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Manufacturing

Set Alert for Manufacturing

Teligent Prepares For Injectables Filings With Strengthened Team

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. 

United States Business Strategies

Lupin Q1 Profit Up 50% But Regulatory Overhang, Slow Product Scale-Up Sparks Concern

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.

Manufacturing Business Strategies

Pooled Data Among AAM’s Concerns On FDA’s Therapeutic Protein Biosimilars Guidance

Three key areas for improvement in in the FDA’s draft guidance on therapeutic protein biosimilars have been highlighted by industry association AAM.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.

Biosimilars Regulation

Momenta Shelves Adalimumab But Persists With Aflibercept

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.

Biosimilars Business Strategies

Jubilant Considers Splitting Itself Into Two for Greater Focus

Jubilant’s board is considering whether to create separate entities for its Pharmaceuticals and Life Science Ingredients business segments to give each greater focus.

Business Strategies Sales & Earnings

Alembic Builds US Launch Pipeline As It Looks To Oncology Arena

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.

Business Strategies Cancer
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