Heron Therapeutics Announces Partnership with CrossLink Life Sciences
SAN DIEGO, Dec. 29, 2022 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, today announced the submission of a supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures and a newly passed congressional bill that is anticipated to provide separate reimbursement outside of the packaged surgical payment for ZYNRELEF for almost 3 years.
ATHLONE, Ireland and CUPERTINO, Calif., Sept. 26, 2022 /PRNewswire/ -- Innocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, and DURECT Corporation ( Nasdaq: DRRX) today announced the recent commercial launch of POSIMIR® (bupivacaine solution) in the United States. POSIMIR is an FDA-approved non-opioid, sustained-release local analgesic for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery.
Enforcement Report - Week of August 24, 2022
FDA Confirms Paragraph IV Patent Litigation for Aprepitant, Azilsartan, Bupivacaine, Cladribine, Elrombopag, Fosnetupitant, Fostamatinib, Ivacaftor and Sodium Thiosulfate.
FDA Confirms Paragraph IV Patent Litigation for Bupivacaine Liposome
TAMPA, Fla., April 12, 2022 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary revenues of $157.4 to $158.4 million for the first quarter of 2022, compared with $119.0 million for the first quarter of 2021. The company’s revenues include net product sales of EXPAREL® (bupivacaine liposome injectable suspension), ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. Pacira currently reports a range for preliminary quarterly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.
The FDA has approved Heron Therapeutics’ supplemental New nDrug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam), to nsignificantly expand the indication.
SAN DIEGO, Dec. 9, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for ZYNRELEF (bupivacaine and meloxicam) extended-release solution to significantly expand the indication. ZYNRELEF is now indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.
Pacira is buying Flexion Therapeutics for an equity value of about $450 million, or $630 million including debt, the two companies said Monday.