Pharmaceutical Law & Industry Report® Index-Summary

BANKRUPTCY

– Biopure files Ch. 11, 893
– Oscient files Ch. 11, 893

BCBS

See BLUE CROSS AND BLUE SHIELD PLANS (BCBS)

BENICAR

– Blood pressure drug, generic ANDAs infringe patent (D.N.J.), 938

BEPREVE

– Application, In Brief, 105
– Ocular itching drug cleared by FDA panel, 781; approved, In Brief, 1238

BERINERT

– Angioedema drug approved, 1207

BESIVANCE

– Bacterial conjunctivitis drug approved, 651

BEXTRA

– Arthritis drug trade secrets, Pfizer must pay $38M to research firm (Cal. Super.), 11
– Consumer fraud and injury class action settlement gets preliminary approval (N.D. Cal.), 339; approved, 1225
– Illegal marketing, Pfizer fined $1.2B, 1047; sentenced, In Brief, 1238
– Off-label marketing

– – Ex-sales manager pleads guilty (D. Mass.), 370; sentenced, 736

BIOGENERICS

– Approval pathway sought by firm, 186; AARP seeks, 290; would cut costs, FTC says, 681; CareFirst supports, 690; MedPAC reports, 710; House debate to continue, 713; Senate panel debates, 801; House panel's pathway includes 12 years of data exclusivity, 831
– Cost containment and biogenerics examined by CBO, 16
– Hatch (R-Utah) pushes, 288
– Health reform

See LEGISLATION, FEDERAL, HR 3200

– Legal outlook 2009, 79
– License revocations, FDA issues notification rule, 532
– Marketing, In Brief, 1208
– Regulatory outlook 2009, 80
– Waxman (D-Cal) pushes, 686

BIOLOGICS

– Approval pathway for generics sought, 186
– Arzerra, In Brief, 720
– Atryn approved by FDA, 190
– Cimzia

See CIMZIA

– Cinryze

See CINRYZE

– Consensus sought on generic biologics, 235
– Data exclusivity, 12 years called too long, 1205
– Delays in regulatory review, advice offered, 1078
– Denosumab, In Brief, 212
– Erbitux

See ERBITUX

– Exclusivity, White House calls for 7 years, 772
– Generics, In Brief, 782
– GSK and Dynavax, In Brief, 26
– Merck follow-on platform, In Brief, 213
– Plant shut down, 718; to reopen, 869
– PolyHeme maker shuts down, 594
– Quality, new analytical methods and standards urged at House hearing, 1143
– R&D deal, In Brief, 811
– Replagal maker plans license application, 1236

BIRTH CONTROL

See CONTRACEPTION

BLOOD PRODUCTS

– PolyHeme maker shuts down, 594
– Taiwanese hemophiliacs claims against concentrate makers time-barred (N.D. Ill.), 466

BLUE CROSS AND BLUE SHIELD PLANS (BCBS)

– Generic drugs, community-based programs expanding use, 450

BOTOX

– Off-label promotions, maker seeks to block FDA enforcement (D.D.C.), 1163

BOX WARNINGS

See LABELS AND PACKAGING

BRAZIL

– Advertising rules revised, 27
– Domestic equivalents to replace drug imports, 487
– Patents, pipeline law challenged, 597
– Price hikes authorized, 387

BUDGET, U.S.

See specific agencies and departments
– FY2010

See LEGISLATION, FEDERAL, SConRes 13