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QLT's oral synthetic retinoid granted orphan drug designation for treatment of Leber Congenital Amaurosis

QLT Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for QLT091001, its oral synthetic retinoid, for the treatment of Leber Congenital Amaurosis (LCA). LCA is an inherited progressive retinal degenerative disease that leads to retinal dysfunction and visual impairment beginning at birth. QLT091001 is an orally administered synthetic retinoid replacement for 11-cis-retinal, which is a key biochemical component of the visual retinoid cycle.

8 Dec 2010

FDA grants QLT's QLT091001 orphan drug designation for treatment of Retinitis Pigmentosa

QLT Inc. today announced that QLT091001, the Company's oral synthetic retinoid, has been granted orphan drug designation for the treatment of Retinitis Pigmentosa (RP) from the U.S. Food and Drug Administration (FDA). This follows the FDA grant of orphan drug designation for QLT091001 for the treatment of Leber Congenital Amaurosis (LCA) also on December 7, 2010.

8 Dec 2010

Positive interim results from elotuzumab Phase 1b/2 study in relapsed multiple myeloma

Abbott and Bristol-Myers Squibb Company today announced interim results from the Phase 2 portion of a Phase 1b/2 open-label study which showed a high objective response rate (ORR) among patients with relapsed multiple myeloma who received elotuzumab plus lenalidomide and low-dose dexamethasone.

7 Dec 2010

$Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL$

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive data from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35) in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, a defining marker of ALCL. The data were presented today during an oral session at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL.

7 Dec 2010

John Theurer Cancer Center presents research findings at ASH meeting

The John Theurer Cancer Center at Hackensack University Medical Center announced today important research findings presented at the annual meeting of the American Society of Hematology taking place December 4-7, 2010 in Orlando, Florida. The ASH meeting is the world's leading scientific gathering of hematologists and hematology researchers.

7 Dec 2010

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Aradigm Corporation today announced that Zogenix, Inc. and Desitin Pharmaceuticals GmbH ("Desitin") were granted approval of the Marketing Authorization Application ("MAA") for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system by the Danish Medicines Agency of Denmark.

7 Dec 2010

$Interim results from Phase 1 study of ENMD-2076 in refractory MM patients presented at ASH 2010$

Interim results from Phase 1 study of ENMD-2076 in refractory MM patients presented at ASH 2010

EntreMed, Inc., today announced the presentation of data for its Phase 2 oncology drug candidate, ENMD-2076 an Aurora A/angiogenic kinase inhibitor. Data from the Phase 1 studies with ENMD-2076 in patients with multiple myeloma and relapsed or refractory leukemia were presented by EntreMed investigators during poster sessions at the 2010 American Society of Hematology Annual Meeting being held December 4-7 in Orlando, Florida.

7 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

Micromet announces presentation of updated results from MT103 Phase 2 trial in MRD positive ALL patients

Micromet, Inc. today announced the presentation of updated results from a Phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). An analysis of long-term efficacy data demonstrated that blinatumomab produced prolonged remissions in patients with ALL. As of November 2010, the hematologic disease free survival (DFS) was 60%, with a follow-up of up to 27.5 months.

7 Dec 2010

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human Interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants.

7 Dec 2010

Promising Phase 2 data of perifosine in CLL and HL presented at 52nd ASH

Keryx Biopharmaceuticals, Inc. today announced data presented for the first time at the 52nd Annual Meeting of the American Society of Hematology showing promising clinical activity, safety and tolerability of perifosine in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL). KRX-0401 (perifosine) is the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway.

7 Dec 2010

Reason behind recurrence of CLL in lymph nodes and bone marrow after chemotherapy

In research to be presented at the American Society of Hematology (ASH) annual meeting, investigators at Dana-Farber Cancer Institute in Boston offer a new explanation of why chronic lymphocytic leukemia (CLL) tends to recur in the lymph nodes and bone marrow after being cleared from the bloodstream by chemotherapy. Their findings will be reported during in an oral session on Monday, Dec. 6, at 4:45 p.m. in room 315 of the Orange County Convention Center.

7 Dec 2010

Encouraging data from perifosine Phase 2 studies in advanced leukemia, Hodgkin's lymphoma

Aeterna Zentaris Inc. today announced Phase 2 data presented for the first time on perifosine, its lead novel oral anti-cancer compound, showing promising clinical activity, safety and tolerability in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL). The data were presented over the weekend at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.

7 Dec 2010

No overall cancer risk in people who donate stem cells

American Society of Hematology reveals that there is no increase in overall cancer risk in people who donate stem cells and that the utilization of a double cord blood stem cell transplant is associated with better overall outcomes when used early in the treatment of acute leukemias.

7 Dec 2010

Clinical trial results of ACY-1215 in multiple myeloma published in scientific journal of ASH

Acetylon Pharmaceuticals today announced the publication of favorable results of preclinical safety and efficacy testing of its oral selective HDAC6 inhibitor drug candidate, ACY-1215, in multiple myeloma.

7 Dec 2010

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

YM BioSciences Inc. today announced positive interim data from the first 60 patients enrolled in the Phase I/II trial for its JAK1/JAK2 inhibitor, CYT387, in myelofibrosis. The results were reported today in an oral presentation at the 52nd American Society of Hematology Annual Meeting being held in Orlando, Florida.

7 Dec 2010

Ascenta, LLS enter agreement to develop AT-406 IAP small molecule inhibitor for acute myeloid leukemia

Ascenta Therapeutics, Inc. and The Leukemia & Lymphoma Society (LLS) today entered into an agreement whereby the LLS will support clinical development of Ascenta's oral small molecule inhibitor of IAPs (inhibitor of apoptosis proteins), AT-406, for patients with acute myeloid leukemia (AML).

7 Dec 2010

New analysis of Soliris in patients with PNH presented at ASH Annual Meeting

Independent investigators reported today that patients with paroxysmal nocturnal hemoglobinuria who were treated long-term with Soliris (eculizumab) achieved survival comparable to that of an age- and gender-matched normal population. Findings from this investigator-led analysis were reported in an oral presentation today at the 52nd American Society of Hematology Annual Meeting and Exposition in Orlando.

7 Dec 2010

Achillion Pharmaceuticals to present clinical study data of ACH-1625 at APASL 2011

Achillion Pharmaceuticals, Inc. today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver to be held February 17-21, 2011 in Bangkok, Thailand.

6 Dec 2010

Telik announces positive results from Phase 2 trial of ezatiostat in patients with MDS

Telik, Inc. today announced positive results from a Phase 2 multicenter trial of oral ezatiostat hydrochloride (TELINTRA, TLK199) in patients with an International Prognostic System Score of low to intermediate-1 risk myelodysplastic syndrome.

6 Dec 2010

Oral News and Research

QLT's oral synthetic retinoid granted orphan drug designation for treatment of Leber Congenital Amaurosis

FDA grants QLT's QLT091001 orphan drug designation for treatment of Retinitis Pigmentosa

Positive interim results from elotuzumab Phase 1b/2 study in relapsed multiple myeloma

Seattle Genetics and Millennium announce positive data from SGN-35 Phase II trial in relapsed or refractory ALCL

John Theurer Cancer Center presents research findings at ASH meeting

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro needle-free delivery system in Denmark

Interim results from Phase 1 study of ENMD-2076 in refractory MM patients presented at ASH 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Micromet announces presentation of updated results from MT103 Phase 2 trial in MRD positive ALL patients

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Promising Phase 2 data of perifosine in CLL and HL presented at 52nd ASH

Reason behind recurrence of CLL in lymph nodes and bone marrow after chemotherapy

Encouraging data from perifosine Phase 2 studies in advanced leukemia, Hodgkin's lymphoma

No overall cancer risk in people who donate stem cells

Clinical trial results of ACY-1215 in multiple myeloma published in scientific journal of ASH

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

Ascenta, LLS enter agreement to develop AT-406 IAP small molecule inhibitor for acute myeloid leukemia

New analysis of Soliris in patients with PNH presented at ASH Annual Meeting

Achillion Pharmaceuticals to present clinical study data of ACH-1625 at APASL 2011

Telik announces positive results from Phase 2 trial of ezatiostat in patients with MDS

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