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UCB Announces US and EU Regulatory Filings for the Investigational Antiepileptic Drug Brivaracetam

January 21, 2015 7:58 am | News | Comments

In the US, the FDA has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication.

UCB Announces CEO Succession Plan

February 20, 2014 8:14 am | News | Comments

Jean-Christophe Tellier, currently UCB’s Executive Vice President, Biopharma Brands and...

Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis

October 18, 2013 8:05 am | News | Comments

UCB has announced hat the FDA has approved Cimzia (certolizumab pegol) for the treatment of...

UCB and Five Prime Therapeutics Announce Strategic Discovery Collaboration

March 19, 2013 7:54 am | News | Comments

UCB and Five Prime Therapeutics announced today that they have entered into a strategic...

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UCB and ConfometRx Announce New R&D Partnership

February 21, 2013 8:20 am | News | Comments

UCB announced today that it has sealed a research agreement with ConfometRx to enable the discovery of novel medicines addressing unmet medical needs in Neuroscience. Under this two-year multi-target agreement, UCB and ConfometRx will leverage structural biology to gain insight into G-protein coupled receptor (GPCR) modulation towards the design of differentiated drugs.

FDA Approves Generic Keppra XR Tablets

July 25, 2012 4:20 am | News | Comments

Qualitest Pharmaceuticals today announced that it has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg, the generic equivalent of UCB's Keppra XR.  

UCB Launches Neupro in the U.S. to Treat Parkinson’s Disease and Restless Legs Syndrome

July 16, 2012 4:21 am | News | Comments

UCB announced today that Neupro® (Rotigotine Transdermal System) is now available in U.S. pharmacies. Neupro® was approved by the U.S. Food and Drug Administration in April to treat the signs and symptoms of early and advanced stage idiopathic Parkinson’s disease and moderate-to-severe primary Restless Legs Syndrome.  


Neupro Approved by FDA for Parkinson's Disease and Restless Legs Syndrome

April 3, 2012 4:14 am | News | Comments

UCB announced today that the FDA has approved Neupro (Rotigotine Transdermal System) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).

Lupin Announces Launch of Generic KEPPRA XR Tablets

September 15, 2011 5:16 am | News | Comments

Lupin Pharmaceuticals, Inc. announced today that the FDA has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market a generic version of UCB's KEPPRA XR tablets.

Amgen and UCB Team Up With NASA on Final Space Shuttle Mission to Conduct Preclinical Test of Sclerostin Antibody on Bone Loss

July 6, 2011 4:50 am | News | Comments

Amgen and UCB announced today that they are collaborating with the National Aeronautics and Space Administration (NASA) Ames Research Center to conduct a preclinical test of a sclerostin antibody in an experiment that will take place aboard space shuttle Atlantis, on the final NASA shuttle mission.

UCB Pleads Guilty to Off-Label Marketing

June 10, 2011 4:59 am | by NEDRA PICKLER,Associated Press | News | Comments

WASHINGTON (AP) — The maker of epilepsy treatment Keppra agreed Thursday to pay more than $34 million for marketing the medication to treat migraine headaches in violation of U.S. drug laws

UCB and PDL BioPharma Resolve Patent Disputes

February 8, 2011 3:36 am | News | Comments

UCB SA, on behalf of its affiliate UCB Pharma S.A. (UCB), and PDL BioPharma, Inc. today jointly announced that the companies have entered into a definitive settlement agreement that resolves all legal disputes between them, including those relating to UCB's pegylated humanized antibody fragment Cimzia.


Aesica Makes European Appointments

February 3, 2011 3:40 am | News | Comments

Following the recent announcement that it has signed contracts ahead of acquiring three manufacturing sites from UCB in Germany and Italy, Aesica Pharmaceuticals has appointed a team to direct and manage its new European operation.

UCB to Expand Manufacturing Capacity for Cimzia®

December 22, 2010 3:29 am | News | Comments

UCB announced today that the company has initiated a project to build in-house biotech microbial manufacturing capacity in Bulle, Switzerland to secure demand for its core product Cimzia® (certoluzimab pegol).

UCB Optimizes its Manufacturing Network

December 15, 2010 3:40 am | News | Comments

UCB has agreed with Aesica, a leading pharmaceutical manufacturer, that Aesica will acquire current UCB manufacturing businesses in Germany and Italy. The agreement is part of UCB’s strategy to optimize its manufacturing network in line with the evolution of its portfolio and includes the manufacturing sites of Monheim and Zwickau in Germany and Pianezza in Italy.

FDA Approves Launch of Generic Version of Xyzal

November 29, 2010 5:21 am | News | Comments

Perrigo today announced that its licensor and supplier Synthon has received final approval from the FDA for Levocetirizine tablets, a generic version of Xyzal tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis.

E Keppra® (levetiracetam) Receives Regulatory Approval in Japan

July 23, 2010 4:28 am | News | Comments

Otsuka Pharmaceutical Co., Ltd. and UCB today announced that UCB Japan has received manufacturing and marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for E Keppra® (250 mg and 500 mg Tablets).


Immunomedics' Lupus Drug Meets Study Goals(2)

June 16, 2010 4:33 am | News | Comments

NEW YORK (AP) — Immunomedics Inc. and partner UCB said today that their potential lupus drug met key goals in a midstage study.  

UCB To Exit The Primary Care Market in the U.S.

January 29, 2010 11:21 am | News | Comments

UCB announced today that it plans to accelerate its U.S. transition to a purely specialty-focused biopharmaceutical company and will exit the primary care market in the U.S., effective 1 March 2010. This strategic decision impacts the reported 2009 net profit with one-time restructuring charges, while freeing more resources for core products.

Mylan Receives Approval for Generic Version of Antiepileptic Keppra(R) 1000 mg

December 11, 2009 3:34 am | News | Comments

Mylan announced that its subsidiary Mylan Pharmaceuticals Inc. received finalapproval from the U.S. Food and Drug Administration (FDA) for its AbbreviatedNew Drug Application (ANDA) for Levetiracetam Tablets, 1000 mg.

Glaxo Plans to Beat Rivals in Emerging Markets

December 10, 2009 4:44 am | News | Comments

JANE WARDELL AP Business Writer LONDON (AP) — GlaxoSmithKline PLC said Thursday it plans to outpace its rivals in the race to emerging markets as revenue from traditional western pharmaceutical markets continues to slow.

Ismail Kola Joins UCB as Executive Vice President, UCB & President of UCB New Medicines

November 10, 2009 3:28 am | News | Comments

UCB today announced the appointment of Ismail Kola, Executive Vice President, UCB & President of UCB New Medicines(TM),UCB's discovery research through to 'proof of concept' organization. Ismail Kola will join UCB's Executive Committee with effect from November 23, 2009.

UCB and AstraZeneca Form Alliance for the Commercialization of Cimzia(R) in Brazil

September 28, 2009 4:30 am | News | Comments

UCB and AstraZeneca announced today that they have entered into a partnership to register and commercialize UCB's PEGylated anti-TNF alpha drug Cimzia (certolizumab pegol) in Brazil. The drug is to be registered for the treatment of rheumatoid arthritis and Crohn's disease.

FDA OKs Sanofi Allergy Drug for Younger Children

August 25, 2009 4:45 am | News | Comments

WASHINGTON (AP) — Sanofi-Aventis SA and Belgian biotech drug maker UCB said Monday their once-daily allergy medication Xyzal has received expanded U.S. approval for children as young as six months. The FDA has approved the drug to treat indoor allergies and hives in children six months and older.

Pfizer Rheumatoid Arthritis Drug Meets Study Goals

June 11, 2009 12:34 pm | News | Comments

NEW YORK (AP) — Pfizer Inc. said Thursday its experimental oral treatment for rheumatoid arthritis has met key goals in two midstage studies by improving tender and swollen joints.

FDA Approves UCB Drug for Rheumatoid Arthritis

May 14, 2009 4:59 am | News | Comments

MATTHEW PERRONE AP Business Writer WASHINGTON (AP) — Belgian drugmaker UCB said Wednesday it received federal approval for an injectable drug to treat arthritis, entering a competitive market dominated by some of the largest U.S. pharmaceutical companies.

Noven and Shire Recall 39 Lots of ADHD Patches

March 20, 2009 6:23 am | News | Comments

NEW YORK (AP) — Shire PLC announced a new recall of the attention deficit hyperactivity disorder patch Daytrana, saying 39 production lots would be pulled from the market because patients could have trouble taking off the protective liner from the patch.

Actavis Receives Approval of Levetiracetam Oral Solution in the U.S.

January 21, 2009 11:47 am | News | Comments

Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the FDA to market Levetiracetam Oral Solution. Distribution of the product has commenced.

Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately

November 4, 2008 11:05 am | News | Comments

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg.

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