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Category: Biosimilars
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By Donald Zuhn — Yesterday, Rep. Anna Eshoo (D-CA) (at right) provided an alternative to Rep. Henry Waxman's (D-CA) follow-on biologics bill, when she introduced the Pathway for Biosimilars Act (H.R. 1548). Rep. Waxman had introduced his own bill (H.R. 1427; the Promoting Innovation and Access to Life Saving Medicines Act) last week. The…
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By Donald Zuhn — It appears that Representative Henry Waxman (D-CA) (at right) will be the first to introduce a follow-on biologics bill in the 111th Congress. According to a Reuters report, Rep. Waxman has initiated a bipartisan effort to create a follow-on biologics regulatory pathway in the United States. Rep. Waxman, who was…
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By Kevin E. Noonan — The Biotechnology Industry Organization (BIO) held one of its periodic meetings with the press today for a wide-ranging discussion of its policy goals and agendas for the new Congress and administration. A panel of BIO officials, headed by President and CEO James Greenwood, answered questions from more than a…
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By Donald Zuhn — Congressman Henry Waxman (D-CA), the Chairman of the House Committee on Energy and Commerce, addressed the Generic Pharmaceutical Association (GPhA) yesterday, telling attendees of the trade group's annual meeting in Naples, FL that "a workable scientific regulatory and legal pathway for biogenerics and biosimilar pharmaceuticals will ensure more affordable medications…
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By Donald Zuhn — Innovators Looking for Help from Follow-on Biologics Last week, Merck announced that it had acquired Insmed's portfolio of follow-on biologic therapeutic candidates as well as its biologics manufacturing facilities in Boulder, CO (see "Biotech/Pharma Business Briefs"). While the timing and target of the acquisition may have been somewhat surprising, Merck's…
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By Donald Zuhn — In an interview with TechJournal South, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood discussed the state of the biotech industry and the biotech issues the new Administration will be facing in the coming year (see "BIO President Sees Biotech Industry Challenges for New Administration"). Mr. Greenwood told the…
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By Donald Zuhn — Earlier today, in a historic moment on the steps of the U.S. Capitol, Barack Hussein Obama was sworn in as the 44th President of the United States. Tomorrow, his Administration will begin to tackle the many serious issues that face our country (the Administration's agenda can be found on the…
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By Donald Zuhn — On New Year's Day, we counted down the first four of the top thirteen stories covered on Patent Docs in 2008 (see "Top Stories of 2008: #13 to #10"). Today, we count down stories #9 to #6, and tomorrow, we will count down last year's top five stories. In case…
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By Donald Zuhn — In November, we noted that the nation's largest mail order pharmacy, Franklin Lakes, NJ-based Medco Health Solutions, Inc., had announced that consumers could expect to see the establishment of a follow-on biologics regulatory pathway in the United States by 2011 (see "Medco Predicts Follow-on Biologics Regulatory Pathway by 2011"). Medco…
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By Donald Zuhn — Earlier this month, we reported on the lobbying efforts of nine biotech/pharma companies and organizations in the third quarter of 2008 (see "Biotech/Pharma Lobbying Scoreboard – Third Quarter Update; BIO Lobbies for Biotech 'Bailout'"). Recent news reports have allowed us to add thirteen biotech/pharma companies and a trade group to…
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