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Sep 15, 2016
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The much anticipated multiple sclerosis drug from Roche, ocrelizumab, has overtaken Merck’s Rebif according to the results of Phase III data, and has also shown great stats that could prove that it might have an edge in the hotly contested market. If the candidate is approved, Ocrevus is expected to be a tough rival, given its data in progressive MS; no other MS drug has yet proven to be effective in those hard-to-treat patients, and that success is expected to help Ocrevus in the market as well.
The researchers from the Office of Prescription Drug Promotion and RTI International analyzed 65 sites for branded cancer meds, and found out that almost all of them cited specific numbers on their effectiveness and side effects- which is not enough. It has not come as a surprise as the regulations require disclosure of effectiveness as well as side effects. The FDA agency has also found that these sites list far more treatment benefits as compared to risks, and are seriously harming the patients by providing incomplete information.
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The Compliance to the US Food and Drug Administration norms might turn out to be a costly affair for Indian Pharma companies. The main reflection of this is in the way legal and professional costs have surged for many companies, more than some’s annual revenues. For 135 listed pharma companies, this has jumped threefold to Rs 5,071 crore in past five years, based on their annual reports.
Takeda has shown a great shift in R&D philosophy after it set aside the major part of drug research and development responsibilities and took up other development deals in oncology, vaccines and CNS. Also, it has set aside close to $15 billion for M&A deals in the USA, to buy companies that fit in with the vision Takeda has for itself.