Pharmaceutical Law & Industry Report® Index-Summary

VACCINES

– Cervarix

– Cervarix cleared by FDA panel, 1234
– Gardasil

– Hiberix gets accelerated approval, 1002
– J&J and Crucell collaboration, In Brief, 1149
– PPD buys vaccine testing lab, 48
– Recombivax HB, In Brief, 50

VALCYTE

– Antiviral patent valid, generic does not infringe (D.N.J.), 1189; appealed, 1251

VANCOCIN

– Antibiotic, FDA panel approves testing guidelines, 922

VANOS

– Skin cream infringement dispute settled (W.D. Mich.), 463

VASOVIST INJECTION

– Contrast imaging agent approved, 23

VELCADE

– Cancer drug maker accused of overstating efficacy, 746

VERMONT

– Data mining, ban on sale of prescription data by MDs upheld (D. Vt.), 495; firms denied injunction, 670
– Gift ban for drug firms, expansion approved, 592; signed, 688
– Marketing, spending by drug firms reported, 474

VIAGRA

– Nonarteritic anterior ischemic optic neuropathy blamed on drug, causation expert barred (D. Minn.), 1040

VIOXX

– Consumer class actions

– – Cal., certification denied (Cal. Super. Ct.), 586
– – N.J., certification denied (N.J. Super. Ct.), 340

– Punitive damages vacated in failure-to-warn suit, appeal dismissed (N.J.), 1168
– Securities fraud, maker accused of misrepresenting safety profile and commercial viability (U.S., rev grant), 608; suit improperly reinstated, 993

VIREAD

– Antiretroviral drug maker accused of misrepresenting sales (N.D. Cal.), 679; some shareholder claims may proceed, 1229
– Gilead accused of material misstatements about demand (U.S., rev den), 464

VIRGINIA

– Privacy, state considers requiring notification of health data breaches, 184

VOTRIENT

– Kidney cancer cleared by FDA panel, 1176; approved, 1235

VYTORIN

– Cholesterol drug clinical trials, Waxman (D-Cal) and Stupak (D-Mich) seek more information, 233
– Misrepresentation claims, makers submit FDA evaluation on effectiveness (D.N.J.), 176
– Myopathy/rhabdomyolysis as side effect, dismissal sought (E.D. Tex.), 1102
– Negative trial data delayed, makers settle with states, 821
– Overcharging, makers to settle with purchasers (D.N.J.), 1247
– Safety reviewed by FDA, 73
– Securities

– – Concealment of adverse effects alleged (D.N.J.), 1035
– – Fiduciary breach over employee stock investments alleged (D.N.J.), 1032
– – Study results suit dismissed (D.N.J.), 1036

– Unfavorable trial results, class action settled (D.N.J.), 908

VYVANSE

– ADHD drug exclusivity decision challenged (D.D.C.), 253; proceedings stayed, 434; FDA affirms exclusivity, 1256