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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels. In October, the U.S.

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Pioneering access to complex generic products 

Drug Discovery World

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

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Should we be worried about pharma’s supply chain?

World of DTC Marketing

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Why would a pharma company take risks like these?

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

Pharmaceutical Technology

California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form. This CMO will be responsible for product roll-out and distribution. In-house manufacturing the norm.

Insulin 328
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Pharma’s climate change vulnerability and opportunity

pharmaphorum

tons of carbon dioxide equivalent (CO 2 e) for every $1m it generated – placing it above even the automotive industry, which emitted 31.4 tons per $1m generated in the same year, in terms of contributing to global greenhouse gases (GHGs). “As In 2019, the pharmaceutical industry produced 48.55 Vulnerability . Adaptability.

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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies. But others do not accept that the EU is less competitive for the pharma industry than North America and Asia.

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How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

pharmaphorum

These supply chain issues raise significant risks for the industry due to shortcuts being taken that are not based on product safety and quality. Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Tackling shortages.