From RPM: Building a Business in Drug Safety
Marketing a portfolio of high-risk drugs is a precarious proposition but Celgene Corp.has turned it into a profitable business model. Extreme risk management is not for everyone: it works best for high-price specialty products. Celgene has two products under risk management programs: thalidomide (Thalomid) and lenalidomide (Revlimid). Amylin Pharmaceuticals Inc. and Intarcia Therapeutics Inc. are also interested in risk management programs.
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One way for Pharma to bolster its lagging growth would be to capture some of the value of the compounds it has shelved during development. Start-ups have created technology platforms and systems biology approaches and are in place to reposition such stalled drugs in new indications, or to reformulate marketed compounds to extend the product life cycle. Nonetheless, drug firms largely remain reluctant to part even with compounds they have decided not to develop themselves. Drug makers say the issue is resources, but it is also desire. Until Big Pharma further loosens its grip on its compounds that are stalled in development, in-licensing will remain an opportunistic, case-by-case exercise, and biotechs must accept the fact that access will depend largely on advance insider knowledge of pharma firms' pipelines.
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.