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RSS FeedPosted by Michael Wonder on 14 Dec 2017
Experts tell Congress how to cut drug prices. We give you some odds.
12 December 2017 - The nation’s most influential science advisory group was set to tell Congress on Tuesday that the ...
Posted by Michael Wonder on 14 Dec 2017
A bipartisan approach on drug prices is emerging
14 December 2017 - Law makers looking at drug-industry tactics to keep costs high. ...
Posted by Michael Wonder on 14 Dec 2017
Months after approval, breakthrough cancer drug given to just five patients
14 December 2017 - No Medicare coverage, one-by-one rulings by private insurers. ...
Posted by Michael Wonder on 14 Dec 2017
Bumper crop of new drugs fails to lift big pharma R&D returns
14 December 2017 - It is shaping up to be a bumper year for drug approvals, with U.S. officials clearing twice ...
Posted by Michael Wonder on 14 Dec 2017
FDA approves new Pfizer biosimilar
13 December 2017 - Pfizer-developed biosimilar medicine Ixifi (infliximab-qbtx) receives FDA approval for all eligible indications. ...
Posted by Michael Wonder on 14 Dec 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in intermediate and poor-risk patients with advanced renal cell carcinoma and grants priority review
13 December 2017 - The Opdivo plus Yervoy combination previously received FDA breakthrough therapy designation. ...
Posted by Michael Wonder on 13 Dec 2017
Massachusetts’ proposed Medicaid reforms — cheaper drugs and better coverage?
13 December 2017 - While health policy attention in recent months has focused on Washington, D.C., several proposals from individual ...
Posted by Michael Wonder on 13 Dec 2017
FDA launches new tool for sharing information that allows doctors to better manage antibiotic use; improve patient care
13 February 2017 - New website streamlines how FDA updates information used to help health care providers choose an appropriate treatment ...
Posted by Michael Wonder on 13 Dec 2017
When can FDA 'Refuse to File' NDAs and BLAs? New draft guidance explains
12 December 2017 - When a new drug application or biologics license application is deemed incomplete by the US FDA, ...
Posted by Michael Wonder on 13 Dec 2017
Omeros Corporation announces FDA approval of Omidria for use in paediatric patients
12 December 2017 - FDA also grants additional market exclusivity. ...
Posted by Michael Wonder on 13 Dec 2017
Alnylam completes submission of new drug application to U.S. FDA for patisiran for the treatment of hereditary ATTR amyloidosis
12 December 2017 - Patisiran could become the first in a new class of medicines known as RNAi therapeutics. ...
Posted by Michael Wonder on 12 Dec 2017
Bringing early feasibility studies for medical devices back to the United States
12 December 2017 - Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices ...
Posted by Michael Wonder on 12 Dec 2017
Indivior announces NDA acceptance of RBP-7000 risperidone monthly depot
12 December 2017 - A novel sustained-release candidate for treatment of schizophrenia. ...
Posted by Michael Wonder on 12 Dec 2017
FDA approves first drug for eosinophilic granulomatosis with polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
12 December 2017 - The U.S. FDA today expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic ...
Posted by Michael Wonder on 12 Dec 2017
Bayer’s rivaroxaban submitted to U.S. FDA for approval in patients with coronary and/or peripheral artery disease
11 December 2017 - The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% ...