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Study explores how blood sugar levels during pregnancy influence children’s fat

Researchers from Manchester have begun a new study to determine whether blood sugar levels during pregnancy, lower than the level used to diagnose gestational diabetes, influences later levels of body fat in children and development of diabetes in mothers after giving birth.

16 Dec 2013

Data show that HCV genotype-1 infected patients may benefit from faldaprevir

Data show that Boehringer Ingelheim’s second-generation protease inhibitor faldaprevir, when used in combination with pegylated interferon and ribavirin, was effective even with the presence of naturally-occurring mutant variants of the hepatitis C virus, such as the NS3 Q80K polymorphism

16 Dec 2013

Janssen receives complete response letter for canagliflozin/metformin FDC therapy for type 2 diabetes

Janssen Research & Development, LLC (Janssen) today announced it has received from the U.S. Food and Drug Administration (FDA) a complete response letter regarding its New Drug Application (NDA) for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes.

16 Dec 2013

FDA accepts Shield Therapeutics' IND application to begin ST10 Phase 3 pivotal study for IDA treatment

Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces that the US Food and Drug Administration has accepted its Investigational New Drug application to initiate a Phase 3 pivotal study of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia in pre-dialysis patients with chronic kidney disease. The Company plans to initiate the Phase 3 study in the US in H1 2014 and positive data would be the cornerstone of a subsequent NDA submission.

16 Dec 2013

RT Oncology and Express Scripts enter into pharmaceutical drug distribution agreement

RT Oncology Services Corporation ("RainTree"), the nation's leading community oncology alliance, and Express Scripts (NASDAQ: ESRX), the nation's leading pharmacy benefit manager, today announced that they have entered into an exclusive, three-year pharmaceutical drug distribution agreement.

16 Dec 2013

Moberg announces positive results from phase ll study of MOB-015 for treatment of nail fungus

Moberg Pharma AB today announced positive interim results from its ongoing phase ll study of MOB-015. After six months of treatment with MOB-015, 40 per cent of the patients were mycologically cured and no safety concerns were identified.

13 Dec 2013

Protein in Salmonella inactivates mast cells that fight against bacteria

A protein in Salmonella inactivates mast cells -- critical players in the body's fight against bacteria and other pathogens -- rendering them unable to protect against bacterial spread in the body, according to researchers at Duke Medicine and Duke-National University of Singapore (Duke-NUS).

13 Dec 2013

Emergent BioSolutions enters into definitive agreement to acquire Cangene

Emergent BioSolutions Inc.announced that it has entered into a definitive agreement with Cangene Corporation (TSX: CNJ) under which Emergent will acquire all of the outstanding common shares of Cangene in an all-cash transaction valued at $3.24 per share on a fully diluted basis for an aggregate purchase price of $222 million.

12 Dec 2013

Crealta to acquire all assets of Savient Pharmaceuticals

Savient Pharmaceuticals, Inc. ("Savient") announced that it has reached agreement on the terms of an acquisition agreement with Crealta Pharmaceuticals LLC ("Crealta") through which Crealta would acquire substantially all of the assets of Savient, including all KRYSTEXXA® assets, for gross proceeds of approximately $120.4 million.

11 Dec 2013

Experimental compound reduces joint inflammation in animal models of rheumatoid arthritis

An experimental compound synthesized and developed by scientists from the Florida campus of The Scripps Research Institute has the capacity to significantly reduce joint inflammation in animal models of rheumatoid arthritis, an autoimmune disease that affects more than two million Americans.

11 Dec 2013

Pronai Therapeutics reports positive results from PNT2258 Phase II study on lymphoma

ProNAi Therapeutics, Inc., a leader in developing nucleic acid therapeutics, presented safety and efficacy data from its ongoing Phase II study yesterday at the 55th Annual Meeting of the American Society for Hematology (ASH) in New Orleans, Louisiana.

11 Dec 2013

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Pharmacyclics, Inc. today announced results of 40 clinical, non-clinical and pre-clinical presentations on ibrutinib (IMBRUVICA™) at the 55TH Annual meeting of the American Society of Hematology (ASH) held in New Orleans, Dec 7 - 10, 2013.

11 Dec 2013

Merck provides update on MK-8931 investigational oral therapy for Alzheimer’s disease

Merck, known as MSD outside the United States and Canada, today provided an update on the development program for MK-8931, a novel investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor.

11 Dec 2013

Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Genzyme, a Sanofi company, announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1.

11 Dec 2013

Acetylon Pharmaceuticals presents positive preclinical data for selective HDAC1/2 inhibitors at ASH meeting

Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, announced that positive preclinical data for its selective HDAC1/2 inhibitors for the treatment of sickle cell disease (SCD) and β-thalassemia (bT) were presented at the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.

11 Dec 2013

FoundationOne Heme identifies clinically actionable genomic alterations in multiple myeloma cases

Foundation Medicine today announced new data from a pilot study demonstrating that its fully informative genomic profile for hematologic malignancies, FoundationOne Heme, identified both novel and previously reported clinically actionable genomic alterations in multiple myeloma cases. These data were presented in an oral presentation titled Pilot Study To Evaluate The Prevalence Of Actionable Oncogenic Mutations In Patients With Relapsed Refractory Multiple Myeloma (abstract number 755) by Alexander Lesokhin, M.D., medical oncologist, Memorial Sloan-Kettering Cancer Center, at the 55th American Society of Hematology Annual Meeting in New Orleans.

10 Dec 2013

Takeda presents clinical study results of oral proteasome inhibitor MLN9708 in multiple myeloma patients

Takeda Pharmaceutical Company Limited today announced final Phase 1 and preliminary Phase 2 results of a study combining oral investigational MLN9708 administered twice a week with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma.

10 Dec 2013

Acetylon announces positive preclinical data of ricolinostat (ACY-1215) in models of lymphoma

Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, announced that positive preclinical data of selective HDAC6 inhibitor, ricolinostat (ACY-1215), in models of lymphoma were presented today in an oral presentation by Dr. Jennifer Amengual, Assistant Professor of Medicine & Experimental Therapeutics, Columbia University Medical Center.

10 Dec 2013

Study recommends cutting down on sweet additive to reduce tooth decay

A study by Newcastle University researchers into the effects of sugars on our oral health recommends cutting down on the sweet additive as part of a global initiative to reduce tooth decay.

10 Dec 2013

ImmunoGen presents Phase I trial results of SAR650984 at ASH annual meeting

ImmunoGen, Inc., a biotechnology company that develops targeted, antibody-based anticancer therapeutics, today announced the first clinical findings with SAR650984 reported in an oral presentation at the ASH annual meeting. The data are from an ongoing Phase I trial assessing this CD38-targeting therapeutic antibody in patients with CD38-positive MM or other hematologic malignancy.

10 Dec 2013

Oral News and Research

Study explores how blood sugar levels during pregnancy influence children’s fat

Data show that HCV genotype-1 infected patients may benefit from faldaprevir

Janssen receives complete response letter for canagliflozin/metformin FDC therapy for type 2 diabetes

FDA accepts Shield Therapeutics' IND application to begin ST10 Phase 3 pivotal study for IDA treatment

RT Oncology and Express Scripts enter into pharmaceutical drug distribution agreement

Moberg announces positive results from phase ll study of MOB-015 for treatment of nail fungus

Protein in Salmonella inactivates mast cells that fight against bacteria

Emergent BioSolutions enters into definitive agreement to acquire Cangene

Crealta to acquire all assets of Savient Pharmaceuticals

Experimental compound reduces joint inflammation in animal models of rheumatoid arthritis

Pronai Therapeutics reports positive results from PNT2258 Phase II study on lymphoma

Pharmacyclics presents ibrutinib trial data for B-cell malignancies at ASH meeting

Merck provides update on MK-8931 investigational oral therapy for Alzheimer’s disease

Genzyme granted Priority Review for Cerdelga investigational oral therapy for Gaucher disease

Acetylon Pharmaceuticals presents positive preclinical data for selective HDAC1/2 inhibitors at ASH meeting

FoundationOne Heme identifies clinically actionable genomic alterations in multiple myeloma cases

Takeda presents clinical study results of oral proteasome inhibitor MLN9708 in multiple myeloma patients

Acetylon announces positive preclinical data of ricolinostat (ACY-1215) in models of lymphoma

Study recommends cutting down on sweet additive to reduce tooth decay

ImmunoGen presents Phase I trial results of SAR650984 at ASH annual meeting

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