http://www.pharmaceutical-business-review.com/ Related Articles en-us Fri, 19 Mar 2010 06:24:22 +0530 Fri, 19 Mar 2010 06:24:22 +0530 Copyright 2010, Pharmaceutical Business Review http://drugdelivery.pharmaceutical-business-review.com/news/shire_recalls_five_lots_of_daytrana_patches_091203/ Noven continues to manufacture and Shire continues to promote Daytrana in the US Thu, 03 Dec 2009 12:00:00 +0530 http://drugdelivery.pharmaceutical-business-review.com/news/shire_recalls_five_lots_of_daytrana_patches_091203/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_settles_litigation_with_teva_091202/ In concern to Shire's supply of Adderall XR to Teva Wed, 02 Dec 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_settles_litigation_with_teva_091202/ http://www.pharmaceutical-business-review.com/news/acceleron_celgene_initiate_second_phase_2_trial_of_ace011_090728/ ACE-011, to treat chemotherapy-induced anemia in patients with metastatic breast cancer Tue, 28 Jul 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/acceleron_celgene_initiate_second_phase_2_trial_of_ace011_090728/ http://contractresearch.pharmaceutical-business-review.com/news/sunesis_obtains_milestone_payment_from_biogen_idec_090713/ For development of Raf kinase inhibitor in treatment of cancer Mon, 13 Jul 2009 12:00:00 +0530 http://contractresearch.pharmaceutical-business-review.com/news/sunesis_obtains_milestone_payment_from_biogen_idec_090713/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_gets_fda_approval_for_intuniv_090903/ INTUNIV, to treat Attention-Deficit/Hyperactivity Disorder Thu, 03 Sep 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_gets_fda_approval_for_intuniv_090903/ http://contractresearch.pharmaceutical-business-review.com/news/curis_signs_agreement_with_debiopharm_for_hsp90_technology_090806/ Debiopharm will assume all future development responsibility and costs related to the licensed Heat Shock Protein technology, including CUDC-305 Thu, 06 Aug 2009 12:00:00 +0530 http://contractresearch.pharmaceutical-business-review.com/news/curis_signs_agreement_with_debiopharm_for_hsp90_technology_090806/ http://www.pharmaceutical-business-review.com/news/gentium_reports_top_line_phase_iii_defibrotide_trial_results_090819/ Defibrotide, for the treatment of severe veno-occlusive disease Wed, 19 Aug 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/gentium_reports_top_line_phase_iii_defibrotide_trial_results_090819/ http://www.pharmaceutical-business-review.com/news/seattle_genetics_receives_milestone_from_medimmune_090810/ In connection with antibody-drug conjugate collaboration agreement Mon, 10 Aug 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/seattle_genetics_receives_milestone_from_medimmune_090810/ http://www.pharmaceutical-business-review.com/news/expected_results_in_sgn35_trial_in_lymphoma_for_seattle_genetics_090608/ SGN-35, an antibody-drug conjugate, comprising anti-CD30 antibody attached by an enzyme-cleavable linker to monomethyl auristatin E. Mon, 08 Jun 2009 07:16:06 +0530 http://www.pharmaceutical-business-review.com/news/expected_results_in_sgn35_trial_in_lymphoma_for_seattle_genetics_090608/ http://www.pharmaceutical-business-review.com/news/seattle_genetics_lintuzumab_trial_shows_mixed_results_090608/ Lintuzumab, a humanized monoclonal antibody that targets CD33 antigen in hematologic malignancies Mon, 08 Jun 2009 07:16:06 +0530 http://www.pharmaceutical-business-review.com/news/seattle_genetics_lintuzumab_trial_shows_mixed_results_090608/ http://www.pharmaceutical-business-review.com/news/seattle_genetics_completes_enrollment_of_brentuximab_vedotin_(sgn35)_pivotal_trial_090824/ Accrual of patients with relapsed and refractory Hodgkin Lymphoma is completed six months ahead of schedule Mon, 24 Aug 2009 06:41:40 +0530 http://www.pharmaceutical-business-review.com/news/seattle_genetics_completes_enrollment_of_brentuximab_vedotin_(sgn35)_pivotal_trial_090824/ http://www.pharmaceutical-business-review.com/news/lawsuit_filed_against_clegene_090825/ Suit alleges misappropriation of an idea and unjust enrichment Tue, 25 Aug 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/lawsuit_filed_against_clegene_090825/ http://www.pharmaceutical-business-review.com/news/seattle_genetics_initiates_phaseii_lymphoma_trial_090618/ SGN-35, an antibody-drug conjugate that empowers antibodies by linking them to potent cell-killing drugs Thu, 18 Jun 2009 07:16:06 +0530 http://www.pharmaceutical-business-review.com/news/seattle_genetics_initiates_phaseii_lymphoma_trial_090618/ http://www.pharmaceutical-business-review.com/news/santaris_forms_multiyear_worldwide_strategic_alliance_with_shire_090824/ To discover and develop new RNA-based medicines to treat rare genetic disorders Mon, 24 Aug 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/santaris_forms_multiyear_worldwide_strategic_alliance_with_shire_090824/ http://www.pharmaceutical-business-review.com/news/celgene_presents_clinical_data_evaluating_amrubicin_as_potential_therapy_for_sclc_090805/ Amrubicin is an anthracyline-like molecule with potent topoisomerase II inhibition Wed, 05 Aug 2009 09:35:40 +0530 http://www.pharmaceutical-business-review.com/news/celgene_presents_clinical_data_evaluating_amrubicin_as_potential_therapy_for_sclc_090805/ http://www.pharmaceutical-business-review.com/news/seattle_genetics_completes_enrollment_in_brentuximab_vedotin_pivotal_trial_090824/ BrentuximabVedotin, to treat patients with Hodgkin Lymphoma Mon, 24 Aug 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/seattle_genetics_completes_enrollment_in_brentuximab_vedotin_pivotal_trial_090824/ http://www.pharmaceutical-business-review.com/news/shire_completes_submission_of_nda_for_velaglucerase_alfa_090901/ Shire reports positive results for remaining two phase III trials Tue, 01 Sep 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/shire_completes_submission_of_nda_for_velaglucerase_alfa_090901/ http://www.pharmaceutical-business-review.com/news/cougar_reports_successful_completion_of_jj_initial_tender_offer_090703/ Over 17.74 million shares of Cougar common stock were validly tendered Fri, 03 Jul 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/cougar_reports_successful_completion_of_jj_initial_tender_offer_090703/ http://www.pharmaceutical-business-review.com/news/vasogen_intellipharmaceutics_to_create_specialty_pharmaceutical_company_090817/ Ne entity to be called IntelliPharmaCeutics International Mon, 17 Aug 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/vasogen_intellipharmaceutics_to_create_specialty_pharmaceutical_company_090817/ http://www.pharmaceutical-business-review.com/news/shire_reports_positive_results_from_phase_iii_studies_of_velaglucerase_alfa_090803/ FDA has accepted Shire's treatment protocol for velaglucerase alfa Mon, 03 Aug 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/shire_reports_positive_results_from_phase_iii_studies_of_velaglucerase_alfa_090803/ http://www.pharmaceutical-business-review.com/news/shire_provides_results_for_phase_3b_vyvanse_study_090701/ Vyvanse improved the ability to focus and organize, as well as hyperactivity and impulsivity Wed, 01 Jul 2009 12:00:00 +0530 http://www.pharmaceutical-business-review.com/news/shire_provides_results_for_phase_3b_vyvanse_study_090701/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_receives_fda_approval_for_intuniv_extended_release_tablets_090903/ For the treatment of attention-deficit/hyperactivity disorder in children and adolescents aged 6 to17 years Thu, 03 Sep 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_receives_fda_approval_for_intuniv_extended_release_tablets_090903/ http://contractresearch.pharmaceutical-business-review.com/news/seattle_genetics_achieves_milestone_with_bayer_schering_pharma_090908/ Bayer Schering Pharma filed IND application for MN-IC to trigger milestone payment Tue, 08 Sep 2009 12:00:00 +0530 http://contractresearch.pharmaceutical-business-review.com/news/seattle_genetics_achieves_milestone_with_bayer_schering_pharma_090908/ http://drugdiscovery.pharmaceutical-business-review.com/news/lorus_publishes_data_supporting_novel_mode_of_anticancer_therapy_for_lor253_090921/ Study demonstrated potent anticancer activity and novel mechanism of action Mon, 21 Sep 2009 12:00:00 +0530 http://drugdiscovery.pharmaceutical-business-review.com/news/lorus_publishes_data_supporting_novel_mode_of_anticancer_therapy_for_lor253_090921/ http://clinicaltrials.pharmaceutical-business-review.com/news/seattle_genetics_discontinues_dacetuzumab_phase_iib_clinical_trial_091005/ To conduct a detailed analysis of data from the SeaGen MARINER trial in collaboration with Genentech Mon, 05 Oct 2009 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/seattle_genetics_discontinues_dacetuzumab_phase_iib_clinical_trial_091005/ http://clinicaltrials.pharmaceutical-business-review.com/news/shire_releases_data_from_headtohead_crossover_study_for_fosrenol_sevelamer_091007/ Study suggested that Fosrenol may offer greater serum phosphorus reduction in CKD patients on haemodialysis Wed, 07 Oct 2009 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/shire_releases_data_from_headtohead_crossover_study_for_fosrenol_sevelamer_091007/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_affirms_fiveyear_grant_to_shires_vyvanse_091026/ For the treatment of attention-deficit hyperactivity disorder Mon, 26 Oct 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_affirms_fiveyear_grant_to_shires_vyvanse_091026/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_receives_european_wide_label_extension_for_fosrenol_091028/ To make the non-calcium, non-resin phosphate binder available throughout the EU, to control hyperphosphataemia in CKD patients who are not on dialysis Wed, 28 Oct 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_receives_european_wide_label_extension_for_fosrenol_091028/ http://clinicaltrials.pharmaceutical-business-review.com/news/shire_reports_new_data_from_intuniv_study_091029/ Extended release tablets showed significant ADHD symptom reduction when assessed using the oppositional subscale of the Conners' ADHD rating scale Thu, 29 Oct 2009 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/shire_reports_new_data_from_intuniv_study_091029/ http://clinicaltrials.pharmaceutical-business-review.com/news/sunesis_completes_enrollment_in_phase_2_voreloxin_trial_091030/ REVEAL-1, a phase 2 dose regimen optimisation trial of single agent voreloxin in newly diagnosed elderly AML patients Fri, 30 Oct 2009 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/sunesis_completes_enrollment_in_phase_2_voreloxin_trial_091030/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_grants_priority_review_for_shires_velaglucerase_alfa_091104/ For the treatment of Type 1 Gaucher disease Wed, 04 Nov 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_grants_priority_review_for_shires_velaglucerase_alfa_091104/ http://itsoftware.pharmaceutical-business-review.com/news/shire_extends_contract_with_medidata_solutions_091104/ To improve clinical research budgets and enhance the management of its clinical development processes Wed, 04 Nov 2009 12:00:00 +0530 http://itsoftware.pharmaceutical-business-review.com/news/shire_extends_contract_with_medidata_solutions_091104/ http://clinicaltrials.pharmaceutical-business-review.com/news/shire_presents_data_for_vyvanse_phase_3_study_091112/ Demonstrated significant improvement in ADHD symptoms Thu, 12 Nov 2009 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/shire_presents_data_for_vyvanse_phase_3_study_091112/ http://contractresearch.pharmaceutical-business-review.com/news/seattle_genetics_agensys_expand_antibodydrug_collaboration_091123/ To co-develop and co-fund an initial ADC program, ASG-5ME Mon, 23 Nov 2009 12:00:00 +0530 http://contractresearch.pharmaceutical-business-review.com/news/seattle_genetics_agensys_expand_antibodydrug_collaboration_091123/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_submits_european_maa_for_velaglucerase_alfa_091124/ For the treatment of type 1 gaucher disease Tue, 24 Nov 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_submits_european_maa_for_velaglucerase_alfa_091124/ http://clinicaltrials.pharmaceutical-business-review.com/news/celgene_presents_positive_phase_iib_clinical_data_for_apremilast_091215/ For patients with moderate-to-severe psoriasis Tue, 15 Dec 2009 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/celgene_presents_positive_phase_iib_clinical_data_for_apremilast_091215/ http://contractservices.pharmaceutical-business-review.com/news/seattle_genetics_enters_into_collaboration_with_glaxosmithkline_091221/ GSK to utilize Seattle Genetics’ antibody-drug conjugate technology Mon, 21 Dec 2009 12:00:00 +0530 http://contractservices.pharmaceutical-business-review.com/news/seattle_genetics_enters_into_collaboration_with_glaxosmithkline_091221/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_submits_bla_for_replagal_to_fda_091222/ Also submitted marketing applications for Velaglucerase Alfa in the US, EU and Canada Tue, 22 Dec 2009 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_submits_bla_for_replagal_to_fda_091222/ http://drugdiscovery.pharmaceutical-business-review.com/news/celgene_acquires_gloucester_100115/ Celgene has closed its acquisition of Gloucester Pharmaceuticals (Gloucester) following the early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Fri, 15 Jan 2010 12:00:00 +0530 http://drugdiscovery.pharmaceutical-business-review.com/news/celgene_acquires_gloucester_100115/ http://drugdiscovery.pharmaceutical-business-review.com/news/shire_launches_intuniv_tablets_in_us_091109/ For the treatment of ADHD in children and adolescents ages 6 to 17 Mon, 09 Nov 2009 12:00:00 +0530 http://drugdiscovery.pharmaceutical-business-review.com/news/shire_launches_intuniv_tablets_in_us_091109/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/adventrx_files_new_drug_application_for_anx530_100104/ Includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of ANX 530 and Navelbine Mon, 04 Jan 2010 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/adventrx_files_new_drug_application_for_anx530_100104/ http://clinicaltrials.pharmaceutical-business-review.com/news/seattle_genetics_millennium_initiate_phase_i_hodgkin_lymphoma_drug_trial_100204/ Seattle Genetics and Millennium Pharmaceuticals, a wholly-owned subsidiary of Takeda Pharmaceutical, have initiated a phase I clinical trial for Brentuximab Vedotin (SGN-35) in combination with chemotherapy, for treatment of patients newly diagnosed with hodgkin lymphoma. Thu, 04 Feb 2010 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/seattle_genetics_millennium_initiate_phase_i_hodgkin_lymphoma_drug_trial_100204/ http://contractservices.pharmaceutical-business-review.com/news/sunesis_licenses_fbld_technology_to_carmot_100208/ Sunesis Pharmaceuticals (Sunesis) has granted Carmot Therapeutics (Carmot) an exclusive license to its proprietary Fragment-Based Lead Discovery (FBLD) technology. Mon, 08 Feb 2010 12:00:00 +0530 http://contractservices.pharmaceutical-business-review.com/news/sunesis_licenses_fbld_technology_to_carmot_100208/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/curis_reaches_milestone_in_hsp90_collaboration_with_debiopharm_100212/ Curis has announced that its licensee, Debiopharm has received approval from France's regulatory authority, Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly known as CUDC-305. Fri, 12 Feb 2010 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/curis_reaches_milestone_in_hsp90_collaboration_with_debiopharm_100212/ http://clinicaltrials.pharmaceutical-business-review.com/news/shire_presents_positive_data_on_velaglucerase_alfa_in_gaucher_disease_100212/ Shire has presented positive results from its first phase III study (TKT 032) evaluating safety and efficacy of velaglucerase alfa, its investigational enzyme replacement therapy, for the treatment of type 1 gaucher disease. Fri, 12 Feb 2010 12:00:00 +0530 http://clinicaltrials.pharmaceutical-business-review.com/news/shire_presents_positive_data_on_velaglucerase_alfa_in_gaucher_disease_100212/ http://drugdiscovery.pharmaceutical-business-review.com/news/chugai_exercises_development_rights_for_gdc0449_in_japan_100218/ Curis, a drug development company involved in development of small molecule drug candidates for cancer treatment, has said that Chugai Pharmaceutical has exercised its right of first refusal for the development and commercialization in Japan of GDC-0449, a Hedgehog pathway inhibitor developed by Genentech, a wholly owned member of the Roche Group, under an existing agreement with F Hoffmann-La Roche. Thu, 18 Feb 2010 12:00:00 +0530 http://drugdiscovery.pharmaceutical-business-review.com/news/chugai_exercises_development_rights_for_gdc0449_in_japan_100218/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_provides_update_on_bla_filing_for_replagal_100224/ Shire has received fast track designation from the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. Wed, 24 Feb 2010 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/shire_provides_update_on_bla_filing_for_replagal_100224/ http://inwardinvestment.pharmaceutical-business-review.com/news/celgene_opens_european_rd_hub_for_translational_science_100226/ Celgene has launched Celgene Institute of Translational Research Europe (CITRE), a European hub for translational science. Based in the central European location of Spain, CITRE demonstrates Celgene’s commitment to research in Europe and to innovations in biomedical research, regenerative medicine, personalised medicine and stem-cell research. Fri, 26 Feb 2010 08:45:34 +0530 http://inwardinvestment.pharmaceutical-business-review.com/news/celgene_opens_european_rd_hub_for_translational_science_100226/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_grants_marketing_approval_for_shires_vpriv_100301/ FDA has granted marketing approval for Shire's Vpriv, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 gaucher disease in pediatric and adult patients. Mon, 01 Mar 2010 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_grants_marketing_approval_for_shires_vpriv_100301/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_refuses_adventrx_to_file_letter_regarding_anx530_nda_100301/ FDA has refused Adventrx Pharmaceuticals (Adventrx) to file a letter regarding new drug application (NDA) for ANX-530 (vinorelbine injectable emulsion). Mon, 01 Mar 2010 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda_refuses_adventrx_to_file_letter_regarding_anx530_nda_100301/ http://contractservices.pharmaceutical-business-review.com/news/renovo_revises_juvista_licensing_deal_with_shire_100302/ Renovo Group (Renovo), the biopharmaceutical product company developing drugs to reduce scarring, improve wound healing and enhance tissue regeneration, has revised licensing deal with Shire for Juvista and acquired from Shire the rights to sell and license Juvista in all territories other than the USA, Mexico and Canada. Tue, 02 Mar 2010 12:00:00 +0530 http://contractservices.pharmaceutical-business-review.com/news/renovo_revises_juvista_licensing_deal_with_shire_100302/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/district_court_upholds_fda_grant_of_nce_exclusivity_to_vyvanse_100304/ Shire, a global specialty biopharmaceutical company, has said that the US District Court for the District of Columbia has backed up the decision of US FDA to award 5-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate, currently marketed by Shire US, for the treatment of attention-deficit hyperactivity disorder, under the name Vyvanse. Thu, 04 Mar 2010 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/district_court_upholds_fda_grant_of_nce_exclusivity_to_vyvanse_100304/ http://regulatoryaffairs.pharmaceutical-business-review.com/news/celgene_to_appeal_against_negative_nice_recommendation_on_vidaza_100304/ Celgene UK has planned to appeal the negative recommendation by the National Institute for Health and Clinical Excellence (NICE) for the use of Vidaza(azacitidine) in patients with higher-risk myelodysplastic syndrome (MDS), a rare type of blood cancer. Thu, 04 Mar 2010 12:00:00 +0530 http://regulatoryaffairs.pharmaceutical-business-review.com/news/celgene_to_appeal_against_negative_nice_recommendation_on_vidaza_100304/ http://drugdiscovery.pharmaceutical-business-review.com/news/seattle_genetics_achieves_milestone_under_adc_collaboration_with_genentech_100304/ Seattle Genetics has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Genentech, a wholly owned member of the Roche Group. Thu, 04 Mar 2010 12:00:00 +0530 http://drugdiscovery.pharmaceutical-business-review.com/news/seattle_genetics_achieves_milestone_under_adc_collaboration_with_genentech_100304/ http://drugdelivery.pharmaceutical-business-review.com/news/seattle_genetics_receives_patent_for_adc_technology_100311/ Seattle Genetics has reported that the US Patent and Trademark Office (USPTO) has issued a patent related to its antibody-drug conjugate (ADC) technology. The Patent No 7,659,241 covers cleavable linkers and potent auristatin drug payloads used in certain of Seattle Genetics’ ADC programs like brentuximab vedotin (SGN-35), as well as many ADC programs in development by its collaborators. Thu, 11 Mar 2010 12:00:00 +0530 http://drugdelivery.pharmaceutical-business-review.com/news/seattle_genetics_receives_patent_for_adc_technology_100311/