Bayer HealthCare Overview
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Sep 262013
DCGI asks Wockhardt, Ranbaxy to explain lapses
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Sep 022013
Indian drug makers Ranbaxy and Wockhardt have been issued a letter by the DCGI to explain deficiencies found at the company’s manufacturing units
Following an import alert by the US FDA, Indian drug maker Wockhardt has now been asked to explain the lapses at the company’s Aurangabad based manufacturing unit that was pulled up by the US drug regulator earlier this year Indian drug makers Ranbaxy and Wockhardt have been issued a letter by the DCGI to explain deficiencies found at the company’s manufacturing units
The Indian Drug Controller General of India (DCGI) has written a letter to the drug maker Wockhardt to explain the deficiencies found at its Aurangabad manufacturing unit. The FDA had issued an import alert to the drug maker earlier this year.
Read more at: http://www.biospectrumasia.com/biospectrum/regulatory/194552/dcgi-wockhardt-ranbaxy-explain-lapses#.UiQ6X6I3CSo
Vibativ Back on the Market
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Aug 162013
Theravance Inc. said Wednesday it is antibiotic Vibativ is now back on the market. Vibativ was approved as a treatment for complex skin infections in 2010, and it was approved for use against hospital-acquired pneumonia in June 2013. It is Theravance’s only approved drug.
read all at
http://www.dddmag.com/news/2013/08/vibativ-back-market?et_cid=3425506&et_rid=523035093&type=cta
Aug 072013
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A five-year agreement between Roche and Unitaid’s Medicines Patent Pool (MPP) will make more antiviral drugs available at knock-down prices in developing countries.
Roche has agreed to supply Valcyte (valganciclovir) at a discount of up to 90% in 138 designated countries, to treat patients with cytomegalovirus as a complication of HIV. The agreement also allows for third parties to license Roche’s valganciclovir patent and develop generic versions of the drug after one year of exclusive sales.
Firm will supply cheap drugs and allow generics in developing countries
Valganciclovir hydrochloride (Valcyte, manufactured by Hoffmann–La Roche (Roche), and also known as Cymeval, Valcyt, Valixa, Darilin, Rovalcyte, Patheon, and Syntex) is an antiviral medication used to treat cytomegalovirus infections. As the L-valyl ester of ganciclovir, it is actually a prodrug for ganciclovir. After oral administration, it is rapidly converted to ganciclovir by intestinal and hepatic esterases.
credit-chemdrug
FDA Lifts Clinical Hold on Canada company Cangene’s Hemophilia Compound
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Jul 312013
FDA lifts clinical hold on Cangene’s hemophilia compound IB1001
WINNIPEG, July 29, 2013 /CNW/ – Cangene Corporation (Cangene) today announces that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on clinical trials evaluating the safety and efficacy of IB1001, a recombinant Factor IX (rFIX) product being developed for the treatment and prevention of bleeding episodes with hemophilia B.
http://www.pharmalive.com/fda-lifts-clinical-hold-on-cangenes-hemophilia-compoun
IB1001 is an intravenous recombinant Factor IX (rFIX) being developed for the treatment and prevention of bleeding episodes in people with hemophilia B. The IB1001 development program includes a comprehensive set of pharmacokinetic, safety, and efficacy data from a Phase 3 clinical trial in people affected by hemophilia B, including a surgery sub-study.
A biologics license application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) in March 2012 and a Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMA) in October 2011.
In July 2012, IB1001 was put on a clinical hold by the FDA due to a higher than expected rate of host cell antibody development in people treated with IB1001.
Cangene Corporation (TSX: CNJ) has completed its previously announced acquisition of the worldwide rights to investigational hemophilia compound IB1001 (recombinant FIX), as well as Inspiration’s rights to two product candidates in pre-clinical development: IB1007 (recombinant FVIIa) and IB1008 (recombinant FVIII) from Ipsen (Euronext: IPN; ADR: IPSEY) and Inspiration Biopharmaceuticals, Inc., in connection with Inspiration’s bankruptcy proceedings.
The transaction was slated to close on February 15, 2013.
Pursuant to the terms of the agreement, Cangene will pay approximately US $5.9 million upfront and up to $50 million in potential additional commercial milestones as well net sales payments equivalent to tiered double-digit percentage of IB1001 annual net sales.
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amcrasto@gmail.com
Perrigo Buying Elan For $8.6B
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Jul 302013
U.S. drugmaker Perrigo agreed to buy Ireland’s Elan for $8.6 billion in a deal that should allow the rapidly growing company to reduce its tax bill and boost its royalty stream.
Perrigo Co. said it would pay Elan Corp.’s investors $6.25 per share in cash and $10.25 in Perrigo stock, an 11% premium over Elan’s closing price on July 26. Elan shares in Dublin surged 13% higher to 12.58 euros ($16.71), above Perrigo’s offer price, following news of the takeover.
http://www.dddmag.com/news/2013/07/perrigo-buying-elan-86b
Indian biopharma giant Biocon clocks revenue worth $121 mn
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Jul 302013
Kiran Mazumdar-Shaw, chairman and managing director, Biocon.
Indian biopharma giant Biocon reported healthy growth of 22 percent for Q1 FY14 riding on the back of an increased geographical footprint in the emerging markets
Bangalore: Indian biopharma giant Biocon reported healthy growth of 22 percent for Q1 FY14. The firm clocked revenues worth $121 million (Rs723 crore), EBITDA of $29.50 million (Rs175 crore); and profit after tax (PAT) of $15.80 million (Rs94 crore).
Read more at: http://www.biospectrumasia.com/biospectrum/news/192549/how-biocon-clock-revenue-worth-usd121-mn#.UfdqX6I3CSo
Biocon’s India-focused branded formulations vertical as well as research services continue to grow at a steady pace
Jun 202013
Amgen In Focus
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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
AMG 110 is an anti-EpCAM (epithelial cell adhesion molecule) x anti-CD3 (BiTE®) bispecific antibody. It is being investigated as a cancer treatment.
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.
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.
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.
AMG 172 is a human anti-CD27L antibody drug conjugate. It is being investigated as a cancer treatment.
AMG 208 is a small molecule inhibitor of MET. It is being investigated as a cancer treatment.
AMG 232 is a small molecule. It is being investigated as a cancer treatment.
AMG 319 is a small molecule inhibitor of PI3 Kinase delta. It is being investigated as a cancer treatment.
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.
AMG 337 is a small molecule inhibitor of MET. It is being investigated as a cancer treatment.
AMG 357 is a small molecule. It is being investigated as a treatment for autoimmune diseases.
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.
AMG 595 is a human anti-EGFRvIII (epidermal growth factor receptor) antibody drug conjugate. It is being investigated as a treatment for glioblastoma.
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.
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.
AMG 811 is a human monoclonal antibody that inhibits interferon gamma. It is being investigated as a treatment for systemic lupus erythematosus.
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.
AMG 876 is a fusion protein. It is being investigated as a treatment for type 2 diabetes.
AMG 900 is a small molecule inhibitor of Aurora kinases A, B, and C. It is being investigated as a cancer treatment.
Phase 2
AMG 151 is a small molecule glucokinase activator. It is being investigated as a treatment for type 2 diabetes.
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
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.
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.
Blinatumumab is an anti-CD19 x anti-CD3 (BiTE®) bispecific antibody. It is being investigated as a cancer treatment.
Blinatumumab is an anti-CD19 x anti-CD3 (BiTE®) bispecific antibody. It is being investigated as a cancer treatment.
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.
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.
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.
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.
Vectibix® is a human monoclonal antibody antagonist of the epidermal growth factor receptor (EGFr) pathway. It is being investigated as a cancer treatment.
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.
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
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.
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.
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.
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.
Rilotumumab is a human monoclonal antibody that inhibits the action of hepatocyte growth factor/scatter factor. It is being investigated as a cancer treatment.
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.
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.
Vectibix® is a human monoclonal antibody antagonist of the epidermal growth factor receptor (EGFr) pathway. It is being investigated as a cancer treatment.
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.
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.
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.
Novo buys Norway’s Xellia for $700 million
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May 222013
Novo A/S, the holding company of Denmark’s Novo Nordisk, has acquired Xellia Pharmaceuticals of Norway in a deal valued at $700 million.
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http://www.pharmatimes.com/Article/13-05-21/Novo_buys_Norway_s_Xellia_for_700_million.aspx