American Oriental Bioengineering to Initiate a Phase One Clinical Trial in the United States of AOBO-001 Oral Capsule
... a phase one clinical
trial of AOBO-001, an oral
capsule developed from traditional Chinese ... currently manufactures and markets the oral
capsule in China under
the Cease Enuresis Oral
capsule brand, which was approved by China's State
Food ...
Cytopia Concludes Phase I Oral Trial for Vascular-Disrupting Agent, CYT997
... (DLTs) for the agent when administered orally in
capsule form every two weeks to patients with a diverse ... CYT997 given as an oral
capsule every two
... CYT997 given as an oral
capsule dose.
...
Mayo Clinic Finds Capsule Endoscopy Can Detect Intestinal Damage Caused by Celiac Disease
... -- Mayo Clinic
researchers have found that
capsule endoscopy can provide a magnified view
of the ... and a gastroenterologist at Mayo Clinic.
The
capsule is approximately the size of a large vitamin, and ... hours to
move through the small intestine. As the
capsule moves through the
digestive tract, images ...
Oramed Pharmaceuticals Announces Launch of Phase 2B Clinical Trials in South Africa of its Oral Insulin Capsule
... to evaluate the safety,
tolerability and efficacy of its oral insulin
capsule ORMD-0801. OnQ
Consulting, a clinical research organization (CRO) located ... through its
patented flagship product, an orally ingestible insulin
capsule currently in
phase 2 clinical trials. Established in 2006, Oramed's ...
Oramed Pharmaceuticals Commences Phase 2A Trials of its Oral Insulin Capsule on Type 1 Diabetics
... trial is focused on assessing the safety and efficacy
of its oral insulin
capsule on nine Type 1 diabetes patients.
The start of this clinical trial on ... serious adverse
events.
"The commencement of trials of our oral insulin
capsule on Type 1
diabetics signals another major step forward for our company in ...
Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing
... with results
previously presented with twice-daily dosing of the
capsule formulation in
the same study. All dosing regimens tested in the study ... tablet formulation, and patients receiving 400 mg twice
daily with the
capsule formulation, experienced a 1.8 - 1.9 log median
reduction in plasma viral ...
Anti-Cancer Drug CYT997 Update
... intravenous administration -- continued dose-escalation in its Phase I
capsule dosing study (oral administration)
Phase II clinical programs
1. ... and clinical activities.
Phase I clinical program
1. Phase I
capsule clinical study
Cytopia has continued to accelerate dose-escalation in ...
Neurocrine Biosciences Reports Fourth Quarter and Year-End 2007 Results
... address issues and or requests set forth in the
December 12, 2007 indiplon
capsule action letter from the FDA in a timely
manner if at all; risk that the ... address issues
and or requests set forth in the December 12, 2007 indiplon
capsule action
letter from the FDA in a manner acceptable to the FDA if at all; ...
Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
... AEROLIZER should not be used to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Do not use more than one
capsule twice daily. FORADIL AEROLIZER should be used with caution in patients with cardiovascular disorders. FORADIL AEROLIZER is not a substitute for ...
Oramed Pharmaceuticals to Present at the 8th National Life Science & Technology Week ILSI -BIOMED Conference, Israel 2009
... via injection.
Oramed is seeking to revolutionize the treatment of diabetes through its
patented flagship product, an orally ingestible insulin
capsule currently in
phase 2 clinical trials. Established in 2006, Oramed's technology is based on
over 25 years of research by top research scientists at ...
PROTECT-1 Phase II/III Induction-Stage Results for ChemoCentryx's Traficet-EN(TM) Presented in Oral Session at DDW 2009 Conference
... gastrointestinal system.
About Traficet-EN(TM) (CCX282-B)
Traficet-EN is a small molecule, orally-available drug that is administered in
capsule form and which is believed to control the inappropriate immune system response underlying inflammatory bowel disease (IBD) by blocking the CCR9 ...
BIOCOM's 4th Annual DeviceFest Honors Companies
... to provide a unique safety solution to prevent accidental needlestick injuries. "The Far Out" award went to CVAC Systems, Inc for its unique
capsule device focused on the application of its Cyclic Variations in Altitude Conditioning process to treat diseases and disorders associated with aging, ...
New Study Shows Probiotic Strain Effective in Boosting Immune Response to Flu Virus
... increases in T-cell production of TNF-alpha, a key immune marker, versus control upon exposure to influenza A in healthy adults who consumed a daily
capsule of Bacillus coagulans GBI-30, PTA-6086 for 30 days. While many health professionals believe that probiotics can help people who have specific ...
Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)
... sample packs to clearly demonstrate the rapid relief and tolerability of RAPAFLO(TM)."
The product label provides that one 8 mg RAPAFLO(TM)
capsule be taken once daily with a meal. Stocking efforts have ensured the product will be available immediately by prescription at retail pharmacies ...
B. Braun Medical Inc. to Demonstrate Infusion Systems Technologies at HIMSS 2009 Interoperability Showcase
... and Outlook(R) Safety Infusion Systems using two-way communication with numerous vendors including Cerner, GE Centricity, Draeger, Philips,
capsule and more.
"We look forward to the opportunity to interact with other healthcare professionals and demonstrate our solutions in the kind of ...
Oramed Pharmaceuticals to Present Oral Insulin Phase 2A Trial Results at the Upcoming Annual Meeting of the ADA (June 5-9, New Orleans, LA)
... with our colleagues," said Nadav Kidron, Oramed CEO. "As we
indicated at the completion of the study, the trial demonstrated that the
oral insulin
capsule had a good safety profile and was well tolerated and
effective in lowering blood glucose levels in patients with type 2 diabetes."
Oramed's ...
ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
... However, OGD proposes without explanation that a Q1Q2 standard developed for oral solutions will nonetheless apply to Vancocin, an oral
capsule product. Then, OGD backs off the sameness supposedly ensured by the Q1Q2 standard, and permits generic applicants to vary their inactive ingredients ...
Harvard Study Shows Folic Acid, B Vitamins in Animi-3(R) May Prevent Vision Loss
... B6, B12, and folic acid, can address deficiencies in these nutrients associated with eye problems, including dry eye and macular health."
Each
capsule of Animi-3 contains 500 mg of omega-3, (350 mg of DHA), 200 mg of phytosterols, 1 mg of folic acid, 12.5 mg of B6, and 12 mcg of B12.
More ...
Oramed Pharmaceuticals Completes Proof of Concept Study of Insulin Suppository
... via injection.
Oramed is seeking to revolutionize the treatment of diabetes through its
patented flagship product, an orally ingestible insulin
capsule currently in
phase 2 clinical trials. Established in 2006, Oramed's technology is based on
over 25 years of research by top research scientists at ...
US Testing Proves Glyc'n Go(TM) Increases NO in the Blood Stream
... of muscle tissue damage due to lactic acid build up.
Glyc'n Go(TM) delivers more pure GlycoCarn(R) per serving than any other GPLC tablet or
capsule on the market today. Glyc'n Go(TM) is the only chewable form of GlycoCarn(R) and has been proven to dissolve 26% faster than tablets, enabling the ...
CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
...
TEMODAR Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the
capsule contents to avoid inhalation or contact with the skin or mucous membranes.
The effectiveness of TEMODAR in children has not been ...
Durezol(TM) in the Treatment of Uveitis and Ganciclovir in the Treatment of Herpetic Keratitis: Studies of Treatments for Leading Causes of Blindness to Be Presented
... in 5-15% of subjects in clinical
studies with Durezol included corneal edema, ciliary and conjunctival
hyperemia, eye pain, photophobia, posterior
capsule opacification, anterior
chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
Other ocular adverse reactions occurring in 1-5% ...
Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)
... in 5-15% of subjects in clinical
studies with Durezol included corneal edema, ciliary and conjunctival
hyperemia, eye pain, photophobia, posterior
capsule opacification, anterior
chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
Other ocular adverse reactions occurring in 1-5% ...
Video: Sirion Therapeutics Launches Durezol for Postoperative Ocular Inflammation and Pain
... in 5-15% of subjects in clinical
studies with Durezol included corneal edema, ciliary and conjunctival
hyperemia, eye pain, photophobia, posterior
capsule opacification, anterior
chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
Other ocular adverse reactions occurring in 1-5% ...
Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
... days. A total of 60 patients have been randomised for this
study.
The key objective of the study is to assess the clinical efficacy of an
oral
capsule formulation of iclaprim as step-down therapy in comparison
with IV vancomycin in the treatment of cSSSI. The primary endpoint is the
clinical cure ...
Oramed Pharmaceuticals Launches GLP1-Analog Program, Based on its Proprietary Drug Delivery Platform
... via injection. Oramed is
seeking to revolutionize the treatment of diabetes through its patented
flagship product, an orally ingestible insulin
capsule currently in phase 2
clinical trials. Established in 2006, Oramed's technology is based on over
25 years of research by top research scientists at ...
Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting
... ALO-01 capsules for priority review. The priority review status
provides for a review period of six months from the date of submission. The
ALO-01
capsule NDA was submitted on June 30, 2008.
In the United States, pain is a serious, undertreated public health
problem, with 19 percent of American adults ...
Cytopia Commences Second Phase II Study in Brain Cancer
... administered by mouth. Preliminary data from the company's
Phase I oral study indicates that the compound is well absorbed after
administration in
capsule form. This key finding differentiates CYT997 from
other vascular disrupting agents currently in development which can only be
administered ...
REMOXY(R) NDA Filing Accepted by FDA and Priority Review Granted
... for moderate-to-severe chronic pain.
About ORADUR(TM) Technology
ORADUR is a proprietary technology designed to transform short-acting
oral
capsule dosage forms into sustained release oral products, with the
added benefit of being less prone to abuse (e.g. by crushing or water
extraction) than ...
Scientists Reveal Roadmap to Brain Health That Can Be Passed Down to Future Generations: Exercise, Omega-3, Folic Acid, Vitamin B6, and Vitamin B12
... particular interest here is the effect addressing deficiencies
in DHA may have on brain health as well as the brains of future
generations."
Each
capsule of Animi-3 contains 500 mg of omega-3, (350 mg of DHA), 1
mg of folic acid, 12.5 mg of B6, and 12 mcg of B12. For more information,
visit ....
ChemoCentryx Completes Enrollment of PROTECT-1, a Phase II/III Clinical Trial of CCR9 Antagonist CCX282-B (Traficet-EN(TM)) in Crohn's Disease
... in
chemokine-based therapeutics."
About CCX282-B (Traficet-EN(TM))
Traficet-EN is a small molecule, orally-available drug that is
administered in
capsule form and which controls the inappropriate immune
system response underlying inflammatory bowel disease (IBD) by blocking the
CCR9 chemokine receptor. ...
Arpida Enrols First Patients in "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
... Infections (cSSSI). Enrolment remains on track for
completion in 2008.
The key objective of the study is to assess the clinical efficacy of an
oral
capsule formulation of iclaprim as step-down therapy in comparison
with a full course of intravenous (i.v.) treatment with vancomycin in the
treatment of ...
Treprostinil Data Presented at American Thoracic Society Conference Demonstrates Significant Clinical Progress in All Four Routes of Administration
... Doses in Patients with PAH, Dr. R. James White of the University of
Rochester presented data from a 12-patient study showing that a
sustained-release
capsule of treprostinil administered twice daily allowed
patients to maintain consistent therapeutic levels of treprostinil in their
bloodstreams in an ...
Alpharma Presents Data Addressing Abuse Liability Features, Safety and Efficacy on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) at the American Pain Society Annual Scientific Session
... an extended-release opioid, morphine sulfate,
with a sequestered core of naltrexone, an opioid antagonist, which is
designed to be released if the
capsule is tampered with by crushing,
chewing or dissolving, thereby significantly reducing the euphoric effect
of the opioid.
According to Phase I study ...
Pregnant Women Need Omega-3 to Boost Infant Development
... President Jack Schramm.
"The DHA in Animi-3 is all natural and purified to eliminate any
contaminants including those commonly found in fish."
Each
capsule of Animi-3 contains 500 mg of omega-3 acids, including 350
mg of DHA. For more information, visit http://www.animi-3.com .
*docosahexaenoic acid
...
InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
... HCV compounds of
different mechanisms of action.
In the Phase 1b study, four cohorts of treatment-nave patients
received ITMN-191 in a gelatin
capsule every 12 hours or every 8 hours with
food for a period of 14 days. In addition, a single cohort of
treatment-experienced chronic hepatitis C patients ...
Diagnostic Center for Disease: Prostate Biopsy Spreads Prostate Cancer Cells
... cancer cells
beyond the prostate when a biopsy is performed. An extensive review of the
literature confirms that once a needle penetrates the
capsule of an organ,
a phenomenon called "needle tracking" takes place. When the needle is
withdrawn from the targeted organ, the chance of spreading cancer ...
Cogentus Pharmaceuticals Begins Clinical Study to Confirm the Full Antiplatelet Benefit of New Combination Medicine CGT-2168
... dosing has begun in a clinical study to confirm
the full antiplatelet activity of its novel combination medicine CGT-2168.
CGT-2168 is a once-daily
capsule that combines clopidogrel (currently
marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix(R)) with
a gastroprotectant (omeprazole) to ...
Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout
... exposure-dependent reduction in serum uric acid (SUA). In the
dose group that resulted in the highest plasma drug levels (400 mg
modified-release
capsule twice daily), there was a 50.9% placebo-adjusted
reduction in SUA (p < 0.001). The following table summarizes the results by
dose group.
Effect ...
Phase 3 Data Show New Anti-TNF, Golimumab, Significantly Improved Arthritis, Skin and Nail Manifestations in Patients with Psoriatic Arthritis
... in enthesitis and dactylitis, two common disease
manifestations causing pain and swelling. Enthesitis, an inflammation of a
tendon, ligament or joint
capsule insertion to the bone and dactylitis, a
swelling of digits in the hands or feet, are estimated to affect more than
one-third of people with psoriatic ...