|February 13, 2014|
|07:19 EDT||ISIS, BIIB||Isis to receive $9.3M in milestone payments for ongoing Phase 2 ISIS-SMN study|
Isis Pharmaceuticals (ISIS) announced that the first child in the 12 mg group was dosed in the ongoing Phase 2 study evaluating ISIS-SMNRx in children with spinal muscular atrophy. Isis also announced that the first child was dosed in an open–label extension study, which is being offered to those children with SMA who have completed dosing in Isis' previous studies. Isis will receive two milestone payments totaling $7.3M for advancements in these studies. Isis also announced that dosing in the Phase 2 study in infants with SMA is being extended. Under the extension, infants who have completed the three initially scheduled study doses will be eligible to receive an additional dose of 12 mg. Isis announced that the first infant in the study has received a fourth dose of ISIS-SMNRx approximately six months after the three initial doses were completed. For this achievement, Isis will receive a $2M milestone payment from Biogen Idec (BIIB).
News For ISIS;BIIB From The Last 14 Days
Check below for free stories on ISIS;BIIB the last two weeks.
|September 15, 2014|
|08:01 EDT||BIIB||Alnylam names Karen Anderson as SVP, Chief Human Resources Officer|
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|September 12, 2014|
|07:32 EDT||BIIB||Biogen, AbbVie announce ZINBRYTA DECIDE Phase 3 study results|
Biogen (BIIB) and AbbVie (ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA, dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis compared to AVONEX. These results are being presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis. Patients on ZINBRYTA demonstrated a statistically significant 45% reduction in annualized relapse rate compared to patients treated with AVONEX. Based on the efficacy and safety data from the ZINBRYTA clinical development program, Biogen Idec and AbbVie plan to file marketing applications for ZINBRYTA with regulatory authorities during 1H15.
|September 11, 2014|
|07:31 EDT||BIIB||Biogen announces 5-year results from TECFIDERA ENDORSE Phase 3 study|
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|07:31 EDT||BIIB||Biogen announces new data from Plegridy Phase 3 ADVANCE trial|
Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of PLEGRIDY were maintained in people with relapsing forms of multiple sclerosis beyond the first year of the study. These results were presented at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis in Boston. Post-hoc analyses from the two-year, Phase 3 ADVANCE clinical trial confirm that PLEGRIDY’s positive effects on reducing disease activity and disability progression were maintained in year two of the study. A significantly higher proportion of patients taking PLEGRIDY during both years of the study experienced no evidence of disease activity – defined as the absence of clinical and MRI disease activity over two years of treatment – compared to those who switched to PLEGRIDY from placebo. Also, those treated with PLEGRIDY for both years of the study had significant reductions in the risk of 24-week confirmed disability progression compared to patients treated with placebo during the first year. In addition, new data from the second year of ADVANCE show that patients who took PLEGRIDY throughout the study experienced statistically significant improvements in clinical and MRI outcomes – including annualized relapse rate, risk of relapse, risk of 24-week confirmed disability progression, and number of brain lesions – when compared to those who switched to PLEGRIDY after taking placebo for the first year. This new data also showed that the safety profile of PLEGRIDY was consistent between years one and two of the study.
|September 8, 2014|
|09:27 EDT||BIIB||Leerink biotech analyst holds a luncheon meeting with a conference call|
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
|07:15 EDT||BIIB||IBC Life Sciences to hold a conference|
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
|September 2, 2014|
|19:28 EDT||ISIS||Isis Pharmaceutical licensing partner Antisense reports ATL1103 phase II results|
Antisense Therapeutics, or ANP, reported the primary efficacy results from its phase II clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. The phase II trial met its primary efficacy endpoint showing a statistically significant average reduction in the serum insulin-like growth factor-I, or sIGF-1, levels of 26% from baseline at week 14 at the 400mg per week dose tested. All patients treated with 400mg per week of ATL1103 had a reduction in sIGF-I levels from baseline at week 14. Greater reductions in sIGF-I were observed in patients who had lower body weights and thereby received a relatively higher dose per kg bodyweight with the patients who received 5.5 mg/kg per week showing a 36% average reduction in their sIGF-I levels. The positive results achieved in this Phase II trial position ATL1103 to move into Phase III stage of development. Consequently, ANP will accelerate out-licencing activities to secure a pharmaceutical development partner for the drug's further development. ANP has 4 products in its development pipeline that it has in-licensed from Isis Pharmaceuticals, including ATL1103.