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

...an MAA to EMA by year-end and a BLA to FDA in mid-2021. Delay for Lipocine’s Tlando Lipocine Inc....
...Brand), Farxiga (Brand), BMS-512148 (Former compound #), dapagliflozin (Generic), Forxiga (Other) Tlando, testosterone undecanoate (LPCN 1021) AstraZeneca plc Lipocine Inc. U.S...
BioCentury | Jun 29, 2019
Finance

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

...Ildong Pharmaceutical Co. Ltd. (KRX:000230) Ublituximab Treat chronic lymphocytic leukemia (CLL) Phase III data 2H19 Lipocine Inc....
BioCentury | May 14, 2019
Company News

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

...new guidance at its R&D day Tuesday. Fresh review for Lipocine’s Tlando after FDA setback Lipocine Inc....
...Nov. 9. Elizabeth S. Eaton, Staff Writer FS118 Humira, adalimumab (D2E7) Tlando, testosterone undecanoate (LPCN 1021) AbbVie Inc. F-star Biotechnology Ltd. Ipsen Group Lipocine Inc. Merck...
BioCentury | Apr 6, 2018
Finance

Smid-cap smorgasbord

...Co. Ltd. (Tokyo:4151) / Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) Burosumab X-linked hypophosphatemia (XLH) PDUFA date 4/17/18 Lipocine Inc....
BioCentury | Jan 12, 2018
Clinical News

Lipocine receives negative panel vote

...period after Lipocine submitted additional data for the candidate (see BioCentury, Dec. 1, 2017 ). Lipocine...
...letter in 2016 identifying problems with its proposed dose titration scheme for clinical practice, which Lipocine...
...is an oral ester prodrug of testosterone that uses Lipocine's Lip'ral promicellar drug delivery technology. Lipocine...
BioCentury | Jan 10, 2018
Company News

Lipocine takes after-hours hit on negative panel vote

...after Lipocine submitted additional data for the candidate (see BioCentury Extra, Nov. 17, 2017) . Lipocine...
...letter in 2016 identifying problems with its proposed dose titration scheme for clinical practice, which Lipocine...
...is an oral ester prodrug of testosterone that uses Lipocine's Lip'ral promicellar drug delivery technology. Lipocine...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...CTCL) in patients who have received at least one prior systemic therapy PDUFA date 6/4/18 Lipocine Inc....
BioCentury | Dec 1, 2017
Clinical News

FDA prolongs review of Lipocine's Tlando

...testosterone undecanoate (LPCN 1021) to treat hypogonadism. The candidate’s new PDUFA date is May 8. Lipocine...
...time for analysis of data submitted by the company as an amendment to Tlando's NDA. Lipocine...
...is an oral ester prodrug of testosterone that uses Lipocine's Lip'ral promicellar drug delivery technology. Lipocine Inc....
BioCentury | Nov 17, 2017
Company News

FDA prolongs review of Lipocine's Tlando

...undecanoate (LPCN 1021) to treat hypogonadism. The candidate’s new PDUFA date is May 8, 2018. Lipocine...
...time for analysis of data submitted by the company as an amendment to Tlando's NDA. Lipocine...
...Lipocine's Lip'ral promicellar drug delivery technology. Lipocine slipped $0.22 to $3.63 on Friday. Jaime De Leon LPCN 1021 Tlando Lipocine Inc. testosterone...
BioCentury | Aug 22, 2017
Company News

Management tracks: Akari, Turnstone, Iconic

...Recro Pharma Inc. (NASDAQ:REPH) named Jyrki Mattila EVP of business development. He was CBO at Lipocine Inc....
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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

...an MAA to EMA by year-end and a BLA to FDA in mid-2021. Delay for Lipocine’s Tlando Lipocine Inc....
...Brand), Farxiga (Brand), BMS-512148 (Former compound #), dapagliflozin (Generic), Forxiga (Other) Tlando, testosterone undecanoate (LPCN 1021) AstraZeneca plc Lipocine Inc. U.S...
BioCentury | Jun 29, 2019
Finance

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

...Ildong Pharmaceutical Co. Ltd. (KRX:000230) Ublituximab Treat chronic lymphocytic leukemia (CLL) Phase III data 2H19 Lipocine Inc....
BioCentury | May 14, 2019
Company News

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

...new guidance at its R&D day Tuesday. Fresh review for Lipocine’s Tlando after FDA setback Lipocine Inc....
...Nov. 9. Elizabeth S. Eaton, Staff Writer FS118 Humira, adalimumab (D2E7) Tlando, testosterone undecanoate (LPCN 1021) AbbVie Inc. F-star Biotechnology Ltd. Ipsen Group Lipocine Inc. Merck...
BioCentury | Apr 6, 2018
Finance

Smid-cap smorgasbord

...Co. Ltd. (Tokyo:4151) / Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) Burosumab X-linked hypophosphatemia (XLH) PDUFA date 4/17/18 Lipocine Inc....
BioCentury | Jan 12, 2018
Clinical News

Lipocine receives negative panel vote

...period after Lipocine submitted additional data for the candidate (see BioCentury, Dec. 1, 2017 ). Lipocine...
...letter in 2016 identifying problems with its proposed dose titration scheme for clinical practice, which Lipocine...
...is an oral ester prodrug of testosterone that uses Lipocine's Lip'ral promicellar drug delivery technology. Lipocine...
BioCentury | Jan 10, 2018
Company News

Lipocine takes after-hours hit on negative panel vote

...after Lipocine submitted additional data for the candidate (see BioCentury Extra, Nov. 17, 2017) . Lipocine...
...letter in 2016 identifying problems with its proposed dose titration scheme for clinical practice, which Lipocine...
...is an oral ester prodrug of testosterone that uses Lipocine's Lip'ral promicellar drug delivery technology. Lipocine...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...CTCL) in patients who have received at least one prior systemic therapy PDUFA date 6/4/18 Lipocine Inc....
BioCentury | Dec 1, 2017
Clinical News

FDA prolongs review of Lipocine's Tlando

...testosterone undecanoate (LPCN 1021) to treat hypogonadism. The candidate’s new PDUFA date is May 8. Lipocine...
...time for analysis of data submitted by the company as an amendment to Tlando's NDA. Lipocine...
...is an oral ester prodrug of testosterone that uses Lipocine's Lip'ral promicellar drug delivery technology. Lipocine Inc....
BioCentury | Nov 17, 2017
Company News

FDA prolongs review of Lipocine's Tlando

...undecanoate (LPCN 1021) to treat hypogonadism. The candidate’s new PDUFA date is May 8, 2018. Lipocine...
...time for analysis of data submitted by the company as an amendment to Tlando's NDA. Lipocine...
...Lipocine's Lip'ral promicellar drug delivery technology. Lipocine slipped $0.22 to $3.63 on Friday. Jaime De Leon LPCN 1021 Tlando Lipocine Inc. testosterone...
BioCentury | Aug 22, 2017
Company News

Management tracks: Akari, Turnstone, Iconic

...Recro Pharma Inc. (NASDAQ:REPH) named Jyrki Mattila EVP of business development. He was CBO at Lipocine Inc....
Items per page:
1 - 10 of 53