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RSS FeedPosted by Michael Wonder on 27 Jun 2017
Synlogic receives fast track designation in U.S. for lead candidate, SYNB1020
26 June 2017 - Novel synthetic biotic medicine, SYNB1020, under development for the treatment of hyperammonemia due to urea cycle disorders. ...
Posted by Michael Wonder on 26 Jun 2017
Senate Republican healthcare bill would cause 22 million to lose insurance
26 June 2017 - Twenty-two million Americans would lose insurance over the next decade under the healthcare bill drafted by ...
Posted by Michael Wonder on 26 Jun 2017
The FDA has never approved a drug like this in its 111 year history
25 June 2017 - This cancer drug produced data so incredible that the FDA approved it immediately for a specific genetic ...
Posted by Michael Wonder on 24 Jun 2017
U.S. FDA approves Bevyxxa (betrixaban) first and only anticoagulant for hospital and extended duration prevention of venous thromboembolism in acutely ill medical patients
23 June 2017 - Portola Pharmaceuticals today announced the U.S. FDA has approved Bevyxxa (betrixaban), the first and only anticoagulant ...
Posted by Michael Wonder on 23 Jun 2017
Cara receives breakthrough therapy designation from FDA for I.V. CR845 for the treatment of chronic kidney disease associated pruritus in hemodialysis patients
23 June 2017 - Phase 3 safety extension trial underway. ...
Posted by Michael Wonder on 23 Jun 2017
Deep cuts to Medicaid remain the centerpiece of the Republicans’ proposals
22 June 2017 - But the Senate leadership has rewritten other parts of the bill that passed the House. ...
Posted by Michael Wonder on 23 Jun 2017
Senate health care bill includes deep cuts to Medicaid
22 June 2017 - Senate Republicans, who for seven years have promised a repeal of the Affordable Care Act, took ...
Posted by Michael Wonder on 23 Jun 2017
Pfizer provides update on proposed epoetin alfa biosimilar
22 June 2017 - Pfizer today announced that it has received a complete response letter from the U.S. FDA regarding the ...
Posted by Michael Wonder on 23 Jun 2017
Haegarda (C1 esterase inhibitor subcutaneous [human]) FDA approval
23 June 2017 - CSL Limited today announced that the U.S. FDA has approved CSL Behring’s Haegarda (C1 esterase inhibitor ...
Posted by Michael Wonder on 23 Jun 2017
FDA approves first subcutaneous C1 esterase Inhibitor to treat rare genetic disease
22 June 2017 - The U.S. FDA today approved Haegarda, the first C1 esterase inhibitor (human) for subcutaneous administration to ...
Posted by Michael Wonder on 22 Jun 2017
Novartis combination targeted therapy Tafinlar and Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small-cell lung cancer
22 June 2017 - Approval provides first targeted treatment in the US specifically for BRAF V600E mutation-positive metastatic non-small-cell lung cancer. ...
Posted by Michael Wonder on 22 Jun 2017
Will Trump’s FDA relax standards for drug approval? We’ll get a clue soon with decision on Portola’s anticoagulant
21 June 2017 - Is the FDA under new Commissioner Scott Gottlieb willing to be flexible with the rules, and ...
Posted by Michael Wonder on 22 Jun 2017
FDA approves Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection in certain blood cancers
22 June 2017 - Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous ...
Posted by Michael Wonder on 22 Jun 2017
Trump plan aims to be pro-pharma and cut drug prices
22 June 2017 - Facing opposition and delay to healthcare reform in Congress, Trump aims to pass an executive order ...
Posted by Michael Wonder on 22 Jun 2017
Senate health care draft repeals Obamacare taxes, provides bigger subsidies for low income Americans than House bill
21 June 2017 - Senate leaders on Wednesday were putting the final touches on legislation that would reshape a big ...