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Biotech IPO market slowdown continues as third quarter is weakest since 2011

MedCity News

Third Harmonic Bio’s stock market debut was the only biotech IPO that crossed the $100 million threshold in the third quarter as the slowdown in IPO activity showed little sign of changing. Small deals continue to represent most of the IPO activity.

Marketing 312
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FDA Finally Pulls Preterm Birth Drug Makena From the Market

MedCity News

FDA withdrawal of Makena from the market comes four years after the drug, granted accelerated approval in 2011, failed a post-marketing study to confirm the drug’s benefit. The FDA decision also affects generic versions of the drug.

Marketing 298
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PTC inks Royalty deal worth up to $1.5B on Genentech-partnered SMA drug Evrydsi

Fierce Pharma

The company licensed the med to Genentech in 2011. Amid a cost-cutting drive and a looming commercial threat in Europe, PTC Ther | PTC will hold on to 19% of its royalty interest in the Genentech drug with the option to sell the rest down the line.

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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 billion, with more than half of that devoted to products that did not provide a “documented overall survival benefit” in clinical trials.

FDA 298
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US Congress passes bill to end Parkinson’s disease

pharmaphorum

The US Congress has passed the first-ever federal bill dedicated to ending Parkinson’s disease, modelled on similar legislation for Alzheimer’s enacted in 2011

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“Game-changing” obesity drug over-promising?

World of DTC Marketing

.” 95% of diets fail and most will regain their lost weight in 1-5 years (Source: Statistics on Weight Discrimination: A Waste of Talent , The Council on Size and Weight Discrimination, Retrieved July 18, 2011, from ([link] The “obesity industry” (commercial weight-loss programs, weight-loss drug manufacturers, and bariatric surgery centers ) (..)

Insurance 306
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New guidance to aid cost-effectiveness analysis of new drugs

European Pharmaceutical Review

The [surrogate endpoints report] was developed following the challenges arising from changes in pharmaceutical clinical trials and regulation” They highlighted that products given conditional or accelerated approval by the European Medicines Agency (EMA) between 2011 and 2018 have predominantly relied on non-validated surrogate endpoints this (..)