Pharmaceutical Law & Industry Report® Index-Summary

CABILLY II

– Antibody production patent, PTO confirms claims of validity, 270

CALIFORNIA

– Medi-Cal cuts challenged by pharmacists (C.D. Cal.), 151; cuts enjoined, 256; hospital and pharmacy reimbursement cuts blocked (9th Cir.), 404
– Overtime for drug firm sales reps, guidance sought from Cal. court (9th Cir.), 555
– Pricing, counties denied class certification in suit against drug firms (N.D. Cal.), 611
– State and local government employees

– – Avastin, CalPERS approves for ovarian cancer, 296
– – E-prescriptions, CalPERS plans pilot project, 348

CAMPATH

– MS drug, Genzyme buys rights, 384

CANADA

– Adverse event reporting changes considered, 721
– Fanapt, In Brief, 1208
– Market exclusivity rules upheld (Fed. Ct.), 897
– Nicoderm pricing hearing, challenge rejected, 1239
– Norvasc patent invalidated, 839; reasons released, 1057
– Pricing

– – Average drug price calculation, decision on rebates and discounts rejected (Fed. Ct.), 898
– – Increase reported for 2008, 928

CANCER

– Afinitor approved for kidney cancer, 383
– Alimta approved for lung cancer, 809
– Antibody license, In Brief, 1265
– Antitumoral agent, In Brief, 191
– AR-12, In Brief, 570
– AR-42, In Brief, 324
– Arzerra called safe and effective by FDA panel, 649
– AT-406, In Brief, 1085
– Avastin

See AVASTIN

– Cervarix

See CERVARIX

– Cervarix cleared by FDA panel, 1234
– Clolar application, more data sought, 1176
– Clolar, more trials urged by FDA panel, 1049
– Combination drugs

See COMBINATION DRUGS

– Combination drugs, In Brief, 571
– Debio 0928, In Brief, 748
– DI-Leu16-IL2 license, In Brief, 323
– DTS-108, In Brief, 25
– Elesclomol, In Brief, 720
– Eloxatin

See ELOXATIN

– EOquin, In Brief, 872
– Erbitux

See ERBITUX

– Ethyol patent dispute settled (D. Md.), 910
– Firmagon, In Brief, 926
– Folotyn, FDA panel reports clinical benefit, 1049; approved, 1146
– Gardasil

See GARDASIL

– Gemzer, method-of-use patent invalid (E.D. Mich.), 962
– Gleevec approved, 23
– GSK and Oxford collaboration, In Brief, 595
– Joint venture to sell cancer drugs, $3M award for negligent misrepresentation (5th Cir.), 799
– Lantus, FDA examines cancer risk, 809
– Liraglutide cancer risk disputed, 414
– MDV3100, In Brief, 324; marketing, In Brief, 1265
– MDX-1203, In Brief, 164
– MDX-1338, In Brief, 626
– Medicare contractor to cover off-label use for ovarian cancer treatment, 471
– MM-121, In Brief, 1178
– MORAb-004, In Brief, 691
– New drugs, 861 in development, 383
– Off-label drug studies vary in quality, 1258
– OncoVex, In Brief, 1084
– (131)I-CLR1404, In Brief, 272
– Onsolsis approved, 867
– Paclical, In Brief, 451
– Pegintron cleared by FDA panel, 1176
– PLK-1, In Brief, 570
– Rexin-G, In Brief, 720
– Romidepsin approval urged by FDA panel, 1050
– Sunitinib, In Brief, 595
– TNF blockers risk, FDA requires stronger warning, 918
– Treanda patients, skin reaction reported, 513
– TRU-016, In Brief, 1055
– Valstar, In Brief, 1054
– Votrient cleared by FDA panel, 1176
– Xeloda, generic challenged (D.N.J.), 438
– Zometa

See ZOMETA

CARBATROL

– Seizure drug generic challenge settled (S.D.N.Y.), 1100

CARDENE

– Cardiac drug, generic ANDA challenged (D.N.J.), 401

CARDIZEM

– Blood pressure drug, firm pleads guilty to illegal marketing (D. Mass.), 1067

CARVEDILOL

– Congestive heart failure treatment, infringement claim settled (D.N.J.), 587

CEFTAROLINE

– Anti-effective in development, 977

CELEBREX

– Consumer fraud and injury class action settlement gets preliminary approval (N.D. Cal.), 339; approved, 1225

CELEXA

– Antidepressant competing patents, two claims invalidated by prior art (S.D.N.Y.), 673; jury awards royalty, 1247

CELLCEPT

– Anemia risk, maker warns providers, 976
– Miscarriage risk, FDA requires medication guide with prescriptions, 210

CEPHALON

– Narcolepsy drug off-label use, class action dismissed (D.N.J.), 1196

CERVARIX

– Cervical cancer vaccine endorsed by FDA panel, 1083; review continues, In Brief, 1149
– Efficacy study, In Brief, 385
– HPV vaccine cleared by FDA panel, 1234

CHANTIX

– Consolidation of product liability suits ordered (N.D. Ala., S.D. Ill.), 1169
– Construction/compensation defect, inadequate warning, and warrant breach claims may proceed (W.D. La.), 1198
– Risks downplayed, suit alleges (D. Minn.), 944
– Smoking cessation drug blamed for violent episodes and resulting death (N.D. Tex.), 1072
– Wrongful death suit, breach of warranty claim may proceed (S.D. Ind.), 178

CHILDREN'S HEALTH CARE

– ADHD drugs tied to cardiac deaths, FDA reports, 714
– Identifying knowledge gaps on drugs and children, NIH plans program, 443
– Off-label use of pediatric products, Special Report, 572

CIMZIA

– Arthritis drug, FDA wants more data before approval, 46
– Licensing, In Brief, 191

CINRYZE

– Angioedema treatment gets priority review, 163; FDA seeks more data, 690

CIPRO

– Antitrust

– – Generic, agreement blocking upheld (Cal. Sup. Ct.), 987
– – Settlement challenged (U.S., rev den), 730

– Reverse payments in patent settlements, DOJ files brief (2nd Cir.), 790

CLARINEX

– Allergy drug patent suit settled (D.N.J.), 437
– Generic permitted (D.N.J.), 943

CLASS ACTIONS

– AndroGel, suits seek to recoup charges paid due to collusion between brand name and generic firms (C.D. Cal.), 174; transferred to Ga. federal court, 435
– Bextra/Celebrex consumer fraud and injury class action settlement gets preliminary approval (N.D. Cal.), 339
– Cal. counties denied class certification in pricing suit against drug firms (N.D. Cal.), 611
– K-Dur purchasers class certified (D.N.J.), 38; special master recommends dropping, 175
– Merck employees class action over alleged artificially inflated stock certified (D.N.J.), 204
– Neurotonin

See NEUROTONIN

– Nexium, false advertising class action remanded (3rd Cir.), 587
– Nifedipine direct purchasers antitrust class action certified (D.C. Cir.), 229
– Off-label use

See OFF-LABEL USE

– Prilosec, maker accused of failure to warn of food poisoning risk (S.D. Ohio), 680
– Securities

See SECURITIES

– Singulair class action voluntarily dismissed (D.N.J.), 1099
– Stiefel accused of undervaluing stock in buy-back scheme (S.D. Fla.), 828
– Trasylol, RICO suit against surgery drug maker dismissed (S.D. Fla.), 965
– Vioxx

See VIOXX

– Viread maker accused of misrepresenting sales (N.D. Cal.), 679; some shareholder claims may proceed, 1229
– Wellbutrin, generic makers accused of making inferior product (Cal. Super. Ct.), 706
– Zyprexa overpayments, class certification for third party payers granted (2nd Cir.), 152

CLINICAL TRIALS

See also HUMAN SUBJECT PROTECTION; RESEARCH AND DEVELOPMENT (R&D)
– Antitumoral agent, In Brief, 191
– AT-406, In Brief, 1085
– ATPace, In Brief, 212; design approved, In Brief, 655
– Billing audit and monitoring conference planned by BNA, In Brief, 76
– BNA plans conference, In Brief, 48
– CD-NP, In Brief, 596
– Certification, FDA issues final guidance, 124
– Clolar, more trials urged by FDA panel, 1049
– CM-AT, In Brief, 352
– CollaRrx Bupivacaine Implant clinical trial enjoined (E.D. Pa.), 149
– Contract research organizations addressed at BNA audioconference, 477
– DP-b99, In Brief, 692
– Esreboxetine, In Brief, 237
– Experimental treatments

– – Seriously ill patients, FDA issues access rules, 946

– Fibromyalgia, In Brief, 237
– Financial disclosures, HHS IG criticizes FDA oversight, 66
– Good Clinical Practices Initiative, FDA reaches agreement with EU agency, 919
– Investigator may be criminally liable for not following FDA reporting requirements (5th Cir.), 175
– IQP-0410, In Brief, 49
– J&J trials under FDA scrutiny, 975
– KRX-0401, In Brief, 926
– MDV3100, In Brief, 324
– MDX-1203, In Brief, 164
– MDX-1338, In Brief, 626
– Minn. psychiatric clinical trial limits, bill signed, 593
– MORAb-004, In Brief, 691
– MoxDuo IR, In Brief, 239
– OncoVex, In Brief, 1084
– (131)I-CLR1404, In Brief, 272
– Payments to providers and institutions, GSK to disclosure, 382
– PD 332,334, In Brief, 237
– PLK-1, In Brief, 570
– Post-marketing studies

– – Draft guidance issued by FDA, 862
– – Oversight at FDA, GAO reports, 1258
– – Timetables met by most firms, FDA reports, 1043

– Principles for conducting trials released by PhRMA, 1112
– Registries use up, reporting requirements of journals and agencies cited, 410
– Review by HHS IG, In Brief, 1175
– Stem cell ALS trial, In Brief, 26
– Syncria, In Brief, 212
– VIA-2291, In Brief, 719
– Warfarin, Medicare to cover clinical trial, 946
– Website seeks to improve participation, 977

CLOBEL

– Psoriasis drug patent infringement alleged (N.D. Tex.), 63

CLOLAR

– Leukemia drug application, more data sought, 1176
– Leukemia drug, more trials urged by FDA panel, 1049

COARTEM

– Approved for malaria infections, 416

COLCHICINE

– Gout drug not enjoined (C.D. Cal.), 1249

COLCRYA

– Gout drug approved, 923

COLLARX BUPIVACAINE IMPLANT

– Pain relief, combination drug clinical trial enjoined (E.D. Pa.), 149

COLLEGES AND UNIVERSITIES

– Ferris State Univ. sued by labor coalition, drug plan data sought (Mich. Cir. Ct.), 283
– Grassley (R-Iowa) wants conflict of interest disclosures by med schools, 741
– Harvard Medical School to revise conflicts of interest policy, 161
– Stanford

– – AIDS therapy, school lacks standing to make infringement claim (Fed. Cir.), 1167
– – Med school to post MD-industry ties, 416

– Univ. of Iowa proposes new conflicts of interest policy, 160

COMBIGAN

– Glaucoma drug, generic challenged (E.D. Tex.), 438

COMBINATION DRUGS

– AIDS, In Brief, 871
– Alogliptin and Actos combo, In Brief, 1053
– Asthma, In Brief, 896
– Cancer

– – Anticancer combo, In Brief, 656
– – AstraZeneca and Merck, In Brief, 656
– – CombinatoRX and Novartis alliance, In Brief, 571
– – Doxil and trabectedin do not have good benefit to risk profile, FDA panel says, 867

– CollaRrx Bupivacaine Implant clinical trial enjoined (E.D. Pa.), 149
– Communication between FDA and makers urged, 409
– Diabetes, In Brief, 896
– Diet drug blamed for death (E.D. Pa.), 438
– Guidance on clinical trials sought by industry, 651
– Industry practices, FDA proposes rule, 1106
– Injection devices, FDA issues draft guidance, 506
– LTX-315 and GV1001, In Brief, 747
– Safety rule proposed by FDA, 1173

COMPARATIVE EFFECTIVENESS

– AHRQ use of funds at issue, 411; agency will expand pre-existing research, 924
– Baucus (D-Mont) and Grassley (R-Iowa) offer policy options, 503; Baucus say no rationing of care, 684
– Coelho to lead research group, 322
– Commonwealth Fund supports research, 211
– Cost savings questioned, 1052
– Data infrastructure, coordinating panel urges funding, 775
– Discussed at conference, 712
– Examined by CBO, 16
– Fact sheet issued by Kaiser, 1177
– GOP senators drafting proposal, 711
– Health reform with comparative effectiveness will give providers more control over treatment decision, report says, 449; comparative effectiveness called essential to reform, 1114
– HELP panel releases draft Senate bill, 683; markup, 739
– Innovation as focus urged for lawmakers, 483
– Institute of Medicine reports, 774
– Labels, FDA urged to include effectiveness data, 1148
– Lewin Group announce research center, 869
– “Listening session,” federal panel hears concerns, 441; panel holds second session, 591; patent-focused research urged, 684
– Medicare, use of comparative effectiveness research urged, 104
– Patient-centered solutions pushed, 75
– Savings and improved outcomes called key, 103; systems in other nations studied, 625
– Stimulus bill

See LEGISLATION, FEDERAL, HR 1, S 1

– Supported by health care leaders, 895

CONCERTA

– ADHD drug, generic no infringement (D. Del.), 364

CONFERENCES AND MEETINGS

– American Bar Ass'n Antitrust Law Section, 372
– American Health Lawyers Ass'n

– – Annual Meeting, 779; 807

– American Intellectual Property Law Ass'n, Mid-Winter Institute, 186
– BIO 2009, 622; 654
– BNA, “Planning for a Post Levine World: Implications and Strategies for Manufacturers, U.S. Consumers and the Courts,” 564
– Center for Business Intelligence, 745
– Food and Drug Law Institute, 1110

– – Annual Conf., 504

– Generic Pharmaceutical Ass'n, 1077

– – Annual meeting, 235

– Natl. Pharmaceutical Council and the Personalized Medicine Coalition, 1264
– Natl. Pharmaceutical Council, Entering a New Era of Evidence, 712
– Pharmaceutical Care Management Ass'n, 1205
– Regulatory Affairs Professional Society, 1000; 1078; 1078
– U.S. Chamber of Commerce, 103; 104

CONFLICT OF INTERESTS

– Medical education funding, GSK limits, 1113

CONFLICTS OF INTEREST

– Association formed to defend industry ties to providers, 892
– Clinical trials, payments to providers and institutions, GSK to disclosure, 382
– Forest Labs payment to Minn. MDs reported, 1080
– Ghostwriting policies

– – HRT suit, discovery documents unsealed (E.D. Ark.), 915

– Gifts to MDs

See PHYSICIANS

– Grassley (R-Iowa) wants disclosures by med schools, 741; seeks information on Natl. Alliance for Mental Illness, 1257
– Lobbying and gift limits, Analysis & Perspective, 1180
– Massachusetts

– – Fees for covered firms due Jul. 1, 648
– – Hospital network to limit interaction with industry, 441

– Medicare compendia, conflicts of interest seen as inherent, 625
– Physicians

See PHYSICIANS

– Univ. of Iowa proposes new policy, 160

CONGRESS, U.S.

– Ed. Note: This heading is used for administrative actions only. For coverage of legislation by bill number, see LEGISLATION, FEDERAL. For information on measures not yet assigned bill numbers see specific subject headings.
– Hill Watch, In Brief, 452

CONNECTICUT

– Gifts to MDs, ban urged, 293

CONTAN

– Parkinson's drug infringement claims settled (D. Del.), 526

CONTRACEPTION

– Loestrin 24, generic sales opposed (D. Del.), 1068
– Mircette, In Brief, 51
– Nuvaring, defendants barred from conducting ex parte interviews with treating MDs (E.D. Mo.), 367
– Ortho Tri-Cyclen maker challenges generic (D.N.J.), 733; generic maker halts shipments, 836; settled, 879
– Plan B

– – Generic by Duramed approved, 741; Watson generic approved, 1055
– – Ill. dispensing requirement challenged by pharmacists (Ill.), 7
– – One-Step, In Brief, 837
– – OTC limits by FDA restrictions arbitrary (E.D.N.Y.), 334
– – Wash. dispensing requirement, injunction vacated (9th Cir.), 823

– RU-486, prescribing for off-label use banned (Ohio), 794; remanded (6th Cir.), 943
– Yasmin

See YASMIN

– Yaz

See YAZ

CORVUE

– Vasodilator drug, FDA panel says data insufficient, 892

COSOPT

– Glaucoma drug, FDA exclusivity ruling upheld, 8

COST CONTAINMENT

– Biogenerics examined by CBO, 16
– Children's hospitals buy low cost drugs through HRSA, 1044
– Comparative effectiveness

See COMPARATIVE EFFECTIVENESS

– Sebelius wants to look at all options, 440
– Trends

– – Forecast for 2010 released, 1004
– – Generic use slows drug spending, CMS says, 42; savings over decade reported, 567; limited spending growth, 567
– – Sales growth slowed in 2008, 350

COUNTERFEIT DRUGS

– Criminal penalties

See LEGISLATION, FEDERAL, HR 1450

– Draft guidance issued by FDA, 835

CRIMINAL PROSECUTION

See also FRAUD AND ABUSE
– Acquiring controlled substances by deception (W.D. Wash.), In Brief, 286
– Bexra illegal marketing, Pfizer fined $1.2B, 1047
– Cardizem maker pleads guilty to illegal marketing (D. Mass.), 1067
– Clinical investigator may be criminally liable for not following FDA reporting requirements (5th Cir.), 175
– Counterfeit drugs

See LEGISLATION, FEDERAL, HR 1450

– False statements, former exec ordered to write book about case (D.D.C.), 679
– Falsified drug paperwork (D.N.H.), In Brief, 617
– InterMune CEO guilty of wire fraud (N.D. Cal.), 1164
– Internet pharmacy (E.D. Mo.), In Brief, 972
– Off-label use

– – Actimmune off-label uses, indictment of CEO upheld (N.D. Cal.), 675
– – Bextra marketing, ex-sales manager pleads guilty (D. Mass.), 370; sentenced, 736
– – Destruction of documents, ex-manager convicted of obstruction of justice (D. Mass.), 316; sentenced, 885

– “Pill mill,” pharmacist convicted (Kan. Dist. Ct.), 617
– Plavix suit, former executive pleads guilty to false statements (D.D.C.), 401
– Smuggling unapproved cancer drugs (C.D. Cal.), In Brief, 558