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RSS FeedPosted by Michael Wonder on 11 Sep 2019
The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018
10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...
Posted by Michael Wonder on 11 Sep 2019
Canada OKs Celltrion's biosimilar
10 September 2019 - Celltrion said that Health Canada has given the go-ahead for Herzuma (trastuzumab), an anticancer antibody biosimilar, ...
Posted by Michael Wonder on 11 Sep 2019
Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations
11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan. ...
Posted by Michael Wonder on 10 Sep 2019
Xeris Pharmaceuticals receives U.S. FDA approval for Gvoke (glucagon), the first ready-to-use stable liquid glucagon for severe hypoglycaemia
10 September 2019 - First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies. ...
Posted by Michael Wonder on 10 Sep 2019
Why do post-marketing drug studies required by the FDA take so long?
10 September 2019 - Often times when a new drug is approved by the FDA, the agency requires more studies be ...
Posted by Michael Wonder on 10 Sep 2019
Frontrunner to lead FDA, dogged by controversies, has developed knack for confronting them
10 September 2019 - Before he interviewed with President Trump last week to become FDA commissioner, Dr. Stephen Hahn had ...
Posted by Michael Wonder on 10 Sep 2019
Horizon Therapeutics announces the FDA has granted priority review of the teprotumumab biologics license application for the treatment of active thyroid eye disease
9 September 2019 - If approved, teprotumumab would be the first FDA approved medicine for this vision-threatening disease. ...
Posted by Michael Wonder on 10 Sep 2019
ProQR receives fast track designation from FDA for QR-1123 for autosomal dominant retinitis pigmentosa
9 September 2019 - ProQR Therapeutics today announced that it received fast track designation from the FDA for QR-1123. ...
Posted by Michael Wonder on 10 Sep 2019
FDA grants fast track status to Amplyx Pharmaceuticals for IV and oral formulations of fosmanogepix (APX001) for seven different indications
9 September 2019 - -- Amplyx Pharmaceuticals announced today that the U.S. FDA has granted fast track designations for both ...
Posted by Michael Wonder on 09 Sep 2019
Reeling from scandal, Novartis vows to voluntarily release info on manipulated data in the future
9 September 2019 - Seeking to appease angry regulators, Novartis committed to notifying the FDA within five business days of ...
Posted by Michael Wonder on 09 Sep 2019
Former agency heads, health groups push for FDA’s Sharpless to be permanent commissioner
4 September 2019 - Supporters say he is the best candidate for the top FDA job. ...
Posted by Michael Wonder on 09 Sep 2019
FDA developing guidance on real world data quality issues, officials say
9 September 2019 - As the US FDA grapples with how to use real-world data for regulatory decisions, two FDA ...
Posted by Michael Wonder on 09 Sep 2019
Allergan and Molecular Partners announce acceptance of U.S. FDA biologics license application and validation of EMA marketing authorisation for abicipar pegol in patients with neovascular (wet) age-related macular degeneration
9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly ...
Posted by Michael Wonder on 09 Sep 2019
Who’s missing from breast cancer trials? Men, says the FDA
9 September 2019 - Men do get breast cancer, but they account for fewer than 1 percent of patients and often ...
Posted by Michael Wonder on 09 Sep 2019
Inside drug makers' strategy to boost cancer medicines with 'Lazarus effect'
6 September 2019 - In the halls of MD Anderson Cancer Center, the drug Vitrakvi is known for having a “Lazarus ...