Blog
RSS FeedPosted by Michael Wonder on 03 Oct 2017
Sucampo Pharmaceuticals announces FDA acceptance of sNDA for Amitiza in children with paediatric functional constipation, with priority review designation
28 September 2017 - Sucampo Pharmaceuticals today announced that the U.S. FDA has accepted for filing its recently submitted supplemental ...
Posted by Michael Wonder on 03 Oct 2017
Seattle Genetics receives FDA breakthrough therapy designation for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin lymphoma
2 October 2017 - Designation based on positive Phase 3 ECHELON-1 trial evaluating Adcetris in front-line advanced Hodgkin lymphoma; data will ...
Posted by Michael Wonder on 03 Oct 2017
Indivior submits new drug application to U.S. FDA for RBP-7000 risperidone monthly depot for treatment of schizophrenia
2 October 2017 - Enters into agreement with Durect to expand patent estate for RBP-7000. ...
Posted by Michael Wonder on 03 Oct 2017
Breakthrough cancer treatments raise difficult questions
1 October 2017 - The approval of a first-of-its kind cancer therapy creates new challenges related to safety, access, and costs. ...
Posted by Michael Wonder on 02 Oct 2017
Statement from FDA Commissioner Scott Gottlieb on the FDA’s adverse event reporting system and new search tool
2 October 2017 - The FDA’s adverse event reporting system is a database that contains adverse event reports, medication error reports ...
Posted by Michael Wonder on 02 Oct 2017
Reducing the hurdles for complex generic drug development
2 October 2017 - Earlier this year, I announced our Drug Competition Action Plan to advance new policies aimed at bringing ...
Posted by Michael Wonder on 02 Oct 2017
Health Secretary Tom Price resigns after drawing ire for chartered flights
29 September 2017 - Tom Price, the health and human services secretary, resigned under pressure on Friday after racking up ...
Posted by Michael Wonder on 30 Sep 2017
Novo Nordisk's new fast-acting mealtime insulin Fiasp approved in the US
29 September 2017 - Novo Nordisk today announced that the US FDA has approved Fiasp (fast-acting insulin aspart), a new ...
Posted by Michael Wonder on 29 Sep 2017
FDA grants priority review for Roche’s Perjeta (pertuzumab) for adjuvant treatment of HER2-positive early breast cancer
29 September 2017 - Roche today announced the US FDA has accepted the company’s supplemental biologics license application and granted priority ...
Posted by Michael Wonder on 29 Sep 2017
Entasis Therapeutics to present Phase 1 Data on ETX2514 at IDWeek 2017
28 September 2017 - FDA grants qualified infectious disease product and fast track designation to ETX2514SUL, the combination of ETX2514 with ...
Posted by Michael Wonder on 29 Sep 2017
FDA improves access to reports of adverse drug reactions
28 September 2017 - New online tool makes it easier for users to search the FDA Adverse Event Reporting System. ...
Posted by Michael Wonder on 28 Sep 2017
FDA approves new treatment for certain advanced or metastatic breast cancers
28 September 2017 - The U.S. FDA today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human ...
Posted by Michael Wonder on 28 Sep 2017
Audentes Therapeutics announces rare paediatric disease and fast track designations for AT132 for the treatment of X-linked myotubular myopathy
27 September 2017 - Preliminary data from ASPIRO, the Phase 1 / 2 study of AT132, expected to be available in ...
Posted by Michael Wonder on 28 Sep 2017
AbbVie announces global resolution of Humira (adalimumab) patent disputes with Amgen
28 September 2017 - Agreements provide non-exclusive license to Amgen for Humira related intellectual property in the U.S. effective 31 January ...
Posted by Michael Wonder on 28 Sep 2017
Intarcia provides corporate update
27 September 2017 - Intarcia receives complete response letter from the FDA for ITCA 650. ...