Aug 6, 2019

FDA: World's most expensive drug was approved using faulty data

Sam Baker

The company that developed the most expensive drug in the world knew about problems with its clinical data, but withheld that information from the FDA until after the drug had been approved, the agency said Tuesday. Nevertheless, the FDA said it's confident that the drug, Zolgensma, is still safe.

Between the lines: Zolgensma is a gene replacement therapy to treat spinal muscular atrophy in children younger than 2, manufactured by Novartis. It was approved in May and carries a $2.1 million price tag. In disclosing the faulty data submission, the FDA said it "will use its full authorities to take action, if appropriate, which may include civil or criminal penalties."

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Orion Rummler

FDA approves new cure for deadly strain of drug-resistant TB

A returning patient provides his fingerprint for a biometrics tracking system at an operation ASHA tuberculosis treatment center in 2011, in New Delhi, India. Photo: Andrew Caballero-Reynolds/Getty Images

The Food and Drug Administration on Wednesday approved Pretomanid Tablets, when used alongside 2 other antibiotics, to treat an extremely drug-resistant strain of tuberculosis.

Why it matters: "Tuberculosis has now surpassed AIDS as the world’s leading infectious cause of death," the New York Times reports. The new drug cured 89% of 107 patients with extensively drug-resistant TB after 6 months, when used in combination with antibiotics bedaquiline and linezolid, the FDA said.

Go deeperArrowAug 15, 2019
Caitlin Owens

How Democrats want to limit drug prices

Illustration: Rebecca Zisser/Axios

The Democratic presidential candidates' plans to lower drug prices are much more aggressive than what the party has supported in the past.

Between the lines: There are big differences among the candidates' platforms, but the entire debate has shifted to the left.

Go deeperArrowAug 8, 2019
Orion Rummler

FDA receives 92 new reports of seizures after vaping

Juul e-cigarette. Photo: Brianna Soukup/Portland Press Herald via Getty Images

The Food and Drug Administration is investigating 127 cases of people, particularly children and young adults, who experienced seizures after using e-cigarettes, CNBC reports.

What's happening: The FDA began this investigation in spring, but has recently received about 92 new reports of seizures after vaping. The agency says the evidence has has not established if e-cigarettes directly caused the seizures, and stressed that the 127 cases occurred over 10 years.

Go deeperArrowAug 7, 2019