Constipation News and Research

Latest Constipation News and Research

NIH awards Avaxia Phase I SBIR grant to develop novel antibody therapeutic for celiac disease

Avaxia Biologics, Inc., a privately-held biotech company using its proprietary platform technology to develop orally-active antibody therapeutics for the treatment of gastrointestinal diseases, announced today that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH), to support the development of a novel antibody therapeutic for celiac disease.

11 Mar 2011

Oral magnesium oxide is a safe treatment for children with chronic constipation

Magnesium-containing cathartics are commonly used to treat chronic constipation. Although hypermagnesemia is a rare clinical condition, it can occur as a side effect of increased intake of magnesium salts.

9 Mar 2011

FDA approves change to prescribing information for Gilead Sciences' Letairis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved a change to the prescribing information for Letairis (ambrisentan 5 mg and 10 mg tablets), the company's once-daily treatment to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (PAH, WHO Group 1) patients with predominantly WHO Functional Class II-III symptoms.

5 Mar 2011

Eisai announces publication of Halaven Phase III study results against breast cancer in The Lancet journal

Eisai announced today that results from the global Phase III clinical study "EMBRACE" will be published online in The Lancet.

3 Mar 2011

ITI, Takeda collaborate to develop and commercialize PDE1 inhibitors for schizophrenia

Intra-Cellular Therapies, Inc. ("ITI") and Takeda Pharmaceutical Company Limited, today announced that they have entered into an exclusive collaboration to develop and commercialize selective phosphodiesterase type 1 (PDE1) inhibitors, discovered by ITI, for the treatment of cognitive impairment associated with schizophrenia. This agreement is targeted worldwide, but ITI has retained the option to co-promote with Takeda in the United States.

3 Mar 2011

Study: HT may affect symptom load and quality of life unrelated to hypothyroidism

Hashimoto's thyroiditis, an inflammatory disorder of the thyroid, is the most common cause of hypothyroidism, but a study has suggested that even when thyroid function is normal, HT may increase symptoms and decrease quality of life, as described in an article in Thyroid, a peer-reviewed journal published by Mary Ann Liebert, Inc.

27 Feb 2011

U.S.-Chile collaborate to study new long-acting local anesthetic derived from algae

A U.S.-Chile collaboration is bringing surgical patients closer to having a long-acting local anesthetic. In a randomized, double-blind trial, patients given neosaxitoxin, a new local anesthetic derived from algae, had significantly less postoperative pain and recovered about two days sooner than those given the commonly used local anesthetic bupivacaine.

25 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011

Genentech granted FDA hearing on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, today announced the U.S. Food and Drug Administration (FDA) has granted a hearing to allow the company the opportunity to present its views on why Avastin® (bevacizumab) should remain FDA-approved for metastatic breast cancer (mBC). The FDA has scheduled the hearing for June 28 to 29, 2011.

25 Feb 2011

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

Tranzyme Pharma and Norgine B.V., have initiated dosing of ulimorelin in the first of two, Phase 3 pivotal studies - ULISES. Ulimorelin is Tranzyme's intravenous promotility agent in development for the management of postoperative ileus in hospital and acute care settings.

23 Feb 2011

KemPharm commences KP201 Phase 1 trial for pain

KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers with KP201, its novel abuse deterrent prodrug of hydrocodone for pain. KP201 is a new chemical entity and is the most advanced opioid-based lead candidate in KemPharm's emerging pipeline.

22 Feb 2011

Positive preliminary data from ongoing PSMA ADC phase 1 study against prostate cancer

Progenics Pharmaceuticals, Inc. today reported positive preliminary data from an ongoing phase 1 study of PSMA ADC, an antibody-drug conjugate designed to selectively deliver chemotherapy to cells that express prostate-specific membrane antigen.

17 Feb 2011

Acorda reports fourth quarter net revenue of $133.1 million for full year ended December 31, 2010

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2010.

17 Feb 2011

State court jury rules in favor of Merck in FOSAMAX trial

Merck & Co., Inc. today said a state court jury in New Jersey found in its favor in the Rosenberg v. Merck case, rejecting the claims of a woman who blamed her dental and jaw related problems on her FOSAMAX use.

15 Feb 2011

FDA waives NDA filing fee for Antares' Anturol NDA

Antares Pharma, Inc. today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol® Gel for overactive bladder (OAB).

14 Feb 2011

Valeant Pharmaceuticals subsidiary acquires Canadian rights to Cholestagel

Valeant Pharmaceuticals International, Inc. today announced that its subsidiary, Biovail Laboratories International SRL, has acquired the Canadian rights to Cholestagel (colesevelam), an oral bile acid sequestrant for hypercholesterolemia, from Genzyme Corporation.

10 Feb 2011

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

Covidien, a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System (FTS) patch. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

10 Feb 2011

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group, announced today that OCEANS, a Phase III study evaluating Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary endpoint.

8 Feb 2011

Constipation News and Research

Latest Constipation News and Research

NIH awards Avaxia Phase I SBIR grant to develop novel antibody therapeutic for celiac disease

Oral magnesium oxide is a safe treatment for children with chronic constipation

FDA approves change to prescribing information for Gilead Sciences' Letairis

Eisai announces publication of Halaven Phase III study results against breast cancer in The Lancet journal

ITI, Takeda collaborate to develop and commercialize PDE1 inhibitors for schizophrenia

Study: HT may affect symptom load and quality of life unrelated to hypothyroidism

U.S.-Chile collaborate to study new long-acting local anesthetic derived from algae

AMAG fourth quarter total revenues increase to $17.2 million

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Genentech granted FDA hearing on Avastin for metastatic breast cancer

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

KemPharm commences KP201 Phase 1 trial for pain

Positive preliminary data from ongoing PSMA ADC phase 1 study against prostate cancer

Acorda reports fourth quarter net revenue of $133.1 million for full year ended December 31, 2010

State court jury rules in favor of Merck in FOSAMAX trial

FDA waives NDA filing fee for Antares' Anturol NDA

Valeant Pharmaceuticals subsidiary acquires Canadian rights to Cholestagel

Mallinckrodt receives FDA approval for Fentanyl Transdermal System patch ANDA

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

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Constipation News and Research

Latest Constipation News and Research

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