GlaxoSmithKline's study of Promacta does not provide "robust" evidence that the proposed drug works better than placebos in reducing bleeding on patients with chronic idiopathic thrombocytopenic purpura, the FDA announced Wednesday. GSK and partner Ligand Pharmaceuticals declined to comment on the findings, which are set to be reviewed by an expert panel Friday.
Genentech, Celgene and other biotech firms seeking to expand their share of the cancer drug market are preparing to present data on their experimental treatments at the American Society of Clinical Oncology's annual meeting in Chicago. Aside from Celgene's Revlimid and Genentech's Avastin, industry experts are also betting on Erbitux -- made by Merck KGaA, ImClone Systems and Bristol-Myers Squibb Co. -- to show promising trial results.
Concerns over the effects of nanoparticles on human health have prompted the EU to reassess regulations on nanomaterials. Regulators failed to make conclusions on nanotechnology for REACH, a new law on chemical standards that will take effect June 1, but they plan to release a report in the next few weeks that will analyze different EU rules on nanomaterials and pinpoint potential gaps.
Some health care analysts and medical experts think Erbitux's market advantage lies in the promise of the kras gene in identifying which colorectal cancer patients would benefit most from the drug. Erbitux makers Merck KGaA and ImClone Systems might gain an edge over Avastin manufacturer Roche once the drug obtains European approval.
Human Genome Sciences announced Wednesday that Albuferon, its hepatitis C drug candidate, and LymphoStat-B, its lupus treatment, could be introduced to the market by 2010. The Rockville, Md., company also said the delivery of Abthrax, its inhalation anthrax drug, will start delivery this fall.