Alexion Pharmaceuticals

Latest Headlines

Latest Headlines

Alexion gets new Form 483 in follow-up inspection

Despite the best efforts of Alexion, the FDA has lingering concerns about manufacturing of the drugmaker's orphan drug Soliris at a plant in Rhode Island and presented it with a Form 483 with new observations following a follow-up inspection of the plant last week.

Science pays: 2013's 10 best-compensated R&D chiefs in biopharma

For an idea of what kind of year a drug developer had, take a look at what it paid its head of R&D. Click through our roundup for a look at who ranks where in the biopharma R&D world. Read more >>

Alexion recalls Soliris for third time for particulate

Alexion brought in a team of experts last year to help the company get on top of the manufacturing problems that led to an FDA warning letter for its plant in Rhode Island. But meanwhile, it has had problems with particulate tied to a contractor and today issued its third recall since August of orphan drug Soliris.

Moderna names big names to manufacturing advisory board

The FDA has been harping at the industry to make sure it gets its manufacturing right and Moderna Therapeutics, which is developing a way to enable the in vivo production of therapeutic proteins, intends to make sure it does.

BMS joins Merck with plans to whack plants in Ireland

Ireland's liberal tax code continues to attract drugmakers, but some of the long-term players are cutting back on their extensive manufacturing there. Bristol-Myers Squibb, with plans to lay off about 160 workers at two facilities, can now be added to that list.

Why does Alexion's Soliris cost $500K-plus? U.K. gatekeepers want to know

It's fairly routine for the U.K.'s cost-effectiveness watchdogs to ask companies for more data to support approval for use by the country's National Health Service. Clinical data, price modeling, the works. But asking for information on R&D costs? That's something different altogether.

Rare-disease powerhouse Alexion grabs an option on muscular dystrophy buyout

The biotech has struck a deal with little Prothelia and the University of Nevada, Reno, where it will step in and conduct development research on a protein replacement therapy for merosin-deficient congenital muscular dystrophy, or MDC1A.

Alexion buys vial-filling facility in Ireland

Alexion, maker of orphan drug Soliris, last year said it was opening a center in Dublin, Ireland, to expand its supply chain operations in Europe. Now the drugmaker is buying a vial-filling facility there, a move that is providing a boost to a manufacturing expansion project by another drugmaker.

Cash-laden Moderna snags $125M in Alexion RNA deal

Cambridge, MA's Moderna Therapeutics is marching on with another high-dollar deal, getting $125 million up front to lend its messenger RNA platform to rare disease luminary Alexion Pharmaceuticals.

Alexion recalls more Soliris

Alexion is again having problems with a contract filler, forcing it to recall two more lots of its rare-disease drug Soliris because of visible particles found in vials. It is the second time in about three months that the company has been in this situation.