The News: The US Food and Drug Administration has given the green light to market a blood cancer drug from Beijing-based BeiGene Ltd., paving the way for American patients to access a Chinese… Read more »
FDA ROUNDUP: In one of the busiest rulings binges of the year, the US Food and Drug Administration last week approved an assortment of pharmaceuticals, medical devices, an AI algorithm… Read more »
The News: The drug industry has taken heat from patient advocates and a US senator for handing out its tax savings to shareholders instead of using its windfall to help patients… Read more »
The News: Unknown to the vast majority of mainland US citizens, a nightmare scenario stemming from “supply chain instability” is unfolding right now in Puerto Rico. Brought to light by… Read more »
The News: Amgen Inc. (Thousand Oaks CA) has agreed to delay the US launch of its FDA-approved biosimilar version of AbbVie Inc.’s (North Chicago) Humira (adalimumab) until 2023, under a… Read more »
The News: Amgen Inc. (Thousand Oaks CA) and Allergan PLC (Dublin IRL) said Thursday (September 14, 2017) that the Food and Drug Administration has approved their biosimilar version of Roche… Read more »
The News: Alexion Pharmaceuticals Inc. (New Haven CT) got another shot in the arm this week with the EU approving its key revenue driver Soliris for an additional indication. EU approval… Read more »
The News: Amgen Inc. (Thousand Oaks CA) and UCB SA (Brussels) no longer expect their experimental osteoporosis drug to win US approval this year after a higher rate of serious… Read more »
The News: Coherus BioSciences Inc. (Redwood City CA) last week announced that the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office ruled in the company’s… Read more »
The News: Akebia Therapeutics Inc. (Nasdaq:AKBA) led advancing issues last week, soaring $4.08, or 45% for the 5-day stretch, to $13.18. The big move came after the Cambridge, MA-based company… Read more »
