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RSS FeedPosted by Michael Wonder on 15 Feb 2019
Sarepta announces FDA acceptance of golodirsen (SRP-4053) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 53
14 February 2019 - FDA grants priority review status. ...
Posted by Michael Wonder on 15 Feb 2019
FDA authorises first interoperable insulin pump intended to allow patients to customise treatment through their individual diabetes management devices
14 February 2019 - The U.S. FDA today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable ...
Posted by Michael Wonder on 14 Feb 2019
How to reduce prescription drug prices: first, do no harm
13 February 2019 - Top-down controls restrict access. Instead, encourage patients to shop around among pharmacies. ...
Posted by Michael Wonder on 14 Feb 2019
Push for Medicare buy-in picks up with '50 and over' bill
13 February 2019 - House and Senate Democrats unveiled a plan Wednesday that would allow anyone over age 50 to ...
Posted by Michael Wonder on 14 Feb 2019
Motif Bio receives complete response letter from the FDA
14 February 2019 - Motif Bio announced today that the Company has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 14 Feb 2019
Harmony Biosciences announces file acceptance of its new drug application for pitolisant
12 February 2019 - FDA grants priority review of the pitolisant new drug application. ...
Posted by Michael Wonder on 14 Feb 2019
Rationing of health care in the United States; an inevitable consequence of increasing health care costs
13 February 2019 - The modern era of medicine began in the 1960s. Health care coverage expanded with the passage ...
Posted by Michael Wonder on 14 Feb 2019
DBV Technologies provides update on regulatory status of Viaskin Peanut for the treatment of peanut-allergic children 4 to 11 years of age
13 February 2019 - Progress made to date to enable resubmission in Q3 2019. ...
Posted by Michael Wonder on 14 Feb 2019
Novartis receives FDA approval for Egaten for the treatment of fascioliasis, a neglected tropical disease
13 February 2019 - Egaten is the only drug approved in the US for the treatment of people with fascioliasis and ...
Posted by Michael Wonder on 13 Feb 2019
Statement from FDA Commissioner on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs
13 February 2019 - Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. ...
Posted by Michael Wonder on 13 Feb 2019
Industry lauds FDA RWE framework, calls for tweaks
12 February 2019 - The US FDA regulatory framework for the use of real-world evidence drew positive reactions from biopharma ...
Posted by Michael Wonder on 13 Feb 2019
Trump's free market approach to drug pricing will help lower costs
13 February 2019 - During President Trump’s State of the Union speech, he spoke about the urgent need to lower ...
Posted by Michael Wonder on 13 Feb 2019
Lynparza (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer
28 January 2016 - AstraZeneca today announced that the US FDA has granted breakthrough therapy designation for the oral poly ...
Posted by Michael Wonder on 13 Feb 2019
Mylan launches Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), at a list price 70% less than the brand
12 February 2019 - Unique pricing of Wixela Inhub immediately benefits patients and reduces overall cost to the U.S. health care ...
Posted by Michael Wonder on 13 Feb 2019
Genmab announces U.S. FDA approval of Darzalex (daratumumab) split dosing regimen
12 February 2019 - Provides healthcare professionals with option to split first Darzalex infusion over two consecutive days. ...