Tag Archives: pharma news

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues. For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues. For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, …

  • Guilty as Charged: The Premature Stop of Clinical Trials Exaggerates the Effects of Treatment

    A study of almost 100 clinical trials that were stopped prematurely because they showed positive treatment effects has shown that a large number of those effects were exaggerated. The study was published in the Journal of the American Medical Association and recommends that researchers do not fall for the temptation to end clinical trials prematurely but rather continue with them for longer periods of time before thinking about ending them. Victor Montori, M.D., Mayo Clinic endocrinologist and …

  • Could a Shot of Tequila Be What People Suffering from Bone Loss Need?

    According to Mexican researchers, agave, the plant from which tequila is made, may help fight osteoporosis and other bone diseases through one of its components. Agave, as well as artichokes, garlic, onions, and chicory, is a powerful natural source of fructans, non-edible carbohydrates that consist of molecules of fructose joined together into chains. Experimental studies indicate that fructans could be helpful for patients with diabetes or obesity, to stimulate the immune system, to decrease …

  • Glaxo and Pfizer Will Provide Pneumonia Vaccines

    Starting now, and for the next 10 years, developing countries will start receiving pneumonia vaccines from GlaxoSmithKline and Pfizer Inc. GAVI Alliance, the public-private partnership based in Geneva, recently announced this new commitment.  The program GAVI established to treat pneumococcal disease initially received $1.5 billion in funding, which came from the Italian, U.K., Canadian, Russian, and Norwegian governments, and from the Bill & Melinda Gates Foundation. This new development …

  • FTC Commissioner Rosch Will Speak at ACI’s Pharmaceutical Antitrust Forum

    FTC Commissioner J. Thomas Rosch will speak about the three main areas of antitrust concern for pharma manufacturers, at ACI’s 5th Annual In-House Counsel Forum on Pharmaceutical Antitrust, to take place at the Helmsley Park Lane Hotel in New York City on February 17th and 18th, 2010. The three areas he will cover are: –    Reverse settlement payments –    Authorized genetics –    Pharmaceutical mergers In past months, a consensus position by DOJ and the FTC has been …

  • New and Amazing Discoveries on the Development of Cells

    A group of top researchers is focusing on understanding how an embryo’s developing pancreas recognize which cells produce insulin and which ones have other functions.  This understanding is crucial in the use of stem cells, developed into beta cells that produce insulin, to treat type-1 diabetes. Today, Lund University scientists have new discoveries to announce in this regard, and they will do it in the journal Cell, which is one of the top biomedical journals. Diabetes researcher Henrik …

  • Advances in Chikungunya Virus DNA Vaccine

    A leader in vaccine design, development, and distribution, Inovio Biomedical Corporation, informed that its SynCon™ Chikungunya virus DNA vaccine generated protective neutralizing antibody responses in a monkey model. The Chikungunya virus is a new alpha virus carried by mosquitoes that originated in tropical Africa and Asia.  It has been known to have an infection rate of up to 45%.  Although not life threatening, this virus causes acute human morbidity, presenting serious fever and …

  • The 6 Crucial Principles in Pharmaceutical Leadership

    Pharmaceutical companies have to develop a leadership approach to effectively deal with today’s confusing business climate, while at the same time address and rise above any cultural differences that could limit the value of development. Nowadays, leadership is the key to maintaining competitive advantage in the market, thus, pharma companies must center on developing leaders to face the coming global challenges. Even though a group of leaders from different regions may think they have reached …

  • How to Prepare for the New Structure for Approval of Follow-on Biologics

    Under the Hatch-Waxman Act, every generic candidate has to give the holder of the approved New Drug Application (NDA) notice of the filing of the ANDA.  As soon as they receive it, in turn it files a patent infringement lawsuit that starts a thirty-month stay, making it impossible for the FDA to approve the ANDA without a final court judgment favoring the generic candidate. With the proposed HR 1427 and HR 1548, the generic candidate has to notify the Biologic License Application (BLA) holder …

  • Patent Holders, Watch Out!

    No matter what happens with the biosimilar legislation, patent holders will have to go through their patent files carefully. The current generic drug industry was born from the Hatch-Waxman Act of 1984.  Among its creations, this Act accounts for a specialized form of patent litigation called Abbreviated New Drug Application (ANDA) litigation.  The Act defined an abbreviated approval process for small molecule drugs’ generics; however, it didn’t establish a structure for approving …