This article was originally published in The Gray Sheet
Chlamydia and gonorrhea testing directly from Cytyc ThinPrep Pap Test collection vial samples using Roche's Cobas Amplicor automated test system gains PMA supplement approval. Cytyc had indicated it would reevaluate a related October 2000 co-marketing agreement with Roche following its February agreement to purchase HPV test maker Digene, which also has chlamydia and gonorrhea testing technology. Roche announced June 6 that it will develop an HPV test to compete with Digene's, in a market expected to exceed $600 mil. by 2010, after acquiring HPV patents from Institut Pasteur. Ironically, the prospect of increased competition could simultaneously make the Digene purchase less attractive to Cytyc and more likely to receive anti-trust clearance, which is pending. Cytyc extended its offer for a sixth time on June 7, to June 21, following submission of requested information to FTC May 28 (1"The Gray Sheet" June 3, 2002, In Brief)...
You may also be interested in...
The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.
US FDA will simultaneously review the vaccines, with Moderna’s advisory committee set a week after Pfizer’s. ACIP emergency meeting scheduled for 1 December with vote likely on distribution priority for health care personnel.