2009-01-04T00:00:00Z opencongress.org tag:opencongress.org,2007:/bill/blog/44856 tag:opencongress.org,2009-01-04:/commentary/3916289 2009-01-04T00:00:00Z Patent Docs Five follow-on biologics bills were introduced during the 110th Congress: H.R. 1956 (which provides twelve years of data exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data ...<br /><br /><a href="http://www.patentdocs.org/2009/01/top-stories-of-2008-9-to-6.html">Go to article</a> tag:opencongress.org,2009-01-02:/commentary/3895380 2009-01-02T00:00:00Z Patent Docs We also reported last summer that the Biotechnology Industry Organization (BIO) indicated that either H.R. 1956 (providing fourteen years of exclusivity), H.R. 5629 (providing twelve years of exclusivity), or S. 1695 (also providing ...<br /><br /><a href="http://www.patentdocs.org/2009/01/teva-ceo-predicts-passage-of-followon-biologics-bill-in-2009.html">Go to article</a> tag:opencongress.org,2008-12-14:/commentary/3688538 2008-12-14T00:00:00Z GoozNews Ted Kennedy’s S.1695, Sen. Judd Gregg’s S.1505 and Rep. Anna Eshoo’s H.R.5629 each call for testing drugs for safety, purity and “potency.â€* The FDA uses potency as a synonym for efficacy. In other words, all three bills would manda<br /><br /><a href="http://www.gooznews.com/archives/001272.html">Go to article</a> tag:opencongress.org,2008-12-02:/commentary/3602285 2008-12-02T00:00:00Z The Sietch Blog Bills targeted include: Climate change (S.2191), CAFE (H.R.5560, S.2555), Biogenerics Legislation (S.1695 et al), Railroad Antitrust Enforcement (H.R.1650, S.772), Ban Asbestos etc. Act (H.R.3339) — for other quarters, see individual ...<br /><br /><a href="http://www.blog.thesietch.org/2008/11/24/general-motors-a-company-that-deserves-to-go-down/">Go to article</a> tag:opencongress.org,2008-11-20:/commentary/3553143 2008-11-20T00:00:00Z Patent Baristas S. 1695, sponsored by Senators Kennedy, Enzi, Clinton and Hatch, would allow for 12 years of data exclusivity. H.R. 5629, sponsored by Representatives Eshoo and Barton, would guarantee 12 years of data exclusivity, with an additional ...<br /><br /><a href="http://patentbaristas.com/archives/2008/11/20/economist-argues-that-7-years-ought-to-be-enough-for-biologic-data-exclusivity/">Go to article</a> tag:opencongress.org,2008-11-20:/commentary/3407371 2008-11-20T00:00:00Z The Unsuitablog Bills targeted include: Climate change (S.2191), CAFE (HR5560, S.2555), Biogenerics Legislation (S.1695 et al), Railroad Antitrust Enforcement (HR1650, S.772), Ban Asbestos etc. Act (HR3339) — for other quarters, see individual links. ...<br /><br /><a href="http://thesietch.org/mysietch/keith/2008/11/20/general-motors-emptying-the-ocean-with-a-thimble/">Go to article</a> tag:opencongress.org,2008-11-20:/commentary/3515314 2008-11-20T00:00:00Z Bio Pharma Bonanza S. 1695, sponsored by Senators Kennedy, Enzi, Clinton and Hatch, would allow for 12 years of data exclusivity. H.R. 5629, sponsored by Representatives Eshoo and Barton, would guarantee 12 years of data exclusivity, with an additional ...<br /><br /><a href="http://www.biopharmabonanza.com/bio-pharma-bonanza/economist-argues-that-7-years-ought-to-be-enough-for-biologic-data-exclusivity/">Go to article</a> tag:opencongress.org,2008-09-21:/commentary/3864752 2008-09-21T00:00:00Z HTA Blog which provides for 14 years; and S. 1695, introduced by Sens. Edward Kennedy (D-Mass.), Orrin Hatch (R-Utah), Michael Enzi (R-Wyo.) and Clinton, which favors 12 years of exclusivity. The periods of some of those generic biologic ...<br /><br /><a href="http://www.htablog.com/2008/09/waxman-fobs-would-ensure-market.html">Go to article</a> tag:opencongress.org,2008-09-17:/commentary/2860805 2008-09-17T00:00:00Z All Articles on Martindale.com Bipartisan legislation (S. 1695 (the Biologics Price Competition and Innovation Act)) that would create a mechanism for FDA approval of "biosimilar" (also referred to as "follow-on," "comparable," or "biogeneric") bi<br /><br /><a href="http://www.martindale.com/health-care-law/article_Arnold-Porter-LLP_506598.htm">Go to article</a> tag:opencongress.org,2008-08-18:/commentary/2687920 2008-08-18T00:00:00Z En Directo Juegos Olimpicos Pekin - Beijing... 10th Wawrinka , S. 1695 Rafael Nadal Becomes 24th Player to Hold No. 1 Ranking Spaniard Rafael Nadal ascended to the No. 1 position in the South African Airways ATP Rankings on Monday by replacing his great rival Roger Federer of ...<br /><br /><a href="http://streamingtheolympics.com/2008/08/honores-al-numero-1-rafa-nadal.html">Go to article</a> tag:opencongress.org,2008-07-06:/commentary/3407378 2008-07-06T00:00:00Z Orange Book Blog On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on ...<br /><br /><a href="http://www.orangebookblog.com/2008/07/obb-news-briefs.html">Go to article</a> tag:opencongress.org,2008-07-03:/commentary/2430604 2008-07-03T00:00:00Z Healthcare, Medical News - The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007.<br /><br /><a href="http://www.londonhygiene.com/healthcare/federal-report-outlines-cost-savings-biosimilars-approval-pathway">Go to article</a> tag:opencongress.org,2008-07-02:/commentary/2440334 2008-07-02T00:00:00Z Pharmaceutical Technology Magazine The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007.<br /><br /><a href="http://pharmtech.findpharma.com/pharmtech/News/Federal-Report-Outlines-Cost-Savings-in-Biosimilar/ArticleStandard/Article/detail/527568?ref=25">Go to article</a> tag:opencongress.org,2008-07-01:/commentary/2425745 2008-07-01T00:00:00Z Pharmaceutical Technology Magazine The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the ?Biologics Price Competition and Innovation Act of 2007.?<br /><br /><a href="http://pharmtech.findpharma.com/pharmtech/Federal-Report-Outlines-Cost-Savings-in-Biosimilar/ArticleStandard/Article/detail/527568?ref=25">Go to article</a> tag:opencongress.org,2008-07-01:/commentary/3407374 2008-07-01T00:00:00Z FDALegislativeWatch "By relying on the provisions in S. 1695, the CBO study also shows that we can achieve meaningful cost savings in biologics spending while providing needed protections to allow for continued innovation," Greenwood continued. ...<br /><br /><a href="http://www.fdalegislativewatch.com/2008/07/biogenerics-get.html">Go to article</a> tag:opencongress.org,2008-07-01:/commentary/2425744 2008-07-01T00:00:00Z Patent Docs By Donald Zuhn -- Last week, the Congressional Budget Office (CBO) released a report on the Biologics Price Competition and Innovation Act (S. 1695), which would establish a pathway for the FDA to approve follow-on biologics. ...<br /><br /><a href="http://www.patentdocs.net/patent_docs/2008/07/cbo-releases-re.html">Go to article</a> tag:opencongress.org,2008-06-30:/commentary/2477728 2008-06-30T00:00:00Z Health Guide Weblog Legislation (&lt;a href=&quot;http://thomas.loc.gov/cgi-bin/query/z?c110:S.1695:&quot; target=&quot;_new&quot;&gt;S 1695&lt;/a&gt;) that would create an &lt;a href=&quot;http://www.fda.gov/&quot; target=&quot;_new&quot;&gt;FDA&lt;/a&gt; approval pathway fo<br /><br /><a href="http://fastuhealth.blogspot.com/2008/06/medical-news-today-news-alert_30.html">Go to article</a> tag:opencongress.org,2008-06-30:/commentary/2514198 2008-06-30T00:00:00Z Improve Your Health Better Legislation (&lt;a href=&quot;http://thomas.loc.gov/cgi-bin/query/z?c110:S.1695:&quot; target=&quot;_new&quot;&gt;S 1695&lt;/a&gt;) that would create an &lt;a href=&quot;http://www.fda.gov/&quot; target=&quot;_new&quot;&gt;FDA&lt;/a&gt; approval pathway fo<br /><br /><a href="http://ubesthealth.blogspot.com/2008/06/medical-news-today-news-alert_30.html">Go to article</a> tag:opencongress.org,2008-06-28:/commentary/2406312 2008-06-28T00:00:00Z Medical Health Articles Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the Congressional Budget Office (CBO) report issued projecting cost savings from S. 1695, the Biologics Price ...<br /><br /><a href="http://google-sina.com/2008/06/28/cbo-savings-estimate-for-follow-on-biologics-underscores-need-for-congress-to-move-quickly-to-create-pathway-for-follow-on-biologics/">Go to article</a> tag:opencongress.org,2008-06-28:/commentary/2554144 2008-06-28T00:00:00Z Biology Biochemistry Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the Congressional Budget Office (CBO) report issued projecting cost savings from S. 1695, the Biologics Price ...<br /><br /><a href="http://biologybiochemistry.blogspot.com/2008/06/cbo-savings-estimate-for-follow-on.html">Go to article</a> tag:opencongress.org,2008-06-27:/commentary/3895381 2008-06-27T00:00:00Z RSS Feed for ATT Inc. "By relying on the provisions in S. 1695, the CBO study also shows that we can achieve meaningful cost savings in biologics spending while providing needed protections to allow for continued innovation. H.R. 1956, the Patient Protection ...<br /><br /><a href="http://news.thomasnet.com/companystory/546186">Go to article</a> tag:opencongress.org,2008-06-27:/commentary/2406313 2008-06-27T00:00:00Z Enquiries Disease Enacting S. 1695 would reduce total expenditures on biologics in the United States Hidden List by $25 billion over the 2009-2018 period. — Enacting the bill would reduce budget deficits (or increase surpluses) ...<br /><br /><a href="http://enquiriesdisease.com/2008/06/cbo-biogenerics-would-save-federal-government-66-billion-over-ten-years-the-congressional-budgetoffice-cbo-today-released-a-cost-analysis-finding-that-the-creation-of-anabbreviated-pathway-fo.html">Go to article</a> tag:opencongress.org,2008-06-26:/commentary/3407375 2008-06-26T00:00:00Z The Hill Blog The Congressional Budget Office (CBO) released a cost estimate yesterday of the “Biologics Price Competition and Innovation Act of 2007,â€* S. 1695, which the HELP Committee approved last year. CBO estimates that, if Congress enacts S. ...<br /><br /><a href="http://blog.thehill.com/2008/06/26/budget-estimate-confirms-biosimilar-bill-will-reduce-long-term-prescription-drug-costs-sen-mike-enzi/">Go to article</a> tag:opencongress.org,2008-06-26:/commentary/2406308 2008-06-26T00:00:00Z PHRMA (Press Releases) “PhRMA thinks the cost estimate released by the Congressional Budget Office (CBO) of S. 1695 shows that it is possible to deliver cost savings to patients and the government through introduction of follow-on biologics while maintaining ...<br /><br /><a href="http://www.phrma.org/news_room/press_releases/phrma_issues_statement_on_follow-on_biologics_legislation/">Go to article</a> tag:opencongress.org,2008-06-26:/commentary/2406310 2008-06-26T00:00:00Z biospace.com Featured News ... Budget Office (CBO) report issued today projecting cost savings from S. 1695, the Biologics Price Competition and Innovation Act of 2007: The CBO report shows that developing a pathway to review and approve follow-on biologics...<br /><br /><a href="http://www.biospace.com/news_story.aspx?StoryID=101663&amp;full=1">Go to article</a> tag:opencongress.org,2008-06-26:/commentary/2559069 2008-06-26T00:00:00Z On The Hill Enacting S. 1695 would reduce total expenditures on biologics in the United States Hidden List by $25 billion over the 2009-2018 period. -- Enacting the bill would reduce budget deficits (or increase surpluses) by a total of $6.6 ...<br /><br /><a href="http://onthehillblog.blogspot.com/2008/06/cbo-biogenerics-would-save-government.html">Go to article</a> tag:opencongress.org,2008-06-26:/commentary/3407380 2008-06-26T00:00:00Z Pharmalot The bills, by the way, are S. 1695, the Biologics Price Competition and Innovation Act of 2007; H.R. 1956, the Patient Protection and Innovative Biologic Medicines Act of 2007; and H.R. 5629, the Pathway for Biosimilars Act. If you go ...<br /><br /><a href="http://www.pharmalot.com/2008/06/biogenerics-would-save-how-much/">Go to article</a> tag:opencongress.org,2008-06-25:/commentary/3407379 2008-06-25T00:00:00Z PCMA Enacting S. 1695 would reduce total expenditures on biologics in the United States by $25 billion over the 2009- 2018 period. Enacting the bill would reduce budget deficits (or increase surpluses) by a total of $6.6 billion over the ...<br /><br /><a href="http://pcmanet.org/cbo-biogenerics-would-save-federal-government-66-billion-over-ten-years/">Go to article</a> tag:opencongress.org,2008-06-25:/commentary/2406309 2008-06-25T00:00:00Z PCMA Enacting S. 1695 would reduce total expenditures on biologics in the United States by $25 billion over the 2009- 2018 period. · Enacting the bill would reduce budget deficits (or increase surpluses) by a total of $6.6 billion over the ...<br /><br /><a href="http://www.pcmanet.org/cbo-biogenerics-would-save-federal-government-66-billion-over-ten-years/">Go to article</a> tag:opencongress.org,2008-06-25:/commentary/2406307 2008-06-25T00:00:00Z Director&#39;s Blog Enacting S. 1695 would reduce total expenditures on biologics in the United States by $0.2 billion over the 2009-2013 period and by about $25 billion over the 2009-2018 period. (Over that 10-year period, such savings would equal roughly ...<br /><br /><a href="http://cboblog.cbo.gov/?p=137">Go to article</a> tag:opencongress.org,2008-06-25:/commentary/2406306 2008-06-25T00:00:00Z cbo&#39;s Latest 10 Documents Cost estimate for the bill as ordered reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2007.<br /><br /><a href="http://www.cbo.gov/ftpdoc.cfm?index=9496&amp;type=1">Go to article</a> tag:opencongress.org,2008-06-25:/commentary/3842524 2008-06-25T00:00:00Z CBO's Latest 10 Documents S. 1695, Biologics Price Competition and Innovation Act of 2007. June 25, 2008. Cost estimate for the bill as ordered reported by the Senate Committee on Health, Education, Labor, and Pensions on June 27, 2007 ...<br /><br /><a href="http://www.cbo.gov/doc.cfm?index=9496">Go to article</a> tag:opencongress.org,2008-06-25:/commentary/3407377 2008-06-25T00:00:00Z Latest Biology Technology from Bio-Medicine.Org Enacting S. 1695 would reduce total expenditures on biologics in the. United States Hidden List by $25 billion over the 2009-2018. period. -- Enacting the bill would reduce budget deficits (or increase surpluses) ...<br /><br /><a href="http://www.bio-medicine.org/biology-technology-1/CBO-3A-Biogenerics-Would-Save-Federal-Government--246-6-Billion-Over-Ten-Years-6223-1/">Go to article</a> tag:opencongress.org,2008-06-24:/commentary/2519269 2008-06-24T00:00:00Z BIO Press Releases ... June 25, 2008) - Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the Congressional Budget Office (CBO) report issued today projecting cost savings from S. 1695, ...<br /><br /><a href="http://www.bio.org/news/newsitem.asp?id=2008_0625_01">Go to article</a> tag:opencongress.org,2008-05-30:/commentary/3407384 2008-05-30T00:00:00Z Managed Healthcare Executive Magazine Online Last year, leading senators developed a compromise follow-on biologics bill (S. 1695), but got stuck over language defining an exclusivity period for innovator therapies. Several biosimilar bills have been introduced in the House, ...<br /><br /><a href="http://managedhealthcareexecutive.modernmedicine.com/mhe/News+Analysis/Agreement-on-biosimilars-emerges/ArticleStandard/Article/detail/519718">Go to article</a> tag:opencongress.org,2008-01-26:/commentary/3515315 2008-01-26T00:00:00Z Open Congress : Sen. Barbara Boxer [D, CA] Bills targeted include: Climate change (S.2191), CAFE (HR5560, S.2555), Biogenerics Legislation (S.1695 et al), Railroad Antitrust Enforcement (HR1650, S.772), Ban Asbestos etc. Act (HR3339) â€â€* for other quarters, see individual links. ...<br /><br /><a href="http://www.opencongress.org/bill/110-s2555/show">Go to article</a> tag:opencongress.org,2007-12-29:/commentary/1467329 2007-12-29T03:27:41Z Patent Docs Biologics Legislation Faces Unresolved Issues By Baltazar Gomez -- We previously reported on the passage by the U.S. Senate Committee on Health, Education, Labor &amp;amp; pensions of bill <strong class="keyword">S.1695</strong>, entitled "The Biol<br /><br /><a href="http://www.patentdocs.net/patent_docs/2007/12/the-biologics-p.html">Go to article</a> tag:opencongress.org,2007-12-28:/commentary/1467327 2007-12-28T00:00:00Z Intellectual Property Law - Justia BlawgSearch.com By Baltazar Gomez -- We previously reported on the passage by the US Senate Committee on Health, Education, Labor &amp; pensions of bill S.1695, entitled &quot;The Biologics Price Competition and Innovation Act of 2007. ...<br /><br /><a href="http://blawgsearch.justia.com/visit.aspx?id=999105&amp;type=post">Go to article</a> tag:opencongress.org,2007-12-24:/commentary/3458272 2007-12-24T00:00:00Z BioPharm International - GMPs/Validation In late June, the Senate’s Health, Education, Labor, and Pensions (HELP) Committee voted in favor of the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which will address the scientific, regulatory, and legal issues ...<br /><br /><a href="http://biopharminternational.findpharma.com/biopharm/News/US-Congress-Acts-on-Follow-On-Biologics-and-FDA-Fu/ArticleStandard/Article/detail/443626">Go to article</a> tag:opencongress.org,2007-11-04:/commentary/3515316 2007-11-04T00:00:00Z Open Congress : Top 20 Bills Most Written... Bills targeted include: Climate change (S.2191), CAFE (H.R.5560, S.2555), Biogenerics Legislation (S.1695 et al), Railroad Antitrust Enforcement (H.R.1650, S.772), Ban Asbestos etc. Act (H.R.3339) â€â€* for other quarters, see individual ...<br /><br /><a href="http://www.opencongress.org/bill/110-h1650/show">Go to article</a> tag:opencongress.org,2007-10-28:/commentary/1317885 2007-10-28T00:00:00Z BIOTECHNOLOGY The Biologics Price Competition and Innovation Act of 2007 (S. 1695, or BPCIA), is the first to command significant bi-partisan support. In particular, Orrin Hatch is one of the sponsors of the new bill. This is an important move; ...<br /><br /><a href="http://nikhiltech.blogspot.com/2007/10/biosimilars-market-coming-of-age.html">Go to article</a> tag:opencongress.org,2007-10-12:/commentary/1221362 2007-10-12T00:00:00Z pharmaceuticals Generics want lowering of the 12-year exclusivity period in S. 1695 in exchange for providing a period of “new useâ€* exclusivitywhile Innovator companies want to stick with the 12-year period agreed to under S. 1695. ...<br /><br /><a href="http://mehdi-pharmaceuticals.blogspot.com/2007/10/news-general-information.html">Go to article</a> tag:opencongress.org,2007-09-19:/commentary/1133860 2007-09-19T00:00:00Z TN Health Law Update In July, the Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovative Act of 2007 (S. 1695), which lays out a pathway for approving the development of follow-on ...<br /><br /><a href="http://tnhealthlawupdate.blogspot.com/2007/09/update-on-follow-on-biologics.html">Go to article</a> tag:opencongress.org,2007-09-19:/commentary/1133859 2007-09-19T00:00:00Z Innovators Network Also on the docket are the Biologics Price Competition and Innovation Act of 2007 (S. 1695) and The Patent Reform Acts of 2007. More on intellectual property protection and what it means for drug companies and biobiz in CEO of BIO Holds ...<br /><br /><a href="http://blog.innovators-network.org/2007/09/shiver-me-timbe.html">Go to article</a> tag:opencongress.org,2007-07-23:/commentary/896813 2007-07-23T00:00:00Z FDA Law Blog Although neither the full Senate, nor the House Energy and Commerce Committee have passed similar legislation, it was widely speculated that S. 1695 (or similar legislation) would be considered in the conference committee established to ...<br /><br /><a href="http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2007/07/support-for-bio.html">Go to article</a> tag:opencongress.org,2007-07-05:/commentary/801866 2007-07-05T00:00:00Z Patent Docs By Donald Zuhn -- Last week, the US Senate Committee on Health, Education, Labor Pensions announced that it had passed the Biologics Price Competition and Innovation Act. According to a Committee press release, the bill (S. 1695) ...<br /><br /><a href="http://patentdocs.typepad.com/patent_docs/2007/07/senate-committe.html">Go to article</a> tag:opencongress.org,2007-07-02:/commentary/801865 2007-07-02T00:00:00Z Public health service 1695 would amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and it would promote innovation in the life sciences.......<br /><br /><a href="http://gl4l.com/gobble/public-health-service/14131/s-1695-a-bill/">Go to article</a> tag:opencongress.org,2007-06-30:/commentary/3407381 2007-06-30T00:00:00Z GovTrack.us Tracked Events S. 1695: Biologics Price Competition and Innovation Act of 2007. Last Action: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. ...<br /><br /><a href="http://www.govtrack.us/congress/record.xpd?id=110-s20070627-50">Go to article</a> tag:opencongress.org,2007-06-25:/commentary/774400 2007-06-25T00:00:00Z washingtonwatch.com - Welcome to washingtonwatc... S. 1695 would amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and it would promote innovation in the life sciences....<br /><br /><a href="http://www.washingtonwatch.com/bills/show/110_SN_1695.html">Go to article</a> tag:opencongress.org,2007-06-25:/commentary/3002433 2007-06-25T00:00:00Z Introduced Legislation -- Monitored by GovTrack.us Sen. Edward Kennedy [D-MA] introduced S. 1695: A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes. ...<br /><br /><a href="http://www.govtrack.us/congress/bill.xpd?bill=s110-1695">Go to article</a>