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news.OctoPlus’s Phase II ear infection study meets endpoint
An independent data and safety monitoring board (DSMB) completed a formal interim analysis of safety and efficacy data from the Phase II study. The interim evaluation was executed
An independent data and safety monitoring board (DSMB) completed a formal interim analysis of safety and efficacy data from the Phase II study. The interim evaluation was executed
The regulatory authorities in the individual countries are to implement this decision within 30 days by granting domestic approvals. The first domestic approvals for Oracea(r) will be granted
The Phase I trial was designed to evaluate the safety and tolerability of M118 in combination with aspirin (ASA) and clopidogrel, the impact of multiple doses of ASA
Among other functions, the laboratory in Wasquehal will complete batch release testing for its pharmaceutical partners within the European community. The laboratory was developed in co-operation with the
Taiho Pharmaceutical, a specialty pharmaceutical company headquartered in Tokyo, plans to use Medidata Rave to conduct a Phase III trial for cervical cancer therapy in Japan, Taiwan, and
The purpose of the Phase I trial was to determine the safety, tolerability and immunogenicity of HspE7 plus escalating doses of adjuvant (50, 500, 1,000 and 2,000mcg of
In connection with this amendment, Impax provided a notice to Endo and Penwest that its submission includes a Paragraph IV certification stating its product does not infringe any
The Phase II study was a randomized, double-blind, placebo-controlled trial, which enrolled 300 subjects who had a positive rapid antigen test indicating acute influenza illness. Subjects were randomized
Probuphine is Titan’s novel, subcutaneous implant formulation designed using its ProNeura technology to deliver six months of buprenorphine. Buprenorphine is currently marketed as a sublingual formulation for the
This approval allows Lannett, through Cody, to directly import raw materials for processing into controlled substance pain management products. The Drug Enforcement Administration (DEA) considered a number of