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As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions.
Lupin’s first-quarter net profit soared nearly 50%, but the strong performance was overshadowed by concerns about regulatory overhang and slower-than-expected scale-up of new products that could jeopardize future revenue growth momentum.
Three key areas for improvement in in the FDA’s draft guidance on therapeutic protein biosimilars have been highlighted by industry association AAM. Pharmaceutical giants such as Pfizer, Novartis and Celltrion have also expressed concerns highlight shortcomings and sought clarification.
Having failed to find a commercial partner, Momenta has halted development on its adalimumab biosimilar. But it is continuing to work on biosimilar aflibercept in conjunction with partner Mylan.
Jubilant’s board is considering whether to create separate entities for its Pharmaceuticals and Life Science Ingredients business segments to give each greater focus.
Alembic is building up an extensive roster of solid-dose, ophthalmic and dermatological drugs to introduce in the US. With facility clearance from the FDA, the Indian firm can now target the US market for oral solids to treat cancer.
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