BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

...suspension, arikace, slit amikacin) Ayvakit, avapritinib (blu-285) belantamab mafodotin, J6M0-mcMMAF (2857916, GSK2857916) Calquence (Brand), ACP-196 (Compound #), acalabrutinib (Generic) bupivacaine/meloxicam...
BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

...in April 2019 and requested additional CMC and non-clinical information for the long-acting formulation of bupivacaine...
BioCentury | Jan 17, 2020
Company News

Jan. 17 Company Quick Takes: FDA expands label of Novo’s Ozempic; plus Intercept, Durect, Coherus-Innovent, CoImmune-Formula and Momenta

...Committee voted 6-6 on Thursday on the question of whether the risk-benefit profile of Posimir bupivacaine...
BioCentury | Jan 14, 2020
Company News

Amid need for new pain options, FDA panel rebuffs Nektar’s ‘safer’ opioid

...extended-release oral formulation of oxycodone from Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI) Wednesday, and an extended-release bupivacaine...
BioCentury | Jan 2, 2020
Clinical News

Durect looks ahead to liver indications after Phase IIa miss in psoriasis

...of cellular activities. The company’s pipeline also includes reformulations of established APIs. The company’s Posimir bupivacaine...
BioCentury | Oct 29, 2019
Company News

Oct. 28 Company Quick Takes: MOR106 dropped in atopic dermatitis; plus Blueprint, Merus, Gilead-Glympse, Heron and GSK

...letter in May and requested additional CMC and non-clinical information for the long-acting formulation of bupivacaine...
BioCentury | Oct 3, 2019
Company News

Oct. 2 Company Quick Takes: Merck, Immunovant, PureTech-Ariya, Viscient-Organovo and Durect

...has set a tentative date of Jan. 16 to discuss an NDA submission for Posimir bupivacaine...
BioCentury | May 1, 2019
Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

...postoperative pain. The agency requested additional CMC and non-clinical information for the long-acting formulation of bupivacaine...
...a fixed-dose combination with meloxicam. Shares of Pacira Pharmaceuticals Inc. (NASDAQ:PCRX), which markets extended-release Exparel bupivacaine...
BioCentury | Jan 4, 2019
Clinical News

Heron's non-opioid HTX-011 gets Priority Review

...committee meeting for the non-opioid therapy. HTX-011 is a long-acting formulation of the local anesthetic bupivacaine...
BioCentury | Dec 31, 2018
Company News

Heron's non-opioid HTX-011 gets Priority Review

...committee meeting for the non-opioid therapy. HTX-011 is a long-acting formulation of the local anesthetic bupivacaine...
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