OLD DRUGS, NEW LIGHT

Researchers are dusting off some old malaria remedies and finding new uses for them. In one case, researchers from the Harvard School of Dental Medicine recently uncovered the scientific secrets behind a root extract from a type of hydrangea native to Tibet and Nepal, known as Chang Shan, which Chinese herbalists have been using for thousands of years as a treatment for malaria.

Halofuginone (HF), a compound derived from this extract’s bioactive ingredient, has long been suspected to be a potential treat- ment for several autoimmune disorders, and now we may know why. In their current study, published online in Nature Chemical Biology, the researchers reveal that HF triggers a stress-response pathway that blocks Th17 cells, which are associated with many autoimmune disorders such as inflammatory bowel disease, rheumatoid arthritis, multiple sclerosis, and psoriasis.

“This study is an exciting example of how solving the molecular mechanism of traditional herbal medicine can lead both to new insights into physiological regulation and to novel approaches to the treatment of disease,” Tracy Keller, an instructor in developmental biology at Harvard School of Dental Medicine and the first author on the paper, said in a statement.

Meanwhile, hydroxychloroquine (HCQ), another malaria treat- ment (although not quite as old) first approved by the FDA in April 1955, is being paired with cancer therapies—chemotherapy, targeted therapy, radiation, immunotherapy—to enhance the antitumor activity of these drugs. This approach blocks autophagy, which is the process of “self-eating” within cells or, more precisely, when the acidic inner cell part chews up proteins for recycling. Autophagy is increased in cancer cells.

Currently, approximately 30 Phase I and II clinical trials involving HCQ have been launched or are in the planning stages for cancers such as melanoma, multiple myeloma, renal cell carcinoma, colon cancer, prostate cancer, and breast cancer. —A.M.

FDA

The FDA was busy last month. Not only did the agency announce the parameters of a new medical device user-fee program, but it also issued three new guidance documents on biosimilar product development.

MEDICAL DEVICE

The agency reached an agreement with the Advanced Medical Technology Association and other medical device trade associations on performance goals that will improve the medical device review process as part of the third reauthorization of the Medical Device User Fee Act.

The performance goals include: reducing total review times, achieving significant performance improvements for premarket approval (PMA) and 510(k) applications, requiring FDA to meet with companies if a performance goal on a PMA or 510(k) is missed and work out a plan for completing the submission, providing interaction with applicants halfway through the targeted time for completion

of review to ensure that the company has adequate time to respond to questions, and implementing an analysis of the FDA’s management of the review process by an independent consulting organization.

The agreement provides the FDA with $595 million in funds over five years, which will allow the agency to hire more than 200 full-time-equivalent workers and help to improve accountability, predictability, and transparency.

BIOSIMILARS

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product is intended to help companies demonstrate that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a 351(k) application.

Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the 351(k).

And Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 provides answers to common questions from people interested in developing biosimilar products in an easy to reference Q&A format. —AndrewMatthius

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