Pharmaceutical Law & Industry Report® Index-Summary

RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS (RICO) ACT

– Epogen and Aranesp off-label promotion, RICO does not apply (C.D. Cal.), 37
– Provigil and Gabitril off-label marketing, dismissal denied (E.D. Pa.), 996
– Third-party payer suit over prices, settlement approved (D. Mass.), 307; appeal planned, 500; challenged, 553; upheld (1st Cir.), 1022
– Trasylol, RICO suit against surgery drug maker dismissed (S.D. Fla.), 965

RAPTIVA

– Psoriasis drug adverse events, FDA issues advisory, 233
– Pulled from market, link to fatal nervous system disorder cited, 413

REDUX

– Diet drug, FDA approval preempts failure to warn claim (N.D. Ohio), 366

REGLAN

– Gastrointestinal reflux drug blamed for movement disorder, failure-to-warn claim against generic maker not preempted (D. Vt.), 6; review denied, 465
– Jurisdiction, liability suit properly removed to federal court (E.D. Pa.), 529
– Neurological movement disorder blamed on drug, failure-to-warn claim not preempted (W.D. Okla.), 310
– Tardive dykinesia blamed on generic drug, brand-name maker not liable (W.D. Ark.), 614

RELENZA

– Death risk from inhalation powder, FDA issues warning, 1206

REMICADE

– Arthritis drug product liability, medical malpractice defendants severed (N.D. Ohio), 798
– Distribution agreement, arbitration sought, 622
– Pulmonary fibrosis blamed on drug, key expert excluded (11th Cir.), 203

REPLAGAL

– Fabry disease treatment, maker plans license application, 1236

REPORTING REQUIREMENTS

– Clinical trials

– – Investigator may be criminally liable for not following FDA reporting requirements (5th Cir.), 175
– – Registries use up, reporting requirements of journals and agencies cited, 410

– Electronic filing of drug data, FDA issues guidance, 645
– Physician gifts

See LEGISLATION, FEDERAL, S 301

RESEARCH AND DEVELOPMENT (R&D)

See also CLINICAL TRIALS
– Antibiotics

See ANTIBIOTICS

– Antibodies

– – HGS and Morphotek, In Brief, 386
– – Synagava and Morphotek, In Brief, 812

– ARX424, In Brief, 237
– Betrixaban, In Brief, 838
– Bifeprunox, In Brief, 927
– Biologics

See BIOLOGICS

– Cancer

See CANCER

– Ceftaroline in development, 977
– Cetrorelix pamoate, In Brief, 298
– Combination drugs

See COMBINATION DRUGS

– Contract research groups, BNA plan audioconference, 297
– Cordex and Cato BioVentures, In Brief, 238
– Debio 0928, In Brief, 748
– Diabetes drugs in development, 594; Debiopharm Group and Mercury Therapeutics, In Brief, 926
– DXL625, In Brief, 271
– Elesclomol, In Brief, 720
– Eli Lilly, In Brief, 1085
– Endo and Alexa, In Brief, 164
– EU signs off on public-private partnership projects, 628
– ExonHit collaborating with Allergan, 47
– Factor VIIa, In Brief, 782
– FASgen and Centocor, In Brief, 50
– Funding reported for 2008, 297
– Genyous, In Brief, 164
– Huntington's drugs, In Brief, 515
– IC14, In Brief, 570
– ImQuest and Arisyn, In Brief, 515
– Influenza drug development, FDA drafts guidance, 233
– J&J and Crucell collaboration, In Brief, 1149
– Malaria, In Brief, 485
– Merck and Cardiome, In Brief, 451
– MS treatment, In Brief, 77; 77
– Nanotechnology collaboration announced by FDA, 291
– Neurological disease drugs, In Brief, 450
– Ophthalmic conditions, In Brief, 516
– Personalized medicine pushed by R&D advocates, 538
– Pimavanserin tartrate, 541
– Riquent, In Brief, 50
– STP-206, 418
– Therapeutic peptides research increasing, 654
– Tuberculosis, In Brief, 720
– UDB, In Brief, 25
– Undenafil, In Brief, 50
– Unpromising drug candidates, firms accused of aggressively ending work, 870
– Urocidin, In Brief, 838
– Wyeth to collaborate with Pharma, In Brief, 77

RESTANZA

– Pneumonia, drug called safe, but not effective by FDA panel, 649

RIASTAP

– Orphan drug approved for bleeding in patients with congenital fibrinogen deficiency, 102; approval, In Brief, 299

RICO

See RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS (RICO) ACT

RIMONABANT

– Obesity drug securities fraud suit dismissed (S.D.N.Y.), 1135

RISPERDAL

– Application, In Brief, 213
– Bipolar disorder, In Brief, 595
– Generic

– – Approved, In Brief, 164
– – Jurisdiction lacking to hear patent counterclaims (U.S., rev den), 340
– – Marketed, In Brief, 656

– Schizophrenia drug, Tex Atty. Gen. amends Medicaid false claims complaint (Tex. Dist. Ct.), 14

RITUXAN

– Arthritis drug associated with brain disease, 1261

RIVAROXABAN

– Anti-clotting drug gets favorable review from FDA panel, 351; gets complete response letter, 650

ROCEPHIN

– Infection treatment, FDA revises prescription information, 447

ROMIDEPSIN

– Lymphoma drug, approval urged by FDA panel, 1050

RYTHMOL SR

– Heart drug patent dispute settled (D. Del.), 463