Pharmaceutical Law & Industry Report® Index-Summary

CADUET

– Cholesterol generic, infringement suit (D. Colo.), 205

CALIFORNIA

– Health reform and drug rebates, 656
– Labels, larger type sought, 788
– Medicaid

– – Pricing, Merck settlement, 21
– – Reimbursement cuts

– – – Chain stores suit, no injunction (9th Cir.), 515
– – – Pharmacists group suit, cuts enjoined (9th Cir.), 319; suits in 4 states, 484

– Step-therapy mandates, proposed ban, 956

CANADA

– Biologics, Health Canada guidelines, 403
– Extraordinary use new drugs, 472
– Generic drugs

– – Atomoxetine generic challenge (Fed. Ct.), 1477
– – Concerta generic cleared (Fed. Ct.), 693
– – Confidentiality order, application (Fed. Ct.), 761
– – Glaucoma drugs, challenge (Fed. Ct.), 1445
– – Norfloxacin generic delay (Fed. Ct.), 502

– Imported drugs

– – Conspiracy to reimport (M.D. Pa.), 650
– – Mont., Canadian drug imports, 362; pilot program with N.D., 525
– – Pricing, agency jurisdiction, 533; appeal, 570

– Innovative product data protection (Fed. Ct. App.), 1638
– Novartis bid for Alcon, 1067
– Patents

– – Biaxin XL antibiotic patent upheld, 905
– – Cefaclor infringement claim (Fed. Ct. App.), 1327
– – Concerta patent invalid (Fed. Cir.), 549
– – Escitalopram infringement alleged, 1235
– – Norvasc patent invalid, 1065
– – Process patent (Fed. Ct. App.), 1417
– – Rosuvastatin infringement claims (Fed. Ct. App.), 604
– – Viagra patent suit (Fed. Ct.), 830; patent upheld (Fed. Ct. App.), 1327

– Pregabalin, no declaration of confidentiality, 571; notice of allegation, 906
– Safety

– – Improvements urged, 1531
– – Side effect reporting, 830

– Spending on drugs, 571
– Teva and Merckle merger, 1037
– Transfer of profits sought, 402
– User fee hike, 796; update, 1477

CANCER

– AEZA-108, 634
– Alimata patent upheld (D. Del.), 1499
– Anemia drug safety, 1377
– ANX-530 application, 45; filing refusal, 332; new name, 370
– Anzemet heart risk, 1632
– AP24534, 294
– ARBs and cancer, 952
– Arimidex for breast cancer, 253
– Avastin and breast cancer, 961; removing indication from label, 1590
– Avodart, new indications, 1561
– Bundle pay test, 1380
– Carfilzomib, 172
– Chemosaturation system, 1636
– Colo. insurance mandate for drugs, 687
– Conn., oral chemo parity, 726
– Eloxatin

See ELOXATIN

– ENMD-2076, 218
– Erwinase, 1443
– Fludarabine phosphate injection, 1290
– Gardasil for anal cancer prevention, 1634
– Graspa, 173
– Halavan approval, 1474
– HRT

See HORMONE REPLACEMENT THERAPY (HRT)

– Hycamtin, 1528
– HyperAcute immunotherapy, 219
– IMGN901, 335
– Ipilmumab, 1097
– Jevtana for prostate cancer, 825
– KRX-0401 trial, 191; expedited review, 471
– Licensing, 760
– Lupron Depot application, 370
– Mersana-Teva collaboration, 501
– Minn., oral chemo parity, 657
– Mylotarg withdrawal, 824
– Omapro application, 397
– Pixuvri application, 397; appeal, 1561
– Proscar, new indications, 1561
– Retrospective analysis of cancer drug approvals, 250
– Rituxan

– – Approved, 254
– – Off-label use (E.D. Pa.), 778

– Sprycel approval, 1411
– T-DM1, 932; no fast track, 1162
– Tarceva, 532
– Tasigna website, FDA letter, 1061
– Taxotere

See TAXOTERE

– Trelstar formulation approved, 368
– Tykerb, approval for breast cancer, 169
– Vandetanib, 1260; additional doses, 1562
– Vesanoid withdrawal, 1191
– Vytorin cancer link, 21
– Xgerva approval, 1524

CAPAXONE

– MS drug formulation, 1633

CARBAGLU

– Hyperammonemia drug approved, 398

CARBATROL

– Anti-seizure drug, generic patent dispute (D.N.J.), 386

CARDIZEM

– Blood pressure drug generic approval, 370

CEFACLOR

– Antibiotic infringement claim (Fed. Ct. App.), 1327

CEFTOBIPROLE

– Skin infection treatment, no approval, 43

CENESTIN

– Estrogen drug, infringement claim (S.D.N.Y.), 776

CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

– Administrator nominated, 526; GOP criticism, 861; recess appointment, 895; sworn in, 926; transparency issues, 1256
– Medicaid

See MEDICAID

– Medicare

See MEDICARE DRUG COVERAGE

CHINA

– Collaboration urged by FDA chief, 1058
– Growth in drug sales, prediction, 369
– Indian partnership, 1639

CIALIS

– ED drug inventorship (Fed. Cir.), 487

CIPRO

– Antibiotic patent suit dismissal (D. Md.), 552
– Antitrust

– – Pay-for-delay settlement upheld (2nd Cir.), 579; rehearing sought, 675; amended, 853; en banc review denied, 1130; (U.S., rev sought), 1579
– – Summary judgment for maker (Cal. Ct. App.), 681

– Tension injury suit (W.D. La.), 556

CIPROFLOXACIN

– Cystic fibrosis drug orphan status, 368

CITALOPRAM

– Antidepressant, EU antitrust probe of maker, 75

CLASS ACTIONS

– Baycol

See BAYCOL

– Digitek and economic suffering (S.D. W.Va.), 158
– K-Dur purchasers settlement challenge (D.N.J.), 411; appeal, 519
– Marketing, Actimmune putative class action (N.D. Cal.), 1182
– Matrixx Initiatives securities fraud (U.S., rev grant), 856
– Prandin purchaser suit (E.D. Mich.), 715
– Schering-Plough stock drop class certification vacated (3rd Cir.), 14; no dismissal (D.N.J.), 891
– Trasylol suits remanded (7th Cir.), 888
– Vioxx purchasers suit, no class certification (Cal. Ct. App.), 13; denial upheld (Cal.), 457
– Zyprexa overpayments class decertified (2nd Cir.), 1217

CLEVIPREX

– Blood pressure drug recall, 24

CLINICAL TRIALS

– A-002, 219
– Adaptive clinical trial designs, FDA draft guidance, 285
– Alzheimer's public database, 793
– Antibiotics noninferiority trials, FDA guidance, 1516
– Antimicrobial skin infection drugs, draft FDA guidance, 1151; guidance issued, 1516
– Asimadoline, 471
– Avandia trial, suspension request, 658
– Biologic trials, report from FDA, 1434
– Carfilzomib, 172
– Cost control, 602
– Falsification of study data, FDA proposed rule, 247
– Foreign studies, HHS IG reports, 862
– HyperAcute immunotherapy, 219
– KRX-0401, 191
– Noninferiority clinical trials, 289; FDA policy, 1154
– Postmarket report from FDA, 1434
– Safety data, FDA final rule, 1251
– Suicide risk, draft FDA guidance, 1151
– Trovan trial injuries (U.S., brief filed), 719; (rev den), 852; limited discovery (S.D.N.Y.), 1345
– Univ. of Rochester pain drug initiative, 1413
– Vascugel, 172

CMS

See CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

COLCRYS

– HIV drug dosing, 632

COLLEGES AND UNIVERSITIES

– Harvard conflicts of interest policy, 998
– Temple controlled substances plan, 1414
– Univ. of Rochester pain drug initiative, 1413
– Vanderbilt, Cialis inventorship (Fed. Cir.), 487
– Washington Univ. and Pfizer collaboration, 661

COLOCHICINE

– Gout drug, unapproved manufacture, 1282

COLORADO

– Cancer drug insurance mandate, 687
– Medicaid OTC drug coverage, 687
– Prescription Drug Monitoring Program, 1374
– Unused drugs donations, 498

COMBIGAN

– Eye drug copy challenge (E.D. Tex.), 1142
– Glaucoma drug, challenge to generic (E.D. Tex.), 35

COMBINATION DRUGS

– Beyaz approved, 1258
– Good manufacturing practices, FDA proposed rule, 186
– Guidance, FDA draft, 1586
– Industry practices, FDA proposed rule, 168
– Tribenzor approval, 998

COMPARATIVE EFFECTIVENESS

– Academic detailing, 524
– Challenges outlined, 601
– Comments from stakeholders, 1089
– Database from patient group, 1525
– Federal board members, 1253; balancing views, 1287
– FY2010 HHS budget, 187
– Guidelines from WellPoint, 689
– Key issues remaining, 965
– Newly covered Medicare services, 1287
– NIH research grants, 359
– Nonpharmacological interventions versus medications, JAMA, 333
– Patient participation, 997
– Relevancy focus of stakeholders and experts, 757
– Tufts comparison of U.S. and Australia, 929
– Useful roles versus adverse effects, 433

CONCERTA

– ADHD drug patent invalid (Fed. Cir.), 549
– Generic

– – ANDA challenge (D. Del.), 1504
– – Authorized generic, 1409
– – Canada, generic cleared (Fed. Ct.), 693

CONFERENCES AND MEETINGS

– American Bar Ass'n, Emerging Issues in Healthcare Law, 259
– American Conf. Institute, Maximizing Patent Life Cycles, 1299
– Annual Pharmaceutical Regulatory and Compliance Conf., 1347
– BIO 2010, 601; 630
– Center for Business Intelligence

– – 4th Annual Forum on Tracking State Laws and Aggregate Spend, 1092
– – 6th Annual Medical Device and Diagnostic Compliance Congress, 787

– Counterfeit Drug Interchange Conf., 1316
– FDA/CMS Summit for BioPharma Executives, 1585; 1588
– Food and Drug Law Institute, 558

– – Emerging Realities in REMS Planning and Execution, 209

– 4th Summit on Biosimilars and Follow-on Biologics, 396
– GPhA/FDA Fall Technical Conf., 1351
– Health Care Compliance Ass'n, Physician Practice Compliance Conf., 1351
– N.Y. State Bar Ass'n Food, Drug, and Cosmetics Law Section, 163; 169
– Risky Business: New Compliance Challenges for FDA-Regulated Industry, 695
– Sixth Annual Personalized Medicine Coalition, 284

CONFLICTS OF INTEREST

– Attitudes toward industry ties, 826
– BNA webinar, 931
– Decline in MD-industry ties, 1440
– Development of drugs affected, 1377
– Disclosure

– – Aggregate spend disclosure, BNA Insights, 666
– – Federal requirements, 1092
– – Pfizer payment disclosure, 468
– – Streamlining disclosure, FDA action sought, 1473
– – Support studied, 563

– FDA, CRS report, 361
– Ghostwriting, Senate panel report, 860
– Gift reporting, effect of federal law, 787
– Harvard policy, 998
– Mass. gift disclosure report, 1521
– Medical society ethics code, 567
– Prescribing decisions, industry influence, 1118
– Reputation and litigation risks outlined, 331
– Teaching hospitals, guide issued, 900
– Vt. free sample reporting, 726

CONNECTICUT

– Discounts, state review of Rite Aid, 1114
– McKesson pricing settlement (D. Mass.), 1340
– Oral chemo parity, 726

CONTRACEPTIVES

– Beyaz approved, 1258
– Ella approved, 1094; available, 1528
– Gianvi

See GIANVI

– HSDD drug, FDA panel rejects, 825
– Lo Loestrin FE, 1381
– Natazia, 632
– Ortho-Evra patch labeling (N.D. Ohio), 160
– Safyral, 1637
– Seasonale license, 623
– Seasonique generic infringement claim (D. Nev.), 454
– Yasmin

See YASMIN

– Yaz

See YAZ

CONTRAVE

– Diet drug development, 1160
– Obesity drug application, 829; FDA panel report, 1562

COPAXONE

– MS drug infringement claim (S.D.N.Y.), 1212

COST CONTAINMENT

– Trends in prescription drug spending, 190; health plan forecasts, 1289

COUMADIN

– Clotting drug recall, 929

COUNTERFEIT DRUGS

– Developing countries, safety concerns, 731
– Foreign drug problems, 595
– GPhA joins safe drug partnership, 1194
– Seizures up, 664
– Tamiflu fakes sold on web, 820
– Zyprexa counterfeiting conviction vacated (5th Cir.), 320

COZAAR

– Exclusivity

– – Apotex, injunction denied (D.C. Cir.), 885; (U.S., rev sought), 1301
– – Teva, exclusivity upheld (D.D.C.), 349; FDA supports, 414

– Generic

– – Actavis, 1325
– – Mylan, 1355

– Hypertension drug generic approval, 451

CRESTOR

– Cholesterol drug, approval of broader indications, 190
– Generic, 1290
– Patents

– – Method-of-use patents (D. Del.), 1610
– – No infringement (E.D. Pa.), 1461
– – Upheld (D. Del.), 919
– – Validity affirmed (D. Del.), 883

CRIMINAL PROSECUTION

– Bristol-Myers, ex-exec alleged financial fraud (3rd Cir.), 491
– Diluted AIDS drugs (C.D. Cal.), 240
– Execs of drug and device makers, prosecutions predicted, 1329; focus on individual liability, BNA Insights, 1480
– Guidelines for sentencing, 593
– Hedge fund insider trading

– – French physician (S.D.N.Y.), 1401
– – Pharma exec (E.D. Pa.), 1148

– Human growth hormone unapproved use (D.R.I.), 1311
– Increased enforcement activity against industry, 1640
– Medicare billing fraud, sentencing (S.D. Fla.), 1108
– Misbranding

– – Lyme disease treatment (D. Kan.), 1222
– – Plastic surgeons (N.D.N.Y.), 240

– Reimported drugs conspiracy (M.D. Pa.), 650
– Wire fraud, InterMume ex-CEO (N.D. Cal.), 1019
– Zyprexa counterfeiting conviction vacated (5th Cir.), 320

CUBICIN

– Antibacterial drug and pneumonia, 1030
– Generic challenge, 1561

CUVPOSA

– Drooling drug approval, 1033

CYMBALTA

– Pain drug, expanded indications, 1118; approved, 1442
– Suicide warning claim (D.S.D.), 1310; summary judgment for maker, 1364