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February 14, 2014
13:34 EDTISIS, GSKIsis reports positive opinion on European ISIS-TTR orphan designation
Isis Pharmaceuticals (ISIS) announced that the Committee for Orphan Medicinal Products has adopted a positive opinion recommending ISIS-TTR for designation as an orphan medicinal product for the treatment of ATTR-Amyloidosis to the European Commission. The opinion will be subject to review by the EC, which ultimately grants the decision on orphan drug designation. ISIS-TTR is an antisense drug in development with GlaxoSmithKline (GSK), which has an option to exclusively license the ISIS-TTRRx program. ISIS-TTR is currently being evaluated in a Phase 2/3 study in familial amyloid polyneuropathy patients.
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September 16, 2014
07:33 EDTGSKMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
07:31 EDTGSKEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.
September 15, 2014
16:10 EDTGSKFive Prime announces option exercise by GlaxoSmithKline to obtain license
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07:27 EDTGSKIBC Life Sciences to hold a conference
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September 10, 2014
09:58 EDTGSKGlaxoSmithKline has a conference call hosted by JPMorgan
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September 9, 2014
06:25 EDTGSKDocuments show DOJ probed GSK China unit in 2012, Reuters says
Internal documents revealed that a U.S. anti-bribery investigation into GlaxoSmithKline (GSK) touched on the firm's Chinese consumer healthcare division two years ago, which infers that the company's compliance issues in the country could be broader than initially discovered, according to Reuters, citing the documents. Reference Link
September 8, 2014
08:48 EDTGSKGilead announces AMBITION study results in collaboration with Glaxo
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September 7, 2014
13:57 EDTGSKGlaxoSmithKline Ebola vaccine works in tests on monkeys, Bloomberg says
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September 2, 2014
19:28 EDTISISIsis 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.

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