New Drug Application

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.

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

Retrieved on: 
Friday, January 19, 2024

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

Prota Therapeutics US $21 Million Financing Led by SPRIM Global Investments

Retrieved on: 
Tuesday, January 16, 2024

MELBOURNE, Jan 16, 2024 - (ACN Newswire) - Prota Therapeutics Pty Ltd (Prota), an Australian biotechnology company focused on the development of novel oral immunotherapy treatments that induce remission of allergy, today announced financing of US$21 million in equity and debt financing.

Key Points: 
  • MELBOURNE, Jan 16, 2024 - (ACN Newswire) - Prota Therapeutics Pty Ltd (Prota), an Australian biotechnology company focused on the development of novel oral immunotherapy treatments that induce remission of allergy, today announced financing of US$21 million in equity and debt financing.
  • The round, led by Singapore-based SPRIM Global Investments (SGI), will help the company prepare for a Phase 3 clinical investigation of the company's PRT120 oral therapy for peanut allergy.
  • "SPRIM brings valuable expertise, capabilities and an international investment network to Prota's technology and clinical program," said Prota Executive Chairman Kelly Constable.
  • "This partnership and funding will accelerate Prota's drug development plans and clinical trial program, and we look forward to this strategic collaboration as Prota moves toward its Phase 3 trial."

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

Retrieved on: 
Tuesday, January 16, 2024

Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.

Key Points: 
  • Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.
  • The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.
  • On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
  • NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis.

FDA Acceptance of Zevra’s Arimoclomol NDA Filing for Niemann-Pick Disease Type C (NPC) Results in XOMA Making a $1 Million Milestone Payment to LadRx

Retrieved on: 
Thursday, January 11, 2024

EMERYVILLE, Calif., Jan. 11, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today that based upon the U.S. Food and Drug Administration’s (FDA) acceptance of Zevra Therapeutics’ New Drug Application (NDA) for arimoclomol, an orally-delivered, first-in-class therapy for Niemann-Pick disease type C (NPC), XOMA will make a $1 million milestone payment to LadRx.

Key Points: 
  • EMERYVILLE, Calif., Jan. 11, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today that based upon the U.S. Food and Drug Administration’s (FDA) acceptance of Zevra Therapeutics’ New Drug Application (NDA) for arimoclomol, an orally-delivered, first-in-class therapy for Niemann-Pick disease type C (NPC), XOMA will make a $1 million milestone payment to LadRx.
  • “NPC is an ultra-rare, progressive, neurodegenerative genetic disorder where those living with NPC lose independence due to physical and cognitive limitations, with key neurological impairments presenting in speech, cognition, swallowing, ambulation, and fine motor skills.
  • Arimoclomol has the potential to be the first approved therapy designed to slow the progress of this devastating disease,” stated Brad Sitko, Chief Investment Officer at XOMA.
  • The transaction also included a mid-single-digit to mid-teens royalty rate on commercial sales of aldoxorubicin depending upon the indication, in addition to potential payments of up to $343 million in development and commercial milestones from ImmunityBio.

HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority Review Status

Retrieved on: 
Thursday, January 11, 2024

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases.

Key Points: 
  • HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”).
  • Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases.
  • “Our submission includes data from the successful Phase III ESLIM-01 trial in China which demonstrated a durable response rate of sovleplenib for patients.
  • There is a significant need for new therapies in adult primary ITP which can significantly impair the quality of life for patients.”

BridgeBio Pharma Announces Publication of Positive Results from Phase 3 ATTRibute-CM Study of Acoramidis for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in the New England Journal of Medicine

Retrieved on: 
Wednesday, January 10, 2024

ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, small molecule stabilizer of transthyretin (TTR).

Key Points: 
  • ATTRibute-CM was designed to study the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, small molecule stabilizer of transthyretin (TTR).
  • Findings presented in the NEJM support acoramidis as an effective and safe treatment option for patients with ATTR-CM and reinforce the hypothesis that greater stabilization of TTR may be associated with improved clinical outcomes.
  • BridgeBio has also presented additional detailed results from ATTRibute-CM at the European Society of Cardiology Congress 2023 in August and at the American Heart Association Scientific Sessions 2023 in November .
  • The Company submitted a New Drug Application to the U.S. FDA in 2023 and intends to submit additional marketing authorization applications to regulatory bodies in 2024.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Milestone Pharmaceuticals Inc.- MIST

Retrieved on: 
Wednesday, January 10, 2024

NEW YORK, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Milestone Pharmaceuticals Inc. (“Milestone” or the “Company”) (NASDAQ: MIST).

Key Points: 
  • NEW YORK, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Milestone Pharmaceuticals Inc. (“Milestone” or the “Company”) (NASDAQ: MIST).
  • The investigation concerns whether Milestone and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Global Oncology Cancer Drugs Market Revenue Projected To Surpass $289 Billion By 2030

Retrieved on: 
Tuesday, January 9, 2024

Cancer is a non-treatable chronic disease that has posed a challenge to the medical fraternity for decades.

Key Points: 
  • Cancer is a non-treatable chronic disease that has posed a challenge to the medical fraternity for decades.
  • The entire medical research fraternity has prioritized cancer research in order to find new ways of treatment and analysis.
  • According to Nova one advisor, the global Oncology Cancer Drugs market was valued at USD 147.2 billion in 2021 and it is expected to hit around USD 289.2 billion by 2030 with a CAGR of 8.4% during the forecast period 2022 to 2030.
  • The article continued: “Drugs such as morphine, fentanyl, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and others are used extensively in treating cancer pain in patients with lung cancer, bone cancer, and other types of cancer.

Tonix Pharmaceuticals Presents Additional Data Highlighting the Favorable Tolerability and Differentiated Side Effect Profile of TNX-102 SL in Second Positive Phase 3 Clinical Trial for the Management of Fibromyalgia

Retrieved on: 
Tuesday, January 9, 2024

CHATHAM, N.J., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of additional safety and tolerability data from RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, at Biotech Showcase™ 2024 in San Francisco, January 8-10.

Key Points: 
  • As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia.
  • Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.
  • Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for TNX-102 SL for the management of fibromyalgia.
  • RELIEF, the first Phase 3 trial of TNX-102 SL 5.6 mg in fibromyalgia, was completed in December 2020.