AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

HOW ICH IS CHANGING DRUG DEVELOPMENT,REG STARTING MATERIALS AND BIG IDEAS

 drugs  Comments Off on HOW ICH IS CHANGING DRUG DEVELOPMENT,REG STARTING MATERIALS AND BIG IDEAS
Jun 212013
 

 

The desire for a dramatic increase in process understanding over
the past eight years has left industry leaders and Global Health
Agencies searching for a more relevant model for developing process and
drug substance understanding. Most recently, the Internationa l Conference on
Harmonization (ICH) has been drafting the ICH guideline q11 on the development and manufacture of drug substances, which takes a considerable step forward, offering sponsors greater flexibility in the definition and selection of Regulatory Starting Materials (RSM).

http://www.triphasepharmasolutions.com/Regulatory%20API%20Starting%20Materials%20Article.pdf

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EMA clears Roche’s polyarticular juvenile idiopathic arthritis drug

 EMA  Comments Off on EMA clears Roche’s polyarticular juvenile idiopathic arthritis drug
Jun 212013
 
EMA clears Roche’s polyarticular juvenile idiopathic arthritis drug
The European Medicines Agency has cleared Roche’s RoACTEMRA for the treatment of a rare form of arthritis, polyarticular juvenile idiopathic arthritis (PJIA), in children aged two years and above…

read all at

http://regulatoryaffairs.pharmaceutical-business-review.com/news/ema-clears-roches-polyarticular-juvenile-idiopathic-arthritis-drug-120613
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Japanese MHLW clears Roche’s Avastin as glioblastoma therapy

 Uncategorized  Comments Off on Japanese MHLW clears Roche’s Avastin as glioblastoma therapy
Jun 212013
 
Japanese MHLW clears Roche’s Avastin as glioblastoma therapy
The Japanese Ministry of Health, Labour and Welfare (MHLW) has cleared Roche’s Avastin (bevacizumab) as a combination therapy and monotherapy to treat the aggressive form of brain cancer glioblastoma…

read all at

http://regulatoryaffairs.pharmaceutical-business-review.com/news/japanese-mhlw-clears-roches-avastin-as-glioblastoma-therapy-170613

 
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Amgen In Focus

 companies, phase 1, phase 2, Phase 3 drug, Uncategorized  1 Response »
Jun 202013
 

Amgen In Focus
Seeking Alpha
According to Amgen, they have 45 drugs in development from Phase 1 to Phase 3. Conversely, Gilead has 32 drugs in development and Pfizer has 64. Meanwhile, Gilead only has 8 drugs in Phase 3, Pfizer has 25, and Amgen has 14. 7 of those Phase 3 …

http://seekingalpha.com/article/1510002-amgen-in-focus?source=google_news

Amgen has the second deepest pipeline of drugs of the three large cap biotechs. According to Amgen, they have 45 drugs in development from Phase 1 to Phase 3. Conversely, Gilead has 32 drugs in development and Pfizer has 64. Meanwhile, Gilead only has 8 drugs in Phase 3, Pfizer has 25, and Amgen has 14. 7 of those Phase 3 drugs are focused on cancer treatments for Amgen, more than either Pfizer or Gilead. Keep in mind that 12.4 million people learn they have cancer each year, while 7.6 million people lose that battle each year. The CDC predicts that the global number of cancer related deaths will increase by 80% by 2030. It doesn’t take a rocket scientist to know that cancer treating drugs presents the largest opportunity for any drug maker considering those statistics. Amgen has the inside track versus Gilead and Pfizer as far as quantity of drugs in late stage development.

 

Pipeline

This information is current as of February 11, 2013. Amgen’s product pipeline will change over time as molecules move through the drug development process, including progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most recent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is providing this information as of the date above and does not undertake any obligation to update any forward-looking statements contained in this table as a result of new information, future events or otherwise.


Phase 1
Cancer Immunotherapy
Various cancer types
AMG 110 is an anti-EpCAM (epithelial cell adhesion molecule) x anti-CD3 (BiTE®) bispecific antibody. It is being investigated as a cancer treatment.
Antibody
Inflammatory diseases
AMG 139 is a human monoclonal antibody. It is being investigated as a treatment for Crohn’s disease. AMG 139 is being jointly developed in collaboration with AstraZeneca.
Antibody
Asthma
AMG 157 is a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP). It is being investigated as a treatment for asthma. AMG 157 is being jointly developed in collaboration with AstraZeneca.
Antibody
Bone-related conditions
AMG 167 is a humanized monoclonal antibody that inhibits the action of sclerostin. AMG 167 is being developed in collaboration with UCB for bone-related conditions.
Other
Modality
Various cancer types
AMG 172 is a human anti-CD27L antibody drug conjugate. It is being investigated as a cancer treatment.
Oral/Small Molecule
Various cancer types
AMG 208 is a small molecule inhibitor of MET. It is being investigated as a cancer treatment.
Oral/Small Molecule
Various cancer types
AMG 232 is a small molecule. It is being investigated as a cancer treatment.
Oral/Small Molecule
Hematologic malignancies
AMG 319 is a small molecule inhibitor of PI3 Kinase delta. It is being investigated as a cancer treatment.
Antibody
Migraine
AMG 334 is a human monoclonal antibody that inhibits the receptor for Calcitonin Gene-Related Peptide (CGRP). It is being investigated for the prevention of migraine.
Oral/Small Molecule
Various cancer types
AMG 337 is a small molecule inhibitor of MET. It is being investigated as a cancer treatment.
Oral/Small Molecule
Autoimmune diseases
AMG 357 is a small molecule. It is being investigated as a treatment for autoimmune diseases.
Antibody
Systemic lupus erythematosus
AMG 557 is a human monoclonal antibody that inhibits the action of B7 related protein (B7RP-1). It is being investigated as a treatment for systemic lupus erythematosus. AMG 557 is being jointly developed in collaboration with AstraZeneca.
Other
Modality
Glioblastoma
AMG 595 is a human anti-EGFRvIII (epidermal growth factor receptor) antibody drug conjugate. It is being investigated as a treatment for glioblastoma.
Antibody
Autoimmune diseases
AMG 729 is a humanized monoclonal antibody that targets CD19 and CD32b to inhibit B cell. It is being investigated as a treatment for systemic lupus erythematosus and rheumatoid arthritis.
Antibody
Various cancer types
AMG 780 is a human anti-angiopoietin antibody that inhibits the interaction between the endothelial cell-selective Tie2 receptor and its ligands Ang1 and Ang2. It is being investigated as a cancer treatment.
Antibody
Systemic lupus erythematosus
AMG 811 is a human monoclonal antibody that inhibits interferon gamma. It is being investigated as a treatment for systemic lupus erythematosus.
Antibody
Various cancer types
AMG 820 is a human monoclonal antibody that inhibits c-fms and decreases tumor associated macrophage (TAM) function. It is being investigated as a cancer treatment.
Protein/Peptibody
Type 2 diabetes
AMG 876 is a fusion protein. It is being investigated as a treatment for type 2 diabetes.
Oral/Small Molecule
Various cancer types
AMG 900 is a small molecule inhibitor of Aurora kinases A, B, and C. It is being investigated as a cancer treatment.

Phase 2
Oral/Small Molecule
Type 2 diabetes
AMG 151 is a small molecule glucokinase activator. It is being investigated as a treatment for type 2 diabetes.
Antibody
Inflammatory bowel disease
AMG 181 is a human monoclonal antibody that inhibits the action of alpha4/beta7. It is being investigated as a treatment for ulcerative colitis and Crohn’s disease. AMG 181 is being jointly developed in collaboration with AstraZeneca.
Other
Modality
Secondary hyperparathyroidism in patients with chronic kidney disease receiving dialysis
AMG 416 is a peptide agonist of the human cell surface calcium-sensing receptor (CaSR). It is being investigated as a treatment for secondary hyperparathyroidism in patients with chronic kidney disease receiving dialysis.
Oral/Small Molecule
Schizophrenia
AMG 747 is a small molecule inhibitor of glycine transporter type-1 (GlyT-1). It is being investigated as a treatment for negative symptoms and cognitive deficits associated with schizophrenia.
Cancer Immunotherapy
Acute lymphoblastic leukemia
Blinatumumab is an anti-CD19 x anti-CD3 (BiTE®) bispecific antibody. It is being investigated as a cancer treatment.
Cancer Immunotherapy
Non-Hodgkin’s Lymphoma
Blinatumumab is an anti-CD19 x anti-CD3 (BiTE®) bispecific antibody. It is being investigated as a cancer treatment.
Antibody
Inflammatory diseases
Brodalumab is a human monoclonal antibody that inhibits the interleukin-17 receptor. It is being investigated as a treatment for a variety of inflammatory diseases. Brodalumab is being jointly developed in collaboration with AstraZeneca.
Oral/Small Molecule
Heart failure
Omecamtiv mecarbil is a small molecule activator of cardiac myosin. It is being investigated for the treatment of heart failure. We are developing this product in collaboration with Cytokinetics, Inc.
Antibody
Rheumatoid arthritis
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.
Protein/Peptibody
Various cancer types
Trebananib is a peptibody that inhibits the interaction between the endothelial cell-selective Tie2 receptor and its ligands Ang1 and Ang2. It is being investigated as a cancer treatment.
Antibody
Squamous cell head and neck cancer
Vectibix® is a human monoclonal antibody antagonist of the epidermal growth factor receptor (EGFr) pathway. It is being investigated as a cancer treatment.
Antibody
Giant cell tumor of the bone
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.
Antibody
Hypercalcemia of malignancy
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.

Phase 3
Antibody
Hyperlipidemia
AMG 145 is a human monoclonal antibody that inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9). It is being investigated as a treatment for hyperlipidemia.
Protein/Peptibody
Myelodysplastic syndromes
Aranesp® is a recombinant human protein agonist of the erythropoietin receptor.
Brodalumab is a human monoclonal antibody that inhibits the interleukin-17 receptor. It is being investigated as a treatment for a variety of inflammatory diseases. Brodalumab is being jointly developed in collaboration with AstraZeneca.
Antibody
Glucocorticoid-induced osteoporosis
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.
Antibody
Male osteoporosis (EU)
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.
Antibody
Gastric cancer
Rilotumumab is a human monoclonal antibody that inhibits the action of hepatocyte growth factor/scatter factor. It is being investigated as a cancer treatment.
Antibody
Postmenopausal osteoporosis
Romosozumab is a humanized monoclonal antibody that inhibits the action of sclerostin. It is being developed in collaboration with UCB for the treatment of postmenopausal osteoporosis.
Sensipar®/Mimpara® is an orally-administered small molecule that lowers parathyroid hormone (PTH) levels in blood by increasing sensitivity of the calcium-sensing receptor (CaSR) to extracellular calcium. It is being evaluated in post renal transplant patients.
Talimogene laherparepvec is an oncolytic immunotherapy derived from HSV-1. It is being investigated as a cancer treatment.
Protein/Peptibody
Ovarian cancer
Trebananib is a peptibody that inhibits the interaction between the endothelial cell-selective Tie2 receptor and its ligands Ang1 and Ang2. It is being investigated as a cancer treatment.
Antibody
First- and second-line colorectal cancer (U.S.)
Vectibix® is a human monoclonal antibody antagonist of the epidermal growth factor receptor (EGFr) pathway. It is being investigated as a cancer treatment.
Antibody
Cancer-related bone damage (skeletal-related events) in patients with multiple myeloma
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.
Antibody
Delay or prevention of bone metastases in breast cancer
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.
Antibody
Delay or prevention of bone metastases in prostate cancer (EU)
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range of conditions including osteoporosis, treatment-induced bone loss, rheumatoid arthritis and numerous tumor types across the spectrum of cancer-related bone diseases, including hypercalcemia of malignancy.

Phase 1 clinical trials investigate safety and proper dose ranges of a product candidate in a small number of human subjects.Phase 2 clinical trials investigate side effect profiles and efficacy of a product candidate in a large number of patients who have the disease or condition under study.Phase 3 clinical trials investigate the safety and efficacy of a product candidate in a large number of patients who have the disease or condition under study.

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London University discovers vital clue to how cancer spreads

 new drugs  Comments Off on London University discovers vital clue to how cancer spreads
Jun 182013
 
Cancer cell

Researchers at University College London have made a key discovery about how cancer spreads through the body, which could lead to drugs being developed to halt the process.

Scientists at the university carried out experiments on frog and zebrafish embryos and discovered a mechanism called ‘chase and run’ that showed how diseased and healthy cells follow each other around the body, reports The Telegraph.

http://www.pharmaceutical-technology.com/news/newslondon-university-discovers-vital-clue-to-how-cancer-spreads?WT.mc_id=DN_News

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Double strike against cancer

 cancer, drugs  Comments Off on Double strike against cancer
Jun 172013
 
Double strike against cancer
13.06.2013 – German researchers have found a way to circumvent chemotherapy resistance in cancer cells.

A new therapeutic approach can take advantage of cancer cells’ need to repair double-strand breaks in DNA, in order to overcome the tumour’s resistance to chemotherapy (Science Transl. Medicine). According to the research group headed by Hans Christian from University Cologne, mutations in the ATM gene protect cancer cells from cell death during chemotherapy. ATM  is instrumental in initiating DNA repair and inducing cell death when repair is not possible in curse of the so-called DNA damage response (DDR).  http://www.eurobiotechnews.eu/news/news/2013-02/double-strike-against-cancer.html

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ThromboGenics’ Jetrea receives NICE approval for eye condition treatment

 drugs  Comments Off on ThromboGenics’ Jetrea receives NICE approval for eye condition treatment
Jun 172013
 

http://drugdelivery.pharmaceutical-business-review.com/news/thrombogenics-jetrea-receives-nice-approval-for-eye-condition-treatment-130613

ThromboGenics’ Jetrea receives NICE approval for eye condition treatment 
Biopharmaceutical company ThromboGenics’ Jetrea has received approval from UK’s National Institute for Health and Care Excellence (NICE) in the treatment of some adults with vitreomacular traction (VMT), a rare eye condition…

Ocriplasmin (trade name Jetrea) is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface. It is used for treatment of symptomatic vitreomacular adhesion, for which it received FDA approval on 17 October 2012. It works by dissolving the proteins that link the vitreous to the macula, resulting in posterior detachment of the vitreous from theretina.[1]

  1. Stalmans, P; Benz, MS; Gandorfer, A; Kampik, A; Girach, A; Pakola, S; Haller, JA; MIVI-TRUST Study, Group (2012 Aug 16). “Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes.”. The New England journal of medicine 367 (7): 606–15.PMID 22894573.
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Elucidating Heterocyclic Chemistry in Pharmaceuticals

 Uncategorized  Comments Off on Elucidating Heterocyclic Chemistry in Pharmaceuticals
Jun 162013
 

Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.

http://www.pharmtech.com/pharmtech/Ingredients+Insider/Elucidating-Heterocyclic-Chemistry-in-Pharmaceutic/ArticleStandard/Article/detail/814894?contextCategoryId=43497

jun 2, 2013
By: Patricia Van Arnum
Pharmaceutical Technology


Patricia Van Arnum

Heterocyclic compounds play an important role in medicinal chemistry and drug synthesis. Like any important functional class of compounds, developments that facilitate their production or elucidate their reaction mechanisms are significant for process chemists in the pharmaceutical industry. In two separate developments, researchers at The Scripps Research Institute (TSRI) in La Jolla, California recently reported on the use of zinc sulfinates as reagents for the direct chemical functionalization of nitrogen-based heterocycles and on reaction-tracking tools to better elucidate copper-catalyzed reactions in making triazoles.

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Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP)

 drugs  Comments Off on Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP)
Jun 142013
 

solithromycin

(3aS,4R,7S,9R,10R,11R,13R,15R,15aR)-1-[4-[4-(3-aminophenyl)-1H-1,2,3-triazol-1-yl]butyl]-4-ethyl-7-fluorooctahydro-11-methoxy-3a,7,9,11,13,15-hexamethyl-10-{[3,4,6-trideoxy-3-(dimethylamino)-β-D–xylo-hexopyranosyl]oxy}-2H-Oxacyclotetradecino[4,3-d]oxazole-2,6,8,14(1H,7H,9H)-tetrone

 
Legal status Phase III clinical trials, North America, South America, Europe
Routes oral, intravenous
Identifiers
CAS number 760981-83-7 
 

Cempra Provides Guidance on the Clinical Program Required for Regulatory …
The Herald | HeraldOnline.com
The Phase 3 solithromycin clinical program in CABP will be planned to consist of an oral trial and an intravenous (IV)-to-oral clinical trial. Cempra followed the CABP guidance that the FDA proposed in a November, 2011, meeting of the Anti-Infective …

READ ALL AT

http://www.heraldonline.com/2013/06/13/4944834/cempra-provides-guidance-on-the.html

 

Solithromycin (formerly known as CEM-101 and OP-1068) is a novel ketolide antibiotic undergoing clinical development for the treatment of community-acquired pneumonia (CAP) and other infections.It is expected to be the first macrolide antibiotic available in intravenous, oral, and pediatric suspension formulations in over 20 years.

Solithromycin exhibits excellent in vitro activity against a broad spectrum of Gram-positive respiratory tract pathogens, including macrolide-resistant strains. Solithromycin has activity against a wide variety of pathogens, and further research is being conducted for other infections.

  • September 2011 : Encouraging results from the phase 2 clinical trial versus levofloxacin were reported.
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