- UCB announced today that the New Drug Application (NDA) for the use of Keppra XR(TM) (levetiracetam) extended- release tablets in the adjunctive treatment of partial onset seizures in adults with epilepsy has been accepted for filing by the U.S. Food and Drug Administration (FDA).
- The European Medicines Agency (EMEA) has been formally notified by Marvel LifeSciences Ltd of its decision to withdraw its applications for a centralised marketing authorisation for the medicines Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel.
- The Reyataz (atazanavir) package insert was revised to include information regarding the administration of atazanavir and/or atazanavir/ritonavir with food, proton pump inhibitors, H2 receptor antagonists, acetaminophen, and fluconazole. Additionally, dosing information in patients with renal impairment was included
- USFDA has issued a public health advisory to alert patients and healthcare professionals about important safety information concerning the drug Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. As a result, FDA is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks.
- Dr Reddy's Laboratories Ltd has launched Supanac (Diclofenac potassium immediate release 50 mg tablets) in India, increasing its offering in the Rs 2700 crore ( $688 million) NSAID market.
- Pfizer Inc and Scil Technology GmbH (Scil) have signed a licensing agreement with Scil Technology GmbH (Scil) to develop and commercialise CD-RAP, Scil's cartilage specific growth factor. Under this agreement, Pfizer will obtain a worldwide exclusive license to develop and commercialise CD-RAP. In addition to receiving royalties on the sale of any products that may be commercialised under this agreement, Scil is eligible for upfront and milestone payments of approximately US $250 million depending on the achievement of various development and regulatory milestones.
- Nycomed announced today that the Food and Drug Administration (FDA) approved Alvesco(ciclesonide) Inhalation Aerosol in the United States for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older. ALVESCO(R) is an inhaled corticosteroid with novel release and distribution properties. Commercialisation and marketing of ALVESCO(R) will be achieved through a U.S. commercial partner.
- Teva Specialty Pharmaceuticals, the U.S. respiratory therapy unit of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and UCB (Euronext: UCB) today announced an agreement to co-commercialize Teva's U.S. respiratory medicines. The initial product to be jointly promoted in the U.S. is Teva's ProAir(R)HFA (albuterol sulfate) Inhalation Aerosol. ProAir(R)HFA is the number-one branded hydrofluroalkane (HFA) albuterol sulfate inhaler in the U.S. Additionally, the agreement will provide UCB future joint promotion opportunities with other products in development by Teva Specialty Pharmaceuticals. Financial terms of the agreement were not disclosed.
- Dynogen Pharmaceuticals, Inc. today announced that the Company has acquired from Arachnova Therapeutics, Ltd. all of its worldwide patent rights and know-how related to DDP225 in an asset purchase agreement. The Arachnova patent rights, which include granted patents and pending applications related to the use of DDP225 for the treatment of functional bowel disorders, genitourinary (GU) disorders and pain, complement and enhance Dynogen's existing extensive worldwide patent estate related to DDP225. Financial terms of the agreement were not disclosed.
