BLA

Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for ARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency

Retrieved on: 
Thursday, June 1, 2023
Biotechnology, FDA, Health, Genetics, Pharmaceutical, Vaccine, Acceleration, Biologics license application, FCP, Diversified Specialty Institute Holdings, Inc., Therapy, Arcturus Therapeutics, Infection, ARCT, MBA, Medicine, RNA, MD, OTC, Liver, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Arcturus

Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company’s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency.

Key Points: 
  • Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company’s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency.
  • Fast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs.
  • Programs granted Fast Track Designation may receive important benefits including more frequent interactions with FDA review teams and the ability to obtain rolling review of a Biologics License Application (BLA).
  • “ARCT-810 has the potential to be an important new medicine for individuals living with OTC deficiency and we are very pleased to have obtained Fast Track Designation for this program.

Selecta Biosciences Announces Presentation of Data from Phase 3 DISSOLVE Program of SEL-212 in Chronic Refractory Gout During Late-Breaking Session at the EULAR 2023 European Congress of Rheumatology

Retrieved on: 
Wednesday, May 31, 2023
Biologics license application, MACR, European Alliance of Associations for Rheumatology, FACP, Immune tolerance, WHO-convened Global Study of Origins of SARS-CoV-2, Disability, Congress, Patient, European, EULAR, Principal, George Washington University, Chronic pain, European Alliance, BLA, Pharmaceutical industry, Palladium, Rheumatology, Medicine

WATERTOWN, Mass., May 31, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR™ platform to develop tolerogenic therapies for autoimmune diseases and gene therapies, today announced the presentation of positive data from the Phase 3 DISSOLVE I and DISSOLVE II double-blind, placebo-controlled studies of SEL-212 in patients with chronic refractory gout. SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase). The data were featured during a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2023 European Congress of Rheumatology being held May 31 – June 3 in Milan, Italy.

Key Points: 
  • SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).
  • The data were featured during a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2023 European Congress of Rheumatology being held May 31 – June 3 in Milan, Italy.
  • The response rate in the high dose group was 56% in DISSOLVE I and 46% in DISSOLVE II.
  • A copy of the presentation will be available in the Resources section of Selecta’s website, http://www.selectabio.com/.

ALVO, ALVOW LOSS ALERT: ROSEN, NATIONAL TRIAL COUNSEL, Encourages Alvotech Investors to Inquire About Securities Class Action Investigation – ALVO, ALVOW

Retrieved on: 
Tuesday, May 30, 2023
Titan, Adalimumab, Advertising, CRL, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, News, I-Space (Chinese company), Food, Cryptocurrency

WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=15814 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=15814 or call Phillip Kim, Esq.
  • toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Valneva Files for Chikungunya Vaccine Authorization with Health Canada

Retrieved on: 
Tuesday, May 30, 2023
Epidemic, Biologics license application, Pan American Health Organization, Saint-Herblain, Vaccination, Priority, Coalition, European Medicines Agency, Valneva SE, CEPI, PAHO, Coalition for Epidemic Preparedness Innovations, Licensure, Chikungunya, Person, Trial of the century, Fast track (FDA), EMA, Euronext Paris, VLA, MD, Instituto Butantan, PDUFA, Ageing, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Vaccine

Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above.

Key Points: 
  • Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above.
  • If accepted, Health Canada will provide additional information on the potential approval timeline.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of ImmunityBio, Inc. - IBRX

Retrieved on: 
Sunday, May 28, 2023
GMP, Biologics license application, LLP, Good manufacturing practice, FDA, Pomerantz, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, News, Food, Private investigator, ImmunityBio COVID-19 vaccine

NEW YORK, May 28, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of ImmunityBio, Inc. (“ImmunityBio” or the “Company”) (NASDAQ: IBRX).

Key Points: 
  • NEW YORK, May 28, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of ImmunityBio, Inc. (“ImmunityBio” or the “Company”) (NASDAQ: IBRX).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether ImmunityBio 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.

Acticor Biotech: Progress in Discussions with EU and US Regulatory Agencies

Retrieved on: 
Tuesday, May 30, 2023
Biotechnology, Pharmaceutical, Health, Intracerebral hemorrhage, Splenic infarction, IDMC, Clinical trial, AIS, PRIME, EMA, Thrombectomy, Patient, ISIN, Mortality, FDA, BLA, Safety, Pharmaceutical industry, Medical device, EU

In the US, Acticor Biotech was granted FDA Type C consultation on its non-clinical and clinical developments for its first-in-class drug candidate, glenzocimab.

Key Points: 
  • In the US, Acticor Biotech was granted FDA Type C consultation on its non-clinical and clinical developments for its first-in-class drug candidate, glenzocimab.
  • Written responses were received by the end of May 2023 on a list of questions regarding potential future marketing authorization (BLA) of glenzocimab in AIS indication.
  • The FDA provided valuable feedback to reinforce the proposed development plan and to best address US requirements on the expected design of a pivotal study.
  • In Europe, Acticor continues to discuss the clinical and pharmaceutical developments for registration with the EMA as part of the PRIME designation program.

CELL WORLD - Aiming at Internationalization, Starting from Regulation - The 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration Successfully Held

Retrieved on: 
Monday, May 29, 2023
Laughter, European Medicines Agency, Tisagenlecleucel, First Affiliated Hospital of Xinjiang Medical University, Soochow University, Patient, Shanghai University, Cell, Medicines and Healthcare products Regulatory Agency, BLA, BioValley, DLBCL, Duke University School of Medicine, EMA, CELL, Anniversary Celebration, FDA, IND, Multimedia, China Institute for Innovation and Development Strategy, Therapy, MD Anderson Cancer Center, RMB, MHRA, Speech, CMC, Medication, Bristol Myers Squibb, Implementation, CDMO, Clinical trial, Novartis, IBLA International Competition, DoubleTree, Bengbu Medical College, Pharmaceutical industry, Medical device, EU, Medicine

SUZHOU, China, May 29, 2023 /PRNewswire/ -- On May 26, 2023, the "CELL WORLD 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration," meticulously planned by Hillgene Biopharma and Biovalley, was successfully held at the DoubleTree by Hilton in Wuzhong District, Suzhou.

Key Points: 
  • SUZHOU, China, May 29, 2023 /PRNewswire/ -- On May 26, 2023, the "CELL WORLD 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration," meticulously planned by Hillgene Biopharma and Biovalley, was successfully held at the DoubleTree by Hilton in Wuzhong District, Suzhou.
  • "This is the 1st summit of CELL WORLD, and Hillgene Biopharma will host this summit in the long term.
  • I hope this 1st CELL WORLD Global Cell Therapy Summit will further promote the development and innovation of cell therapy industry globally and provide more thoughts and practical examples."
  • The "CELL WORLD 1st Global Cell Therapy Summit and Hillgene Biopharma Anniversary Celebration" came to a perfect end amid the laughter and joy of the banquet.

Iovance Biotherapeutics Announces U.S. Food and Drug Administration Acceptance of the Biologics License Application of Lifileucel for the Treatment of Advanced Melanoma

Retrieved on: 
Friday, May 26, 2023
Priority review, Interim, Prescription Drug User Fee Act, Regenerative Medicine Advanced Therapy, File, TIL, Clinical trial, Cancer, Iovance Biotherapeutics, Patient, Physician, Melanoma, PDUFA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry

SAN CARLOS, Calif., May 26, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for lifileucel for patients with advanced melanoma. The FDA granted lifileucel Priority Review and assigned November 25, 2023 as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA). The FDA is not currently planning to hold an advisory committee meeting to discuss this application and, after a preliminary review, has not at this time identified any potential review issues.

Key Points: 
  • The FDA granted lifileucel Priority Review and assigned November 25, 2023 as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA).
  • Lifileucel is a TIL therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable.
  • The FDA also previously granted a Regenerative Medicine Advanced Therapy ( RMAT ) designation for lifileucel in advanced melanoma.
  • If lifileucel receives accelerated approval, the randomized Phase 3 TILVANCE-301 trial in frontline advanced melanoma can serve as the confirmatory study to support full approval.

Ferring Announces Positive Topline Phase 3 Results for SI-6603, an Investigational Treatment for Lumbar Disc Herniation

Retrieved on: 
Friday, May 26, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Comparison, Biologics license application, Ferring Pharmaceuticals, Visual analogue scale, Sciatica, Hope, VAS, Spinal disc herniation, Patient, MPH, BLA, Pharmaceutical industry, MD

Ferring Pharmaceuticals (Ferring) announced that its clinical development partner, Seikagaku Corporation (Seikagaku), achieved positive topline results for its registrational Phase 3 clinical trial of SI-6603, an investigational treatment for lumbar disc herniation (generic name: Condoliase).

Key Points: 
  • Ferring Pharmaceuticals (Ferring) announced that its clinical development partner, Seikagaku Corporation (Seikagaku), achieved positive topline results for its registrational Phase 3 clinical trial of SI-6603, an investigational treatment for lumbar disc herniation (generic name: Condoliase).
  • The study was a randomized, double-blind, controlled, parallel-group, comparative study of SI-6603 in 352 patients with lumbar disc herniation.
  • Ferring plans to commercialize the product in the United States and has received further rights to develop, register and commercialize SI-6603 worldwide, excluding Japan.
  • “The positive topline results offer the hope of a non-surgical treatment option for patients and their healthcare providers.”

Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001

Retrieved on: 
Wednesday, May 24, 2023
FDA, Health, Genetics, Other Health, Pharmaceutical, Biotechnology, Biologics license application, SRPT, Sarepta, Rare, Mutation, Therapy, Duchenne muscular dystrophy, DMD, BLA, Patient, Agency, Pharmaceutical industry, Duchenne

Following discussions with FDA, the Agency has indicated that, subject to the completion of the BLA review, it is working toward potentially granting an accelerated approval for SRP-9001, initially for use in Duchenne patients ages 4-5 years old.

Key Points: 
  • Following discussions with FDA, the Agency has indicated that, subject to the completion of the BLA review, it is working toward potentially granting an accelerated approval for SRP-9001, initially for use in Duchenne patients ages 4-5 years old.
  • EMBARK, the global, randomized, double-blind, placebo-controlled Phase 3 trial of SRP-9001, is the proposed confirmatory study.
  • The FDA has also informed Sarepta that it requires modest additional time to complete the review, including final label negotiations and postmarketing commitment discussions, and that it anticipates that the review will be complete by June 22, 2023.
  • Sarepta will remain in a quiet period for the duration of the BLA review.