drug development

Welcome to the 'drug development' tag page at Technorati. This page features content from the farthest reaches of the Blogosphere that authors have "tagged" with 'drug development'.

Latest blogosphere posts tagged “drug development”

• FDA Finalizes Guidance on the Use of Patient-Reported Outcomes to Support Labeling Claims

  
  FDA Law Blog — Authority: 469
  By Nisha P. Shah – On December 8, 2009, the Food and Drug Administration ("FDA") issued its final, non-binding guidance for industry on “ Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims .”  A draft guidance was published in February 2006.  The final guidance ...
  13 hours ago

• Scandal, Swine Flu, Shareholder Disputes, and More: 2009 Was Quite a Year for San Diego’s Life Sciences Industry

  
  Xconomy — Authority: 663
  Life Sciences , Biotech , Drug Development Denise Gellene wrote: Covering the life sciences in San Diego is never dull, and the news flow last year provided plenty of drama. What follows are some highlights from the past year: — Embattled tools company Sequenom (NASDAQ: SQNM ) scuttled the debut of ...
  1 day ago

• Citizen Petition Requests FDA’s Confirmation that Prescription Prenatal Vitamins are GRAS/E

  
  FDA Law Blog — Authority: 469
  By Riëtte van Laack – Earlier this month, a citizen petition was submitted to FDA requesting that the Agency issue an order confirming that prescription prenatal vitamins containing 1-4 mg folic acid, either alone or in combination with other vitamins and minerals, and used to reduce the risk of neural tube ...
  3 days ago

• Michael Merzenich on Brain Training, Assessments, and Personal Brain Trainers

  
  SharpBrains — Authority: 456
  Dr. Michael Merzenich , Emeritus Professor at UCSF, is a leading pioneer in brain plasticity research. In the late 1980s, Dr. Merzenich was on the team that invented the cochlear implant. In 1996, he was the founding CEO of Scientific Learning Corporation (Nasdaq: SCIL), and in 2004 became co-founder and Chief ...
  6 days ago

• Physician Reporting Obligations: New Jersey’s Proposed Conflict of Interest Regulations Go a Step Further

  
  FDA Law Blog — Authority: 469
  By Carrie S. Martin – New Jersey’s Attorney General recently endorsed a report prepared by the Division of Consumer Affairs (the “Division”), recommending certain restrictions and obligations on physicians and industry to limit potential conflicts of interest.  Many of the recommendations are similar to ...
  1 week ago

• Reimportation of Drugs Promises to Destroy Innovation

  
  BizPlusBlog.com — Authority: 120
  Innovation in health care, particularly in the area of developing new drugs, is one of the crowning achievements of US health care. According to Forbes Magazine, 80 percent of all new drugs are developed in the United States and one of the primary reasons for this is because companies still have an incentive to do ...
  1 week ago

• Court Rejects FDA’s Interpretation of “Affiliate” in PDUFA User Fee Case As Contrary To Plain Language

  
  FDA Law Blog — Authority: 469
  By Nisha P. Shah & Michelle L. Butler – We recently blogged about an action commenced by Winston Laboratories, Inc. (“Winston”) against FDA, which denied a small business waiver for a new drug application (“NDA”) user fee under the Prescription Drug User Fee Act.  See Winston Labs, Inc. v. ...
  1 week ago

• Guest Q&A: Dr. Brad Spellberg and RISING PLAGUE

  
  Superbug — Authority: 120
  Im thrilled today to present another guest blogger : Dr. Brad Spellberg , associate professor of medicine at the David Geffen School of Medicine at UCLA and author of the new book Rising Plague: The Global Threat from Deadly Bacteria and Our Dwindling Arsenal to Fight Them (Prometheus Books) . This new book ...
  1 week ago

• GAO Finds Continued Need for FDA Drug Postmarket Safety Oversight Improvement; Seeks Timeline for Transfer of Certain Protocol Reviews from OND to OSE

  
  FDA Law Blog — Authority: 469
  By Jamie K. Wolszon – The U.S. Government Accountability Office (“GAO”) released a report earlier this week finding that FDA’s postmarket drug safety decision-making and oversight, while improved since a prior investigation a few years ago, continues to have gaps.  The GAO recommended that FDA establish ...
  1 week ago

• Adamis Merges with La Jolla Pharmaceutical

  
  Xconomy — Authority: 663
  Merger , Biotech , Drug Development Bruce V. Bigelow wrote: San Diego’s La Jolla Pharmaceutical, which was unable to muster a sufficient number of investors to approve its liquidation plan , has agreed to a merger with Adamis Pharmaceuticals, a Del Mar, CA, biotech with shares that trade ...
  2 weeks ago

• H1N1 influenza adopted novel strategy to move from birds to humans

  
  Science Blog - Science news straight from the source — Authority: 629
  The 2009 H1N1 influenza virus used a new strategy to cross from birds into humans, a warning that it has more than one trick up its sleeve to jump the species barrier and become virulent. Link:  http://www.berkeley.edu
  2 weeks ago

• FDA Approves Over-the-Counter Version of Santarus Drug, Pioneer of Algal Biofuels Says Algae Will Make Drugs Too, Receptos Gets $25M, & More San Diego Life Sciences News

  
  Xconomy — Authority: 663
  Roundup , Life Sciences , Drug Development Bruce V. Bigelow wrote: San Diego’s biotech news picked up in pace following the Thanksgiving holiday, with Phenomix announcing a major partnership, Santarus benefitting from FDA approval of its over-the-counter heartburn drug, and Receptos getting a VC ...
  3 weeks ago

• Nervy research: Researchers take initial look at ion channels in a model system

  
  Science Blog - Science news straight from the source — Authority: 629
  Before one of your muscles can twitch, before the thought telling it to flex can race down your nerve, a tiny floodgate of sorts -- called an ion channel -- must open in the surface of each cell in these organs to let in the chemical signals that spur the cell to action.
  3 weeks ago

• WLF Supports Allergan’s Challenge to FDA’s Policies on Off-Label Speech

  
  FDA Law Blog — Authority: 469
  By Carrie S. Martin –       On November 19, the Washington Legal Foundation (“WLF”), along with three other organizations, filed an amicus curiae brief in support of Allergan, Inc.’s First Amendment challenge to FDA’s ban on “truthful, accurate and nonmisleading speech” proactively ...
  3 weeks ago

• A Sapphire Energy Co-Founder Sees Solutions in Algae for Drugs as Well as Biofuels

  
  Xconomy — Authority: 663
  Algae-based technologies , Drug Development , people Denise Gellene wrote: The potential of algae as a clean energy source has been generating a lot of entrepreneurial excitement in San Diego. At last count, 10 local companies are busy working on technologies focused on transforming ordinary pond scum ...
  3 weeks ago

• Scripps research study describes new tool in the fight against autoimmune diseases, blood cancers

  
  Science Blog - Science news straight from the source — Authority: 629
  Jupiter, Florida, November 30, 2009 -- A study led by a Scripps Research Institute scientist describes a new, highly pragmatic approach to the identification of molecules that prevent a specific type of immune cells from attacking their host.
  3 weeks ago

• Scripps research study describes new tool in the fight against autoimmune diseases, blood cancers

  
  Science Blog - Science news straight from the source — Authority: 629
  Jupiter, Florida, November 30, 2009 -- A study led by a Scripps Research Institute scientist describes a new, highly pragmatic approach to the identification of molecules that prevent a specific type of immune cells from attacking their host.
  3 weeks ago

• Recent Preemption Decisions Offer a Mixed Bag for Generic Drug Manufacturers

  
  FDA Law Blog — Authority: 469
  By Kurt R. Karst –     Returning from the Thanksgiving Holiday, we found our inbox chock-full of recent preemption decisions of note involving generic drugs.  First off is a decision from the U.S. Court of Appeals for the Eighth Circuit in Mensing v. Wyeth .  That case involves generic REGLAN ...
  3 weeks ago

• Georgia Federal District Court Grants Defendant’s Motion For Summary Judgment in Lanham Act Suit Involving Two Unapproved Drugs

  
  FDA Law Blog — Authority: 469
  By J.P. Ellison –       Earlier this month a federal district court in Georgia granted summary judgment  in a Lanham Act suit that raised a number of FDA issues.  The plaintiff in the suit manufactured two prescription acne products under the trade name Benziq.  Defendant manufactured two products ...
  3 weeks ago

• Antibiotics - the EU pipeline is empty too

  
  Superbug — Authority: 120
  Weve talked before about the shrinking number of drugs available to treat MRSA and about the challenges of getting new drugs to market . Well, its not just a problem in the United States. A new report from the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency ...
  3 weeks ago

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