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RSS FeedPosted by Michael Wonder on 16 Mar 2017
Sunovion submits supplemental new drug application to FDA for use of Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 years of age and older
15 March 2017 - If approved, Aptiom would provide an important new monotherapy or adjunctive therapy treatment option for individuals ...
Posted by Michael Wonder on 16 Mar 2017
GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (influenza vaccine) for infants 6 months and older
15 March 2017 - GSK today announced the submission of a supplemental biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 16 Mar 2017
House Obamacare repeal bill faces first big test Thursday
15 March 2017 - The House Republican bill to repeal and replace Obamacare will face its first real test Thursday ...
Posted by Michael Wonder on 16 Mar 2017
Marathon's $89,000 drug scrutinised for ‘unusual’ approval
16 March 2017 - Marathon Pharmaceuticals is under new scrutiny as Washington lawmakers press U.S. regulators about the “unusual circumstances” ...
Posted by Michael Wonder on 15 Mar 2017
US cancer patients skipping medicines or delaying treatment due to high drug prices
15 March 2017 - John Krahne received alarming news from his doctor last December. His brain tumours were stable, but ...
Posted by Michael Wonder on 15 Mar 2017
G.O.P. Senators suggest changes for health care bill offered by House
15 March 2017 - A day after a harsh judgment by the Congressional Budget Office on the House plan to ...
Posted by Michael Wonder on 15 Mar 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and paediatric patients with classical Hodgkin lymphoma refractory to treatment, or who have relapsed after three or more prior lines of therapy
14 March 2017 - Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat classical Hodgkin's lymphoma regardless of prior ...
Posted by Michael Wonder on 15 Mar 2017
Merck provides update on supplemental biologics license application for Keytruda (pembrolizumab) in previously treated advanced microsatellite instability-high cancer
14 March 2017 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics ...
Posted by Michael Wonder on 15 Mar 2017
First biosimilar monoclonal antibody in oncology granted EU approval: implications for the U.S. market
14 March 2017 - Recent developments in Europe may augur a new push for oncology biosimilars in the United States. ...
Posted by Michael Wonder on 15 Mar 2017
Can a statistical method speed drug approvals?
13 March 2017 - Not likely, says F. Perry Wilson, MD. ...
Posted by Michael Wonder on 14 Mar 2017
Trading health care for the poor for tax cuts for the rich
13 March 2017 - So much for President Trump’s pledge of “insurance for everybody.” ...
Posted by Michael Wonder on 14 Mar 2017
Trumpcare vs. Obamacare: apocalypse foretold
13 March 2017 - The Congressional Budget Office report on Trumpcare is out, and it’s devastating: 14 million people losing ...
Posted by Michael Wonder on 14 Mar 2017
How Republicans want to change the health insurance market
14 March 2017 - This is the second of a two-part explainer on Republican plans to overhaul Obamacare. ...
Posted by Michael Wonder on 14 Mar 2017
Novartis wins U.S. approval for breast cancer drug; to compete with Pfizer's Ibrance
14 March 2017 - Kisqali priced 18-20% cheaper than Pfizer's Ibrance. ...
Posted by Michael Wonder on 14 Mar 2017
24 million would lose health insurance coverage by 2026 under GOP's Obamacare replacement, new estimate says
13 March 2017 - Many more Americans would be uninsured, and insurance premiums would temporarily spike under the leading Republican ...