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 | Apr 7, 2020
Product Development

April 6 Quick Takes: Second anemia approval for BMS, Acceleron therapy; plus EU approves trio of metabolic disease drugs, Dicerna-Alnylam and Axsome

...endpoints in the Phase III INTERCEPT trial for early treatment of migraine. Administration of the meloxicam/rizatriptan...
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

...CMC and non-clinical information for the long-acting formulation of bupivacaine in a fixed-dose combination with meloxicam...
BioCentury | Feb 1, 2020
Company News

Any chance left for safer opioids?

...Pink:ZCOR) with a new focus on non-opioid analgesics through the acquisition of four programs from Iroko...
BioCentury | Jan 23, 2020
Politics & Policy

MNCs lead price cuts in China’s second round of centralized procurement

...unit of Boehringer Ingelheim GmbH secured market share for the non-steroidal anti-inflammatory drug (NSAID) Mobic meloxicam...
BioCentury | Dec 30, 2019
Clinical News

Migraine readout completes December hat trick for surging Axsome

...a niche for AXS-07 in acute migraine. Axsome Therapeutics Inc. (NASDAQ:AXSM) said Monday that its meloxicam/rizatriptan...
...administered, fixed-dose AXS-07 combines the company’s Molecular Solubility Enhanced Inclusion Complex (MoSEIC) meloxicam and rizatriptan. Meloxicam...
...said on the call. “Axsome’s MoSEIC technology significantly increases the speed of absorption of the meloxicam...
BioCentury | Oct 29, 2019
Company News

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

...CMC and non-clinical information for the long-acting formulation of bupivacaine in a fixed-dose combination with meloxicam...
BioCentury | May 1, 2019
Company News

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

...CMC and non-clinical information for the long-acting formulation of bupivacaine in a fixed-dose combination with meloxicam...
BioCentury | Apr 6, 2019
Finance

Everybody up

...Assessment. AXS-07 is an oral, fixed dose combination of Molecular Solubility Enhanced Inclusion Complex (MoSEIC) meloxicam...
...burden (TMB) Recro Pharma Inc. (NASDAQ:REPH) FDA issues a second complete response letter for IV meloxicam...
BioCentury | Mar 29, 2019
Company News

FDA rejects Recro's meloxicam NDA for second time

...Recro said FDA issued a second complete response letter for its NDA for IV meloxicam (N1539...
...Recro Pharma Inc. (NASDAQ:REPH) said the agency was concerned with onset and duration of IV meloxicam...
...drugs. The company also said the letter cited regulatory concerns about the role of IV meloxicam...
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