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RSS FeedPosted by Michael Wonder on 27 Apr 2017
Pfizer's next generation ALK/ROS1 inhibitor lorlatinib, granted breakthrough therapy designation from FDA for ALK positive metastatic non-small-cell lung cancer
27 April 2017 - Pfizer today announced that its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, was granted breakthrough therapy ...
Posted by Michael Wonder on 27 Apr 2017
U.S. top court grapples over making copycat biologics available sooner
26 April 2017 - U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes ...
Posted by Michael Wonder on 27 Apr 2017
FDA approves first treatment for a form of Batten disease
27 April 2017 - The U.S. FDA today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten ...
Posted by Michael Wonder on 27 Apr 2017
FDA expands approved use of Stivarga to treat liver cancer
27 April 2017 - The U.S. FDA today expanded the approved use of Stivarga (regorafenib) to include treatment of patients with ...
Posted by Michael Wonder on 26 Apr 2017
Lilly gives no time frame on arthritis drug delay; shares fall
25 April 2017 - Eli Lilly said Tuesday provided no new information on how long U.S. regulators might delay approval ...
Posted by Michael Wonder on 25 Apr 2017
Epizyme announces tazemetostat fast track designation for follicular lymphoma and plenary session on Phase 2 NHL data at ICML
25 April 2017 - Interim efficacy and safety data from ongoing Phase 2 study in follicular lymphoma and DLBCL selected for ...
Posted by Michael Wonder on 25 Apr 2017
Sanofi and Regeneron announce FDA approval of a new once monthly dosing option for Praluent (alirocumab) injection
25 April 2017 - Monthly dosing schedule now approved in both United States and European Union. ...
Posted by Michael Wonder on 25 Apr 2017
FDA takes action against fraudulent cancer products
25 April 2017 - A cancer diagnosis often provokes a sense of desperation. Unfortunately, rogue operations exploiting those fears peddle untested ...
Posted by Michael Wonder on 25 Apr 2017
FDA approves new drug that could take a slice out of Johnson & Johnson’s best seller
24 April 2017 - Pharma giant Johnson & Johnson's Remicade brought in nearly $7 billion in sales last year. ...
Posted by Michael Wonder on 24 Apr 2017
Sanofi receives FDA approval of Thymoglobulin for the prevention of acute kidney transplant rejection
24 April 2017 - New U.S. indication approved for Thymoglobulin [anti-thymocyte globulin (rabbit)]; first since 1998. ...
Posted by Michael Wonder on 22 Apr 2017
FDA approves Samsung Bioepis' copy of J&J's Remicade: company
21 April 2017 - South Korea's Samsung Bioepis said on Saturday the U.S. FDA approved its copy of Johnson & ...
Posted by Michael Wonder on 22 Apr 2017
Valeant's Patient Access And Pricing Committee announces pricing for Siliq (brodalumab) as the lowest priced injectable biologic for moderate-to-severe plaque psoriasis
21 April 2017 - Valeant Pharmaceuticals today announced that following the evaluation and approval of its Patient Access and Pricing ...
Posted by Michael Wonder on 20 Apr 2017
Tesaro undercuts PARP rivals with $118K price tag on Zejula—or did it?
20 April 2017 - Tesaro has rolled out its much-anticipated cancer drug Zejula—and unveiled its so-far-secret price. ...
Posted by Michael Wonder on 19 Apr 2017
Reevaluating eligibility criteria — balancing patient protection and participation in oncology trials
19 April 2017 - Specific patient populations are often excluded from oncology trials without clear reasons, which renders results less clearly ...
Posted by Michael Wonder on 19 Apr 2017
Improving access to cancer treatments: the role of biosimilars
18 April 2017 - Biologics play a key role in cancer treatment and are principal components of many therapeutic regimens. ...