FDA Drug Approvals and Rejections
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InterMune Is Set To Outperform Its Main Competitor

InterMune Is Set To Outperform Its Main Competitor | FDA Drug Approvals and Rejections | Scoop.it
InterMune's (ITMN) sole product pirfenidone (brand name Esbriet) is an orally active, small molecule drug currently seeking approval from the FDA for the treatment of idiopathic pulmonary fibrosis, a progressive and fatal lun
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2013 Biotech & Pharma IPO Review – Most Popular Therapeutic trends, Trending Clinical Stages and post-IPO Winners & Losers

2013 Biotech & Pharma IPO Review – Most Popular Therapeutic trends, Trending Clinical Stages and post-IPO Winners & Losers | FDA Drug Approvals and Rejections | Scoop.it
Bioassociate's insight:

Biotech continues to outperform other sectors, even as venture capital wallets are shrinking. An unprecedented 46 biotech and pharma companies went public this year, in what has become an IPO frenzy of over a decade. For the most part, thenewly public companies are developing drugs targeting cancer, infectious disease (especially antibiotic-resistant bacteria) and brain disorders. But some new therapeutic areas which are gaining popularity might surprise you. Check out our latest blog post to find out which diseases are "popular" in the pharma world, and who, so far, are the biggest gainers and losers of this year's IPO craze

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Bioassociate's curator insight, December 14, 2013 10:34 AM

Biotech continues to outperform other sectors, even as venture capital wallets are shrinking. An unprecedented 46 biotech and pharma companies went public this year, in what has become an IPO frenzy of over a decade. For the most part, thenewly public companies are developing drugs targeting cancer, infectious disease (especially antibiotic-resistant bacteria) and brain disorders. But some new therapeutic areas which are gaining popularity might surprise you. Check out our latest blog post to find out which diseases are "popular" in the pharma world, and who, so far, are the biggest gainers and losers of this year's IPO craze

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Gilead stock trending up on anticipated sofosbuvir approval today, Auxilium surges intraday prior to Xiaflex Peyronie's verdict

Gilead stock trending up on anticipated sofosbuvir approval today, Auxilium surges intraday prior to Xiaflex Peyronie's verdict | FDA Drug Approvals and Rejections | Scoop.it
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FDA Tells Google-Backed 23andMe to Halt DNA Test Service

FDA Tells Google-Backed 23andMe to Halt DNA Test Service | FDA Drug Approvals and Rejections | Scoop.it
23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S.

Via Ari Massoudi
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Ari Massoudi's curator insight, November 25, 2013 5:31 PM

23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.”

https://www.23andme.com/

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Upcoming FDA Advisory Committee (AdCom) meeting: Nov 13, 2013 - Sanofi (Genzyme) - Lemtrada (Alemtuzumab) for the treatment of Mul...

Upcoming FDA Advisory Committee (AdCom) meeting: Nov 13, 2013 - Sanofi (Genzyme) - Lemtrada (Alemtuzumab) for the treatment of Mul... | FDA Drug Approvals and Rejections | Scoop.it
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Government Shutdown May Delay FDA AdCom, PDUFA dates and Stock Catalysts

Government Shutdown May Delay FDA AdCom, PDUFA dates and Stock Catalysts | FDA Drug Approvals and Rejections | Scoop.it
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FDA Drug Calendar: PDUFAs, AdComs, Drug Approvals and Rejections: Upcoming FDA PDUFA: Oct 3 2013 - Ligand Pharmaceuticals and Pfizer - Aprela (Duavive) for menopause

FDA Drug Calendar: PDUFAs, AdComs, Drug Approvals and Rejections: Upcoming FDA PDUFA: Oct 3 2013 - Ligand Pharmaceuticals and Pfizer - Aprela (Duavive) for menopause | FDA Drug Approvals and Rejections | Scoop.it
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FDA Drug Calendar: PDUFAs, AdComs, Drug Approvals and Rejections

FDA Drug Calendar: PDUFAs, AdComs, Drug Approvals and Rejections | FDA Drug Approvals and Rejections | Scoop.it
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Bioassociate Reiterated BUY Recommendation on RedHill Biopharma Following February 2014 Update - WSJ.com

Bioassociate Reiterated BUY Recommendation on RedHill Biopharma Following February 2014 Update - WSJ.com | FDA Drug Approvals and Rejections | Scoop.it
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APPROVED: Gilead Sovaldi (sofosbuvir) for the treatment of Hepatitis C. What Next?

APPROVED: Gilead Sovaldi (sofosbuvir) for the treatment of Hepatitis C. What Next? | FDA Drug Approvals and Rejections | Scoop.it

Hepatitis C may have been a terrible liver-destroying feat which tormented the likes of Pamela Anderson, Keith Richards and Steven Tyler, but today, the virus can walk away with its tail between its legs, as a new, breakthrough drug reached the market

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Auxilium Pharma (AUXL) stock still riding the wave of Xiaflex sBLA approval expectation on December 6

Auxilium Pharma (AUXL) stock still riding the wave of Xiaflex sBLA approval expectation on December 6 | FDA Drug Approvals and Rejections | Scoop.it
Bioassociate's insight:

On November 25 Auxilium Pharma released new results of their Phase III IMPRESS trial for the company's sBLA of Xiaflex for the treatment of Peyronie's disease. Amidst high expectations of FDA approval on Dec 6, 2013, the company's share price continues to climb up to the date

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Pre-AdCom FDA report slams Lemtrada, crashes Sanofi CVR stock over weekend

Pre-AdCom FDA report slams Lemtrada, crashes Sanofi CVR stock over weekend | FDA Drug Approvals and Rejections | Scoop.it
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Upcoming FDA PDUFA: Auxilium Pharmaceuticals + Biospecifics Technologies - Xiaflex (collagenase clostridium histolyticum) - Peyronie's Disease

Upcoming FDA PDUFA: Auxilium Pharmaceuticals + Biospecifics Technologies - Xiaflex (collagenase clostridium histolyticum) - Peyronie's Disease | FDA Drug Approvals and Rejections | Scoop.it
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Upcoming FDA PDUFA: Oct 14 2013 - Antares Pharma - Otrexup for Rheumatoid arthritis (RA), poly-articular-course juvenile RA and mod...

Upcoming FDA PDUFA: Oct 14 2013 - Antares Pharma - Otrexup for Rheumatoid arthritis (RA), poly-articular-course juvenile RA and mod... | FDA Drug Approvals and Rejections | Scoop.it
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Kythera Biopharmaceuticals - A Buyout Target Following Phase III Results

Kythera Biopharmaceuticals - A Buyout Target Following Phase III Results | FDA Drug Approvals and Rejections | Scoop.it
Yesterday evening, after trading hours, Kythera Biopharmaceuticals (KYTH) announced positive top line results from its Phase III studies with ATX-101 for the reduction of submental fat.
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