Vertex Pharmaceuticals (NASDAQ:VRTX) shares are trading lower on heavy volume after Pharmasset (NASDAQ:VRUS) announced it will further expand its Hepatitis C treatment trial, with tests showing positive results at a higher dose when combined with other treatments, hurting Vertex’s prospects for its own Hep-C line.
The FTC approved the merger of Teva Pharmaceutical (NASDAQ:TEVA) with Cephalon (NASDAQ:CEPH) over the weekend, but will require Teva to divest two abbreviated new drug applications: fentanyl citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER capsules, a generic version of Amrix.
The FDA is maintaining the clinical hold it placed in August on Insmed’s (NASDAQ:INSM) Phase 3 trials of the Arikace drug for treating lung infections, requesting that Insmed conduct an additional study to determine the drug’s toxicity.
United Therapeutics (NASDAQ:UTHR) has landed a $45 million contract from the NIH for studies related to the development of antiviral drugs.
Natus Medical (NASDAQ:BABY), which manufactures systems for monitoring the health of newborns, warns that its third-quarter revenue will be roughly $51.5 million rather than $58 million as thought in July. Natus also expects fourth-quarter EPS of $0.15, below an earlier consensus of $0.19, blaming the shortfall on weakness in the company’s neurology business