Medical Dynamics

“Abbott Expands Use of Sustainable Packaging as Park of Global Environmental Efforts” (Abbott Press Release)

“Medicis Declairs Cash Dividend” (Medicis Press Release)

“Bayer names outsider as CEO, Higgins to leave as pharma chief” (PharmaTimes.com)

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“Alkermes Exec Shakeup: CEO Quits, Replaced By Board Chair Richard Pops” (The Pink Sheet)

“Goodwin Biotechnology Inc. Completes cGMP Manufacturing of AREVA Med’s Conjugate” (InterestAlert.com)

“Globalequityreport.com Announces an Investment Report Featuring Bioscience Company Genova Biotherapeutics Inc.” (InterestAlert.com)

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“Liraglutide Favorably Reshapes Carciovascular Risk in Type 2 Diabetes” (Elsevier Global Medical News)

Barcelona — Liraglutide, a once-daily investigational human glucagon-like peptide-1 analogue, achieved impressive reductions in multiple cardiovascular risk biomarkers in type 2 diabetes patients in a meta-analysis of six phase III randomized trials.

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“Financings Of The Fortnight: PIPEing Hot Returns?” (The Pink Sheet)

The deal that Norwegian biotech Algeta just signed with Bayer for its Phase III Alpharadin bone metastases candidate sent its shares soaring. The stock spiked to NOK83, closing the day on an all-time high of NOK56.

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“FDA Device Center Loses Another Top Staffer” (The Gray Sheet)

CDRH’s associate director for regulations and policy Kate Cook is leaving the device center, the agency said Thursday. She reportedly will join FDA’s biologics center…

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“New research indicates 95% of patients are in moderate to severe chronic pain despite one year of treatment” (TherapeuticsDaily.com)

“Case Reports Show Natalizumab-Associated PML Resolution in MS Patients” (Elsevier Global Medical News)

Treatment with plasma exchange to accelerate the clearance of natalizumab resulted in significant improvements in two patients who had developed progressive multifocal leukoencephalopathy during treatment with the monoclonal antibody for multiple sclerosis, two reports in the Sept. 10 issue of the New England Journal of Medicine show.

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“PDUFA V ‘Wish List’ From Consumers Union Includes Comparative Effectiveness Standard” (The Pink Sheet)

A requirement to determine the comparative value of new drugs is on Consumers Union’s wish list for inclusion in the next round of prescription drug user fee legislation.

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“Obama to make case for big healthcare changes” (Reuters)

“’Lagging Indicators’: Is There A “Drug Lag’ Between U.S. And Europe?” (The Pink Sheet)

The “drug lag” is back.

The term – biopharma industry shorthand for the belief that new drugs reach the market faster in other countries (especially in Europe) than they do the in U.S. – was a common refrain in the late 1980s and early 1990s, and the Prescription Drug User Fee Act of 1992 was intended in part to address the perception that US consumers suffered while FDA reviews dragged on.

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“Industry Balks At Baucaus Proposal For $4 Billion Annual Device Sector Charge” (The Gray Sheet)

Medical device manufacturers would have to pay $4 billion in annual fees to help finance health care reform under a framework proposed by Senate Finance Committee Chair Max Baucus on Sept. 8…

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“Preparing for a Stressful Flu Season” (New York Times)

“Where did All The Flowers Come From?” (New York Times)

“Obama says ‘time to act’ for healthcare reform” (Reuters)

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“Dainippon to buy U.S. drug firm Sepracor for $2.6 billion” (Reuters)

“Algeta and Bayer sign deal worth over 560 million euros” (PharmaLive)

“Pfizer settles illegal marketing case for massive $2.3 billion” (PharmaLive)

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US health reforms will raise prices of breakthrough drugs (PharmaTimes)

Curetech gets FDA nod for liver cancer trial (Globes)

Acadia and Biovail’s pimavanserin fails in Phase III trial (PharmaTimes)

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