Category: Biotech/Pharma News

  • "Biotech/Pharma" Top 50 (+1)     By Donald Zuhn — On Monday, the Intellectual Property Owners Association (IPO) released its annual list of the top 300 organizations receiving U.S. patents in 2006.  The IPO’s release of the list comes three months after the U.S. Patent & Trademark Office (PTO) announced that it would no longer…

  •     By Kevin E. Noonan — The recent first Office Action in the re-examination of the Thomson stem cell patents before the U.S. Patent and Trademark Office (see "WARF Stem Cell Patent Claims Rejected in Re-examination") has predictably resulted in press releases and commentary regarding these patents.  However, while the Patent Office has initially…

  •     By Donald Zuhn — On Tuesday, Abbott announced that it had reached an agreement with World Health Organization (WHO) Director General Margaret Chan to reduce the price of its Kaletra/Aluvia (lopinavir/ritonavir) AIDS drugs in the developing world.  In particular, Abbott will be offering the drugs to about forty low and low-middle income countries…

  •     By Kevin E. Noonan — Single nucleotide polymorphisms (SNPs) have been detected since the beginning of the third revolution in genetics characterized by cloning, sequencing, and the various organismal genome projects (rediscovery of Mendel’s laws being the first and Watson and Crick’s elucidation of the structure of DNA being the second).  SNPs were…

  •     By Kevin E. Noonan The Wisconsin Alumni Research Foundation (WARF) owns the most significant U.S. patents protecting human embryonic stem cell technology.  These patents, U.S. Patent Nos. 5,843,780 (claiming primate embryonic stem (pES) cells); 6,200,806 (claiming human embryonic stem cell (hES) cells); and 7,029,913 (hES) (collectively, the Thomson patents) were challenged in a…

  •     By Christopher P. Singer Transition Therapeutics, Inc. announced in an April 3, 2007 press release that its investigational Alzheimer’s disease drug, AZD-103/ELND005, developed in collaboration with Elan Corporation, plc has received Fast Track designation from the FDA.  The drug is currently undergoing Phase I clinical trials, and is expected to enter Phase II…

  •     By Mark Chael — On March 30, 2007, Cephalon, Inc. announced that it had received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding Cephalon’s Nuvigil® (armodafinil) new drug application (NDA).  The approvable letter was accompanied by draft labeling that includes a proposed warning section in bold type describing a…

  •     By Christopher P. Singer — In a March 29, 2007 press release Baxter International, Inc. announced that it will begin a Phase III clinical trial for an adjuvant-free vaccine against the H5N1 strain of influenza.  The Phase III trial will be conducted in Europe in the first half of 2007, with results expected…

  •     By Kevin E. Noonan — Indonesia fulfilled its earlier promise (see "Bird Flu Flying to WHO Again") to provide the World Health Organization (W.H.O.) with samples of H5N1 strains of influenza virus (otherwise known as "bird flu"), according to The New York Times (see "Indonesia to Send Bird Flu Samples, With Restrictions").  However,…

  •     By Kevin E. Noonan — Somewhere between Darwin’s On the Origin of Species and Watson and Crick’s discovery of the double helix, biology changed from its roots as "natural history" into a modern science.  Biology (and biologists) retain some residual fondness for the "butterfly collecting" aspects of the profession, however; something illustrated by…