FDA goes on a rulings binge
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 »
Tag Archives: Amgen Inc.
Wondering why some of your Pharma shares keep going up? Thank Trump’s tax “reform;” no, really.
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 »
Largely ignored by Trump, Puerto Rico’s hurricane disaster slams island’s pharmaceutical industry; US mainland’s access to crucial medicines could take a big hit.
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 »
Patients lose, lawyers win, as AbbVie does deal with Amgen to delay Humira biosim.
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 »
Amgen, Allergan get nod for Avastin biosim; FDA’s Gottlieb making good on vow to hasten generic approvals, catch the EU.
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 »
Alexion on a roll as Soliris gets label expansion in EU; although flying under the radar, analysts, investors still bullish.
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 »
Amgen’s osteoporosis med almost a home run in latest trial; fate now murky on heart safety
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 »
Abbvie’s biosimilar fight over Humira patent highlights differences between EU and US regulatory mindsets
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 »
Akebia shares soar on rich partnership with Otsuka; risky but rational gamble?
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 »
Week’s opening stock salvo: Esperion, Nektar, CytomX soar; Aevi Genomic thrashed
Esperion Therapeutics Inc. (Nasdaq: ESPR) stock recently recovered big time from last Amgen-induced beat down to touch an 18-month high after the company outlined its path to FDA approval for its… Read more »