Clarus Therapeutics Inc

Type: Company
Name: Clarus Therapeutics Inc
First reported Oct 24 2014 - Updated Oct 24 2014 - 1 reports

BioSpace ???s Favorite FDA Tricks Or Treats

October 24, 2014By Riley McDermid , BioSpace.com Breaking News Sr. EditorFeeling spooky yet? In the third of our four Halloween-themed features this month, BioSpace took a lighthearted look at both the ghoul and the fairy godmother of the biotech industry: ... [Published BioSpace - Oct 24 2014]
First reported Oct 20 2014 - Updated Oct 21 2014 - 1 reports

TesoRx licenses oral low-T drug to Aspen amid FDA crackdown

While the testosterone therapy field is under fire from government regulators, Menlo Park, CA-based TesoRx is licensing its oral-testosterone replacement therapy to a subsidiary of South African generics maker Aspen Pharmacare.The Aspen Group's holding ... [Published FierceBiotech - Oct 20 2014]
First reported Sep 26 2014 - Updated Sep 26 2014 - 1 reports

Here‘s Why Repros Therapeutics Is Surging Today

Repros Therapeutics has recorded strong gains so far today, after the company announced a November meeting with the FDAPage 1 of 2Published: September 26, 2014 at 1:27 pm EST By: Hannah Ishmael Click Ticker to See live coverage RPRX ABBVRepros Therapeutics ... [Published Bidness Etc - Sep 26 2014]
First reported Sep 26 2014 - Updated Sep 26 2014 - 1 reports

FDA Advisory Panels Reject Testosterone Replacement Therapy

Two FDA advisory panels have overwhelmingly recommended the agency not approve Clarus Therapeutics’ Rextoro testosterone replacement therapy.In an 18-3 vote last week, members of the agency’s Bone, Reproductive and Urologic Drugs Advisory Committee ... [Published FDA News - Sep 26 2014]
First reported Sep 24 2014 - Updated Sep 24 2014 - 1 reports

FDA moves aggressively on low-T drugs, but replacement pill still aims to enter market

Last week the FDA cracked down hard on low-T therapies. Its expert panel voted to advise the agency to restrict the use of such drugs for a specific medical need. And a majority wanted cardiovascular studies to assess age-related risks. Then the agency ... [Published Fierce Drug Delivery - Sep 24 2014]
First reported Sep 23 2014 - Updated Sep 24 2014 - 1 reports

FDA Advisory Committee Comments Create Buying Opportunity In Lipocine

Summary Lipocine’s (LPCN) stock price was down 32% on September 18th after consecutive FDA advisory committee meetings held in regards to testosterone replacement therapy (TRT). Regarding TRT, the committee overwhelmingly voted to alter labeling language ... [Published Seeking Alpha - Sep 23 2014]
First reported Sep 22 2014 - Updated Sep 23 2014 - 1 reports

Want testosterone? Grow your own

It’s just another futile search for the Fountain of Youth. In recent years, the idea that low levels of testosterone (T) were responsible for multiple afflictions in older males has spurred a cottage industry in testosterone replacement therapy—in both ... [Published American Council On Science & Health - Sep 22 2014]
First reported Sep 21 2014 - Updated Sep 21 2014 - 1 reports

The Friday Five – 5 questions raised last week in pharma

Are M&A sharks running out of prey?Despite the best efforts of some US politicians, the window for tax-inversion M&A deals appears to very much open according to the pharma industry, while specialty pharma players remain committed to cost-cutting opportunities...but ... [Published FirstWord Pharma - Sep 21 2014]
First reported Sep 19 2014 - Updated Sep 19 2014 - 1 reports

Weekly Roundup 9.19.14

Argh!  It is International Talk Like a Pirate Day ! Fear not Matey!  I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder. There were lots of approvals this week and finally a wee bit of action from the ... [Published Eye on FDA - Sep 19 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 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

Warren Buffett famously said "Be fearful when others are greedy, and greedy when others are fearful." We think this is the time to be greedy, as investors currently fear that the TRT market will shrink considerably, with Lipocine's stock price suffering...
Positively, lower real-world drop-out rates seen with Sovaldi when used as part of an all-oral combination (with Johnson & Johnson's Olysio) could "be an incremental driver of an improved realised price per patient" for Gilead's Sovaldi plus ledipasvir combination, remarked analysts at Credit Suisse...
Mr. Shea commented, "This is a great opportunity to join a talented management team that has unique expertise in T-replacement therapy and is poised to commercialize a product that addresses an unmet need in the treatment of hypogonadal men. If approved, there is significant opportunity for REXTORO to capture market share given the severity of potential side effects from transference and the inconvenience of administration associated with the currently approved treatment options. I look forward to working with the team as Clarus enters this exciting and important phase of its development." Clarus is an emerging men's specialty pharmaceutical company preparing for the commercial launch of REXTORO, an oral testosterone, or T, replacement...

More Content

All (17) | News (9) | Reports (0) | Blogs (3) | Audio/Video (0) | Fact Sheets (0) | Press Releases (5)
sort by: Date | Relevance
BioSpace ???s Favorite FDA Tricks Or Treats [Published BioSpace - Oct 24 2014]
TesoRx licenses oral low-T drug to Aspen amid F... [Published FierceBiotech - Oct 20 2014]
Here‘s Why Repros Therapeutics Is Surging Today [Published Bidness Etc - Sep 26 2014]
FDA Advisory Panels Reject Testosterone Replace... [Published FDA News - Sep 26 2014]
FDA moves aggressively on low-T drugs, but repl... [Published Fierce Drug Delivery - Sep 24 2014]
FDA Advisory Committee Comments Create Buying O... [Published Seeking Alpha - Sep 23 2014]
Want testosterone? Grow your own [Published American Council On Science & Health - Sep 22 2014]
The Friday Five – 5 questions raised last week ... [Published FirstWord Pharma - Sep 21 2014]
Weekly Roundup 9.19.14 [Published Eye on FDA - Sep 19 2014]
Clarus Therapeutics Reports FDA Advisory Commit... [Published GlobeNewswire: Acquisitions News - Sep 18 2014]
Upcoming AdComms By Subject Matter [Published Eye on FDA - Jul 28 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]
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sort by: Date | Relevance
Weekly Roundup 9.19.14 [Published Eye on FDA - Sep 19 2014]
Argh!  It is International Talk Like a Pirate Day ! Fear not Matey!  I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder. There were lots of approvals this week and finally a wee bit of action from the ...
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, ...
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Press Releases

sort by: Date | Relevance
Clarus Therapeutics Reports FDA Advisory Commit... [Published GlobeNewswire: Acquisitions News - Sep 18 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]
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