Five generic companies will have the right to manufacture and sell generic versions of the drug in mostly lower-income countries, as well as higher-income countries that face "significant obstacles" to healthcare access.
Intercept Pharmaceuticals and bluebird bio said they had encountered regulatory snags at the FDA for their investigational drugs, while Pfizer is pausing most of its clinical trials and delaying completion of a deal with Mylan to create a new company.
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.
Deal value for the third quarter fell sharply from what it was in the first and second quarter, but that was due to the absence of the large acquisitions that took place earlier this year rather than an overall downward trend.
The new firm, currently known only as "NewCo," will be rebranded at the deal's close. In connection with the agreement, Mylan's CEO since 2012, Heather Bresch, plans to retire from her position.
A federal court last year put the kibosh on a deal whereby Allergan transferred to the tribe the Restasis patents, which the tribe then licensed back to Allergan, asserting tribal sovereign immunity to have generic companies' challenge to the patents dismissed.
The drugmaker's generic had originally met with FDA rejection in early 2016, amid a national debate over EpiPen's price.
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.
Market forecast rosy, though market in United States remains young.
FDA has announced two more initiatives designed to foster greater generics competition, a key priority for new commissioner Scott Gottlieb.
Mylan evidently subscribes to a "living in the gray" mentality when it comes to business operations.
A healthy dose of competition has been injected into the market for life-saving emergency epinephrine injectors.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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.
Mylan settled with the U.S. Department of Justice to head off potential Medicaid liability claims by federal and state governments.
The abrupt rise is notable because many people think that life-threatening allergies are less common among the elderly. In addition, epinephrine — the active ingredient in EpiPens — can pose greater risks to older adults.
High-profile deaths in several states have helped to spur legislative action and fuel demand for consumer-dispensed epinephrine. At the same time, no other company has been able to effectively compete with Mylan’s EpiPen.
The maker of EpiPen, the life-saving auto-injector for anaphylaxis, is under fire for exorbitant price hikes so much so that even Martin Shkreli called Mylan out for price-gouging last week.