January 30, 2016 |
A small Texas pharmaceutical company that is building a sales and marketing headquarters in Blue Bell has won Food and Drug Administration approval for a first-of-a-kind treatment for Attention Deficit Hyperactivity Disorder in patients 6 years and older. Neos Therapeutics Inc. secured final FDA approval late Wednesday for Adzenys, the first oral tablet for ADHD that dissolves in the mouth in less than 30 seconds, and does not require swallowing a pill or capsule. Adzenys is an amphetamine and the bioequivalent of Shire PLC's Adderall XR, said the company, whose local operation is headed by a former Shire employee.
March 16, 2013 |
James McGough might be a highly qualified psychiatrist, but he served on an FDA advisory committee Thursday in part because his conflict-of-interest issues were less disturbing than seven other doctors the agency tried to recruit. McGough and another committee member offered two more examples of the conflicting interests inherent in parts of the U.S. drug-approval process. As required by law, the pediatric advisory committee was reviewing applications for several drugs to be used for children or for wider groups of children.
February 10, 2013 |
Shire P.L.C. will pay $48 million to Impax Laboratories Inc. to settle litigation between the two drugmakers over delivery of generic Adderall XR, which is supposed to be used to treat attention deficit hyperactivity disorder. Shire is based in Ireland, but its U.S. headquarters is in Wayne, Chester County. Impax is based in Hayward, Calif., but its two other U.S. facilities are in Philadelphia and Chalfont, Bucks County. Both companies announced the agreement. Shire produces the original Adderall XR but had an agreement to supply so-called authorized generic versions to Impax for that company to sell.
February 3, 2013 |
Shire P.L.C. said Friday that it would pay $57.5 million as part of a tentative agreement with the Justice Department to settle an investigation related to marketing practices of five drugs. A spokeswoman for the U.S. Attorney's Office in Philadelphia, which handled the investigation, declined comment. Shire has its headquarters in Ireland, but its main office is in Wayne, Pa. Shire said the drugs involved are Adderall XR, Vyvanse, Daytrana, Lialda, and Pentasa. Some companies will announce such tentative agreements because they want to avoid criticism from investors or financial regulators for not disclosing information that can have an impact on earnings.
October 26, 2012 |
On his 13th anniversary with drugmaker Shire P.L.C., chief executive officer Angus Russell said Thursday he will retire next year and be succeeded by Bayer executive Flemming Ornskov. Shire, a leading seller of drugs for attention deficit hyperactivity disorder, began in Britain but operates in 29 countries and has its U.S. headquarters in Chesterbrook. The company said this week it plans to move its 1,500 local employees to a bigger campus in Malvern. "It's been the most amazing period of my career," Russell, 56, said of his 32-year industry run during a conference call with stock market analysts to discuss third-quarter earnings.
October 25, 2012 |
Shire P.L.C. said Tuesday it plans to move from Chesterbrook to Malvern and into a new facility to hold its growing workforce of pharmaceutical employees. Demonstrating the value of infrastructure, Shire chose a site in the Atwater Corporate Center, which is along Route 29 in East Whiteland Township and is served by a brand new interchange for the Pennsylvania Turnpike. Based in the United Kingdom, Shire has grown from about 100 to nearly 1,500 local employees and contractors, in part because it is squarely in the growing market for drugs that treat attention deficit hyperactivity disorder.
August 15, 2012 |
Shire P.L.C., which has grown from 100 local employees to about 1,100 since the specialty pharmaceutical company landed in Wayne in 2004, is nearing a decision on a likely move of its North American headquarters from Wayne to another spot in the region. Shire chief executive officer Angus Russell said during a recent wide-ranging interview that the company needed a campus-like setting to handle its current workforce and future growth. Although he said he had met with Mayor Nutter on a variety of topics, including the move, Russell would not identify possible relocation sites, in the city or elsewhere.
August 25, 2011 |
WASHINGTON - The Food and Drug Administration said Thursday it approved a drug from Shire PLC to treat a rare inherited disease that can cause dangerous swelling in the limbs, face and intestines. The drug Firazyr was approved to treat flare-ups of hereditary angioedema, a condition that affects less than 30,000 people in the United States. The disease can cause rapid swelling of the hands, feet, windpipe and other internal organs, which can cause disfigurement and even death.
May 17, 2011 |
Shire P.L.C., a specialty biopharmaceutical company with North American headquarters in Wayne, said Tuesday that it agreed to pay $750 million for Advanced BioHealing Inc. Advanced BioHealing's key product is Dermagraft, which is designed to be used to treat diabetic foot ulcers. The company's U.S. facilities include a headquarters in Westport, Conn., a manufacturing facility in La Jolla, Calif., and a research center in Brentwood, Tenn. "This acquisition is a strong and complementary strategic fit for Shire," Mike Cola, president of Shire's specialty pharmaceuticals business, said in a statement.
August 5, 2010
In the Region Hired in May, president departs Destination Maternity Corp. president Emilia Fabricant resigned after less than three months on the job, the Philadelphia clothing retailer said Wednesday. Fabricant cited her desire to return to Southern California to be with her family. Fabricant had been president and chief merchandising officer of Charlotte Russe. Destination Maternity chief executive officer Ed Krell will also serve as president, the company said. - Paul Schweizer Shire earnings sharply higher Shire P.L.C.