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The Death of ‘Innocent Until Proven Guilty’?

February 16, 2012 – 4:04 pm | By Mari Serebrov | No comments yet

blog Feb 16, 2012

Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action –…

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Posted in drug importation, FDA | Tagged FDA, Janet Woodcock

What Would Albus Do? And What Should We?

February 13, 2012 – 11:27 am | By Anette Breindl | No comments yet

DC12-16-11

There’s a story, sometimes used to illustrate the difference between counseling and research psychology, about a man who pulls out one, then a second, then a third drowning person out of a river. When he sees a…

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Posted in Biotechnology, Cancer, Clinical Trial | Tagged Albus Dumbledore, Harry Potter, Mari Serebrov

Licensing or Acquisition? Big Pharma Shares How They (and YOU) Decide

February 8, 2012 – 6:47 pm | By Trista Morrison | No comments yet

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When I was at the Biocom Global Life Science Partnering Conference last week, one of the more interesting debates I heard was about whether it’s better to in-license an asset or acquire the whole company. While every…

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Posted in Big pharma, Biotechnology, Deals, License, M&A | Tagged George Golumbeski, Greg Wiederrecht, Martin Birkhofer, WWBD

The FDA: Stuck in 1984

January 23, 2012 – 12:38 pm | By Mari Serebrov | 1 comment

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While 2012 has dawned everywhere else in the world, it’s still 1984 at the FDA. With its Bad Ad program, whistle-blower suits and spotters of conference crimespeak serving as its globalwise eyes and ears, the agency has…

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Posted in Biotechnology, Clinical Trial, FDA | Tagged BB, FDA, GLAC, QOL

Like Warren Buffett, J&J Throws Down Incubator Gauntlet . . .Who’s Next?

January 19, 2012 – 6:18 pm | By Trista Morrison | No comments yet

blog Jan 20, 2012

When people talk about Johnson and Johnson’s new San Diego incubator, Janssen Labs, they can’t help but be a little bit skeptical about the fact that J&J isn’t taking any options or first-rights to compounds developed by…

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Posted in Big pharma, Biotechnology, Financing | Tagged Diego Miralles, Janssen Labs, San Diego, Warren Buffett

San Diego Scene: Sanford-Burnham Queuing Up Behind J&J to Launch Incubator

January 19, 2012 – 6:11 pm | By Trista Morrison | No comments yet

Incubator Jan 20, 2012

The San Diego biotech industry has been buzzing this week with the grand opening of Johnson and Johnson’s new incubator, Janssen Labs. But already plans for another San Diego incubator are being laid, this time at the…

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Posted in Big pharma, Biotechnology | Tagged Janssen Labs, Paul Laikind, San Diego, Sanford Burnham

Five New Trends in Biotech Venture

January 17, 2012 – 6:46 pm | By Trista Morrison | No comments yet

Blog Jan 18, 2012

The cover story for BioWorld Insight this week is about the biotech venture capital world, and how despite its much-publicized contraction, there’s a lot of exciting stuff going on like established firms closing new funds, established players…

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Posted in Biotechnology, Financing | Tagged Cleave Biosciences, Dermira Inc, Jay Lichter, NDA

He Said What?!?! Best Biotech Quotes of 2011

December 29, 2011 – 3:26 pm | By Trista Morrison | 2 comments

Blog Dec 29, 2011

As BioWorld Insight readers know, our “Word on the Street” column provides a sample of the most entertaining and thought-provoking quotes our staff stumbles upon each week. Some are gathered during interviews, some gleaned from analyst reports,…

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Posted in Accelerated approval, Antibody, Big pharma, Biologic, Biosimilar, Biotech conferences, Biotechnology, BLA, Cancer, Cardiovascular, Clinic, Clinical Trial, Collaboration, Complete Response Letter, Deals, Drug Approval, European Medicines Agency, FDA, Financing, Gene Therapy, Genomics, Healthcare reform, immunotherapy, IND, Investigational New Drug Application, IPO, NDA, New Drug Application, Orphan disease, Patents, PDUFA, Personalized medicine, Pharmaceutical, Phase I, Phase II, Phase III, Pipeline, Preclinical, Rare disease, Reimbursement, RNAi, siRNA, Stem cell, Supplemental new drug application, Uncategorized, venture captial | Tagged ASCO, BIO, CEO, General Wisdom

The Good, the Bad and . . . the Huh? A 2011 Biotech Recap

December 28, 2011 – 6:11 pm | By Jennifer Boggs | 1 comment

blog Dec 29, 2011

The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised…

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Posted in Accelerated approval, Antibody, Big pharma, Biologic, Biosimilar, Biotech conferences, Biotechnology, BLA, Cancer, Cardiovascular, China, Clinic, Clinical Trial, Collaboration, Complete Response Letter, Deals, Drug Approval, European Medicines Agency, FDA, Financing, Gene Therapy, Genomics, Healthcare reform, immunotherapy, IND, Investigational New Drug Application, IPO, NDA, New Drug Application, Orphan disease, Patents, PDUFA, Personalized medicine, Pharmaceutical, Phase I, Phase II, Phase III, Pipeline, Preclinical, Rare disease, Reimbursement, RNAi, Uncategorized | Tagged ABH, AMAG, FDA, Posthumous Nobels

Evidence and its Limits

December 20, 2011 – 4:57 pm | By Anette Breindl | No comments yet

blog Dec 20, 2011

The evidence on evidence-based medicine speaks for itself. The approach is a vast improvement over everything that came before, and over current rival approaches. It’s often enough to give its practitioners a bit of hubris –which is…

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Posted in Cancer | Tagged PCI, Ralph Meyer
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BioWorld Perspectives is the official blog for news, analysis, debates, commentary and camaraderie related to the development of biotechnology drugs.

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Recent Posts

  • The Death of ‘Innocent Until Proven Guilty’?
  • What Would Albus Do? And What Should We?
  • Licensing or Acquisition? Big Pharma Shares How They (and YOU) Decide
  • The FDA: Stuck in 1984
  • Like Warren Buffett, J&J Throws Down Incubator Gauntlet . . .Who’s Next?

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