Bluebird bio to sell sickle cell FDA voucher for $103 mln if therapy approved

Posted on:
Key Points

Oct 30 (Reuters) - Bluebird bio (BLUE.O) said on Monday it has agreed to sell its priority review voucher for $103 million if it gets the U.S. Food and Drug Administration's approval for its gene therapy to treat sickle cell disease...

The voucher, which is transferable, allows a drug developer to expedite the review process of its product even if it does not fit requirements for a quick process...

The FDA's advisers are scheduled to meet on Tuesday to decide on the sickle cell disease gene therapy jointly developed by Vertex Pharmaceuticals (VRTX.O) and Crispr Therapeutics (CRSP.BN)..

You might be interested in

New cure for sickle cell disease coming soon

31, Oct, 23

US food advisors will look at a gene therapy that could tackle the root cause of the sickle cell disease.

US approves CRISPR gene-editing to treat sickle cell disease

10, Dec, 23

The treatment for sickle cell disease uses the revolutionary gene-editing tool CRISPR to permanently change DNA in the patient's blood cells. | Health

Cure for sickle cell disease on the horizon? US drug regulator is reviewing 2 new gene therapies

03, Nov, 23

FDA is scheduled to review gene therapies from two American companies — Vertex Pharmaceuticals & Bluebird Bio Inc. If approved, therapies could mean a breakthrough for curing SCD.

Bluebird bio submits US marketing application for blood disorder gene therapy

25, Apr, 23

Bluebird bio Inc said on Monday it has submitted a marketing application to the U.S. Food and Drug Administration for its gene therapy to treat sickle cell disease.

US approves two gene therapies for sickle cell disease

08, Dec, 23

The U.S. Food and Drug Administration (FDA) on Friday approved a pair of gene therapies for sickle cell disease, including the first treatment based on the breakthrough CRISPR gene editing technology.

US FDA advisers to consider need for more studies for Vertex/CRISPR gene therapy

27, Oct, 23

The U.S. Food and Drug Administration's staff reviewers on Friday asked the regulator's advisory panel to consider the need for additional studies for Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics' (CRSP.BN) sickle cell disease gene therapy.

A Gene Therapy Cure for Sickle Cell Is on the Horizon

15, Mar, 23

Two life-altering treatments could soon be available, but questions remain about how accessible and affordable they’ll be.

New Gene Therapy Could Face Uphill Battle

29, Jun, 23

Potential FDA approval of BioMarin’s gene therapy for hemophilia would be major win, but uptake could be slow

US regulators inspect Dr Reddy's, other Indian pharma majors

05, Dec, 23

The U.S. Food and Drug Administration is inspecting Dr Reddy's (REDY.NS) research and development centre in the southern Indian city of Hyderabad, the pharma company said on Tuesday.

US FDA gives second approval to Eli Lilly's drug for type of blood cancer

03, Dec, 23

Eli Lilly (LLY.N) said on Friday the U.S. Food and Drug Administration (FDA) gave a second approval for its drug Jaypirca, which is used to treat a form of blood cancer.