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Biologic approvals in 2008
Amgen (Thousand Oaks, California), Regeneron (Tarrytown, New York), ViroPharma (Exton, Pennsylvania) and ZymoGenetics (Seattle, Washington) all received US Food and Drug Administration (FDA) approvals last year for novel types of biologics (Table 1). For a full list of FDA approvals of drugs from public biotech companies, see Supplementary Table 1 online.
Table 1 Selected biologic approvals from public biotech companies in 2008a Company/partner Product (generic) Indication Amgen Nplate (romiplostim, a 60-kDa Thrombocytopenia in adults with peptide with a thrombopoietin idiopathic thrombocytopenic receptor (Mpl)-binding domain purpura Biogen Idec (Boston)/ Tysabri (natalizumab) Moderately to severely active Elan (Dublin) Crohn’s disease Cangene (Winnipeg, Accretropin (somatropin) Growth failure in children with growth Manitoba, Canada) hormone deficiency and short stature associated with Turner’s syndrome Genentech (S. San Francisco, Avastin (bevacizumab) Metastatic breast cancer California)/Roche (Basel) Regeneron Arcalyst (rilonacept, single-chain CIAS1-associated periodic fusion of the extracellular binding syndrome domains of interleukin (IL)-1 receptor I and IL-1 receptor accessory protein coupled to Fc portion of a human IgG) ViroPharma Cinryze (serum-derived Prevent angioedema attacks in complement factor C1-esterase individuals with hereditary angioe- inhibitor) dema ZymoGenetics (Seattle)/ Recothrom (recombinant General aid to achieving hemostasis Bayer (Leverkusen, Germany) thrombin) during surgery aAs defined by Nat. Biotechnol. 26, 753–762 (2008).
in their words
“If people don’t want to “It’s practically a paradise for conducting clinical buy bonds in General trials.” © All rights reserved. 2009 Inc. Nature America, Electric, what’s going A spokesperson for Quintiles, the world’s largest to make them want to contract research organization, on the company’s invest in an early-stage success in enrolling 204 infants for a vaccine study biotech company?” in just three days in India. (Pharmalot, December Randy Scott, chairman 18, 2008) of Genomic Health, laments the bleak “The senator’s worried that something’s situation that biotechs ghostwritten. I mean, give me a break.” face in raising capital Lila Nachtigall, a New York University professor in the current financial climate. (The Wall Street and director of its Women’s Wellness Center, on Journal, January 11, 2009) Senator Charles Grassley’s enquiry into the role of Wyeth in the writing of a journal article she authored “Whatever it takes to make friends and influence extolling hormone treatment. (The New York Times, people—whether it’s building a school or December 12, 2008) handing out Viagra.” “2009 will be a year A CIA operative on how the agency occasionally of anticipation for the wins over Afghanistan warlords by offering venture capital industry as Pfizer’s (New York) impotence drug. (Washington the economic turmoil will Post, December 26, 2008) engender a fair amount of Darwinian change.” “Practically anything you can put a name onis National Venture Capital branded in a doctor’s office, short of branding, Association President Mark like a Nascar driver, on the doctor’s white coat.” Heesen celebrates the Physician Robert Goodman decries pharma’s bicentenary of Darwin’s marketing efforts to brand almost everything birth by suggesting it will in the doctor’s office. (The New York Times, be survival of the fittest in the biotech sector. (NVCA December 30, 2008) press release, December 18, 2008)
nature biotechnology volume 27 number 2 february 2009 105