review comes after the bitter health-care reform debate, which was marked by accusations about rationing and "death panels." The appointment of Donald M. Berwick to head Medicare only intensified anxieties. President Obama sidestepped a Senate battle by naming Berwick, who has advocated for scrutinizing costs, when Congress was in recess in July.
Because men tend to be elderly when they get diagnoses of advanced prostate cancer, Medicare's decision will have a major effect on Provenge's availability. Regional Medicare providers paying for Provenge would have to stop. Private insurers also tend to follow Medicare's lead.
Medicare officials, who are convening a panel of outside advisers to vet the issue at a public hearing Nov. 17, say Provenge's price tag isn't an issue. But Berwick and other officials declined to discuss the rationale for the review.
"Certainly no one in the Medicare program would publicly state that the price tag would have anything to do with Medicare looking at it. But they are human beings, too. They notice things like that," said Sean Tunis, director of the Center for Medical Technology Policy and a former chief medical officer at Medicare. ...
A Pennsylvania pharmacist testified that only generic drug makers are benefiting from large price increases for generic medications. The pharmacist cited drug shortages, industry consolidation, and fewer manufacturers as reasons for the price hikes, with some generics increasing in price by as much as 8,000%. A government investigation into the sudden price increases was announced. An analysis found that more than 12,000 generic drugs have seen dramatic price rises in the last 18 months, hardest hit being patients paying out of pocket for prescriptions.
The document summarizes 10 health stories from the past week, including Ontario increasing efforts to reduce smoking by banning flavored tobacco and prohibiting smoking in certain public places. It also discusses Health Canada's inability to recall drugs on its own and a legal challenge launched in British Columbia to the federal ban on prescription heroin. Concerns were also raised regarding increased powers proposed for naturopaths in Ontario.
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
2. It is unacceptable that some cancer patients can’t
readily get the drugs they need because of supply
problems, the Canadian Cancer Society says.
The society is hearing from worried patients and
doctors across the country, said Dan Demers, the
group's director of public issues.
"We shouldn't have to wait for a crisis to respond," said
Demers.
3. The cancer society urged the federal government to:
Ensure there is mandatory listing of unavailable drugs by drug manufacturer.
Develop early warning systems to identify potential drug shortages.
Put systems in place to prevent shortages from escalating.
Work with other jurisdictions to investigate the root causes of the shortages and act to prevent
them where possible.
Canada's supply of injectable drugs such as painkillers, antibiotics and anesthetics became more
precarious following a fire in the boiler room at Sandoz Canada's plant in Boucherville, Que.
"Production has resumed in the portion of the plant that was not directly affected by the
incident, which took place on March 4," the company said in a email to CBC News on Monday.
"Our objective is to restore previous levels of supply as soon as possible, and we will make every
effort to meet medical needs, while ensuring consistent high quality standards."
4. Rationing supplies
The company was unable to quantify how much more capacity it now
has.
Anthony Dale, vice-president of policy and public affairs at the
Ontario Hospital Association in Toronto, called it "outrageous" that
one company could have this kind of effect on drug supplies.
Dale also called for a national strategy, noting hospitals are taking
inventory of their supplies and trying to share and to compound or
carefully mix drugs from raw ingredients under sterile conditions.
5. Hospitals and drug purchasers have been holding daily conference calls to
mitigate shortages. Doctors are carefully selecting patients who can swallow to
give them oral forms of the medications, said Myrella Roy, executive director
of the Canadian Society of Hospital Pharmacists in Ottawa.
Last week, officials with Alberta Health Services asked doctors to conserve
injectable medications. Cancer patients were asked to get oral anti-nausea
medications instead of injections before chemotherapy treatment.
In mid-February, Sandoz informed hospitals and other health-care clients that
it was partially closing its plant in Boucherville while it improved its process to
meet U.S. safety standards, the Canadian Anesthesiologists' Society said in a
news release.
6. The company told the anesthesiologists group that
dozens of critical medications will no longer be
manufactured while others will be available on
"allocation" based upon previous usage, a
manufacturing and delivery situation that could last
12 to 18 months, the group said in their release.
Health Canada said last week it is working to identify
alternate sources of supply and expedite approvals for
any drug companies that meet Canadian standards for
safety and effectiveness.
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