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Co-development guidance sets road map, but hurdles remain

Tuesday, January 18th, 2011

You have about a month left to weigh in publicly, if so moved, on FDAâ€™s new draft guidance on the co-development of drugs designed for use in combination therapy. Deadline for written comments is Valentineâ€™s Day. The agency, in its guidelines released before the holidays, acknowledged the need for a ...

Posted in FDA, cancer, clinical trials, drug discovery | No Comments »

Biosimilars picture has â€˜so many unknownsâ€™

Thursday, November 18th, 2010

I donâ€™t know about you, but I canâ€™t get enough biosimilars talk these days (thereâ€™s a sentence I thought I would never write). FDAâ€™s two-day hearing earlier this month featured many opinions, and though most didnâ€™t stray too far from party lines (hereâ€™s the official releases from BIO, PhRMA, GPhA, ...

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Long path for Prolia

Wednesday, June 2nd, 2010

Amgenâ€™s anticipated bone-strengthening drug, also known as denosumab, has notched approvals in Europe and the United States in the last five days, the latter almost two months ahead of schedule. A whirlwind week to say the least for Amgen, a company whose fate, fair or not, has been pegged largely on ...

Posted in Uncategorized | 1 Comment »

Hands-on training for SDTM conversion

Wednesday, March 10th, 2010

With FDA's adoption of a standardized data file format for clinical data submissions, clinical researchers need to know these new standards when collecting and preparing their clinical trial data for submission, since it is the only way that clinical data can be submitted. The ultimate purpose of using the Study ...

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Eyes on screen! Better biological tools sought

Wednesday, November 11th, 2009

If youâ€™re a technology company specializing in high throughput screening and characterization of protein-based drugs, chances are the FDA wants to hear from you. Just call it part of the agencyâ€™s fact-finding mission. With biotech pursuits rapidly becoming a go-to option in mainstream drug development, FDA, like most in the ...

Posted in Uncategorized, drug discovery, vaccines | No Comments »

More muscle needed for regulatory science …

Thursday, September 17th, 2009

Or all the billions of dollars poured into biomedical research and development in the U.S. wonâ€™t mean a thing. That was the prevailing message delivered yesterday by new FDA commissioner Margaret Hamburg during a candid keynote address at the Regulator Affairs Professionals Societyâ€™s annual conference in Philadelphia. â€œIn order to strengthen ...

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Regulatory minds meet in Philly

Tuesday, September 15th, 2009

Â The City of Brotherly Love is the site of this week's Regulatory Affairs Professionals Society'sÂ 2009 Annual Conference & Exhibition. With much change afoot these days at FDA and healthcare reform dominating the American consciousness (more on that later), it's no surprise the theme for this year's event is "Succeed in ...

Posted in Uncategorized, animals, cancer, clinical trials, vaccines | No Comments »

Big stage for diabetes hopeful

Friday, August 28th, 2009

Recent regulatory setbacks aside, Takeda Pharmaceutical Co. is plowing full steam ahead on its quest to win approval for the companyâ€™s key type 2 diabetes drug alogliptin, another potential entrant into the suddenly competitive field of DPP-4 inhibitors. The Japanese drug giant said today that it received the â€œall-clearâ€ from FDA ...

Posted in CRO, Uncategorized, clinical trials, diabetes, filed for approval | No Comments »

‘Milestone’ journey for anti-clotting agent

Thursday, July 16th, 2009

Since FDAâ€™s decision to green light long-awaited blood thinner entry Effient was announced late last week, there has been much talk on the financial front over just how big a threat the Eli Lilly and Daiichi Sankyo Co. drug, which must carry a black box warning, will pose to longtime ...

Posted in Uncategorized, clinical trials | No Comments »

Prasugrel not pleasing

Wednesday, June 3rd, 2009

Since January 2008, FDA has been discussing the benefits over the risks of Eli Lillyâ€™s prasugrel. The drug prevents more heart attacks than Plavix, but causes more internal bleeding, according to a study conducted by Lilly. Consumer health advocates and Dr. Victor Serebruany, who worked on the early development of ...

Posted in filed for approval | No Comments »

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