Alexion Pharmaceuticals

Latest Headlines

Latest Headlines

UPDATED: Alexion wins FDA OK on Strensiq, but startles analysts on price

Alexion's $1.08 billion deal to buy Enobia has paid off with an FDA approval of the "breakthrough" therapy that it gained in the blockbuster bargain. The FDA announced Friday afternoon that asfotase alfa--to be sold as Strensiq--won marketing clearance as a new therapy for extremely rare cases of a metabolic disease known as hypophosphatasia.

Biopharma's 10 highest-paid heads of R&D

The year's 10 highest-paid development executives pulled in $124.4 million in total compensation, a roughly 35% jump over 2013's top earners. And while each entrant benefited from meeting individual company goals, the whole group benefited from biopharma's macroeconomic moment in the sun, as the value of stock awards skyrocketed alongside the industry index.

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.