Pharmaceutical Law & Industry Report® Index-Summary

BANKRUPTCY

– Oscient, 749; approval of liquidation plan (Bankr. D. Mass.), 920
– Vaso Active Ch. 11 filing (Bankr. D. Del.), 389
– Vion Ch. 11 filing (Bankr. D. Del.), 39; liquidation plan, 492

BAYCOL

– Cholesterol drug marketing class actions

– – Cal., dismissal sought (Cal.), 275
– – Economic injury class action enjoined (8th Cir.), 61; (U.S., rev grant), 1273
– – Ill., dismissal (Ill.), 8

– Muscle damage, exclusion of expert (8th Cir.), 354

BENICAR

– Blood pressure drug and adverse events, 786
– Patent not invalid for obviousness, 1175; (U.S., rev sought), 1615

BENLYSTA

– Lupus drug, FDA panel recommends, 1474

BEYAZ

– Contraceptive combination approved, 1258

BIAXIN XL

– Antibiotic patent upheld in Canada, 905

BIOLOGICS

– Applications

– – Erwinase, 1443
– – Fabry disease treatment biologic application, 291
– – Filbrin Pad, 1529
– – Kidney transplant biologic, 291
– – Krystexxa for gout, 369; approval, 1193; available, 1528
– – Neutroval biologics license, 170
– – Prevnar 13, 44
– – Privigen, 531
– – Simponi, 1260; new indication, 1476
– – T-DM1, 932; no fast track, 1162
– – Zalbin BLA, 794

– Clinical trials, report from FDA, 1434
– Closeout letter for Baxter, 432
– Follow-on biologics and FDA agenda, 396; CRS report, 561
– Health Canada guidelines, 403
– Intellectual property process/platform, 1257
– Patents

– – Filigrastim infringement suit (E.D. Pa.), 1498
– – MS drugs patent infringement (D.N.J.), 749

– Posting of safety reports by FDA, 784

BIOLOGICS PRICE COMPETITION AND INNOVATION ACT (BPCI)

– Implementation issues, BNA Insights, 1597

BONIVA

– Bone drug infringement claim (D.N.J.), 1137; summary judgment, 1182
– Generic blocked (D.N.J.), 1460
– Osteoporosis drug infringement claim (D.N.J.), 1087

BOTOX

– Approval for migraines, 1352
– Botulism jury award (Okla. Dist. Ct.), 682
– Cerebal palsy patient's death, verdict for maker (Cal. Super. Ct.), 322
– False claims settlement (N.D. Ga.), 1131
– Spacticity treatment, 334

BPCI

See BIOLOGICS PRICE COMPETITION AND INNOVATION ACT (BPCI)

BRAZIL

– Diovan patent extension denial, 26
– Generic drugs, EU seizures, 664
– Gleevec patent decision, 1382
– Lipitor patent expiration, 1163
– Price control adjustment for drugs, 372
– Retaliation for U.S. cotton subsidies, 373
– Valeant purchase, 531
– Viagra patent expiration, 604

BRILINTA

– Heart drug application, 1633

BUDGET, U.S.

– Excess returns tax, White House proposal, 248
– Specific agencies

See specific agencies and departments

BYDUREON

– Diabetes drug application, 566; action date, 634

BYETTA

– Diabetes drug application, FDA response, 368; more data sought, 1353