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DuraSite 2 ophthalmic drug delivery system from InSite Vision

InSite Vision Incorporated today introduced DuraSite 2, its next-generation enhanced drug delivery system which provides a broad platform for developing superior ophthalmic therapeutics.

6 Sep 2012

Alnylam announces complete results from ALN-RSV01 Phase IIb trial on RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today complete results from its Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.

6 Sep 2012

Real-time prescription system reduces inappropriate prescribing of medications

A centralized prescription network providing real-time information to pharmacists in British Columbia, Canada, resulted in dramatic reductions in inappropriate prescriptions for opioid analgesics and benzodiazepines, widely used and potentially addictive drugs. The findings are reported in a study in CMAJ (Canadian Medical Association Journal).

5 Sep 2012

Epizyme commences EPZ-5676 Phase 1 study for MLL-r leukemia

Epizyme, Inc., a company leading the creation of a new class of personalized therapeutics for patients with genetically defined cancers, announced today that it has initiated a Phase 1 Study of EPZ-5676. EPZ-5676 is a novel small molecule inhibitor of DOT1L, a histone methyltransferase (HMT) that is critical to the development of a specific type of acute leukemia defined by rearrangement of the MLL gene (MLL-r leukemia).

5 Sep 2012

Phase 1b trial validates efficacy of Pulmatrix PUR118 to treat COPD

Pulmatrix, Inc., a clinical stage biotechnology company creating novel inhaled therapeutics, today announced top line results from a clinical study showing that the novel inhaled therapeutic, PUR118, demonstrated anti-inflammatory efficacy and was well-tolerated in two Phase 1b studies in patients with chronic obstructive pulmonary disease (COPD).

5 Sep 2012

Baxter seeks FDA BLA approval for BAX 326 rFIX protein to treat hemophilia B

Baxter International Inc. today announced that the company has submitted a biologics license application to the United States Food and Drug Administration for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B.

From Baxter International Inc. 5 Sep 2012

Biokine, BioLineRx sign license agreement to develop and commercialize BL-8040 for AML

BioLineRx Ltd., a biopharmaceutical drug development company, announced today that it has signed an exclusive, worldwide license agreement with Biokine Therapeutics Ltd., a Clal Biotechnology Industries portfolio company, for the development and commercialization of BL-8040 (formerly BKT-140), a Phase II ready drug candidate for the treatment of acute myeloid leukemia (AML), as well as other types of hematological cancer.

4 Sep 2012

Converting blood cells to a stem cell state: an interview with Elias Zambidis, M.D., Ph.D.

The primitive stem cell state we created is called an “induced pluripotent stem cell” (iPSC). iPSC are a new, unique, and artificially-created type of stem cell that were first described in 2006 by a Japanese scientist named Shinya Yamanaka.

4 Sep 2012

VLST, Pfizer enter in-licensing agreement for anti-CD40 monoclonal antibody

VLST Corporation, a Seattle-based biotechnology company focused on the development of therapeutics for cancer and autoimmune and inflammatory disorders, today announced an in-licensing agreement with Pfizer Inc. for an anti-CD40 monoclonal antibody.

31 Aug 2012

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

Transition Therapeutics Inc. today announced that its licensing partner, Elan Corporation, plc has commenced a Phase 2, placebo-controlled, safety and efficacy study of oral ELND005 as an adjunctive maintenance treatment in patients with Bipolar I Disorder (BPD 1) to delay the time to occurrence of mood episodes.

31 Aug 2012

Enrollment complete in Arrowhead’s CALAA-01 phase 1b trial on solid tumors

Arrowhead Research Corporation, a targeted therapeutics company, today announced that, through its Calando Pharmaceuticals subsidiary, it has completed enrollment of a phase 1b clinical trial of CALAA-01, its RNAi therapeutic candidate targeting solid tumors. All patients participating in the trial have completed dosing with the exception of one patient who is still receiving treatment and will continue to be monitored.

31 Aug 2012

Chronic nerve pain: an interview with Professor Sally Lawson

Chronic nerve pain results from pathological changes within a nerve that appear to be self-sustaining and thus the pain continues for a long time.

30 Aug 2012

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

Elan Corporation, plc today announced that it has commenced a Phase 2, placebo-controlled, safety and efficacy study of oral ELND005 as an adjunctive maintenance treatment in patients with Bipolar I Disorder (BPD 1) to delay the time to occurrence of mood episodes.

30 Aug 2012

FDA grants orphan designation to Aerial BioPharma’s ARL-N05 for treatment of narcolepsy

Aerial BioPharma, a biopharmaceutical company focused on developing biologics and small molecules for conditions in the central nervous system, has received orphan drug designation for its narcolepsy drug in development.

30 Aug 2012

Sleep disorder treatment: an interview with Dr Seth Lederman, President and CEO of Tonix Pharmaceuticals

Sleep disorders are a large area. We are focused on one particular type of sleep disturbance called “non-restorative” sleep. People with this problem do sleep, but they don’t wake up feeling refreshed or feeling that their sleep has had the restorative effects of healthy sleep.

29 Aug 2012

Novelos expects to submit CLR1502 IND with FDA for non-invasive tumor imaging

Novelos Therapeutics, Inc., a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it is developing CLR1502 (GLOW2), a preclinical cancer-targeted optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging.

29 Aug 2012

Acorda’s GGF2 can improve erectile function after cavernous nerve damage

Acorda Therapeutics, Inc. announced data from a preclinical study showed that treatment with Glial Growth Factor 2 (GGF2) improved erectile function in an animal model following a cavernous nerve (CN) injury, a common complication of prostate surgery.

29 Aug 2012

Top-line results from Rexahn’s Archexin Phase II study on metastatic pancreatic cancer

Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in oncology and CNS, today announced top-line results from a Phase II clinical study of Archexin, its clinical-stage oncology drug candidate.

29 Aug 2012

Altheus Therapeutics initiates enrollment in Zoenasa Phase 2 study for ulcerative colitis

Altheus Therapeutics announced today it has randomized its first patient in a comparator-controlled Phase 2 efficacy study of Zoenasa, a novel combination therapy for ulcerative colitis (UC).

29 Aug 2012

Three Pulmatrix PUR118 clinical studies on COPD, asthma to be presented at ERS Annual Congress

Pulmatrix, Inc., a clinical stage biotechnology company creating novel inhaled therapeutics, announced today that three posters on its lead iCALM therapeutic, the first treatment developed utilizing its iSPERSE inhaled drug platform, will be presented at the European Respiratory Society (ERS) Annual Congress taking place September 1-5, 2012, in Vienna, Austria.

28 Aug 2012

Therapeutics News and Research

DuraSite 2 ophthalmic drug delivery system from InSite Vision

Alnylam announces complete results from ALN-RSV01 Phase IIb trial on RSV infection

Real-time prescription system reduces inappropriate prescribing of medications

Epizyme commences EPZ-5676 Phase 1 study for MLL-r leukemia

Phase 1b trial validates efficacy of Pulmatrix PUR118 to treat COPD

Baxter seeks FDA BLA approval for BAX 326 rFIX protein to treat hemophilia B

Biokine, BioLineRx sign license agreement to develop and commercialize BL-8040 for AML

Converting blood cells to a stem cell state: an interview with Elias Zambidis, M.D., Ph.D.

VLST, Pfizer enter in-licensing agreement for anti-CD40 monoclonal antibody

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

Enrollment complete in Arrowhead’s CALAA-01 phase 1b trial on solid tumors

Chronic nerve pain: an interview with Professor Sally Lawson

Elan commences ELND005 Phase 2 study in Bipolar I Disorder

FDA grants orphan designation to Aerial BioPharma’s ARL-N05 for treatment of narcolepsy

Sleep disorder treatment: an interview with Dr Seth Lederman, President and CEO of Tonix Pharmaceuticals

Novelos expects to submit CLR1502 IND with FDA for non-invasive tumor imaging

Acorda’s GGF2 can improve erectile function after cavernous nerve damage

Top-line results from Rexahn’s Archexin Phase II study on metastatic pancreatic cancer

Altheus Therapeutics initiates enrollment in Zoenasa Phase 2 study for ulcerative colitis

Three Pulmatrix PUR118 clinical studies on COPD, asthma to be presented at ERS Annual Congress

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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