Bupivacaine

Virpax Pharmaceuticals Reports 2023 Year-End Results

Retrieved on: 
Tuesday, March 26, 2024

Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced its financial results for the twelve months ended December 31, 2023, and other recent developments.

Key Points: 
  • Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced its financial results for the twelve months ended December 31, 2023, and other recent developments.
  • “Recently we reported the initial results from the pilot study of Probudur™ performed by the U.S. Army Institute of Surgical Research (USAISR).
  • On November 17, 2023, Virpax announced the resignation of Anthony P. Mack as CEO and Chairman effective immediately.
  • As of December 31, 2023, Virpax had cash of approximately $9.1 million, compared to $19.0 million as of December 31, 2022.

Meitheal Pharmaceuticals Announces Recent Business Progress Reinforcing Commitment to Sustainable Generics Development

Retrieved on: 
Tuesday, March 19, 2024

As we prepare to launch multiple new products in 2024, we are intently focused on expediting delivery of medicines in short supply,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals.

Key Points: 
  • As we prepare to launch multiple new products in 2024, we are intently focused on expediting delivery of medicines in short supply,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals.
  • As of March 1, 2024, both the U.S. Food and Drug Administration (FDA) and the American Society of Health-System Pharmacists (ASHP) websites list multiple presentations of Bupivacaine Hydrochloride Injection on drug shortage.
  • These approved lines add over 200 million units of capacity for vial and cartridge products that support current and future demand for generic injectables.
  • These lines are expected to produce commercial products that will have an impact on drug shortages beginning in the second half of 2024.

Heron Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Updates

Retrieved on: 
Tuesday, March 12, 2024

ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and twelve months ended December 31, 2023 were $5.6 million and $17.7 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022.

Key Points: 
  • ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and twelve months ended December 31, 2023 were $5.6 million and $17.7 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022.
  • APONVIE® Net Product Sales: Net Product Sales of APONVIE for the three and twelve months ended December 31, 2023 were $0.5 million and $1.4 million, respectively, with no sales in the comparable prior year periods.
  • CINVANTI® Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2023 were $24.3 million and $94.9 million, respectively, which increased from $23.1 million and $87.3 million, respectively, for the same periods in 2022.
  • SUSTOL® Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2023 were $3.8 million and $13.0 million, respectively, which increased from $3.0 million and $10.2 million, respectively, for the same periods in 2022.

Pacira BioSciences Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Thursday, February 29, 2024

TAMPA, Fla., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the fourth quarter and full-year of 2023.

Key Points: 
  • ET —
    TAMPA, Fla., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the fourth quarter and full-year of 2023.
  • Fourth quarter 2023 iovera° net product sales were $6.0 million, a 32% increase over the $4.6 million reported in the fourth quarter of 2022.
  • Total operating expenses were $148.1 million in the fourth quarter of 2023, versus the $181.8 million reported for the fourth quarter of 2022.
  • Cash provided by operations was $47.6 million in the fourth quarter of 2023, compared to $42.0 million in the fourth quarter of 2022.

Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy

Retrieved on: 
Thursday, February 15, 2024

TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl. The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.

Key Points: 
  • TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy.
  • The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl.
  • The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.
  • “The role of EXPAREL as a sciatic nerve block in the popliteal fossa, particularly for pain control following foot and ankle procedures, is pivotal as clinical goals toward outpatient migration continue to grow,” said Gary Schwartz, MD, FASA, Vice Chair of Pain and Anesthesiology at Maimonides Medical Center and lead author on the publication.

Pacira BioSciences Awarded Brand Pharmaceuticals Agreement With Premier, Inc.

Retrieved on: 
Wednesday, February 7, 2024

TAMPA, Fla., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, has been awarded a national group purchasing agreement for Brand Pharmaceuticals with Premier, Inc.

Key Points: 
  • TAMPA, Fla., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, has been awarded a national group purchasing agreement for Brand Pharmaceuticals with Premier, Inc.
  • Effective January 1, 2024, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for EXPAREL® (bupivacaine liposome injectable suspension).
  • “Premier has an impressive network of U.S. hospitals and health systems, and this collaboration provides Pacira an excellent opportunity to expand reach while improving patient safety and care,” said Frank D. Lee, Chief Executive Officer of Pacira BioSciences.
  • This collaboration will allow Pacira to further achieve these important objectives while making a lasting impact on healthcare providers and patients across the country.

Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

Retrieved on: 
Wednesday, January 24, 2024

SAN DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.

Key Points: 
  • ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults.
  • This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures.
  • To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty.
  • The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache.

Heron Therapeutics Announces Partnership with CrossLink Life Sciences to Expand Promotional Effort for ZYNRELEF®, the First and Only Non-Opioid Dual Acting Local Anesthetic for Post-Operative Pain

Retrieved on: 
Sunday, January 7, 2024

The partnership will launch in several phases, initially at a regional level, followed by an expanded national rollout.

Key Points: 
  • The partnership will launch in several phases, initially at a regional level, followed by an expanded national rollout.
  • In total, approximately 650 representatives will be added to Heron's sales network over the next year.
  • CrossLink will be the lead partner in the United States to expand ZYNRELEF promotion for orthopedic indications.
  • "CrossLink has a proven track record of success in building relationships, providing superior service to healthcare providers and improving patient outcomes.

Pacira Reports Preliminary Unaudited Fourth Quarter and Full-Year 2023 Revenues

Retrieved on: 
Thursday, January 4, 2024

Fourth quarter ZILRETTA net product sales of $28.7 million in 2023, compared with $28.0 million in 2022.

Key Points: 
  • Fourth quarter ZILRETTA net product sales of $28.7 million in 2023, compared with $28.0 million in 2022.
  • Fourth quarter iovera° net product sales of $6.0 million in 2023, compared with $4.6 million in 2022.
  • Other revenue, including sales of bupivacaine liposome injectable suspension and royalties, was $2.6 million in the fourth quarter of 2023, compared with $1.4 million in the fourth quarter of 2022.
  • Pacira expects to report its complete financial results for the fourth quarter and full-year 2023, along with the company’s financial guidance and capital allocation strategy for 2024, in the first quarter of 2024.

Pacira Announces FDA Approval of Expanded EXPAREL Label to Include Two Additional Nerve Block Indications

Retrieved on: 
Friday, November 10, 2023

TAMPA, Fla., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) to expand the EXPAREL® (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.

Key Points: 
  • An adductor canal block is used for anesthesia and analgesia for surgery of the knee, medial lower leg, and ankle surgeries.
  • A sciatic nerve block in the popliteal fossa is used for anesthesia and analgesia for foot, ankle, achilles tendon, and other lower leg surgeries.
  • One study evaluated EXPAREL as a single-dose adductor canal block and the second study evaluated EXPAREL as a single-dose sciatic nerve block in the popliteal fossa.
  • EXPAREL as a sciatic nerve block in the popliteal fossa also achieved statistical significance for the percentage of opioid-free subjects (P