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A key objective of the FDA's Office of Drug Safety (ODS) in fiscal 2003 was
to develop a more cohesive working relationship with the review division staff
in the Office of New Drugs (OND), according to ODS, which has come under attack
recently for allegedly being too close to OND.
The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC)
has issued an untitled letter to Schering informing the company of misleading
information it published recently in a professional detail aid promoting the
use of Foradil Aerolizer 12 mcg.
Pfizer's highly anticipated nerve pain medication Lyrica received FDA approval
Dec. 31, 2004, but the victory was somewhat bittersweet for the firm, as the
agency decided to classify the drug as a controlled substance, which could negatively
affect its sales.
The Biotechnology Industry Organization (BIO) has not relaxed its position regarding
an abbreviated approval process for generic biologics, despite comments in a
recent docket submission to the FDA that appear to indicate some softening on
the topic, according to a representative of the trade group.
Puerto Rico's manufacturing industry was sustained during 2004 by expansions,
which stimulated economic activity by creating jobs in construction and related
industries.
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.
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.
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.