BioCentury | Sep 1, 2020
Product Development

Aug. 31 Quick Takes: Mylan, Biocon launch cheaper insulin in U.S.; plus: AZ, bluebird, Lipocine, Amgen, AbbVie-Morphic, Polyphor-Fosun and Milestone

...FDA in mid-2021. Delay for Lipocine’s Tlando Lipocine Inc. (NASDAQ:LPCN) said FDA needs additional time to review Tlando testosterone...
...not provided a new action date but expects to complete review of the company's oral testosterone...
...transforming growth factor Danielle Golovin Forxiga (Brand), Farxiga (Brand), BMS-512148 (Former compound #), dapagliflozin (Generic), Forxiga (Other) Tlando, testosterone...
BioCentury | Dec 14, 2019
Company News

Management Tracks: Alector hires new president, COO and appoints R&D committee co-chairs; plus Pyxis, Translate Bio, Canaan, PMV, Janpix, Kiadis and more

...Hagen to SVP finance from VP finance, and the two will take over Holmes' responsibilities. Testosterone...
BioCentury | Nov 19, 2019
Clinical News

Big gain for Myovant as oral prostate cancer therapy heads for submission

...company revealed Phase III data showing its oral GnRH receptor antagonist relugolix led to sustained testosterone...
...primary endpoint measured the proportion of prostate cancer patients who achieved and maintained castrate level testosterone...
...injectable products can lead to delayed testosterone recovery after discontinuing treatment; HERO's results showed mean testosterone...
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

...KRX:000230) Ublituximab Treat chronic lymphocytic leukemia (CLL) Phase III data 2H19 Lipocine Inc. (NASDAQ:LPCN) Tlando testosterone...
BioCentury | May 14, 2019
Company News

May 14 Company Quick Takes: F-star rejiggers Merck KGaA deal; plus Roche/Spark, AbbVie/Boehringer, Ipsen

...setback Lipocine Inc. (NASDAQ:LPCN) said FDA has accepted an NDA for Tlando testosterone undecanoate as testosterone...
...complete response letter. Its PDUFA date is Nov. 9. Elizabeth S. Eaton, Staff Writer FS118 Humira, adalimumab (D2E7) Tlando, testosterone...
BioCentury | Apr 6, 2019
Finance

Everybody up

...lymphoblastic leukemia (ALL) in pediatric patients Clarus Therapeutics Inc. FDA approves Jatenzo testosterone undecanoate for testosterone...
BioCentury | Apr 1, 2019
Emerging Company Profile

Arixa: Breaking resistance with oral beta lactamase inhibitors

Arixa has made an IV antibiotic oral with prodrug chemistry. Arixa Pharmaceuticals Inc. is modifying diazabicyclooctanes, a class of β-lactamase inhibitors that suffer from poor absorption across the GI tract, for use in combination with...
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...
...hypogonadism and hypogonadotropic hypogonadism, which are conditions associated with a deficiency or absence of endogenous testosterone...
..."Clarus Resubmits NDA for Oral Testosterone Replacement Therapy Jatenzo" ). The product is an oral testosterone...
BioCentury | Jan 12, 2019
Finance

We all fall down

...hereditary transthyretin-mediated amyloidosis Antares Pharma Inc. (NASDAQ:ATRS) FDA approves Xyosted testosterone enanthate injection as a testosterone...
BioCentury | Nov 16, 2018
Clinical News

FDA approves Antares' Xyosted testosterone replacement therapy

...FDA approved in October Xyosted from Antares Pharma Inc. (NASDAQ:ATRS) as a testosterone replacement therapy in...
...or absence of endogenous testosterone. Antares expects launch the drug by year end. Xyosted is testosterone...
...Issues CRL for Antares’ Hypogonadism Candidate” ). Antares Pharma Inc. (NASDAQ:ATRS), Ewing, N.J. Product: Xyosted testosterone...
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