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The pharmaceutical industry in the US is facing a tougher environment for drug approvals and a decreasing pipeline of new medications, experts claim.
The challenges appear to illustrate that the development of so called “blockbuster” drugs is coming to an end as the sector looks at new ways of using laboratory technology.
And analysts believe the biggest hurdle will be a shift towards discovering treatments for patients with rare diseases, or unusual strains of common conditions.
GlaxoSmithKline chief executive Jean-Pierre Garnier appears to agree.
He said: “The hurdle has been raised, there’s no question about it.
“What is unclear is exactly how we should modify our drug development plans to meet this higher hurdle.”
Steve Brozak, an analyst with WBB Securities, said pharmaceutical firms are now looking at modifying drugs already on the market, rather than investing millions in unknown and unproven developments.
“No pharmaceutical executive has ever lost his job for saying no to a new drug project,” he said. “And no FDA employee has ever lost his job for saying no to a new drug application.”
The regulatory framework for drugs is also getting tougher this year, as new rules have come in that allow the Food and Drug Administration (FDA) to limit how medicines are promoted and distributed to patients and doctors.
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