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CTI initiates enrollment in pacritinib Phase 3 trial for myelofibrosis

Cell Therapeutics, Inc. (CTI) today announced that the Company has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis.

9 Jan 2013

Lilly, Boehringer Ingelheim announce top-line results from empagliflozin Phase III trials on T2D

Boehringer Ingelheim and Eli Lilly and Company today announced top-line results for four completed Phase III clinical trials for empagliflozin, an investigational sodium glucose co-transporter-2 (SGLT2) inhibitor being studied for treatment of patients with Type 2 Diabetes (T2D).

9 Jan 2013

Oramed files IND with FDA to begin ORMD-0801 Phase 2 trial for type 2 diabetes

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801.

9 Jan 2013

Sublingual immunotherapy can effectively treat peanut allergy

Peanuts are one of the most common triggers of severe food-induced allergic reactions, which can be fatal, and the prevalence of peanut allergy is increasing. However, there is currently no clinical treatment available for peanut allergy other than strict dietary elimination and, in cases of accidental ingestion, injections of epinephrine.

9 Jan 2013

Beta blockers can reduce risk of Alzheimer's, other types of dementia

People taking the blood pressure drugs called beta blockers may be less likely to have changes in the brain that can be signs of Alzheimer's disease and other types of dementia, according to a study released today that will be presented at the American Academy of Neurology's 65th Annual Meeting in San Diego, March 16 to 23, 2013.

9 Jan 2013

Esperion reports positive results from ETC-1002 Phase 2 clinical trial on type 2 diabetes

Esperion Therapeutics, the leading developer of small molecule therapies for the treatment of cardiometabolic disorders, today announced positive results of a recently completed Phase 2 clinical trial of ETC-1002 in patients with type 2 diabetes with LDL-C lowering of up to 43% compared to placebo.

8 Jan 2013

Spectrum Pharmaceuticals reveals positive RenaZorb Phase 1 clinical trial results

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced positive, statistically significant data from the Company's Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb (also referred to as SPI-014) in healthy volunteers.

8 Jan 2013

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA’s review to be completed in the first half of 2013.

7 Jan 2013

Industry sponsored drug and device studies: an interview with Professor Lisa Bero

Our review included analyses of drug and device studies conducted in humans. The drugs or devices could be compared to placebo or sham treatments, or other effective treatments. The drugs and devices examined for this review are used for a wide variety of clinical conditions, including cardiovascular and psychiatric diseases.

7 Jan 2013

Edison Pharmaceuticals to commence EPI-743 phase 2B Friedreich's ataxia study

Edison Pharmaceuticals today announced the initiation of a phase 2B study entitled, "Safety and Efficacy Study of EPI-743 on Visual Function in Patients with Friedreich's Ataxia."

7 Jan 2013

arGEN-X commences ARGX-110 Phase Ib trial to treat cancer

arGEN-X, a biopharmaceutical company specialized in the discovery and development of highly differentiated human monoclonal antibody therapeutics, announced today the initiation of a Phase Ib first-in-man cancer study with ARGX-110, its first SIMPLE Antibody program to enter the clinic in just three years from initiation of discovery.

7 Jan 2013

Inovio, MVI collaborate to advance malaria vaccine development and new delivery technologies

The PATH Malaria Vaccine Initiative (MVI) and Inovio Pharmaceuticals, Inc. today announced a follow-on collaboration to advance malaria vaccine development and new vaccination delivery technologies.

7 Jan 2013

Rhythm commences RM-493 Phase 2 trial in obesity

Rhythm announced today the initiation of a Phase 2 clinical trial with RM-493, the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of obesity.

7 Jan 2013

Top-line results from Biogen Idec’s dexpramipexole Phase 3 trial on amyotrophic lateral sclerosis

Today Biogen Idec reported top-line results of EMPOWER, a Phase 3 trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS).

3 Jan 2013

Pfizer, Repligen sign licensing deal to advance spinal muscular atrophy program

Repligen Corporation announced today that it has entered into an exclusive worldwide licensing agreement with Pfizer Inc. to advance Repligen's spinal muscular atrophy (SMA) program, originally in-licensed from Families of SMA (FSMA).

3 Jan 2013

Celtaxsys commences CTX-4430 Phase 1 study to treat pulmonary inflammation

Celtaxsys, Inc., a private biopharmaceutical company developing a new class of drugs to treat chronic inflammatory disorders, today announced the initiation of a first-in-human Phase 1 clinical study of CTX-4430, which blocks the pro-inflammatory enzyme Leukotriene A4 Hydrolase (LTA4H).

3 Jan 2013

$Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer$

Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival.

3 Jan 2013

Kareus announces start of KU-046 Phase I study in Alzheimer's

Kareus Therapeutics SA, the private biotechnology company focused on the development of novel therapeutics for the unmet treatment of age-related and chronic diseases, today announces the start of a Phase I clinical study following the Investigational New Drug (IND) approval from the US Food and Drug Administration for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer's disease using Kareus' proprietary bioenergetics and KARLECT platforms.

3 Jan 2013

EPIRUS’ BOW-015 achieves bioequivalence to Remicade in a single dose comparator trial

EPIRUS Biopharmaceuticals, Inc., formerly known as fourteen22 Inc, announced that its lead asset, BOW-015, achieved bioequivalence to Remicade in a single dose comparator trial.

3 Jan 2013

Soligenix's OrbeShield granted FDA oral BDP orphan drug designation

Soligenix, Inc., a development stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

2 Jan 2013

Drug Trial News

CTI initiates enrollment in pacritinib Phase 3 trial for myelofibrosis

Lilly, Boehringer Ingelheim announce top-line results from empagliflozin Phase III trials on T2D

Oramed files IND with FDA to begin ORMD-0801 Phase 2 trial for type 2 diabetes

Sublingual immunotherapy can effectively treat peanut allergy

Beta blockers can reduce risk of Alzheimer's, other types of dementia

Esperion reports positive results from ETC-1002 Phase 2 clinical trial on type 2 diabetes

Spectrum Pharmaceuticals reveals positive RenaZorb Phase 1 clinical trial results

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Industry sponsored drug and device studies: an interview with Professor Lisa Bero

Edison Pharmaceuticals to commence EPI-743 phase 2B Friedreich's ataxia study

arGEN-X commences ARGX-110 Phase Ib trial to treat cancer

Inovio, MVI collaborate to advance malaria vaccine development and new delivery technologies

Rhythm commences RM-493 Phase 2 trial in obesity

Top-line results from Biogen Idec’s dexpramipexole Phase 3 trial on amyotrophic lateral sclerosis

Pfizer, Repligen sign licensing deal to advance spinal muscular atrophy program

Celtaxsys commences CTX-4430 Phase 1 study to treat pulmonary inflammation

Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer

Kareus announces start of KU-046 Phase I study in Alzheimer's

EPIRUS’ BOW-015 achieves bioequivalence to Remicade in a single dose comparator trial

Soligenix's OrbeShield granted FDA oral BDP orphan drug designation

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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