Articles Published in 2012

FDA approves Stendra for ED

Monday, April 30, 2012 03:45 PM

The FDA has approved Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S., according to biopharmaceutical company Vivus.

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Actelion's macitentan meets primary endpoint in phase III PAH study

Monday, April 30, 2012 12:10 PM

Switzerland-based Actelion Pharmaceuticals' initial analysis indicates that the pivotal, long-term phase III SERAPHIN study with macitentan, a novel dual endothelin receptor antagonist, has met its primary endpoint.

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Pharmanest initiates phase I SHACT trial

Monday, April 30, 2012 11:45 AM

Pharmanest, a Stockholm-based pharmaceutical company, has dosed its first patient has in an open label pharmacokinetic phase I study with its drug candidate SHACT, a product developed for pain relief in connection with intrauterine device (IUD) insertion.

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Mannkind grants Tolero worldwide rights to BTK inhibitors

Monday, April 30, 2012 09:34 AM

Tolero Pharmaceuticals, a Salt Lake City, Utah-based company focused on cancer, has been granted exclusive worldwide rights to develop and commercialize compounds from Valencia, Calif.-based MannKind’s novel BTK (Bruton’s tyrosine kinase) program, which are currently being developed for the treatment of hematological malignancies and inflammatory diseases.

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Astellas and Drais to develop Astellas compound through Telsar

Friday, April 27, 2012 02:13 PM

Astellas Pharma of Tokyo and Drais Pharmaceuticals of Bridgewater, N.J., have entered into a uniquely structured partnership to develop and commercialize an Astellas compound currently in phase IIa study.

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Novo Nordisk plans 15% expansion of U.S. work force

Friday, April 27, 2012 01:36 PM

Novo Nordisk, a global healthcare company headquartered in Denmark, is planning a nearly 15% expansion of its U.S. work force in 2012.

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Jazz to acquire EUSA Pharma for $650 million

Friday, April 27, 2012 01:21 PM

Jazz Pharmaceuticals has agreed to acquire EUSA Pharma, a privately-held, specialty pharmaceutical company with headquarters in the U.S. and U.K., for $650 million in cash and a potential $50 million milestone payable in cash based upon its lead product, Erwinaze, achieving a specified U.S. net sales target in 2013.

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Watson to acquire Actavis Group for $5.6 billion

Friday, April 27, 2012 01:02 PM

Watson Pharmaceuticals has decided to acquire privately held generics pharmaceutical company Actavis Group for an upfront payment of $5.6 billion. As a result, Watson will become the third largest global generics company with 2012 anticipated pro forma revenue of approximately $8 billion.

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Frontage to develop AtheroNova clinical trial supplies

Friday, April 27, 2012 11:59 AM

Frontage, a global CRO based in Ecton, Penn., has signed an agreement to develop clinical trial supplies with AtheroNova, a biotech company focused on R&D of compounds to regress atherosclerotic plaque.

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AstraZeneca’s CEO Brennan to retire

Friday, April 27, 2012 11:30 AM

Global biopharmaceutical company AstraZeneca has announced that CEO and board member David Brennan has decided to retire, effective June 1, 2012.

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CWWeekly

May 21

Parexel consultant testifies on FDA biosimilars guidance

Global Telecom Testing checks worldwide toll-free phone lines for multinational clinical trials

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CWWeekly

May

Newer sites most optimistic about the future
Investigative sites of all sizes, from part-time physician-run sites to large dedicated research centers, report a rebound in operating conditions, according to a new CenterWatch analysis, yet sites from each subgroup indicate they have concerns…

Risk-based monitoring slow to catch on with industry
It's estimated that the cost of physically sending monitors to all investigative sites at regular intervals, a model the industry itself developed and has adhered to for about a decade, eats up one-third to one-half of…

Eye On Millennium
Millennium, The Takeda Oncology Company, discovers and develops novel treatments applying world-class recombinant technology to a wide variety of oncology disease targets…

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