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DAPT shows positive outcomes following treatment with OrbusNeich's Genous Stent

Data from patients who are considered high-risk due to underlying clinical conditions and who cannot be treated with drug eluting stents and the accompanying requirement of long-term dual antiplatelet therapy showed positive safety and short- and long-term clinical outcomes following treatment with OrbusNeich's Genous Stent, according to a study published online in EuroIntervention.

11 Jan 2011

Pharmasset, Bristol-Myers Squibb collaborate for proof of concept study on chronic HCV

Bristol-Myers Squibb Company and Pharmasset announced today that the companies have entered into a clinical collaboration agreement to evaluate the utility of BMS-790052, Bristol-Myers Squibb's NS5A replication complex inhibitor, in combination with PSI-7977, Pharmasset's nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus.

11 Jan 2011

Pro-Pharmaceuticals to begin DAVANAT Phase III development program following FDA approval

Pro-Pharmaceuticals, the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that on December 17, 2010, Company representatives met with officials from the U.S. Food & Drug Administration to present its Phase III clinical development program for DAVANAT.

11 Jan 2011

NPS completes treatment phase in GATTEX Phase 3 registration study in short bowel syndrome

NPS Pharmaceuticals, Inc. a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of the 24-week treatment phase of the company's Phase 3 registration study of GATTEX® (teduglutide).

11 Jan 2011

LibiGel may be the first FDA approved product to treat HSDD in menopausal women

BioSante Pharmaceuticals, Inc., a pharmaceutical company developing products for the treatment of female sexual health, today announced results of a survey of over 100 Obstetrician/Gynecologists and Primary Care Physicians regarding the need for an FDA-approved drug to treat a form of Female Sexual Dysfunction (FSD) known as Hypoactive Sexual Desire Disorder (HSDD).

11 Jan 2011

Enobia Pharma completes ENB-0040 Phase II study in juveniles with hypophosphatasia

Enobia Pharma, today announced that it has successfully completed a Phase II study of ENB-0040, a bone targeted enzyme replacement therapy being investigated in juveniles with hypophosphatasia, a serious, rare metabolic bone disorder.

10 Jan 2011

Celator, Cephalon extend cancer research agreement

Celator Pharmaceuticals today announced that it has agreed with Cephalon, Inc. to extend an existing research agreement into the next phase of development. The research agreement provides for the utilization of Celator's proprietary technology in an ongoing drug development and life-cycle management program at Cephalon.

10 Jan 2011

Advanced Targeting Systems awarded $3 million NCI grant to advance SP-SAP clinical program

Advanced Pain Remedies, a subsidiary of Cato BioVentures, announces that a three million dollar grant has been received, to advance its lead development candidate, SP-SAP. Advanced Targeting Systems, the company that pioneered the targeting of specific cell types to manipulate them for the treatment of diseases, has been awarded a $3 million grant from the National Cancer Institute (NCI).

10 Jan 2011

Vicept reports positive data from V-101 Phase II clinical trial for Type I Rosacea

Vicept Therapeutics, Inc. announced positive study results from a Phase II clinical trial evaluating the dose-response relationship of four concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematotelangiectatic Rosacea). The results demonstrated a statistically significantrebound" or tachyphylaxis was observed.

10 Jan 2011

Adolor initiates second ADL5945 Phase 2 study in opioid-induced constipation

Adolor Corporation today announced that it is initiating a second Phase 2 study of ADL5945 in chronic non-cancer pain patients suffering from opioid-induced constipation (OIC).

10 Jan 2011

Sangamo completes enrollment in SB-509-901 Phase 2b clinical trial in diabetic neuropathy

Sangamo BioSciences, Inc. announced today that the company completed enrollment of its Phase 2b double-blind, placebo-controlled clinical trial (SB-509-901) in subjects with diabetic neuropathy (DN). The company expects to have efficacy data from this study in the second half of 2011. The company also plans to present the first human clinical data from its Phase 1 trials of SB-728-T in HIV/AIDS in the first quarter of 2011.

10 Jan 2011

Enzon to commence EZN-4176 Phase 1a/1b study in castration-resistant prostate cancer

Enzon Pharmaceuticals, Inc. today announced the Investigational New Drug (IND) approval by the US Food and Drug Administration (FDA) and plan to commence enrollment into a Phase 1a/1b study shortly. The study will evaluate the safety and tolerability of EZN-4176, the company's novel androgen receptor (AR) mRNA antagonist, for the treatment of patients with castration-resistant prostate cancer (CRPC).

10 Jan 2011

Oncolytics opens enrollment in REOLYSIN combination U.S. Phase I colorectal cancer study

Oncolytics Biotech Inc. announced today that a U.S. Phase I study of REOLYSIN® in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer (REO 022) is now open to enrollment. The principal investigator is Dr. Sanjay Goel of the Montefiore Medical Center at The Albert Einstein College of Medicine in New York.

10 Jan 2011

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. A pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer (MTC) and the company expects to release top-line phase 3 results in the first-half of 2011 and potentially file a New Drug Application (NDA) for the compound in the second-half of 2011.

10 Jan 2011

KYTHERA and Intendis initiate ATX-101 European Phase III studies for reduction of submental fat

KYTHERA Biopharmaceuticals, Inc. and Intendis, Bayer HealthCare's dermatology business, today announced the initiation of two European Phase III studies evaluating ATX-101, a first-in-class injectable adipolytic agent, for the reduction of localized fat under the chin (submental fat).

10 Jan 2011

Positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C virus

Inovio Pharmaceuticals, a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the publication of a scientific paper highlighting positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C viruses in the journal Vaccine.

10 Jan 2011

FDA, EMA accept boceprevir for expedited review

Merck, known as MSD outside the United States and Canada, announced today that regulatory applications for boceprevir, Merck's investigational oral hepatitis C virus (HCV) protease inhibitor, were submitted in 2010 and have been accepted for expedited review in both the U.S. and the European Union.

10 Jan 2011

Positive PK study results from ECLIPSE trial against cardiovascular disease

Omthera Pharmaceuticals, a privately-held emerging specialty pharmaceuticals company, today announced data from its ECLIPSE trial, designed to evaluate the bioavailability of Epanova™, the Company's lead compound for the treatment of very high triglycerides, in comparison to Lovaza®, the leading prescription Omega 3.

10 Jan 2011

Positive results form INX-189 Phase 1b trial against hepatitis C virus

Inhibitex, today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus.

10 Jan 2011

AFQ056 drug improves symptoms in Fragile X patients: Study

The first drug to treat the underlying disorder instead of the symptoms of Fragile X, the most common cause of inherited intellectual disability, shows some promise according to a new study published in the January issue of Science Translational Medicine.

9 Jan 2011

Drug Trial News

DAPT shows positive outcomes following treatment with OrbusNeich's Genous Stent

Pharmasset, Bristol-Myers Squibb collaborate for proof of concept study on chronic HCV

Pro-Pharmaceuticals to begin DAVANAT Phase III development program following FDA approval

NPS completes treatment phase in GATTEX Phase 3 registration study in short bowel syndrome

LibiGel may be the first FDA approved product to treat HSDD in menopausal women

Enobia Pharma completes ENB-0040 Phase II study in juveniles with hypophosphatasia

Celator, Cephalon extend cancer research agreement

Advanced Targeting Systems awarded $3 million NCI grant to advance SP-SAP clinical program

Vicept reports positive data from V-101 Phase II clinical trial for Type I Rosacea

Adolor initiates second ADL5945 Phase 2 study in opioid-induced constipation

Sangamo completes enrollment in SB-509-901 Phase 2b clinical trial in diabetic neuropathy

Enzon to commence EZN-4176 Phase 1a/1b study in castration-resistant prostate cancer

Oncolytics opens enrollment in REOLYSIN combination U.S. Phase I colorectal cancer study

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

KYTHERA and Intendis initiate ATX-101 European Phase III studies for reduction of submental fat

Positive preclinical results from Inovio's novel DNA vaccine targeting HIV Clade C virus

FDA, EMA accept boceprevir for expedited review

Positive PK study results from ECLIPSE trial against cardiovascular disease

Positive results form INX-189 Phase 1b trial against hepatitis C virus

AFQ056 drug improves symptoms in Fragile X patients: Study

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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