Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2019
Some insurers are pushing back on the high price for a Novartis gene therapy
3 July 2019 - Barely a month after Novartis won U.S. regulatory approval for its gene therapy — the most ...
Posted by Michael Wonder on 18 Jun 2019
FDA releases new data to help generic drug competitors
18 June 2019 - Generic drug applicants will now have more information from the US FDA when deciding whether to ...
Posted by Michael Wonder on 14 Jun 2019
Ensuring innovation and competition for biologics leads to more timely products for patients
13 June 2019 - Today, the FDA approved the agency’s 20th biosimilar product, Kanjinti (trastuzumab-anns), for the treatment of patients with ...
Posted by Michael Wonder on 04 Jun 2019
FDA to make it easier for doctors to get unapproved cancer drugs for patients
3 June 2019 - Agency will work closely with physicians seeking treatments through its “expanded access” program. ...
Posted by Michael Wonder on 03 Jun 2019
FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer
3 June 2019 - Today, the U.S. FDA Oncology Center of Excellence announced a new pilot program to assist oncology health ...
Posted by Michael Wonder on 01 Jun 2019
When ‘right to try’ isn’t enough: Congress wants a single ALS patient to get a therapy never tested in humans
31 May 2019 - A family in Iowa believes the FDA will decide whether their only surviving daughter lives or ...
Posted by Michael Wonder on 24 May 2019
AveXis announces innovative Zolgensma gene therapy access programs for US payers and families
24 May 2019 - Annualised cost of Zolgensma is USD 425,000 per year for 5 years; 50% less than multiple established ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar groups offer proposals to help US better mirror EU successes
19 March 2019 - With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups ...
Posted by Michael Wonder on 20 Mar 2019
Biosimilar approval and adoption in the U.S. needs to be expedited
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
Posted by Michael Wonder on 14 Mar 2019
Patient advocates applaud Cancer Drug Parity Act filed in both the U.S. House and Senate
13 March 2019 - The Coalition to Improve Access to Cancer Care and its members from across the cancer patient ...
Posted by Michael Wonder on 04 Mar 2019
Senators tell FDA to speed up approvals of generic insulin
1 March 2019 - A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy ...
Posted by Michael Wonder on 08 Feb 2019
Generic drug approvals surge, but hundreds still aren't for sale
7 February 2019 - The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines
30 January 2019 - As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many ...
Posted by Michael Wonder on 21 Jan 2019
FDA's banner year for approvals: will market access to new drugs follow suit?
21 January 2019 - It's not hyperbolic to say that 2018 was a sensational year for FDA approvals of new drugs ...
Posted by Michael Wonder on 26 Nov 2018
Migraine patients’ coverage headache: FDA OK doesn’t mean insurance will pay
25 November 2018 - Last spring, weeks before the new migraine drug Aimovig hit the market, the phone calls and ...