These box office numbers do not include the cost of production or marketing costs. They also don't count the billions in merchandising that Disney has made over the last...Entertainmentread more
Instagram began tests that hide "like" counts on posts. That means influencers who market products on Instagram will have to rely on different metrics to show success.Technologyread more
Peter Neupert worked for Microsoft and Amazon-backed Drugstore.com, where he got to know Jeff Bezos. He now advises start-ups.Technologyread more
Facebook Vice President David Marcus is the face of the company's Libra digital currency, but the original driving force was a 26-year-old female corporate-development...Technologyread more
Regional stability, oil prices and potential for war will all depend on what Iran does with its nuclear program in the event of the deal's termination.World Politicsread more
The firing of the tear gas was the latest confrontation between police and protesters who have taken to the streets for over a month to fight a proposed extradition bill and...China Politicsread more
Amazon's new policy for account suspensions doesn't go far enough to protect sellers from potentially unfair and wrongful suspensions, merchants say.Technologyread more
There is no end in sight to the Boeing 737 Max grounding after two fatal crashes, prompting airlines to rethink their growth plans.Airlinesread more
After a year of flooding, Midwest farmers face a stifling heat wave that's spreading across the U.S.Weather & Natural Disastersread more
On Saturday, Disney's Marvel Studios announced its upcoming slate of superhero films during a panel at San Diego Comic-Con.Entertainmentread more
"It troubles me that the most important political office in the world is becoming the face of racism and exclusion," Kaeser said in a Twitter post.Politicsread more
U.S. regulators cleared the first generic competitor to Mylan's EpiPen, after a yearslong delay that many said contributed to the emergency allergy drug's rapid rise in price.
Teva Pharmaceuticals received Food and Drug Administration approval for generic versions of both the EpiPen and EpiPen Jr, the agency said in a statement Thursday.
The products are the first competitors cleared by the FDA that are direct generic copies of the EpiPen and could be substituted for the brand-name product by a pharmacist. Other versions of epinephrine auto-injectors, such as the Adrenaclick and Auvi-Q, are on the market, but aren't considered EpiPen generics.
Teva shares rose nearly 6 percent on the news.
"This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," FDA Commissioner Scott Gottlieb said in the statement.
It may be an especially welcome time for a new entrant into the market, as the EpiPen has been facing supply issues, according to Mylan and Pfizer, which makes the EpiPen in a partnership with Mylan.
"We're applying our full resources to this important launch in the coming months and eager to being supplying the market," Teva said in a statement. The company didn't provide any details about specific timing or the planned price.
Mylan introduced its own authorized generic form of the EpiPen in late 2016, after an uproar about the branded version's price, which rose more than 400 percent over a decade. The authorized generic, identical to the original except without the brand name, cost half the price: $300 for a two-pack.
Mylan wasn't immediately available to comment on the FDA's decision.
Teva could seek to compete by pricing its generic version even lower; typically, it takes multiple generic copies of a medicine entering the market to see prices collapse substantially.
The Israeli company's application for a generic EpiPen was rejected by the FDA in early 2016, not long before the rising price of Mylan's product exploded into a major news story heading into back-to-school season, when parents often stock up for kids with allergies.
Though the key ingredient in the EpiPen, epinephrine, has been available for decades and is no longer covered by a patent, generic copies of the device have struggled to reach the market because the product is technically a drug-device combination, and the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators.
The FDA issued guidance in November 2017 to try to make it easier for generic copies of complex medicines like the EpiPen to reach the market, saying some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended.
The FDA said Teva's generic products are expected to produce the same clinical effect and have the same safety profile as the EpiPen and EpiPen Jr. There are small differences in design, the regulator said, but they won't affect safety or efficacy.