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FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, today announced the filing of a New Drug Application with the U.S. Food and Drug Administration for Anturol Gel in patients with overactive bladder.

22 Dec 2010

Ketamine tried on college students in experiments sparks outrage

Department of Psychiatry at Cambridge University designed experiments to investigate treatment methods for schizophrenia. Like schizophrenics who sometimes believe that external objects have become part of their body, injection of ketamine – an anesthetic agent also produces similar feelings. Ketamine is a hallucinogenic drug.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

BioCryst Pharmaceuticals, Inc. announced the initiation of a Phase 2b study of BCX4208 as add-on therapy in gout patients who have not responded to allopurinol therapy alone.

22 Dec 2010

Maternal prenatal supplements boost child's intellectual and motor function

In an area where iron deficiency is prevalent, children of mothers in rural Nepal who received prenatal iron, folic acid and vitamin A supplementation performed better on measures of intellectual and motor functioning compared to offspring of mothers who received vitamin A alone, according to a study in the December 22/29 issue of JAMA.

22 Dec 2010

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

Echinacea may have minimal impact in relieving common cold

An over-the-counter herbal treatment believed to have medicinal benefits has minimal impact in relieving the common cold, according to research by the University of Wisconsin-Madison School of Medicine and Public Health.

21 Dec 2010

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

Ambit Biosciences, today announced that it has initiated separate Phase I trials for two products AC430, a selective Janus Kinase 2 (JAK2) inhibitor, and AC480, a pan-HER inhibitor.

20 Dec 2010

Fibrocell Science submits response to FDA CR letter for azficel-T BLA

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted its complete response to the Complete Response (CR) letter issued by the U.S. Food & Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles.

20 Dec 2010

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

Icagen, Inc. today provided an update on its sodium channel program for pain and related disorders, which is being conducted in collaboration with Pfizer. As previously reported, the companies recently selected a candidate compound to advance into further clinical studies. Dosing of this candidate compound has now been initiated in a Phase I study in healthy volunteers.

20 Dec 2010

Exciting progress made in MS research during 2010

Exciting advances were made in 2010 in virtually every field of MS research. Progress toward finding new therapies for MS is illustrated by the availability of the first oral disease-modifying therapy for MS. Progress was also made toward finding ways to restore function and improving quality of life and specific MS symptoms through exercise, meditation, rehabilitation and medications, including the first therapy specifically approved to treat a symptom of MS (Ampyra).

20 Dec 2010

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Inspire Pharmaceuticals, Inc. announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.

20 Dec 2010

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

20 Dec 2010

CF patients with normal to mildly impaired lung function may benefit from new investigational drug

Cystic fibrosis patients with normal to mildly impaired lung function may benefit from a new investigational drug designed to help prevent formation of the sticky mucus that is a hallmark of the disease, according to researchers involved in a phase 3 clinical trial of the drug.

19 Dec 2010

Goji berries' components are available in fruits and vegetables

A University of Granada professor specialist in Nutrition explained that the species Lycium Barbarum -currently imported from China- comes from the Mediterranean regions and grows in other mild regions of the world. Also, he stated that "Goji berries will not have any positive effect on people that do not follow a balanced diet".

17 Dec 2010

Viron's Phase 2a trial for VT-111 meets primary, secondary endpoints in ACS patients

Viron Therapeutics Inc. today announced that the results of Viron's Phase 2a trial for VT-111 were published today in Circulation: Cardiovascular Interventions. In the study led by Dr. Jean-Claude Tardif, Director of the Research Centre at the Montreal Heart Institute, VT-111, also known as Serp-1, met both its primary and secondary endpoints of safety and biological activity in Acute Coronary Syndrome patients receiving coronary stents.

17 Dec 2010

New study suggests PSA test effective for men with prostate cancer

The PSA screening test for prostate cancer is not perfect. It can indicate cancer when none is present and miss life-threatening tumors. But a new study suggests the test is more reliable in men taking dutasteride (Avodart®), a drug widely prescribed to shrink an enlarged prostate gland.

17 Dec 2010

Researchers begin placebo-controlled trial to test drug treatment for Rett syndrome

Researchers at Children's Hospital Boston have begun a randomized, placebo-controlled trial to test a potential drug treatment for Rett syndrome, the leading known genetic cause of autism in girls.

16 Dec 2010

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Manhattan Pharmaceuticals, Inc. announced preliminary results today from a Phase 1/2 study of AST-915 for the treatment of essential tremor. Data from this single dose study demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power.

16 Dec 2010

Placebo News and Research

FDA approves Watson's novel oral contraceptive

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Ketamine tried on college students in experiments sparks outrage

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

BioCryst commences BCX4208/allopurinol combination Phase 2b study in gout patients

Maternal prenatal supplements boost child's intellectual and motor function

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Echinacea may have minimal impact in relieving common cold

Ambit commences Phase I advanced solid tumor trials for AC430 and AC480 inhibitors

Fibrocell Science submits response to FDA CR letter for azficel-T BLA

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

Exciting progress made in MS research during 2010

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

CF patients with normal to mildly impaired lung function may benefit from new investigational drug

Goji berries' components are available in fruits and vegetables

Viron's Phase 2a trial for VT-111 meets primary, secondary endpoints in ACS patients

New study suggests PSA test effective for men with prostate cancer

Researchers begin placebo-controlled trial to test drug treatment for Rett syndrome

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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