BioCentury | Apr 6, 2019
Finance

Everybody up

...Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in pediatric patients Clarus Therapeutics Inc. FDA approves Jatenzo...
BioCentury | Mar 29, 2019
Company News

FDA approves Clarus' oral testosterone replacement therapy

...Clarus said FDA approved Jatenzo testosterone undecanoate for testosterone replacement therapy in adult males for primary...
...Ill.) resubmitted Jatenzo's NDA in 2017 (see "Clarus Resubmits NDA for Oral Testosterone Replacement Therapy Jatenzo"...
...to promote absorption via the intestinal lymphatic system. Chris Lieu, Staff Writer Jatenzo, testosterone undecanoate (clr-610, rextoro, OriTex) Clarus...
BioCentury | Jul 28, 2017
Clinical News

Clarus resubmits NDA for oral testosterone replacement therapy Jatenzo

...Last month, Clarus Therapeutics Inc. (Northbrook, Ill.) said it resubmitted an NDA to FDA for Jatenzo...
...trial comparing Jatenzo vs. topical Axiron testosterone. Clarus said that 87% of patients who received Jatenzo...
...Therapeutics Inc. , Northbrook, Ill. Product: Jatenzo testosterone undecanoate (formerly CLR-610 , Rextoro) Business: Endocrine/Metabolic Alex Himes Jatenzo Clarus...
BioCentury | Oct 24, 2016
Company News

Clarus Therapeutics, Lipocine endocrine/metabolic, drug delivery news

...LPCN 1021 testosterone replacement therapy infringed U.S. Patent No. 8,828,428 that is related to its Jatenzo...
...submitted the trial protocol, which the agency said it would review through an SPA. Clarus’ Jatenzo...
BioCentury | May 30, 2016
Clinical News

Jatenzo testosterone undecanoate: Phase III started

...Clarus began the open-label, U.S. Phase III inTUne trial to compare 237 mg oral Jatenzo twice...
...Clarus’ NDA. Clarus Therapeutics Inc. , Northbrook, Ill. Product: Jatenzo testosterone undecanoate (formerly CLR-610 , Rextoro...
BioCentury | Sep 22, 2014
Clinical News

Rextoro regulatory update

...committees voted against approval of Rextoro oral testosterone from Clarus. The committees voted 18-3 that Rextoro's...
...efficacy evidence is insufficient. The PDUFA date is Nov. 3. In June, Clarus said twice-daily Rextoro...
..."very high" levels of serum testosterone. Clarus Therapeutics Inc. , Northbrook, Ill. Product: Rextoro (formerly CLR-610...
BioCentury | Sep 19, 2014
Company News

FDA panel rebuffs Clarus' testosterone

...of Rextoro oral testosterone from Clarus Therapeutics Inc. (Northbrook, Ill.). The committees voted 18-3 that Rextoro's...
...its efficacy evidence is insufficient. The PDUFA date is Nov. 3. In June, Clarus said Rextoro...
BioCentury | Sep 4, 2014
Politics & Policy

Reviewers question CV risks/clinical benefit of testosterone therapies

...In Clarus Therapeutics Inc. (Northbrook, Ill.) for Rextoro , an oral testosterone under review as testosterone...
...with primary or hypogonadotropic hypogonadism. FDA has not yet released briefing documents for that meeting. Rextoro...
BioCentury | Aug 4, 2014
Clinical News

Rextoro: Phase III data

...in 144 hypogonadal men with serum testosterone levels of <300 ng/dL showed that twice-daily oral Rextoro...
...showing that Rextoro met the primary endpoint (see BioCentury, Oct. 1, 2012). An NDA for Rextoro...
...with a Nov. 3 PDUFA date. Clarus Therapeutics Inc. , Northbrook, Ill. Product: Rextoro (formerly CLR-610...
BioCentury | Jul 21, 2014
Clinical News

Rextoro regulatory update

...Management advisory committees will meet on Sept. 18 to discuss an NDA from Clarus for Rextoro...
...events in men prescribed testosterone therapy. Clarus Therapeutics Inc. , Northbrook, Ill. Product: Rextoro (formerly CLR-610...
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