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Navigating the Challenges of Biopharma Product Launches: A Blueprint for Success

PM360

The landscape is highly competitive with new prescription medications launching worldwide each year. Early shaping of the label during clinical trial design, risk mitigation, and avoiding approval delays are crucial for seizing a competitive advantage.

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FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The agency describes the current system as “confusing, conflicting, incomplete, or repetitive”, based on study data.

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DEA organises Drug Take Back Day to fight addiction

Pharmaceutical Technology

The US Drug Enforcement Agency (DEA) will hold the 24th National Prescription Drug Take Back Day to gather unwanted, old or expired medication for safe disposal , on April 22. According to the agency’s website, this event aims to prevent the circulation of unused prescription drugs that could potentially harm American citizens.

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Illegal online pharmacies gain traction as regulators lag behind

Pharmaceutical Technology

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

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US government plans proposal to push down Medicaid drug prices

Pharmaceutical Technology

The US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have announced steps to push down prescription drug prices under Medicaid as part of a new proposal. The legislation would allow states to see if manufacturers classify the covered drugs accurately.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Throughout 2022, Novartis was at the opposing ends of legal cases.

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OTC Narcan will cost ‘less than $50’, company says

Pharmaceutical Technology

On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.