Tag Archives: Amgen Inc.

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 »

Biotech predictions for 2017 return to positive fundamentals; 2016 meltdown still in rear-view mirror

The NASDAQ Biotech Index got hammered in 2016–-but mostly due to the market melting in January 2016. The Nasdaq Biotech Index collapsed 28% in the opening weeks of 2016 and… Read more »

Novo Nordisk to cap price increases as drug costs face more scrutiny; do two drugmakers equal a trend?

With drug companies under fire over prices, the world’s largest insulin maker plans to limit increases and join competitors by introducing a model that ties the cost of medicines to… Read more »