3 days, 5 approvals-Celgene, AbbVie, Roche meds push FDA tally to 23 for the year

FiercePharma | August 19, 2019

3 days, 5 approvals-Celgene, AbbVie, Roche meds push FDA tally to 23 for the year
Lawmakers may have left the nations capital for summer vacation, but regulators at the FDA are staying busy. The agency churned out five approvals just last week from companies large and small and five more decisions are due by months end. Three of last weeks green lights opened the way for launches worth half a billion or more in annual sales. But the week started with a couple of OKs smaller on the sales side, if still significant for the organizations that developed them. Pretomanid, a tuberculosis med developed by the nonprofit TB Alliance, kicked things off Wednesday with an FDA nod in drug-resistant forms of the disease. On the same day, Philly-area pharma company Harmony Biosciences picked up its first FDA nod ever, passing agency gatekeepers with narcolepsy med Wakix. GlobalData pharma analyst Sarah Elsayed said she expects Wakix to pick up a “small share” of the $1.5 billion narcolepsy market. The drug is a “welcome addition” for doctors and patients, she said, but key opinion leaders told the firm they “believe that Wakix is not as effective" as Jazz Pharma's competing Xyrem, the analyst said. After those Wednesday approvals, the agency stayed busy Thursday and Friday. Regulators signed off on Roche’s targeted cancer drug Rozlytrek, Celgene’s myelofibrosis med Inrebic and AbbVie’s rheumatoid arthritis treatment Rinvoq in quick succession.

Spotlight

While the co-rotating, intermeshing TSE is more commonly used in pharmaceutical R&D and production, the counter-rotating, intermeshing TSE is a viable tool to successfully process these formulations. Energy input must be strategically balanced to perform mixing functions without degradation of API. Changes of screw rpm, temperature, residence time, residence time distribution, and feed rate all played roles in both degradation and solubility.

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Spotlight

While the co-rotating, intermeshing TSE is more commonly used in pharmaceutical R&D and production, the counter-rotating, intermeshing TSE is a viable tool to successfully process these formulations. Energy input must be strategically balanced to perform mixing functions without degradation of API. Changes of screw rpm, temperature, residence time, residence time distribution, and feed rate all played roles in both degradation and solubility.