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

Carly Helfand 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 ...

Novo Nordisk rolls out long-awaited Tresiba, aiming for blockbuster market share

Tracy Staton Novo Nordisk finally launched its next-gen diabetes treatment Tresiba in the U.S., approved by the FDA last September. The Danish drugmaker has high hopes ...

Hemophilia marketing tactics raise questions as market heats up

Carly Helfand While there are plenty of drugs for hemophilia, new patients can be few and far between. To build their market share, some drugmakers and specialty pharmacies have begun ...

CEO Frazier expects Merck to be player in hep C market, M&A this year

Eric Palmer Merck & Co.'s CEO Kenneth Frazier expects his company to be a player in that lucrative hepatitis C market again with the anticipated approval this month of its hep ...

Merck poised to win bigger market for cholesterol-fighting Zetia

Tracy Staton Merck & Co.'s cholesterol drug Zetia gets another day in the spotlight on Monday. An FDA advisory panel is debating results from an outcomes trial, Improve-It, ...

Boehringer wins FDA approval for its Pradaxa antidote with eyes on a bigger market share

Damian Garde Boehringer Ingelheim picked up an FDA nod for an injection designed to reverse the effects of its blockbuster anticoagulant Pradaxa, marking the first approval for an antidote ...

Intas CEO expects to break into U.S. biosimilar market yet this year

Eric Palmer The CEO of Intas Pharmaceuticals expects his company to get FDA approval this year for its biosimilar of Amgen's Neulasta, a drug it developed with Canada's Apotex. FiercePharma ...

New standout Imbruvica data bode well for market expansion in CLL

Carly Helfand Johnson & Johnson and AbbVie's Imbruvica has already shown in one Phase III study that it can extend progression-free survival in patients with previously treated ...

J&J, Novartis lead pharma companies by market cap

Carly Helfand Which Big Pharma companies have the biggest market caps in the industry? The Motley Fool has a breakdown of the top 10, but we'll give you a hint: The list ...

Cost watchdogs back Novartis’ Xolair for big new market in chronic hives

Tracy Staton England's cost-effectiveness watchdogs have changed their mind on Xolair. The National Institute for Health and Care Excellence decided to back the Novartis asthma ...

Daiichi’s Savaysa goes up against next-gen anticoagulant trio in heated market race

Carly Helfand What's long been a three-horse race just gained a fourth horse with the FDA's green light for Daiichi Sankyo's clot-fighter Savaysa. With the FDA's Thursday ...

IPOs: Molecular Partners and Xenon pull off downsized debuts amid a shaky market

Damian Garde Biotechs Molecular Partners and Xenon Pharmaceuticals finally made their way to the public markets after previously postponing their IPOs, but each had to settle for a ...
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