Tag Archives: United States

  • Lean Manufacturing: What it means to the Pharmaceutical Industry

    Over the past decade or so, the pharmaceutical industry has sporadically attempted to embrace lean manufacturing. While a manufacturing philosophy that aims to reduce waste and boost productivity would certainly appear to be a good partner for this industry, so far the results have been less that optimum. This does not have to be the case, however.

  • Is the Pharmaceutical Industry Going Green?

    Recent reports coming out of Europe and the United States are all showing that the pharmaceutical industry, at large, is taking tremendous steps into “Going Green”, so to speak.  Because of the recent economic decline, as well as market uncertainty, and overall economic uncertainty plaguing the Big Pharma industry, many pharmaceutical companies are doing whatever it takes to cut costs, and that includes looking for cheaper alternatives.  Recent studies indicate, that many large …

  • AAI, CONSUMER GROUPS ENCOURAGE CONGRESS TO BAN PATENT SETTLEMENTS AND RESTORE COMPETITION IN MARKET FOR GENERIC DRUGS

    Seven of the leading consumer groups in the United States, the American Antitrust Institute, Consumers Union, Families USA, The National Legislative Association on Prescription Drug Prices, Consumer Federation of America, US PIRG and Community Catalyst wrote to Speaker Pelosi and Majority Leader Reid asking Congress to include a per se ban on reverse payments in the revised healthcare reform legislation. Here is the official press release from AAI AAI, CONSUMER GROUPS ENCOURAGE CONGRESS TO BAN …

  • Novel Stem Cell Technology for Bone Fractures Developed

    … options: amputation or long periods of disability.  Equally, prosthetic implants have proven inefficient in the long term.  When there is too much loss of bone, the fracture may not heal, and this is the case of more than a million people per year, just in the United States. In the last years, there have been promising advances for biological therapy to treat complicated fractures and skeleton disorders, specifically by using mesenchymal or multipotent stem cells (MSC’s), which can …

  • Advances in Chikungunya Virus DNA Vaccine

    … weakening joint pain, and it could take over a year to cure. It has been discovered that different mosquitoes normally found in developed countries, including Europe and the United States, can transmit the Chikungunya virus, making it a threat for people in other geographies outside its territories of origin.  The virus is already prevalent in several world regions and clearly has epidemic potential. Currently, there are no vaccines in the market to treat this virus.  The truth is that very …

  • CDER’s Small Business Assistance Bulletin

    … auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Disintegration Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions …

  • Looking for Money in New Places

    … behind.  The outcome of these is obvious, serious liquidity issues. It has been established that 25% of the 370 public biotech companies in the United States possess less than six months worth of cash, and private companies are probably in worse shape, making it urgent to find money and credit lines in new ways.  But, how? 1.    When a firm requires short-term liquidity it should look for the help of existing private investors who already have gambled on a company’s future.  Doing this …

  • Biosimilars at Full Speed

    … patents in the next few years.  To date,  the progress has been  slow, with a great vdeal of attention centered on three crucial concerns that will probably determine the future of the whole pharmaceutical market: 1.    A regulatory deal is almost certain To date,  the nonstop backbiting between the FDA, Congress and interested parties, along with the lack of a regulatory trail for biosimilars in the United States, has contributed to an overwhelming market expansion inside and outside the …

  • The Future Lies in Two Words – Emerging Markets

    It is no surprise that as emerging markets, like China and India, continue to grow at a record pace, that drug makers all over the world need to wake up to the fact that the future of their business may depend on markets outside of the United States and Europe.  As these emerging markets in China and India, as well as Brazil continue to grow full speed ahead, it is becoming more evident to the pharmaceutical industry as a whole, that they better start paying more attention to these parts of the …

  • Importation Law and Mandatory FDA Inspections

    Not too long ago, a bipartisan group of senators in the United States introduced legislation that could spell big problems for the pharmaceutical industry.  The “Pharmaceutical Market Access and Drug Safety Act” is a piece of legislation being pushed through the Senate to immediately reduce drug prices for consumers, which will ultimately force the Bio-Pharma Industry to have to drastically reduce the price of drugs here in the United States.  According to the Congressional Budget …

  • Why the Pharmaceutical Industry Needs to Adapt to Emerging Markets

    … pharmaceutical markets in the world were the United States, Japan, and Europe, accounting for nearly 75% of the growth in the global pharmaceutical marketplace.  Now compare that to today, where these major markets only account for nearly 45% of the global pharmaceutical growth rate, whereas the emerging markets have jumped from 8% to nearly 30% in this same period.  And this trend is only suspected to grow. While Europe and the US and Japan, are seen as the major players in the pharmaceutical …

  • Scenarios For Health Care Reform

    With the health care debate raging in the United States, many experts have already forecasted many possible scenarios for what could be the end result, but are they accurate? As lawmakers continue to wrestle over such issues as the public option, and extending coverage to the uninsured, there is no debate that the government is looking to cut costs in the health care system, which could spell trouble for the pharmaceutical industry.  The pharmaceutical industry knows that with health-care …