Clarus Therapeutics Inc

Type: Company
Name: Clarus Therapeutics Inc
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Lipocine Is A Compelling Investment Opportunity With Impending Phase 3 Data

Summary Lipocine is a specialty pharmaceutical company with a novel drug delivery technology for application in men’s and women’s health. The company’s lead product, LPCN 1021, is an oral testosterone replacement therapy (TRT) in a Phase 3 pivotal trial ... [Published Seeking Alpha - Aug 19 2014]
First reported Aug 13 2014 - Updated Aug 13 2014 - 1 reports

Lipocine: An Undervalued Biotech With An Approaching Catalyst

Summary Lipocine's Phase III results for its lead compound LPCN-1021 are expected to be announced in the third quarter of 2014. LPCN-1021 could be the first and only oral testosterone replacement therapy indicated for low testosterone in the U.S. LPCN-1021 ... [Published Seeking Alpha - Aug 13 2014]
First reported Aug 11 2014 - Updated Aug 11 2014 - 1 reports

Urology Product Preview: Testosterone agent meets efficacy endpoint in phase III studies

Testosterone agent meets efficacy endpoint in phase III studiesClarus Therapeutics, Inc. recently presented phase III clinical data from two studies that it says support the safety and efficacy of oral testosterone undecanoate (REXTORO) for testosterone ... [Published Urology Times - Aug 11 2014]
First reported Aug 11 2014 - Updated Aug 11 2014 - 1 reports

Testosterone, clomiphene yield similar satisfaction

No difference in qADAM scores among clomiphene, T injection, and T gel groupsOrlando, FL— Symptomatic hypogonadal men treated with clomiphene citrate (Clomid) or testosterone gels report similar satisfaction levels as age-matched men treated with testosterone ... [Published Urology Times - Aug 11 2014]
First reported Jul 30 2014 - Updated Jul 30 2014 - 1 reports

Patent Issued for Pharmaceutical Delivery Systems for Hydrophobic Drugs and Compositions Comprising Same

By a News Reporter-Staff News Editor at Biotech Week According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventors Dudley, Robert E. (Rosemary Beach, FL); Constantinides, Panayiotis P. (Gurnee, IL), ... [Published Pharmacy Choice - Jul 30 2014]
First reported Jul 29 2014 - Updated Jul 30 2014 - 1 reports

FDA Seeks Answers From Advisory Panels As Testosterone Lawsuits Mount Against "Low T" Drug Makers

) Chicago, IL -- Wright & Shulte LLC has learned that the U.S. Food & Drug Administration (FDA) has called for a meeting on September 17 for two of its advisory panels to weigh in on the potential for testosterone replacement therapy drugs to cause heart ... [Published EMAILWIRE.com - Jul 29 2014]
First reported Jul 28 2014 - Updated Jul 28 2014 - 1 reports

Upcoming AdComms By Subject Matter

In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so often.  It is just a different way of ... [Published Eye on FDA - Jul 28 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 1 reports

Sarepta science officer Krieg 'terminated' quietly

Sarepta TherapeuticsArthur Krieg was let go from his senior VP and CSO position.Biotech> GliaCure has appointed Joseph Zakrzewski to its board of directors. Release> Cannabis Science has appointed Roscoe Moore for a second term on its scientific ... [Published FierceBiotech - Jul 25 2014]
First reported Jul 22 2014 - Updated Jul 22 2014 - 1 reports

Do testosterone meds boost heart attack risks? FDA asks advisory panels to weigh the data

The FDA has zoomed in on testosterone products for the cardiovascular risks they might pose to consumers, even slapping a new warning on their official labels. Now, the agency has called a special advisory committee meeting to probe two trials that flagged ... [Published FiercePharma - Jul 22 2014]
First reported May 27 2014 - Updated May 27 2014 - 1 reports

The Daily Startup: VCs Feeling Confident About Gene Therapy Again

Gene therapy investments soared in the middle of the last decade before falling off a cliff. Now the sector is rebounding. Global venture investment in gene therapies peaked in 2006 with $507.7 million, according to data from Dow Jones VentureSource, ... [Published WSJ.com: Venture Capital Dispatch - May 27 2014]
First reported May 21 2014 - Updated May 21 2014 - 1 reports

Clarus Therapeutics Appoints Patrick Shea Chief Commercial Officer

(GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc., a men's health specialty pharmaceutical company focused on the development and commercialization of REXTORO, an oral testosterone (T) replacement product, today announced that Patrick Shea has joined the ... [Published GlobeNewswire - May 21 2014]

Quotes

...The American Society of Andrology states that, "Testosterone replacement therapy in aging men is indicated when both clinical symptoms and signs suggestive of androgen deficiency and decreased testosterone levels are present" ( ASA, 2006 ). In other words, they do not believe a simple blood test is adequate to determine who should receive TRT...
"The first lipid component may exhibit an HLB of 10 to 45, preferably 10 to 30, and more preferably 10 to 20. The second lipid component may exhibit an HLB of less than about 10, preferably less than about 7, and more preferably less than about 5. Further, the second lipid component may exhibit a melting point in the range of about 25.degree. C to about 80.degree. C , preferably about 35.degree. C to about 65.degree. C , and more preferably about 40.degree. C to about 60.degree. C The second lipid component may be chosen from the group consisting of stearic acid, palmitic acid, glycerol and PEG esters thereof, Precirol ATO 5 and Gelucires."
...Dudley. "Low testosterone impacts millions of men in the U S There is a substantial need in the market for an oral treatment that mitigates risks associated with the currently approved options, and we believe REXTORO is the product to address these risks and patient concerns."

More Content

All (16) | News (9) | Reports (0) | Blogs (2) | Audio/Video (0) | Fact Sheets (0) | Press Releases (5)
sort by: Date | Relevance
Lipocine Is A Compelling Investment Opportunity... [Published Seeking Alpha - Aug 19 2014]
Lipocine: An Undervalued Biotech With An Approa... [Published Seeking Alpha - Aug 13 2014]
Testosterone, clomiphene yield similar satisfac... [Published Urology Times - Aug 11 2014]
Urology Product Preview: Testosterone agent mee... [Published Urology Times - Aug 11 2014]
Patent Issued for Pharmaceutical Delivery Syste... [Published Pharmacy Choice - Jul 30 2014]
FDA Seeks Answers From Advisory Panels As Testo... [Published EMAILWIRE.com - Jul 29 2014]
Upcoming AdComms By Subject Matter [Published Eye on FDA - Jul 28 2014]
Sarepta science officer Krieg 'terminated' quietly [Published FierceBiotech - Jul 25 2014]
Do testosterone meds boost heart attack risks? ... [Published FiercePharma - Jul 22 2014]
Clarus Therapeutics Expands Board of Directors ... [Published GlobeNewswire: Acquisitions News - Jul 21 2014]
Clarus Therapeutics Presents Phase 3 Data for R... [Published GlobeNewswire: Acquisitions News - Jun 22 2014]
Clarus Therapeutics Secures $31.5 Million in Fi... [Published GlobeNewswire: Advertising News - Jun 12 2014]
Clarus Therapeutics to Present Phase 3 Data for... [Published GlobeNewswire: Advertising News - May 28 2014]
The Daily Startup: VCs Feeling Confident About ... [Published WSJ.com: Venture Capital Dispatch - May 27 2014]
Clarus Therapeutics Appoints Patrick Shea Chief... [Published GlobeNewswire - May 21 2014]
Clarus Therapeutics Appoints John Gargiulo Chie... [Published GlobeNewswire: Acquisitions News - Mar 17 2014]
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Blogs

sort by: Date | Relevance
Upcoming AdComms By Subject Matter [Published Eye on FDA - Jul 28 2014]
In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so often.  It is just a different way of ...
The Daily Startup: VCs Feeling Confident About ... [Published WSJ.com: Venture Capital Dispatch - May 27 2014]
Gene therapy investments soared in the middle of the last decade before falling off a cliff. Now the sector is rebounding. Global venture investment in gene therapies peaked in 2006 with $507.7 million, according to data from Dow Jones VentureSource, ...
1

Press Releases

sort by: Date | Relevance
Clarus Therapeutics Expands Board of Directors ... [Published GlobeNewswire: Acquisitions News - Jul 21 2014]
Clarus Therapeutics Presents Phase 3 Data for R... [Published GlobeNewswire: Acquisitions News - Jun 22 2014]
Clarus Therapeutics Secures $31.5 Million in Fi... [Published GlobeNewswire: Advertising News - Jun 12 2014]
Clarus Therapeutics to Present Phase 3 Data for... [Published GlobeNewswire: Advertising News - May 28 2014]
Clarus Therapeutics Appoints John Gargiulo Chie... [Published GlobeNewswire: Acquisitions News - Mar 17 2014]
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