EpiPen, often chided for high price, gets first generic competitor
The drugmaker's generic had originally met with FDA rejection in early 2016, amid a national debate over EpiPen's price.
Report blames gaming of patent system for high drug prices
Most drugs named are biologics, and manufacturing trade secrets make competition especially tricky, legal expert says.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Will pricey old drugs bust Medicaid bank?
“People always thought, ‘They’re generics. They’re cheap,’” said Matt Salo, who runs the National Association of Medicaid Directors. But with drug prices going up “across the board,” generics are far from immune.
Wanted: Generic competition
FDA has announced two more initiatives designed to foster greater generics competition, a key priority for new commissioner Scott Gottlieb.
Here’s an infographic of drug patents expiring in 2017
Drug patents are always more complicated than they seem, but a new infographic from Dickson Data spells out some of what you need to know in 2017, in an easily consumable way.
Generic drug price fixing may have roots in pharma ‘Girls Nights Out’
The high prices Americans pay for generic drugs may have been cooked up by pharmaceutical salespeople on golf courses, at a New Jersey steakhouse or over martinis at a “Girls Nights Out” in Minnesota.
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A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Investigation into drug price hikes yields first lawsuit
Attorneys general in 20 states have filed an anti-trust lawsuit against Heritage, Mylan, Teva and three other generic drug companies, alleging price-fixing and market-splitting tactics between the competition.
Study: Medicare coverage of prescription painkillers with built-in abuse deterrants falls
The abuse-deterrent labeling approval for prescription painkillers means they are formulated to make it tougher for patients to abuse.
FDA studying how generics’ size, shape and color impact medication adherence
The FDA is studying whether generic pill size, shape and color impact patient adherence.
Bion Pharma, the startup launched by ex-Ranbaxy execs, raises $21M
Bion Pharma, the New Jersey startup freshly launched by a cadre of former execs from Indian generic drugmaker Ranbaxy, has raised $21 million from two investors, according to a regulatory filing. The company’s aiming to raise $30 million. Five execs at the U.S. branch of Ranbaxy quit last month, and aim through this Princeton-based startup to […]
BioLabs Pegasus Park Cultivates Life Science Ecosystem
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
Here are the answers to FDA Law Blog’s Hatch-Waxman 30th anniversary trivia quiz
Thanks to everyone who participated in our “30 for 30” Hatch-Waxman Trivia! Based on the corrrespondence we received since posting the trivia questions earlier this week, FDA Law Blog readers enjoyed the trip down memory...
Generic drugmaker Nephron Pharmaceuticals raises $75 million in debt financing
Nephron Pharmaceuticals, a maker of generic respiratory meds, has raised $75 million in debt financing, according to a regulatory filing. The company is based in Orlando, Florida and employs about 500. It announced two years ago that it would expand its operations, building out an expansive South Carolina site with a $313 million investment. The company’s […]
Advair’s manufacturing challenges could be a barrier for GSK’s generic competitors
When GSK introduced its Advair Diskus to the market about 15 years ago, it wasn’t expected to be such a big hit, never mind reaching close to $8 billion in sales as it did last year. It’s actually not so abnormal for demand for new drugs to be way off their initial projections and it’s […]