The market resurrection of Tysabri demonstrates the power of risk management but raises a tough question: how far can FDA and industry go into the practice of medicine? Biogen Idec declare they are nt trying to tell doctors how to practice. The strict rules of the risk management plan suggest otherwise.
By Ramsey Baghdadi
"We are not trying to become the surrogate doctor," Biogen Idec Inc. EVP-development Burt Adelman told investors during a...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
