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Central Role For Industry Beckons As Europe Rebuilds After COVID

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

Policy Regulation

Bill & Melinda Gates Foundation Commits $120m For Molnupiravir In Lower-Income Countries

The Bill & Melinda Gates Foundation has extended a financial commitment of up to $120m to secure a dedicated, low-cost supply of generic molnupiravir to lower-income countries. The Gates Foundation is looking to “significantly reduce the time it takes for a new drug to reach low-income countries after it becomes available in high-income markets.”

International Coronavirus COVID-19

Phlow Seeks To Build On Fresenius Kabi Collaboration

US-based Phlow and Fresenius Kabi have announced an alliance to supply essential medicines, including injectables, for public health emergencies and to Children’s Hospital Coalition, a project by Phlow. In an exclusive interview with Generics Bulletin, Phlow chief business officer Dan Hackman talks about the partnership, addressing US supply chain disruptions, domestic manufacturing and more.

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EMA Moves Ahead With Tailored Scientific Advice For Biosimilars

A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

Biosimilars Europe

Roche Makes Tocilizumab Launch Prediction As Biosimilars Progress

Roche gave small insight into its expectations around biosimilar competition for its Actemra/RoActemra (tocilizumab) treatment for inflammatory diseases. Extraordinary demand for the biologic led sales to skyrocket by 143% in the third quarter and caused supply constraints for the originator.

Biosimilars Market Access

Central Role For Industry Beckons As Europe Rebuilds After COVID

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

Policy Regulation
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Adamis Receives FDA Approval For 505(b)(2) Naloxone

Adamis has announced receiving FDA approval for Zimhi, its high-dose naloxone hydrochloride for injection, indicated for the treatment of opioid overdose. The company has partnered with US WorldMeds to market Zimhi by the first quarter of 2022. 

United States Approvals

Hyloris Prepares For UK And Ireland Maxigesic IV Launch

Value-added medicines specialist Hyloris has announced launch plans for its Maxigesic IV analgesic in the UK and Ireland after receiving approvals for the intravenous paracetamol/ibuprofen solution. The nods follow two deals aimed at bolstering the firm’s pipeline.

Approvals Deals

Glenmark Celebrates European Ryaltris Approvals

Glenmark is celebrating the approval of its Ryaltris nasal spray in 13 European countries, with the Indian company and partner Menarini set to begin rolling out the allergic rhinitis combination product.

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