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Showing posts with label global pharma. Show all posts
Showing posts with label global pharma. Show all posts
Wednesday, October 16, 2013
DIA EuroMeeting 2014 Advance Programme now available ~ March 2014 in Vienna
Tuesday, April 2, 2013
India's Supreme Court Allows Continued Low-Cost Generics.
The New York Times (4/2, A1, Harris, Thomas,
Subscription Publication) reports in a front-page story, "Production of
the generic drugs in India, the world's biggest provider of cheap medicines,
was ensured on Monday in a ruling by the Indian Supreme Court," meaning
the populations of developing countries "will continue to have access to
low-cost copycat versions of drugs for" HIV and cancer. The court ruled
that a previous patent for Novartis' Gleevec prevented the company from taking
out a new patent on the drug. According to the Times, "the debate over
global drug pricing is one of the most contentious issues between developed
countries and the developing world." Because the US allows companies to
repatent a drug by altering its formula or changing its dosage, the country
"pays the highest drug prices in the world." Now, "the United
States government has become increasingly insistent in recent years that other
countries adopt far more stringent patent protection rules, with the result
that poorer patients often lose access to cheap generic copies of medicines
when their governments undertake trade agreements with the United States."
The Washington Post (4/1, Lakshmi) reports,
"Many international drug companies have said that the Novartis trial was
crucial to addressing the rapidly growing perception around the world that
India's patent protection system for drugs is weak." Recently, "other
Western pharmaceutical companies have been facing similar patent-related
setbacks in India." While health activists and Indian drug companies argue
"most Indians cannot afford expensive patented drugs," the ruling
also "is a huge boost for India's $26 billion generic drug industry."
The New York Times (4/1, Gottipati) reports in its
"India Ink" blog, "The case represents a high-stakes showdown
between defenders of intellectual property rights, who say generic versions
stifle innovation by drug makers, and Indian drug companies and international
aid groups, who warned that a ruling in favor of Novartis could have dried up
the global supply of inexpensive medicines to treat AIDS, cancer and other
diseases."
The AP (4/2, George) reports, "Novartis
called the ruling a 'setback for patients,' and said patent protection is
crucial to fostering investment in research to develop new and better drugs.
Ranjit Shahani, the vice chairman and managing director of Novartis India, said
the ruling 'will hinder medical progress for diseases without effective
treatment options.'"
Another AP (4/1) story reports, "Major drugmakers
such as Pfizer and Bayer AG on Monday declined to say what they might do
regarding the ruling and other recent decisions by poor countries to let local
drugmakers sell cheap generic versions for medicines that have monopolies under
patents in Western countries. ... One thing is clear, though: Emerging markets
are not the gold mine that optimistic pharmaceutical executives have been
making them out to be."
The Los Angeles Times (4/1, Alpert) reports,
"Despite its objections to the ruling, Novartis said it was unlikely to
challenge the court decision." Meanwhile, Tahir Amin, co-founder of the
Initiative for Medicines, Access and Knowledge, "said the next battleground
for generic drugs will be a Pacific free trade agreement under negotiation
among a long list of countries, including the U.S., Canada, Mexico, Vietnam and
Malaysia."
Also reporting this story are the Wall Street Journal (4/2, Subscription Publication), Bloomberg News (4/1, Von Schaper, Patnaik), Reuters (4/2), another Reuters (4/2), The Hill (4/2, Viebeck) "Healthwatch" blog, Time (4/1), NPR (4/1) "The Two Way" blog, Forbes (4/1), and BBC News (4/2).
| DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning. |
Subscribe to the DIA Daily.View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.
If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.
Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044 Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191
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Thursday, March 14, 2013
Industry Groups Urge Lawmakers To Address Trade Policies With India's Regulators.
Reuters (3/14, Palmer) reports executives from
agricultural, pharmaceutical and technology industries on Wednesday, called for
the US government to step up pressure on India to revise its trade and
intellectual property policies, which the industry reps claim are stifling US
exports and violating its patent rights. In testimony before the House Ways and
Means trade subcommittee, Pfizer's Chief Intellectual Property Counsel Roy
Waldron said the protectionist policy India has developed to enable its generic
drug makers to thrive is hurting US employment growth. He cited several
examples, such as India's revocation of the patent Pfizer held on the cancer
treatment Sutent (sunitinib malate), emphasizing the country's tendency to
dissolve drug patents by issuing compulsory licenses, which are supposed to be
awarded only in certain situations. Waldron concluded his testimony by urging
Federal lawmakers to address those issues actively, though direct talks with
Indian regulators and to use available policy standards to compel India to
honor intellectual property rights.
Subscribe to the DIA Daily.
View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.
If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.
Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191
 | DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning. |
Subscribe to the DIA Daily.
View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.
If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.
Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044
Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191
Tuesday, February 12, 2013
Pre-conference Tutorials - Monday, 4 March 2013 Amsterdam
 | View in Programme [PDF] |
Available with new instructors!
Tutorial 1 - Highlights of the Implementation of the New Pharmacovigilance Legislation with Regard to Adverse Reaction Reporting Rules, Use of New International Standards and Signal Management in Eudravigilance
Tutorial 2 - Analysis of Safety Data from Clinical Trials
Tutorial 3 - Update on Practical Work with Variations Under the Revised Regulation
Tutorial 4 - Introduction to EU Mecical Device Regulation
Tutorial 5 - Recent and Current Developments in Pharmaceutical Law
Tutorial 6 - CANCELLED - Incentives for Drug Development
NEW!Tutorial 7 - The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committee of the European Medicines Agency
Tutorial 8 - Health Technology Assessment (HTA) of Drugs and Medical Devices
Tutorial 9 - The European Qualified Person for Pharmacovigilance; Everything you ever wanted to know but were afraid to ask
Tutorial 10 - Non-Clinical Safety Assessment in Global Pharmaceutical Development
Tutorial 11 - Interactions Between Regulatory and Intellectual Property, Privacy and Product Liability
Tutorial 12 - Development Safety Update Report (DSUR) Kick-Off in 2011 - And now in practice
Tutorial 13 - Technology Transfer for Biopharmaceuticals
Tutorial 14 - Pharmacovigilance Audits and Inspections
Tutorial 15 - Coding with Confidence
Tutorial 16 - Understanding Translational Medicine
Tutorial 17 - Creating Compliant Clinical Study Reports (CSRS) for the EU and US
Tutorial 18 - Roundtable Discussion (Special Fee €200 + VAT): GCP Inspection and Audit Findings
Friday, February 1, 2013
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