Tag Archives: Shire

Shire: U.S. FDA approval makes CINRYZE® available to help prevent angioedema attacks in children with hereditary angioedema

CINRYZE is the first and only therapy indicated in the U.S. to help prevent angioedema attacks in pediatric patients with hereditary angioedema (HAE) as young as 6 Shire is the only drug developer to complete a pediatric study for the … Read the full press release

U.S. FDA approval for Shire’s first submission for its new plasma manufacturing facility near Covington, Georgia

New facility will add 30% capacity to Shire’s internal plasma manufacturing network once fully operational Expanded capacity supports continued strong growth of Shire’s leading immunoglobulin portfolio and further strengthens ability to deliver complex therapies for rare immune-mediated conditions DUBLIN, 25-Jun-2018 … Read the full press release

Shire to present new data on recombinant human parathyroid hormone and on the management of chronic hypoparathyroidism at the Endocrine Society’s 100th Annual Meeting and Exposition

Clinical and real-world insights on recombinant human parathyroid hormone (1-84) (rhPTH[1-84]) and the management of chronic hypoparathyroidism to be presented Hypoparathyroidism is a rare endocrine disease that can have a significant impact on patients New data highlight Shire’s commitment to … Read the full press release

Shire CMO Howard Mayer, M.D.: no patient is currently being denied access to treatment with Hemlibra

DUBLIN, 16-Jan-2018 — /EuropaWire/ — At Shire, we’ve been committed to the hemophilia community and the lives of every patient afflicted with this disease for more than 70 years. We are very proud of this legacy and take our role as … Read the full press release

Shire: EU approval of ADYNOVI is an important milestone in our continued commitment to provide new treatment options for patients with hemophilia A

Marketing Authorization will enable patient access to ADYNOVI throughout Europe ZUG, 16-Jan-2018 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that the European Commission (EC) has granted Marketing Authorization for ADYNOVI … Read the full press release

Shire MYDAYIS now available by prescription in the United States

Mydayis, which is now available in the U.S., demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-dose, compared to placebo, in total score on a skill-adjusted math test that measures attention in ADHD Lexington, … Read the full press release

Shire submits MAA for lifitegrast: If approved it will address the signs and symptoms of dry eye disease in adults in Europe

Lifitegrast, if approved, would be the first and only new class treatment to address the signs and symptoms of dry eye disease in adults in Europe ZUG, 16-Aug-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the Marketing Authorization … Read the full press release

Shire to present ADHD research at the 170th Annual Meeting of the American Psychiatric Association (APA) in San Diego

Latest Research Supports Greater Understanding of the Evolving Needs of Adults with ADHD Lexington, M.A., 18-May-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) will present research on the evolving needs of adults living with Attention-Deficit/Hyperactivity Disorder (ADHD) at the … Read the full press release

Shire unveils powerful spoken word video to raise awareness of some of the issues many adults with ADHD face

Spoken word performer communicates plight of adults with ADHD who remain overlooked and unsupported. ZUG, 25-Oct-2016 — /EuropaWire/ — To mark ADHD Awareness Month, Shire plc (LSE: SHP, NASDAQ: SHPG) has today launched a powerful spoken word video to communicate the … Read the full press release

Shire expands its portfolio of intravenous and subcutaneous immunoglobulin (IG) products with U.S. FDA approval of CUVITRU

Approval follows positive data from clinical studies on efficacy and tolerability, as well as infusion time and number of injection sites Lexington, Mass., 14-Sep-2016 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the United States Food and Drug … Read the full press release

Shire Q2 2016: completed the combination with Baxalta to create the leading global biotechnology company

Integration on track; operating cost synergy expectations increased Pipeline progression continues with FDA approval of XIIDRA for dry eye disease DUBLIN, 04-Aug-2016 — /EuropaWire/ — Shire plc (“Shire”) (LSE: SHP, NASDAQ: SHPG) announces unaudited results for the three months ended June … Read the full press release