Latest Headlines

Latest Headlines

NICE, in reversal, OKs Amgen's Repatha while snubbing Sanofi and Regeneron's Praluent

Amgen's Repatha is in a market brawl with Sanofi and Regeneron's Praluent as the competitors rush to sew up as many OKs around the world as possible for the new-gen cholesterol fighters following their FDA approval last year within weeks of one another. Now Amgen has pulled ahead in England after the country's drug pricing watchdog has both changed course to cover Repatha for some patients, while dealing its competitors a blow with a rejection for Praluent.

Samsung's Benepali biosimilar wins first EU sales in Norway

Norway became the first overseas country to approve the Enbrel biosimilar made by Samsung Bioepis for sale, coming two weeks after the drug, Benepali, was approved by the European Commission.

Amgen says it's awaiting reimbursement details after Japan Repatha nod

Amgen said that the approval for Repatha (evolocumab) in Japan filed by Amgen Astellas Biopharma K.K., a joint venture with Tokyo-based Astellas Pharma, could be launched within months pending reimbursement details.

Genentech snags a PhII-ready IL-33 asthma/COPD drug from Amgen

Genentech has moved to the head of a small group of players in the anti-inflammatory arena, bagging rights to an antibody that scrambles the connection between IL-33 and the ST2 receptor--two biomarkers pegged for their role in a variety of lung ailments--from Amgen.

UPDATED: Amgen beats in Q4 as established drugs come through

Amgen had a steady stream of significant new drug approvals in 2015, like the FDA nod for its Repatha which is in a new class of cholesterol fighters that are expected to generate significant sales. But Repatha and several others are too early in their launch to register separately on the sales line, and it was growth in sales of Amgen's tried-and-true drugs that allowed the biotech to breeze by analyst expectations.

Amgen's Humira biosim is one step closer to FDA approval. But how close is it to market?

On Monday, Amgen said the FDA had accepted its application for its biosimilar of AbbVie's Humira, so-called ABP 501--but earlier this month, the U.S. Patent and Trademark Office shut down its challenge to Humira's patents.

Amgen's Humira biosimilar nears FDA nod, but legal hurdles remain

Amgen's take on AbbVie's top-selling inflammation treatment is in line for FDA approval this year, but a patent fight between the two companies could keep it off the market into the next decade.

Sanofi and Regeneron likely to cough up royalties to end Amgen's PCSK9 patent suit: Analyst

One of the hottest races for market share in pharma these days is between Amgen's cholesterol-fighter Repatha and Praluent, from Sanofi and Regeneron. They're apparently neck and neck with payers, and their script numbers aren't much different either, at least so far.

Amgen's Repatha wins first PCSK9 OK in Japan

Amgen and the Sanofi and Regeneron team have been duking it out with their PCSK9 meds in the U.S., racing to ink payer deals in an effort to get ahead. But now, Amgen has the chance to get ahead start in another of the world's largest pharma markets.

Amgen's Kyprolis wins 'backbone therapy' FDA nod after trumping Velcade in trial

Back in March, Amgen's Kyprolis posted impressive results in a head-to-head trial with Takeda behemoth Velcade--and now, those results have helped it grab an important thumbs up from the FDA.