Monday, March 3rd, 2008
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection, 20 mg/mL. Shipment of this product, available in 40 mg/2 mL ...
Posted in Pharma Industry | No Comments »
Friday, February 29th, 2008
Baxter International Inc announced yesterday, Thursday 28th February, that it was recalling all remaining multi-dose and single-dose heparin sodium and HEP -LOCK heparin flush products now that alternative suppliers are able to meet national demand for them.
Heparin sodium is a vital ingredient in surgical and medical procedures that has been ...
Posted in Blood / Hematology | No Comments »
Monday, February 25th, 2008
Corgenix Medical Corporation (OTCBB: CONX), a worldwide developer and marketer of diagnostic test kits, has received notification of European Patent Office (EPO) approval for technology to which Corgenix holds exclusive worldwide licensing rights.
McMaster University (McMaster) of Hamilton, Ontario, is the owner of the patent covering the aspirin resistance measurement method. ...
Posted in Medical Devices | No Comments »
Monday, February 25th, 2008
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced the receipt of a positive opinion from the CHMP, the scientific committee of the European Medicines Agency ("EMEA"), for its human granulocyte colony stimulating factor ("G-CSF") product. Teva's product is the first biosimilar G-CSF to receive a positive opinion in the European Union.
The ...
Posted in Pharma Industry | No Comments »
Monday, February 25th, 2008
Ipsen (Paris:IPN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) provided a positive opinion for Adenuric® (febuxostat) 80 mg and 120 mg tablets for the treatment of chronic hyperuricaemia in gout and recommended it for marketing authorisation. The CHMP recommendation will ...
Posted in Gout | No Comments »
Monday, February 25th, 2008
ALTARGO(R) (retapamulin ointment, 1%), the first new topical antibiotic in nearly 10 years, is launched in the UK. The treatment is effective against localised impetigo,1 a contagious skin infection common in children and people who play contact sports or live in close vicinity to others.2,3
ALTARGO works fast; a five day ...
Posted in Dermatology | No Comments »
Monday, February 25th, 2008
Artisan Pharma, Inc. announced that the Japanese Pharmaceutical and Medical Device Agency approved Artisan's lead drug, ART-123 (human, soluble, recombinant thrombomodulin), on January 25, 2008 for the treatment of disseminated intravascular coagulation ("DIC") in Japan.
The approval of ART-123, which was received by Artisan's partner and licensor of ART-123, Asahi Kasei ...
Posted in Blood / Hematology | No Comments »
Monday, February 25th, 2008
AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced that Rotarix(R), an oral, two-dose rotavirus candidate vaccine to prevent rotavirus gastroenteritis in infants, received a favorable recommendation from the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). AVANT licensed the technology for Rotarix® to GlaxoSmithKline in 1997 ...
Posted in GastroIntestinal | No Comments »
Saturday, February 23rd, 2008
Arbios Systems, Inc. (OTC Bulletin Board: ABOS) announced that the Company has received conditional approval from the U.S. Food and Drug Administration ("FDA") of an Investigational Device Exemption ("IDE") to begin the pivotal clinical trial for SEPET(TM), Arbios' extracorporeal (outside the body) artificial liver assist device for blood purification of ...
Posted in Liver Disease / Hepatitis | No Comments »
