16
Sep
2019
Tag: commercialization
2
Sep
2019
Bionest
Zolgensma Launch “On Track,” but Significant Challenges Remain
On July 18, Novartis told analysts its Zolgensma launch was “on track.” Despite the gene therapy’s $2.1 million price tag, the company states the launch is “one of the most successful launches from an access standpoint in rare diseases.” Novartis said it had reached coverage deals with more than 20 commercial insurance plans, covering approximately 40%...
6
May
2019
Bionest
Landmark Approvals in Depression
Depression is a challenging condition to treat. Most antidepressants take four to six weeks to take effect, and patient response to such drugs varies widely from person to person. As a result, most patients must try several drugs over a period of months before they can find relief. In March, the U.S. Food and Drug...
2
Apr
2019
Bionest
Wearables Evolve from Wellness to Clinical Medicine
Wearables – including consumer products like FitBit wristbands and smartwatches – are quickly moving beyond their use as wellness products that track steps and sleep patterns to incorporate serious medical device capabilities and clinical applications. In September 2018, the Apple Series 4 model smartwatch became the first such product to have its software officially...
25
Mar
2019
Bionest
The Changing World of Medical Marketing
A recent survey published in the Journal of the American Medical Association (JAMA) reported that the medical marketing spend in the United States rose from approximately $17.7 billion in 1997 to just under $30 billion in 2016. The biggest growth came from Direct-to-Consumer (DTC) marketing, which increased from 11.9% to 32% of the total spend....
18
Feb
2019
Bionest
One-and-Done Pricing Challenges
As more gene and cell therapies come to market, a big challenge facing both drug developers and payers is designing and instituting appropriate pricing models for these one-time, potentially curative treatments. Innovation should be rewarded, and a curative — or at least, very long-lasting — treatment is likely to save significant dollars in the typical...
5
Nov
2018
Bionest
DEA Greenlights Epidiolex Launch with Drug Schedule Reclassification
Earlier this year, we wrote that GW Pharmaceuticals was poised to receive the first approval from the U.S. Food and Drug Administration (FDA) for a drug derived from the cannabis plant — Epidiolex (cannabidiol, also known as CBD), a treatment for seizures related to Lennox-Gastaut syndrome and Dravet syndrome, rare forms of epilepsy. The FDA...
29
Oct
2018
Bionest
First RNAi Drug Hits the Market — At a Very High Price
On August 13, the U.S. Food and Drug Administration (FDA) approved Alnylam’s Onpattro (patisiran), rapidly followed by that product’s approval in Europe three weeks later. Onpattro, which we previously wrote about, is the first RNAi-based treatment to reach the marketplace. It is intended to treat peripheral nerve disease caused by a rare genetic condition called...
4
Sep
2018
Bionest
The Drug Pricing Blueprint — and Audience Reactions
In May of this year, the Trump White House issued its “Blueprint to Lower Drug Prices” in response to the Administration’s views that excessively high drug prices “burdening the American people” were in part caused by “foreign freeloading” and a system currently rigged “to reward list price increases.” The policy document, which was open...
16
Jul
2018