Trials & Filings
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April 14, 2008
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for Risperdal Consta to the FDA seeking approval for adjunctive maintenance treatment to delay the occurr…
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April 4, 2008
GlaxoSmithKline received approval from the FDA for its Rotarix vaccine for the prevention of rotavirus gastroenteritis in infants. With two doses, Rotarix offers protection against the most common rotavirus types in the U.S. and allows infants to com…
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April 4, 2008
Spectrum Pharmaceuticals, Inc. received approval to market Levoleucovorin for Injection from the FDA following application submissions supported by data from BioScreen Testing Services, Inc.
"We offer our since…
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April 2, 2008
Pfizer has discontinued a Phase III clinical trial of single-agent tremelimumab (CP-675,206) in patients with advanced melanoma, after the review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.
The…
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April 2, 2008
Abraxis BioScience, Inc. has initiated enrollment in its Phase II clinical trial to evaluate the efficacy and safety of Coroxane for the prevention and reduction of restenosis following revascularization of the superficial femoral artery (SFA).
Co…
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March 25, 2008
Array BioPharma has filed an Investigational New Drug (IND) application for ARRY-614 with the FDA and has initiated a Phase 1 clinical trial. ARRY-614, a potent, orally active p38 / Tie2 inhibitor, has shown good efficacy and a low side effect profil…
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March 18, 2008
Centocor, Inc. and Schering-Plough have submitted a Marketing Authorization Application (MAA) to the EMEA requesting the approval of golimumab (CNTO 148) as a monthly intravenous (IV) infusion therapy for adults with rheumatoid arthritis, psoriatic a…
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March 17, 2008
Amgen and Wyeth have added a "black box" warning to the U.S. prescribing information (PI) of Enbrel. The warning relates to the risk of infections, including tuberculosis. The companies contend that this warning is similar to labeling for o…
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March 10, 2008
Eli Lilly and Co. terminated its AIR Insulin development program with partner Alkermes, Inc. The program has been in Phase III development as a potential treatment for type 1 and type 2 diabetes. According to the company, the decision is not related…
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March 7, 2008
Gilead Sciences has submitted a Marketing Authorisation Application (MAA) for aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the EU. Aztreonam lysine is an investigational therapy in development for people with cystic fibr…
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March 3, 2008
Wyeth Pharmaceuticals received approval from the FDA for Pristiq, a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD). Wyeth expects to begin shipping the d…
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February 28, 2008
Eli Lilly and Co. received a not approvable letter from the FDA for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance of schizophrenia in adults. Zyprexa LAI is an investigational formulation that combines the antipsych…
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February 25, 2008
Genentech received accelerated approval from the FDA for Avastin in combination with paclitaxel chemotherapy for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on Phase III study (E2100)…
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February 25, 2008
Abbott received FDA approval to market Humira as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. The approval is based on safety and…
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February 22, 2008
The NDA for prasugrel, a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI), has received priority review status from the FDA. Prasugrel, submitted by Daiichi Sankyo Co. and Eli Lilly…
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