White Light Rock & Roll Review

South Rampart Pharma Expands Global Patent Portfolio with EU Approval for FDA Fast-Tracked SRP-001 for Pain

Retrieved on: 
Wednesday, November 1, 2023
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NEW ORLEANS, Nov. 1, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage life science company focused on developing innovative pain treatments, announced today the issuance of European Patent No. 3672938 by the European Patent Office (EPO) effective November 1, 2023. This patent will apply to all Unified Patent Court-participating and non-participating European Unitary member states.

Key Points: 
  • This patent will apply to all Unified Patent Court-participating and non-participating European Unitary member states.
  • This patent, excluding possible patent term extensions, is expected to provide South Rampart with market exclusivity in the EPO member states until 2038, aligning with the U.S. Patent No.
  • On October 4, 2023, the U.S. FDA granted Fast Track designation to SRP-001 for acute pain.
  • The FDA Fast Track designation allows for more frequent interactions with the FDA, streamlining the clinical development plan and trial design to expedite drug approval.

Introducing An AI-powered Music Distribution: 52Eighty Distro

Retrieved on: 
Tuesday, October 10, 2023
Pink, Partnership, Ford, United Talent Agency, The Island Def Jam Music Group, Distro, Opaque (rapper), 2014 Latin Billboard Music Awards, NFL, AI, Culture, Publishing, Music, Creative Artists Agency, Fortune 500, Entrepreneurship, White Light Rock & Roll Review, NBA, Disco Donnie Presents, Paradigm Talent Agency, MLB, Chameleon, DJ, Sun City Music Festival, Bass, Social media, Endeavor (company), EVP, Paradigm, NHL, Video game, Nightclub

52 Eighty Distro engages with the creative community via direct partnerships with artists, as well as through strategic alliances with like-minded entrepreneurs.

Key Points: 
  • 52 Eighty Distro engages with the creative community via direct partnerships with artists, as well as through strategic alliances with like-minded entrepreneurs.
  • Through this partnership, 52 Eighty Distro first brought the song “HYM” to TikTok and it is available on all streaming platforms .
  • Ford's unique perspective and bold vision will make 52 Eighty Distro a leader in the music distribution industry.
  • 52 Eighty Distro utilizes various channels, such as streaming services, online music stores, and physical retailers.

South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain

Retrieved on: 
Thursday, October 12, 2023
Pain, Male, Priority review, Food, Female, Plasma protein binding, PAG, U.S. FDA, MD, Aes, Communication, Liver, PK, Safety, Western world, MAD, Vital signs, Paracetamol, FDA, White Light Rock & Roll Review, Collection, Accelerated approval (FDA), Kidney, NDA, Acute liver failure, Automated ECG interpretation, Fast Track, New Drug Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Volunteering, CNS, Patient, Pharmaceutical industry, Medical device

NEW ORLEANS, Oct. 12, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage biopharmaceutical company targeting the safer treatment of pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company for SRP-001 for the treatment of acute pain. SRP-001 is a novel, first-in-class non-opioid analgesic that activates pain signaling pathways in the midbrain's periaqueductal grey (PAG) region without liver and kidney toxicities. The Fast Track designation facilitates the development and expedites the review of new therapies for serious conditions, aiming to bring important new drugs to patients earlier and address unmet medical needs.

Key Points: 
  • The Fast Track designation accelerates SRP-001's path to U.S. FDA submission for the treatment of acute pain
    Enhanced time-to-market delivers a therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.
    NEW ORLEANS, Oct. 12, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage biopharmaceutical company targeting the safer treatment of pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company for SRP-001 for the treatment of acute pain.
  • SRP-001 is a novel, first-in-class non-opioid analgesic that activates pain signaling pathways in the midbrain's periaqueductal grey (PAG) region without liver and kidney toxicities.
  • The Fast Track designation facilitates the development and expedites the review of new therapies for serious conditions, aiming to bring important new drugs to patients earlier and address unmet medical needs.
  • "In the CNS and pain space, Fast Track designation for SRP-001 isn't just a regulatory milestone; it's a commercial accelerant.

Centessa Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for SerpinPC for Hemophilia B

Retrieved on: 
Monday, May 22, 2023
Priority review, CNTA, Fast Track, Accelerated approval (FDA), Person, White Light Rock & Roll Review, Patient, Haemophilia, APC, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

BOSTON and LONDON, May 22, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors.

Key Points: 
  • BOSTON and LONDON, May 22, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors.
  • "We are pleased with the FDA’s decision to grant Fast Track designation for SerpinPC as we continue to advance the PRESent registrational studies for SerpinPC in hemophilia B,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa.
  • “This designation is important recognition of SerpinPC’s novel mechanism of action and underscores the critical need for new treatment options for persons with hemophilia B.
  • A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval, Priority Review, or Rolling Review.

PharmaTher Holdings Submits Fast Track Application to FDA for KETARX™ (Ketamine) for the Treatment of Parkinson’s Disease

Retrieved on: 
Tuesday, May 2, 2023
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Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Key Points: 
  • Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
  • NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
  • Summary results of the Phase I/II clinical study:
    Enrolled subjects with moderate to advanced Parkinson’s disease with a target infusion rate being 0.30 mg/kg/hr.
  • Parkinson’s disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.

Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation

Retrieved on: 
Monday, January 23, 2023
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Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • The purpose of Fast Track is to get important new drugs to the patient earlier.
  • Fast Track addresses a broad range of serious conditions.
  • The FDA had previously granted an Orphan Drug Designation (ODD) for tecarfarin.

Sedana Medical receives FDA Fast Track Designation in the United States

Retrieved on: 
Wednesday, January 4, 2023
Richmond Agitation-Sedation Scale, Patient, Fast track (FDA), Communication, Respiratory failure, Food, Accelerated approval (FDA), Fast Track, Propofol, Inhalation sedation, Certification, III, FN, ICU, New Drug Application, FDA, Safety, Priority review, News, FTD, White Light Rock & Roll Review, NDA, Isoflurane, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RASS, Pharmaceutical industry, Medical device, Weapon, Nordic

Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.
  • Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the United States.
  • Sedana Medical will engage in discussions with the FDA on how the development program can benefit from the FTD.
  • Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.

Sedana Medical receives FDA Fast Track Designation in the United States

Retrieved on: 
Wednesday, January 4, 2023
Richmond Agitation-Sedation Scale, Patient, Fast track (FDA), Communication, Respiratory failure, Food, Accelerated approval (FDA), Fast Track, Propofol, Inhalation sedation, Certification, III, FN, ICU, New Drug Application, FDA, Safety, Priority review, News, FTD, White Light Rock & Roll Review, NDA, Isoflurane, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RASS, Pharmaceutical industry, Medical device, Weapon, Nordic

Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.

Key Points: 
  • Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need.
  • Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the United States.
  • Sedana Medical will engage in discussions with the FDA on how the development program can benefit from the FTD.
  • Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.

Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an Allogeneic Anti-CD19 CAR-T Cell Therapy

Retrieved on: 
Tuesday, November 29, 2022
CR, PMBCL, B-cell lymphoma, PD-1, Food, RNA, DNA, Rachel Haurwitz, Risk, Safety, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, EHA, White Light Rock & Roll Review, Accelerated approval (FDA), Annual report, CRISPR/Cpf1, TRAC, Orphan drug, European Hematology Association, Fast Track, Genome, CAR, Lymphatic system, Security (finance), Reindeer, Phenotype, Research, Congress, Clinical trial, Priority, CRISPR, DLBCL, FDA, Vaccine, Pharmaceutical industry, Sewing

BERKELEY, CA, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted CB-010 Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory large B cell lymphoma (LBCL) and Fast Track designation for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, is being evaluated in the company’s ongoing ANTLER Phase 1 clinical trial in patients with r/r B-NHL, which can enroll three LBCL subtypes: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), and high-grade B cell lymphoma (HGBL). CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion.

Key Points: 
  • We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies.
  • Encouraging safety data and antitumor activity for CB-010 at dose level 1 (40x106 CAR-T cells) have been reported from the ANTLER trial .
  • CB-010 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations.
  • Caribou Biosciences and the Caribou logo are registered trademarks of Caribou Biosciences, Inc.

G1 Therapeutics Completes Enrollment in Global Multi-Center Phase 3 Clinical Trial of Trilaciclib in Patients with Metastatic Triple Negative Breast Cancer (TNBC)

Retrieved on: 
Monday, October 10, 2022
PFS, Therapy, RESEARCH, Review, Group 2, New Drug Application, Carboplatin, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Carrier Strike Group 2, Patient, PARK, GC, Group 3, HIV disease progression rates, White Light Rock & Roll Review, G1, UFDA, Nasdaq, Bone marrow, OS, Trilaciclib, Food, Company, TNBC, Accelerated approval (FDA), Toxicity, ORR, Survival, Fast Track, GLOBE, Priority review, FDA, CRO, Pharmaceutical industry, Simcere Pharmaceutical

The trial includes 187 patients receiving first line trilaciclib or placebo prior to gemcitabine and carboplatin (GC).

Key Points: 
  • The trial includes 187 patients receiving first line trilaciclib or placebo prior to gemcitabine and carboplatin (GC).
  • PRESERVE 2 is exciting as it is evaluating trilaciclib in mTNBC to build on the robust survival benefit observed in the Phase 2 program.
  • PRESERVE 2 is a global multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in patients with metastatic TNBC receiving first line trilaciclib or placebo administered prior to GC.
  • G1Therapeutics and the G1 Therapeutics logo and COSELA and the COSELA logo are trademarks of G1 Therapeutics, Inc.