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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin.

Insulin 328
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FDA rejects Provention’s type 1 diabetes drug teplizumab

pharmaphorum

Three months ago, the FDA said it was unconvinced by a bridging study designed to show equivalence between Provention’s product intended for commercial sale, made by contract manufacturer AGC Biologics, and the drug that teplizumab’s original developer Eli Lilly used in clinical trials.

Drugs 98
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FDA sets August decision date for Provention’s type 1 diabetes drug

pharmaphorum

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. Teplizumab is thought to work by binding to CD3, preventing the activation of T cells that attack and kill insulin-producing pancreatic beta cells in the autoimmune disease.

Drugs 52
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Outsourcing Peptide Synthesis: Preferred Choice of Drug Developers

Roots Analysis

The peptide therapeutics market has undergone substantial evolution since the inception of insulin. Presently, over 80 peptide-based drugs are available in the market for myriad of disorders and diseases. Presently, over 80 peptide-based drugs are available in the market for myriad of disorders and diseases.

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Provention finally gets FDA nod for type 1 diabetes drug teplizumab

pharmaphorum

” T1D occurs when the immune system attacks and destroys the insulin-producing pancreatic beta cells that make insulin, and occurs in three stages. In stage 1 there are antibodies against the beta calls, but blood glucose levels remain normal and there are no symptoms.

Drugs 52
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Decline of novel drug approvals means less business for cutting-edge CMOs

Pharmaceutical Technology

This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manufacture of the most innovative products. The drug increases insulin synthesis and release.

Drugs 130
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Biologics – The Next Step in Revolutionary Medication

Roots Analysis

Expression Systems for Biologics The processes associated with the manufacturing of biopharmaceuticals are complex and require highly sterile and aseptic conditions. In this competitive global market, outsourcing has evolved into a viable and profitable business model.