Breakthrough Therapy Designation

All articles by Breakthrough Therapy Designation

Five things for pharma marketers to know: Thursday, January 18, 2018
Five things for pharma marketers to know: Thursday, January 18, 2018
Virginia Lau
January 18, 2018
11:00 am

Senate committee votes in favor of Azar as new HHS head; FDA and DoD launch breakthrough designation program; Walmart offers free opioid disposal solution

Five things for pharma marketers to know: Thursday, January 4, 2018
Five things for pharma marketers to know: Thursday, January 4, 2018
Virginia Lau
January 4, 2018
3:10 pm

Allergan to cut 1,000 jobs; McKesson acquires RxCrossroads from CVS Health; Pfizer and Sangamo enter collaboration to develop ALS gene therapy

Five things for pharma marketers to know: Monday, July 31, 2017
Five things for pharma marketers to know: Monday, July 31, 2017
Virginia Lau
July 31, 2017
2:35 pm

FDA launches digital health pre-certification pilot; J&J’s experimental RA drug raises safety concerns; AstraZeneca gets breakthrough status for Imfinzi

Five things for pharma marketers to know: Wednesday, June 7, 2017
Five things for pharma marketers to know: Wednesday, June 7, 2017
Kevin McCaffrey
June 7, 2017
2:50 pm

Pfizer receives breakthrough designation for experimental rare disease drug; Endocyte cuts 30 jobs; AbbVie RA drug meets Phase-III goals

Five things for pharma marketers to know: Tuesday, April 18, 2017
Five things for pharma marketers to know: Tuesday, April 18, 2017
Jaimy Lee
April 18, 2017
2:35 pm

Novartis gets Breakthrough designation for its CAR-T therapy; Duchesney continues working with Kardashian; new user-fee deal to speed up FDA approvals

Roche sclerosis drug granted Breakthrough Therapy status
Roche sclerosis drug granted Breakthrough Therapy status
June 10, 2015
7:00 pm

Roche’s Actemra is already approved for three forms of arthritis.

Study: 10 medications will cost US $50 billion over 10 years
Study: 10 medications will cost US $50 billion over 10 years
Deborah Weinstein
June 9, 2015
8:30 pm

An analysis by Avalere Health says 10 breakthrough therapy drugs will account for billions in spending.

FDA grants Breakthrough status to Niemann-Pick drug
FDA grants Breakthrough status to Niemann-Pick drug
June 4, 2015
6:30 pm

Genzyme’s experimental enzyme-replacement therapy olipudase alfa is being investigated for the Type B form of the condition.

AbbVie leukemia drug gets breakthrough status
AbbVie leukemia drug gets breakthrough status
May 6, 2015
6:00 pm

AbbVie expected to submit chronic lymphocytic leukemia drug venetoclax to the FDA this year.

FDA grants Pfizer lung-cancer drug Breakthrough Designation
FDA grants Pfizer lung-cancer drug Breakthrough Designation
April 22, 2015
6:00 pm

Xalkori received the designation to treat a new subset of non-small cell lung cancer patients.

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