Trials & Filings
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May 11, 2006
Pfizer received approval from the FDA for its anti-smoking pill, Chantix. The drug had received priority review designation by the FDA and is the first new prescription medication approved for smoking cessation in nearly a decade.
Addiction to n…
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May 8, 2006
Bristol-Myers Squibb received approval for its sBLA for the licensure of Lonza Biologics to support increased production capacity for Orencia, enabling the company to meet expected long-term demand. This follows the December 2005, FDA approval of Ore…
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May 5, 2006
Lilly lost the first round in its patent-infringement battle with Ariad Pharmaceuticals, which was granted a $65.2 million award. The award includes a 2.3% royalty on all sales of Lilly drugs Evista and Xigris, until Ariad's patent expires in 2019.…
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May 4, 2006
Biopartners has received marketing authorization for the EU from the European Commission for its biosimilar medicinal product Valtropin, a recombinant human growth hormone used for the treatment of human growth deficiency in children and Turner's Syn…
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May 2, 2006
Chemokine Therapeutics has started patient dosing in a Phase Ib/II trial using CTCE-9908, the company's lead anti-cancer product. This trial represents the first investigation of CTCE-9908's safety and ability to reduce the spread of cancer in humans…
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May 1, 2006
MedImmune's data from a Phase III study showed that its next-generation investigational influenza vaccine, CAIV-T (cold adapted influenza vaccine, trivalent), was 55% more effective than the trivalent injectable inactivated influenza vaccine (TIV) in…
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April 27, 2006
Bristol-Myers Squibb and Gilead Sciences have submitted an NDA to the FDA for a product that combines the anti-HIV medications Sustiva (BMS) and Truvada (Gilead) in a once-daily single tablet regimen.
Truvada itself is a fixed-dose product that co…
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April 24, 2006
Akorn, Inc. has received approval for a supplemental new drug application (SNDA) approval for Inapsine injection. Akorn is the NDA holder of this drug product, which has been off the market since 2001 due to compliance issues associated with Akorn's…
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April 18, 2006
Millennium Pharmaceuticals and Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) initiated a Phase III trial of Velcade in combination with Rituxan in patients with relapsed or refractory follicular lymphoma, a subtype of n…
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April 17, 2006
OSI Pharmaceuticals, Inc. has submitted an NDA in Japan covering the use of Tarceva for the treatment of advanced or recurrent non-small cell lung cancer (NSCLC). The application was submitted to the Japanese Ministry of Health, Labor and Welfare (MH…
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April 13, 2006
Roche and Genentech have filed an sBLA for Avastin in the U.S. for the treatment of non-squamous, non-small cell lung cancer (NSCLC). The sBLA has been submitted for use of Avastin in combination with a platinum-based chemotherapy for previously untr…
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April 7, 2006
Noven Pharmaceuticals has received approval from the FDA for Daytrana as a new therapeutic option for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years. Shire, the global licensee of Daytrana, is ex…
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April 6, 2006
Cytogen Corp. submitted an IND application to the FDA for CYT-500, the company's lead therapeutic candidate targeting prostate-specific membrane antigen (PSMA). Subject to FDA acceptance and Institutional Review Board (IRB) approval at the planned cl…
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April 6, 2006
Gemin X Biotechnologies achieved positive preclinical study results evaluating GX15-070 both as a monotherapy and in combination with the proteasome inhibitor Velcade for the treatment of mantle cell lymphoma (MCL). The data demonstrated that GX15-07…
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April 5, 2006
Vertex Pharmaceuticals initiated a Phase II development program for VX-680, an investigational drug candidate targeting Aurora kinase. In connection with the Phase II program, Vertex earned a $10 million milestone payment from Merck. The two companie…
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