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Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Stemedica Cell Technologies, Inc. received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimer's disease (AD), the sixth leading cause of death in the United States.

9 Jun 2015

Study shows how GLP-1 receptor agonists modify the brain's response to food

Gut hormone-based medications used to treat diabetes, such as GLP-1 receptor agonists, have also been shown to reduce body weight. Researchers have been working to understand how. This study, presented today at the American Diabetes Association's 75th Scientific Sessions, sheds light on how GLP-1 receptor agonists alter the brain's response to food, possibly reducing cravings and increasing satisfaction while eating.

9 Jun 2015

Glucose-control drug sitagliptin does not raise risk of cardiovascular events

A clinical trial of the glucose-control drug sitagliptin among patients with type 2 diabetes and established cardiovascular disease has found it did not raise the risk of major adverse cardiovascular events.

9 Jun 2015

Lactobacillus reuteri may reduce risk of necrotizing enterocolitis in premature infants

A new study finds that supplementing enteral nutrition with Lactobacillus reuteri (L. reuteri) DSM 17938 as a probiotic may reduce the risk of necrotizing enterocolitis (NEC) in premature infants.

9 Jun 2015

Ibrutinib shows promise in CLL/SLL

The addition of ibrutinib to bendamustine and rituximab significantly prolongs progression-free survival in patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma, according to the HELIOS trial.

8 Jun 2015

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Sanofi announced today the presentation of full results of the Phase IIIb ELIXA study, which was designed to assess the cardiovascular (CV) safety of Lyxumia (lixisenatide) in adults with type 2 diabetes and high CV risk.

8 Jun 2015

Jazz enrolls first patients in JZP-110 Phase 3 study for treatment of EDS in patients with narcolepsy or OSA

Jazz Pharmaceuticals plc announced today that the first patients have been enrolled in a Phase 3 clinical development program evaluating the safety and efficacy of its investigational drug candidate, JZP-110, as a wake-promoting agent in the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy or with obstructive sleep apnea (OSA).

8 Jun 2015

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

Intarcia Therapeutics, Inc. today announced the presentation of results from its first two phase 3 clinical trials (FREEDOM-1 and FREEDOM-1 HBL) of its late-stage investigational candidate ITCA 650 (exenatide delivered continuously via a small matchstick-size subcutaneous osmotic mini-pump just once or twice yearly) at the 75th Scientific Sessions of the American Diabetes Association.

8 Jun 2015

DalCor, MHI partner to conduct Phase III clinical trial of investigational cardiovascular drug

DalCor Pharmaceuticals and the Montreal Heart Institute announced today a collaboration in principle to conduct an international Phase III clinical trial which could result in a major clinical advance in cardiovascular personalised medicine.

8 Jun 2015

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction.

8 Jun 2015

Nuvo obtains Health Canada approval to conduct WF10 Phase 2 trial for treatment of allergic rhinitis

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced it has received Health Canada approval to conduct a new Phase 2 clinical trial (the 2015 WF10 Trial) to assess WF10 for the treatment of allergic rhinitis.

8 Jun 2015

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza 0.9 mg after 52 weeks of treatment. Eli Lilly and Company will present these data at the 75th American Diabetes Association Scientific Sessions in Boston.

7 Jun 2015

PALOMA3 supports palbociclib use in advanced breast cancer

Advanced breast cancer patients who have failed prior endocrine treatment may receive a progression-free survival benefit if palbociclib is added to fulvestrant, a phase III trial indicates.

5 Jun 2015

Pivotal Therapeutics enrolls first patient in POMEGA Phase IIa clinical trial of PVT-100

Pivotal Therapeutics Inc., a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, announced today the enrollment of the first patient in Pivotal's POMEGA Phase IIa clinical trial with PVT-100.

4 Jun 2015

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Rhythm announced today the initiation of two Phase 2 clinical trials focused on evaluating the safety and effectiveness of setmelanotide (RM-493), the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of Prader-Willi Syndrome (PWS) and POMC-null obesity.

4 Jun 2015

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21").

4 Jun 2015

Ardelyx signs termination agreement with AstraZeneca, regains rights to portfolio of NHE3 inhibitors

Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced that it has entered into a termination agreement with AstraZeneca, such that all the rights to Ardelyx's portfolio of NHE3 inhibitors, including Ardelyx's lead product candidate, tenapanor, are returned to Ardelyx.

3 Jun 2015

Apatorsen added to first-line chemotherapy benefits metastatic bladder cancer patients

OncoGenex Pharmaceuticals, Inc. announced that results from an exploratory analysis of the Phase 2 Borealis-1 trial showed that metastatic bladder cancer patients with poor prognostic features benefited from apatorsen 600mg added to first-line chemotherapy compared to chemotherapy alone.

2 Jun 2015

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Elusys Therapeutics, Inc. today announced the U.S. Food and Drug Administration has accepted for filing and review its Biologics License Application for Anthim® (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness.

2 Jun 2015

Vitamin D and calcium supplements may not help relieve menopausal symptoms, reveals study

Women who took vitamin D and calcium supplements had the same number of menopausal symptoms as women who did not take the supplements, according to a study published today in Maturitas, the official journal of the European Menopause and Andropause Society.

2 Jun 2015

Placebo News and Research

Stemedica receives FDA's IND approval for itMSC Phase IIa clinical trial to treat Alzheimer's disease

Study shows how GLP-1 receptor agonists modify the brain's response to food

Glucose-control drug sitagliptin does not raise risk of cardiovascular events

Lactobacillus reuteri may reduce risk of necrotizing enterocolitis in premature infants

Ibrutinib shows promise in CLL/SLL

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Jazz enrolls first patients in JZP-110 Phase 3 study for treatment of EDS in patients with narcolepsy or OSA

Results from Intarcia's two phase 3 clinical trials of ITCA 650 to be presented at ADA's Scientific Session

DalCor, MHI partner to conduct Phase III clinical trial of investigational cardiovascular drug

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Nuvo obtains Health Canada approval to conduct WF10 Phase 2 trial for treatment of allergic rhinitis

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

PALOMA3 supports palbociclib use in advanced breast cancer

Pivotal Therapeutics enrolls first patient in POMEGA Phase IIa clinical trial of PVT-100

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Ardelyx signs termination agreement with AstraZeneca, regains rights to portfolio of NHE3 inhibitors

Apatorsen added to first-line chemotherapy benefits metastatic bladder cancer patients

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Vitamin D and calcium supplements may not help relieve menopausal symptoms, reveals study

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