Articles by Lori Clapper

  1. FDA Initiates Programs To Improve REMS, Ease Pharma Manufacturers' Burdens 9/25/2014

    In a move to improve its Risk Evaluation and Mitigation Strategies (REMS), the U.S. Food and Drug Administration (FDA) plans to implement four pilot programs, as part of its commitments under the Food and Drug Administration Safety and Innovation Act (FDASIA). With a plan in place, the FDA is ready to "measure the effectiveness of REMS and standardize and better integrate REMS into the healthcare system."

  2. India To Conduct Nationwide Survey To Improve Drug Quality 9/25/2014

    Due to the recent increase in low quality and counterfeit drugs in India, the Indian government will be conducting what is being called “the largest nationwide survey ever conducted” to not only gage the extent of the problem, but to strategize measures to “plug the gaps” in drug quality, The Economic Times reports.

  3. Germany Initiates Plan To Expand Pharmaceutical R&D Business 9/22/2014

    The German government initiated a strategy last week that aims to attract more pharmaceutical research and development into Germany.  Government officials hope to strengthen Germany’s “international clout” and to convince the pharma industry the country is a prime locale for pharmaceutical research, development, and production. Representatives from pharmaceutical research and manufacturing sectors will participate in several rounds of discussion, which are expected to wrap up in January 2016.

  4. Servier And CTI Biopharma Enter $133.5 Million Lymphoma Drug Collaboration 9/19/2014

    Servier and CTI Biopharma have entered an exclusive license and collaboration agreement to develop and commercialize the lymphoma drug Pixuvri (pixantrone).

  5. EU Medicines Verfication System Formed To Close Supply Chain Loopholes 9/19/2014

    With recent supply chain breeches in the EU, including the counterfeit vials of  Roche’s lymphoma drug MabThera discovered in Germany last week, along with the €10 million in seized fakes across eight EU countries earlier in the month, the European Federation of Pharmaceutical Industries and Associations (EFPIA) holds high hopes that its pan-European medicines verification system will deter thieves and counterfeiters in Europe’s pharma supply chain. 

  6. India Faces Crisis Shortage Of HIV/AIDS Treatments 9/16/2014

    Hundreds of thousands of HIV/AIDS patients in India may not be getting the life-saving drugs they need because of delays in the HIV/AIDS medication procurement process. Now, the country, which is home to the third largest number of AIDS patients in the world, faces a drug shortage.

  7. Mylan To Market Generic Arixta, Launches Osteoporosis Med 9/12/2014

    It was a busy week for Mylan, with its announcement that its subsidiary Mylan Ireland Limited will acquire the U.S. commercialization, marketing, and intellectual property rights of Aspen Global’s Arixtra (fondaparinux sodium) Injection and the authorized generic version. Both are used to treat deep vein thrombosis (DVT), which could lead to the development of pulmonary embolism (PE) following complications in various surgery situations.

  8. Why Are Indian Drug Makers Heading Overseas? 9/11/2014

    India’s Domestic generic pharmaceutical companies may be snubbing opportunities in their homeland in lieu of promising R&D capabilities overseas. The complaint? Too much red tape.

  9. India Drug Market Expands, Eyes Potential Opportunities in South America 9/10/2014

    Riding on the coattails of Argentina’s move to permit Indian finished drug imports last month, officials in Peru now plan to investigate the loan licensing system in India.  A loan-licensing system is essentially a form of contract manufacturing, as a small or medium sized pharma company can utilize another company’s licensed manufacturing facility to create drugs targeted for a particular market, The Business Standard says.

  10. New Serialization Guidance Published in Brazil 9/10/2014

    Brazilian drug regulator ANVISA has published the country’s new guidance for its pharmaceutical track-and-trace system, revealing what specific information will have to be submitted to ANVISA and distributed between parties in the supply chain.