AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER
Aug 012013
 
The prevalence of diabetes is growing globally, and with that the size of the diabetes drug market. There are more than 370 million people in the world with diabetes, about 90% of those with Type 2 diabetes. More children are developing the disease and more people are dying from diabetes, and so more and more people need treatment. Standard & Poor’s has estimated the annual market will hit $58 billion by 2018, from about $35 billion today.Read more:

http://www.fiercepharma.com/special-reports/10-top-selling-diabetes-drugs-2012?page=0,0&utm_medium=nl&utm_source=internal

 

 

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FDA Lifts Clinical Hold on Canada company Cangene’s Hemophilia Compound

 companies  Comments Off on FDA Lifts Clinical Hold on Canada company Cangene’s Hemophilia Compound
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.

http://canadianprivateequity.com/cangene-closes-56-million-acquisition-of-inspirations-ib1001-hemophilia-b-product/2013/02/20/

 

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Perrigo Buying Elan For $8.6B

 companies  Comments Off on Perrigo Buying Elan For $8.6B
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

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Indian biopharma giant Biocon clocks revenue worth $121 mn

 companies, Uncategorized  Comments Off on Indian biopharma giant Biocon clocks revenue worth $121 mn
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

Biocon’s India-focused branded formulations vertical as well as research services continue to grow at a steady pace

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B Family Album -Structural Biology: First structures of class B G protein-coupled receptors may aid drug hunts

 Uncategorized  Comments Off on B Family Album -Structural Biology: First structures of class B G protein-coupled receptors may aid drug hunts
Jul 292013
 
Two new G-Protein Coupled Receptor structures, the glucagon receptor (computer model with extracellular domain) and corticotropin-releasing factor receptor, showing their location on the GPCR family tree.

A computer model of a full-length glucagon receptor (left) and a crystal structure of a corticotropin-releasing factor receptor (right) add details of class B receptors to the class A structures already on the GPCR family tree.
Credit: Katya Kadyshevskaya
As many as 30% of drugs on the market target G protein-coupled receptors (GPCRs), a family of signaling conduits that snake back and forth across cell membranes. But there are several classes of these proteins, and scientists’ knowledge of the structures is almost entirely restricted to just one, the class A subtype. So drugs could be missing a lot of targets. Aim could improve, however, now that researchers have the first two reports of class B GPCR structures (Nature 2013, DOI: 10.1038/nature12357 and10.1038/nature12393
read all at
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AstraZeneca: FDA-RESUBMISSION OF THE NDA FOR DAPAGLIFLOZIN FOR THE TREATMENT OF TYPE 2 DIABETES

 Uncategorized  Comments Off on AstraZeneca: FDA-RESUBMISSION OF THE NDA FOR DAPAGLIFLOZIN FOR THE TREATMENT OF TYPE 2 DIABETES
Jul 272013
 

File:Dapagliflozin structure.svg

DAPAGLIFLOZIN

AstraZeneca and Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act goal date of January 11 2014.

The dapagliflozin Phase II/III clinical development program included more than 12,000 adult patients with diabetes (more than 8,000 patients received dapagliflozin) in 26 clinical trials. In response to the FDA’s January 2012 complete response letter requesting additional data to allow a better assessment of the benefit-risk profile of dapagliflozin, the NDA resubmission includes several new studies and additional long-term data (up to four years’ duration) from previously submitted studies, resulting in an overall increase in patient-years exposure to dapagliflozin of more than 50 percent.

Dapagliflozin, an investigational compound, is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently of insulin. It is currently approved for the treatment of type 2diabetes in the European Union, Australia, Brazil, Mexico and New Zealand

READ ALL AT

http://www.swedishwire.com/press-releases/17843-astrazeneca-fda-acknowledges-receipt-of-resubmission-of-the-new-drug-application-for-investigational-compound-dapagliflozin-for-the-treatment-of-type-2-diabetes

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