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Anacor gets $15M from GSK

Friday, July 30th, 2010

GlaxoSmithKline ( NYSE: GSK )

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With losses rising, Vertex rolls out its telaprevir app

Thursday, July 29th, 2010

Faced with a rising tide of red ink, Vertex ( NASDAQ: VRTX ) says it has begun rolling out its NDA for the

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A State Tries To Restrict Excessive Use Of Painkillers

Thursday, July 29th, 2010

To what extent, if any, should restrictions be placed on prescribing powerful painkillers that are increasingly linked to abuse and overdose deaths? That issue is being debated in the state of Washington, where regulations are being developed to would prevent docs from prescribing higher doses to patients who are not benefiting from the meds, The New York Times reports.

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AZ’s blockbuster Brilinta wins landslide FDA panel vote

Wednesday, July 28th, 2010

AstraZeneca scored a big win in front of an FDA advisory panel on Wednesday afternoon, gaining solid support for its blockbuster blood thinner Brilinta in a seven-to-one vote in favor of approval. Astra’s biggest obstacle was the relatively small contingent of 1,431 American patients in a large international Phase III who failed to benefit from the drug. But the 17,000 patients

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Pfizer Halts Trial of Pain Drug: Biotech’s Latest Mishaps

Sunday, July 25th, 2010

The Burrill Report submits: Pfizer ( PFE ) said it was halting a trial of its experimental drug tanezumab to treat chronic low back pain and diabetic peripheral neuropathy at the request of the U.S. Food and Drug Administration

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FDA accepts Mannkind’s response, sets PDUFA date

Tuesday, July 20th, 2010

The FDA has accepted MannKind’s resubmission of its NDA for the inhaled insulin drug Afrezza and set a PDUFA action date of December 29, 2010. The much-watched Afrezza NDA received a complete response

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Cadus Corporation: Less a Company Than a Publicly Traded Checking Account – WSJ

Monday, July 19th, 2010

Greenbackd submits: In September last year I picked up a small position in Cadus Corporation (OTC: KDUS.OB ). The idea was as follows: Cadus Corporation is an interesting play, but not without hairs on it

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BREAKING NEWS: Panel not convinced by Vivus’ Qnexa

Thursday, July 15th, 2010

GAITHERSBURG, MD — Expressing the need for more information–especially about teratogenicity–an FDA expert panel has recommended against approval of Vivus’ ( NASDAQ: VVUS ) obesity drug Qnexa. The vote was six in favor and

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Preterm birth drug app heads back to FDA

Wednesday, July 14th, 2010

KV Pharmaceutical ( NYSE: KV-B ) is a step closer to getting its hands on a new drug to prevent preterm births. The company says that Hologic has resubmitted its FDA application for Gestiva, a drug KV paid $70 million for upfront back in January. KV also committed to $120 million in additional payments

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The “Me” in Social Media

Tuesday, July 13th, 2010

I’ve been blogging, tweeting, pinging (updates all my business social media outlets at once) for a while now. Most of the time when I am sending something “out there” I think about the message and the relevance and then I blast away

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