PharmExec Blog

NIH Translational Research Partnership Yields Promising Therapy

A potential treatment for sickle cell disease has come through the “valley of death” of early stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The results of early clinical trials demonstrated sufficient effectiveness in addressing the underlying cause of this high-profile disease to attract commercial interest – in this case from Baxter International, which announced July 9, 2014 the acquisition of Mass.-based AesRx and its experimental drug Aes-103, a small-molecule, oral drug for SCD.  Read More »

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Is There Potential for Growth in Brazil’s Phytotherapic Drug Market?

It is well known that Brazil has an immense biodiversity and that the Amazon is the largest tropical rainforest in the world. Traditional Brazilian medicines include African elements, rooted on indigenous groups. Few pharmaceutical companies, however, know at what level phytotherapic drugs are commercialized in the country, how much regulation is imposed for herbal medicines, and if there are any opportunities in this unspoken, mysterious market in Brazil.

Dozens of studies link Brazil’s herbal medicines to successful treatments and cures of various ailments. According to Japanese scientists, there is strong anticancer activity in certain Brazilian traditional medicines (e.g., basic and applied studies for physiological activities of Brazilian traditional medicine). Another study analyzed antifungal properties of plants used in Brazilian traditional medicine against clinically relevant fungal pathogens. One more study made a comparison between ethnopharmacology in traditional Chinese medicine and Brazilian popular phytotherapy.

One would suppose that due to the potential of the market, there would be dozens of companies investing in the sector. This potential, however, is not translating into market growth, according to industry sources.

So why is the herbal drugs market in Brazil almost completely undiscovered and profoundly undeveloped? Is there any real potential for new or existing companies to enter this market?

Hellen Berger addresses these questions and more in this Pharmaceutical Technology article.

 

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EMA Responds Robustly to Conflict-of-Interest Claims

By Philip Ward, Applied Clinical Trials.

The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area. Read More »

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The Medical Technology Disconnect

By Doug Mowen.

The medical technology industry has a legacy of creating life-enhancing, life-extending products while rewarding its investors in the process. In fact, this connection between innovation and profitability has been a fundamental driver in the C-suites and boardrooms of many medical device, diagnostics and equipment companies.

But change is underway. Dominating external forces are disrupting the traditional strategies of medical technology leaders. Companies face greater economic pressures, a reformed healthcare system, new hospital and physician alignments, and new technological challenges. Read More »

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Industry Seeks Clearer Track-and-Trace Standards

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain, writes Jill Wechsler.

Beginning Jan. 1, 2015, manufacturers and distributors will need to have in place systems able to transmit information on prescription drug movement in the United States from plant, to packagers and various wholesalers and distributors, and ultimately to dispensers. FDA is charged by the Drug Supply Chain Security Act (DSCSA), a key component of the Drug Quality and Security Act (DQSA) of 2013, to issue guidance and rules for establishing such a process and is consulting with all stakeholders on viable approaches and policies (1).

FDA held a public workshop in May 2014 (2) to gain input from manufacturers and other supply-chain parties on developing standards for what eventually will be an interoperable tracking system for prescription drugs. FDA officials and industry leaders further reviewed DSCSA requirements, along with broader supply-chain security issues, at a June conference in Washington, D.C. sponsored by the Parenteral Drug Association (PDA). Read More »

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