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.
Jean-Christophe Tellier, currently UCB’s Executive Vice President, Biopharma Brands and...
UCB has announced hat the FDA has approved Cimzia (certolizumab pegol) for the treatment of...
UCB and Five Prime Therapeutics announced today that they have entered into a strategic...
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.
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 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.
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 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 LossJuly 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.
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 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.
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 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 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.
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.
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).
NEW YORK (AP) — Immunomedics Inc. and partner UCB said today that their potential lupus drug met key goals in a midstage study.
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 Inc.today 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.
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.
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 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.
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.
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.
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.
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 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 ImmediatelyNovember 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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