article thumbnail

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.

275
275
article thumbnail

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 117
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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.

FDA 106
article thumbnail

The need for mental healthcare is great

World of DTC Marketing

The national rate of suicidal ideation among adults has increased every year since 2011-2012. This is a massive problem as the percentage of adults with a mental illness reported an unmet need for treatment every year since 2011. Suicidal ideation continues to increase among adults in the U.S. who are going untreated. In 2019, 24.7%

article thumbnail

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 234
article thumbnail

New antibody drug formulation wins novel MHRA approval

European Pharmaceutical Review

MHRA confirmed that this new marketing authorisation was granted to Amgen Limited, as a line extension of the original marketing authorisation for XGEVA 120mg solution for injection, which was granted on 13 July 2011. The post New antibody drug formulation wins novel MHRA approval appeared first on European Pharmaceutical Review.

article thumbnail

Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 EMA/95098/2010.

Safety 115