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A California state bill requiring drugmakers to turn over all safety and effectiveness
data on every drug product sold in the state is part of a batch of Rx-related
legislation that California lawmakers are scheduled to address this session.
The FDA has withdrawn a direct final rule to incorporate
exemptions from the Freedom of Information Act (FOIA) into the agency's public
information regulations because of what the agency called "significant
adverse" comments from the public.
A joint panel of FDA advisers has recommended the agency not approve Merck's
application to convert its cholesterol-lowering statin Mevacor from prescription
to OTC status -- a move that will likely dampen efforts for OTC switches of other
statins that are set to lose patent protection.
The FDA has approved labeling revisions to antidepressants, clearing the way
for drugmakers to add required "black box" warnings to their products
to describe the increased risk of suicidal behavior in children and adolescents
who take the drugs.
Dharmacon, the world's leading supplier of innovative
RNA and RNA interference (RNAi) research products, has announced that Genentech
has selected Dharmacon's advanced RNAi technology for use in its drug discovery
and development research.
Peregrine Pharmaceuticals, a biopharmaceutical company with a broad portfolio
of products under development, has entered into an agreement with Merck KGaA
of Darmstadt, Germany, that will give Peregrine access to Merck's technology
and expertise in protein expression.
Li-Taka Pharmaceuticals, a Pune-based Pharmaceutical Formulation Company, has
recently entered into a manufacturing agreement with Wockhardt for manufacturing
of Anti-TB range of products.
CoTherix, strengthened by regulatory approval of its drug for pulmonary hypertension,
filed a registration statement with the SEC for a 4 million-share offering.
BioAdvance is set to unveil its third round of investments, which will provide
roughly $3.5 million to seven local life sciences researchers or companies.
A Miami man has pleaded guilty in federal court to his role in a multimillion
dollar conspiracy to sell counterfeit and illegally imported Lipitor in the
U.S. Julio Cesar Cruz, 42, pleaded guilty Friday in U.S. District Court in Kansas
City to charges that he sold the counterfeit drugs and conspired to sell them
between February 2002 and April 2003.
PhytoMedical Technologies, an early-stage research-based biopharmaceutical company
specializing in the discovery, development and eventual commercialization of
innovative plant-derived pharmaceutical and nutraceutical compounds, has announced
that Connecticut-based, Planta Analytica, will undertake the extraction, fractionation
and isolation of potentially active pharmacological elements in PhytoMedical's
BDC-03, a plant-derived compound that has been successful in reducing body fat
percentage, increasing lean muscle mass and lowering cholesterol in studies
of growing animals.