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Vol. 8, Nos. 1-50 pp. 1-1650 Jan. 1 - Dec. 31, 2010 A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z
MAINE
– Prescribing data sales limits (1st Cir.), 1049
– Malaria drug generic, infringement settlement (D. Del.), 485
– Nausea drug off-label promotion (U.S., rev den), 815
– Actimmune putative class action (N.D. Cal.), 1182
– Amag webpages, FDA scrutiny, 1378 – Aralast misleading brochure, 1159 – Aton promotions, violation letters, 499 – Baycol
See BAYCOL
– Cambia, 759 – Caraco and Sun distribution pacts, 1636 – Consumer video, violation letter, 565 – Depakote probe, e-mails sought (W.D. Va.), 518 – Desoxyn generics, 569 – Donations to mental health organization, 596 – Genentech, FDA violation letter, 600 – Gilead promotions, violation letters, 499 – Increlax promotional materials, 1442 – Intuniv starter kit, FDA says misleading, 899 – Johnson & Johnson communications to MDs (W.Va.), 1501 – Kalbitor, 172 – Ky. GSK marketing settlement, 1156 – Lilly overseas marketing probe, 252 – Livalo, 828 – Lodosyn, 568 – Lorcaserin, 902 – Lumigan promotion, 1563 – Lyrica, 532 – Nexium deceptive marketing suit (D. Del.), 645 – Oleptro, 1064 – Online marketing, FDA actions sought, 1516 – Oral colchicine unapproved uses (D.N.J.), 1397 – Patient profile, violation letter, 565 – Pennsaid, 568 – Professional sales aids, violation letter, 565 – Qutenza, 471 – Rapamune, 633; promotion for unauthorized uses, 784 – Reorganization plan for FDA, 243 – Reyataz maker barred from AIDS group facilities, 1032 – Seroquel illegal marketing settlement, 563 – Shire, FDA violation letter, 600 – Social media, guidance for industry, 259; FDA guidance sought, Special Report, 297 – Staple peptide therapeutics, 1121 – Targeting by FDA, misleading promotions, 73 – Testopel promotional materials, 530 – Trends
– – Diagnostic imaging technology usage, 250
– – Digestive conditions, drug use up, 187 – – Global market growth, 529 – – Health reform, effect on markets, 527 – – Prescription drug sales up in 2009, 466 – – Psychotropic drugs usage, 44 – – Use of prescription drugs up, 1155 – VA, drug promotion, 597 – Vermont
– – Disclosure requirements for drug firms, 656
– – Spending by drug firms, 465 – Vioxx purchasers suit, no class certification (Cal. Ct. App.), 13; denial upheld (Cal.), 457 – Vivitrol welcome kit at issue, 1475 – VVD treatment, 662 – Warning letters from FDA, 365 – Workforce cuts for pharmaceutical industry, 1324 – Xifaxan for overt hepatic encephalopathy, 692 – Zetia generic, 603 – Zipsor, 471 – Zirgen, 568
– E-prescriptions, leading state, 1259
– Gift disclosure report, 1521 – Pricing
– – Actavis inflated settlement (D. Mass.), 314
– – False claims overcharging settlement (N.D. Ill.), 1213 – – Merck false price reporting (D. Mass.), 1274 – – Mylan inflated settlement (D. Mass.), 1430 – – Par settlement (D. Mass.), 1613 – – Watson settlement (D. Mass.), 208 – – Workers comp overcharges settlement (Mass. Super. Ct.), 1156
– Avandia, Utah suit (Utah Dist. Ct.), 1466
– Average wholesale price
– – Mass. BCBS, dismissal (U.S.), 1272
– – Miss. misrepresentation suit (Miss.), 517 – – Qui tam relator as original source (D. Mass.), 155 – – S.C. settlements, pharmacies held harmless, 787 – – Utah suit against firms dismissed (Utah Dist. Ct.), 271 – Enhanced funding, bill signed, 1059 – False claims
– – Defending state suits, BNA Insights, 1533
– – Eon Labs settlement (D. Mass.), 232 – – Pfizer off-label marketing and kickbacks suit dismissal (D. Mass.), 1214; appeal (1st Cir.), 1398 – – Pharmacy owner (D. Mass.), 1187 – – Pricing
See Pricing, this heading
– – Rebate action dismissal (D. Md.), 1143 – Generic drugs
– – Rates, GAO report, 1628
– – Savings and switching, 930; substitutions, 996 – Health reform – N.C. preferred drug list, 363 – OTC coverage
– – Colo., 687
– – New York, 1284 – PBM changes, savings, 1592 – Pharmacist reimbursement, GAO report, 18 – Pricing
– – Idaho
– – – Actavis settlement (Idaho Dist. Ct.), 714
– – – Sandoz settlement (Idaho Dist. Ct.), 1341 – – La. overcharges (La. Dist. Ct.), 1430 – – Mass. overcharging settlement (N.D. Ill.), 1213 – – Merck settlements with U.S., Cal., Fla., 21 – – Mich. overcharging settlement (N.D. Ill.), 1213 – – N.Y. AWP suit dismissal (D. Mass.), 1465 – – Part B price substitution, 1407 – – Protonix overcharges (D. Mass.), 646 – – Teva settlements, 189 – – U.S. trade policy and negotiation limits, 290 – – Withdrawal of pricing rules proposed, 1149; final rule, 1435
– – Guidance from CMS, 560
– – Reform provisions, 469; effect of reform, 564; effect of new rules, 1114 – – Uncollected drug rebates, HHS IG report, 393 – – Unit rebate amounts calculations, 686
– – Cal. rate cuts
– – – Chain stores suit, no injunction (9th Cir.), 515
– – – Pharmacist group suit, cuts enjoined (9th Cir.), 319; suits in 4 states, 484 – – Miss. pharmacy cuts rescinded, 822 – – N.Y. rate cuts challenge (N.D.N.Y.), 484 – – Wash. rate cuts challenge (W.D. Wash.), 484 – Reporting drug data, HHS IG enforcement, 1251 – Technical corrections – W.Va. E-prescription initiative, 1350
– Inhalers and ozone-depleting substances, 496
– Maximum out-of-pocket liability, 464
– Rate freeze for 2011, 462
– Ed. Note: Entries at this heading refer to Medicare Part D unless otherwise indicated.
– Approval by FDA requirement, CMS warning, 9 – Cardiovascular agent use, AHRQ report, 359 – Catastrophic coverage, GAO report, 288 – Coverage gap
– – Accords signed, 1254
– – Discount concerns, 752 – – Fines for drugmakers, 683 – – Options for drugmakers, 655 – – Provisions to close, 462 – Dialysis, CMS rule, 426 – Discounts
– – Codes for drugmakers, 1316
– – Effect, 1518 – – Manufacturers pact from CMS, 1028 – – Program guidelines, 595 – Elimination of plans, 1255 – Formulary
– – Access, Aetna enrollment, 497
– – Guideline changes, 1288 – – Tiers, 1527 – Hospital acquisition costs, 1372 – Invalid identifiers, HHS IG report, 897 – Least costly drug option, HHS authority (D.C. Cir.), 9 – Meaningfully different plans, 1154 – Off-label use – Prices
– – Average wholesale price suit, qui tam relator as original source (D. Mass.), 155
– – Negotiated prices, authority urged, 282 – – Speciality-tier drugs, price concessions, 357
– – CMS panel supports, 1515
– – National coverage analysis, 896 – Savings from adjusted rates, HHS IG report, 897 – Success of program, MedPAC report, 1437 – Vt., rebates and drug assistance program, 789 – Waiver of overpayment (D.C. Cir.), 815
– Abbot purchase of Piramal branded generics unit, 690
– Alcon complaint against Novartis (S.D.N.Y.), 920; pact announced, 1592 – Astellas and OSI, 662; completion, 759 – BioMarin and ZyStor, 1097 – Biovail and Valeant, 828 – Bristol-Myers and ZymoGenetics, 1160 – Cardinal Health purchase of Healthcare Solutions, 793 – Cephalon and Mepha, 501 – CVS Caremark, antitrust issues, 1472 – Emergent and Trubion, 1097 – Endo
– – Penwest purchase, 1064
– – Qualitest purchase, 1260 – Genzyme
– – Bioenvision, disclosure issues (2nd Cir.), 492
– – LabCorp, sale of unit to, 1563 – – Sanofi offer, 1159 – Horizontal merger guidelines, 592 – Hospira and Javelin, 532 – Hypertension drug, 633 – IMS Health purchase, EU clearance, 171 – Insmed and Transave, 1564 – Lilly
– – Alnara purchase, 901
– – Avid Radiopharmaceuticals, 1442; purchase completed, 1635 – McKesson to buy US Oncology, 1412 – Medco and United BioSource, 1097 – Merck purchase of SmartCells, 1563 – Mylan to buy Bioniche Pharma, 966; completed, 1161 – Novartis bid for Alcon, EU conditions, 1067; divestment required, 1090 – Noven marketing rights, 1063 – Pfizer
– – FoldRx, 1161
– – King Pharmaceuticals merger, 1324 – – Laboratorio Teuto Brasileiro, 1381 – – Wyeth merger challenge (N.D. Cal.), 516 – Sandoz and Oriel, 531 – Shire and Movetis, 1034 – Teva
– – Merckle purchase, 1037
– – Ratiopharm purchase, 400; EU conditions, 1066
– Diet drug, challenge to generic (D. Del.), 36
– Obesity drug, new certification sought (N.D. Ill.), 977 – Public Citizen seeks ban, 328 – Stroke and heart attack risk, 1158 – Withdrawal considered by FDA panel, 1231; Abbott to pull, 1319
– Muscle relaxant, generic blocked (D.N.J.), 641
– Black box warning (M.D. Fla.), 1623
– Branded maker liability (D. Vt.), 1467 – Experts and causation (S.D. W.Va.), 1554 – Failure to warn claims (U.S., rev sought), 677; (brief filed), 1086; DOJ position (brief filed), 1428; (rev grant), 1577 – Gastroesphageal drug blamed for tardive dyskinesia (5th Cir.), 1367
– Blood pressure drug, preemption of liability claims (E.D. Mo.), 66
– GERD treatment, FDA warning on promotional materials, 469
– Actinic keratosis treatment patent extension, 617; BNA Insights, 762
– Antitrust, firms fined, 295; appeal denied, 869
– Biocomparable approvals, 1065
– False claims overcharging settlement (N.D. Ill.), 1213
– Hypertension drug approval withdrawal, 1096; public hearing sought, 1190
– Canadian drug access program termination, 72
– Medicaid pharmacy cuts challenge (D. Minn.), 234; access issues , 484 – Oral chemo parity, 657
– Antitrust, laxative direct purchasers' suit (D. Del.), 678
– Gambling losses based on drugs (D. Minn.), 1185
– Generic
– – Antitrust dispute (W.D. Pa.), 413
– – Approval, 1381 – – Enjoined (M.D. Fla.), 1020 – – Mylan agreement (D.N.J.), 1106
– Anemia drug patent settlement (D. Mass.), 5
– Average wholesale price misrepresentation suit (Miss.), 517
– Pharmacies, Medicaid cuts rescinded, 822 – Seroquel suit remanded (N.D. Miss.), 1343
– Canadian drug imports, 362; pilot program with N.D., 525
– Respiratory virus drug application, 45; FDA panel rejects, 757; more data sought, 1162
– Pain drug labeling, preemption of Tex. law (N.D. Tex.), 157
– Colonoscopy preparation settlement (D.N.J.), 1144
– Chest congestion drug, generic no infringement (W.D. Mich.), 200; vacated, 1051
– Leukemia drug withdrawal, 824
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