Ed Silverman

Pharma narrowly defines when compulsory licenses should be used

As the U.S. Trade Representative holds a hearing today to discuss how countries protect intellectual property, the pharmaceutical industry hopes to persuade the agency that countries should only be allowed to grant licenses to companies to make low-cost generic drugs when there is a health emergency. That posture, however, contradicts the position taken by the World Health Organization.

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A new index measures impact pharma has on infectious diseases

The pharmaceutical industry regularly boasts that its efforts to develop treatments for infectious diseases in poor nations are making a difference. But for those wondering how to gauge those efforts, a new metric has been created.

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U.S. senators re-introduce a bill to speed approval of antibiotics

In the latest bid to combat antibiotic resistance, two U.S. senators have re-introduced legislation to create a so-called regulatory pathway to hasten approval of new treatments.

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Advocates protest meetings between pharma lawyers and Indian officials

Patient advocates in India are protesting meetings being held this week between a trade group that advocates for intellectual property rights on behalf of global drug makers and Indian government officials, including leading judges, who decide patent policies and cases.

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Developing a drug costs $2.6 billion, but not everyone believes this

The cost to develop a new drug and win FDA marketing approval is now pegged at nearly $2.6 billion, according to a new report from the Tufts Center for the Study of Drug Development. The estimate will likely hearten drug makers that argue rising prices reflect rising costs, but consumer advocates reacted as if someone was trying to sell them a bridge.

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Pharma trade group head causes a stir with a remark about patents

File this under ‘Nothing like getting off to a good start.’

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Is AstraZeneca getting ready to exit antibiotics research?

For the past year, the fate of antibiotics R&D at AstraZenecahas been uncertain. The drug maker, which possesses what is generally regarded as having the strongest antibiotics pipeline in the pharmaceutical industry, indicated that spending on this area would be reduced as part of a larger cutback and strategic refocusing. Ever since, speculation has grown that antibiotics may be abandoned altogether.

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Generic drug makers tussle with international standards group

A nasty spat has broken out between the generic pharmaceutical industry and an international organization that develops widely accepted standards for developing prescription drugs.

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India looks to tighten rules for filing pharma patents

In a move that is likely to concern brand-name drugmakers, the Indian Patent Office is considering a proposal that would require the generic drug names assigned by the World Health Organization to be disclosed on patent applications, according to The Economic Times. And if the proposal is approved, India would become the first country to mandate this condition.

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WikiLeaks reveals White House view on trade and drug prices

For months, consumer advocates have railed that the Obama administration was taking a secretive approach toward the Trans-Pacific Partnership trade talks and likely jeopardizing access to essential medicines throughout the Asia and the Pacific region. They warned that a restrictive deal would increase the power of the pharmaceutical industry and, eventually, bind Americans to the same terms.

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