FDAnews Drug Daily Bulletin

The FDA is searching for volunteers to participate in an agency pilot project to evaluate the Study Data Tabulation Model (SDTM) and Implementation Guide that sponsors of human-drug clinical trials can use to submit data to the agency.

A Democratic congressman believes momentum is building for his bipartisan legislation that would allow the HHS secretary to negotiate drug prices under the Medicare prescription drug bill, according to a congressional aide.

A federal court has ordered the operators of a prescription drug importation enterprise to send letters to customers notifying them that the business is illegal and that the safety, purity and efficacy of products sold by the company cannot be assured, according to the FDA.

The preliminary injunction, issued by the U.S

Drug giant Pfizer will provide up to $35 million worth of medicines and financial aid to help the victims of the recent earthquake and tsunami that have devastated countries in Asia and along the east coast of Africa.

NeoPharm has announced that Nippon Kayaku has signed an exclusive license agreement with NeoPharm for the Japanese development rights for IL13-PE38QQR, generically known as cintredekin besudotox, which is NeoPharm's lead drug candidate for the treatment of glioblastoma multiforme (GBM).

Pharma major Cipla has launched "MOBIX" capsules and topical cream for treatment of osteoarthritis and rheumatoid arthritis under a technical collaboration with Cymbiotics of San Diego, USA.

Vitae Pharmaceuticals, formerly Concurrent Pharmaceuticals, has announced its new corporate branding to clearly mark its strategic evolution to a product-focused drug development company with a robust pipeline of novel clinical candidates.

Nereus Pharmaceuticals, a pioneer in drug discovery and development from marine microbial sources, has announced a $42.6 million private placement of its Series D preferred stock to be received in two tranches.

Unsure of the legalities involved, the government is unlikely to implement the retail trade margins order on drugs in its present form.

ID Biomedical has signed agreements with Alexandria Real Estate Equities for the sale and leaseback of two ID Biomedical facilities: the newly constructed Vaccine Research Centre in Laval, Quebec, Canada; and a vaccine development facility in Northborough, Mass., U.S.

Collegium Pharmaceutical, a specialty pharmaceutical product development company, and HEALTHPOINT a leader in the research, development, and marketing of branded pharmaceuticals for tissue management, dermatology and surgical applications today announced that they have entered into a licensing agreement for the commercialization of two of Collegium's topical analgesic products.

Puerto Rico's manufacturing industry was sustained during 2004 by expansions, which stimulated economic activity by creating jobs in construction and related industries.