Biologics license application

Pancreatic Cancer Research Gains Momentum Amidst Soaring Young-Onset Cases

Retrieved on: 
Tuesday, September 26, 2023
Gastrointestinal cancer, MDT, Breakthrough therapy, MBA, GH, Congress, Incidence, Helmy Eltoukhy, Patient, JAMA Network Open, Health, NYSE, Polyp, News, Disease, Oncolytics Biotech, Research, Attention, Biologics license application, MRD, ONC, Pancreatic Cancer Action Network, Data, JD, TSX, FDA, Lancet, GI, Pancreatic cancer, Human, CAD, NSCLC, Biomarker, NRG1, Colorectal cancer, CR, United States Congress, ORR, Clinical trial, FOLFIRINOX, ASCO, American Society of Clinical Oncology, Physician, EUS, Annual general meeting, Poster, Recurrence, Society, FTD, Breast cancer, Pharmaceutical industry, Medical imaging, Meru Networks, Nvidia, Medtronic

VANCOUVER, British Columbia, Sept. 26, 2023 /PRNewswire/ -- USA News Group - The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merus N.V. (NASDAQ: MRUS), Guardant Health, Inc. (NASDAQ: GH), Medtronic plc (NYSE: MDT), and even NVIDIA Corporation (NASDAQ: NVDA).

Key Points: 
  • This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now.
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN.

Pancreatic Cancer Research Gains Momentum Amidst Soaring Young-Onset Cases

Retrieved on: 
Tuesday, September 26, 2023
Gastrointestinal cancer, MDT, Breakthrough therapy, MBA, GH, Congress, Incidence, Helmy Eltoukhy, Patient, JAMA Network Open, Health, NYSE, Polyp, News, Disease, Oncolytics Biotech, Research, Attention, Biologics license application, MRD, ONC, Pancreatic Cancer Action Network, Data, JD, TSX, FDA, Lancet, GI, Pancreatic cancer, Human, CAD, NSCLC, Biomarker, NRG1, Colorectal cancer, CR, United States Congress, ORR, Clinical trial, FOLFIRINOX, ASCO, American Society of Clinical Oncology, Physician, EUS, Annual general meeting, Poster, Recurrence, Society, FTD, Breast cancer, Pharmaceutical industry, Medical imaging, Meru Networks, Nvidia, Medtronic

VANCOUVER, British Columbia, Sept. 26, 2023 /PRNewswire/ -- USA News Group - The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merus N.V. (NASDAQ: MRUS), Guardant Health, Inc. (NASDAQ: GH), Medtronic plc (NYSE: MDT), and even NVIDIA Corporation (NASDAQ: NVDA).

Key Points: 
  • This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now.
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN.

Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa

Retrieved on: 
Tuesday, September 26, 2023
Biologics license application, Priority review, ISID, RDEB, Quality of life, Concha bullosa, Regenerative medicine, Rare, Orphanet Journal of Rare Diseases, Patient, Tissue Engineering and Regenerative Medicine International Society, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Safety, Wound healing, Pharmaceutical industry, New Drug Application

As part of the submission, Abeona requested a Priority Review, which, if granted, would shorten the FDA’s review period to six months from the filing acceptance of the BLA, instead of 10 months under standard review.

Key Points: 
  • As part of the submission, Abeona requested a Priority Review, which, if granted, would shorten the FDA’s review period to six months from the filing acceptance of the BLA, instead of 10 months under standard review.
  • “We appreciate the FDA’s level of engagement and constructive guidance in the months leading up to the pre-BLA meeting.
  • If accepted with Priority Review, Abeona expects potential BLA approval in the second quarter of 2024, at which time, Abeona believes that it would be eligible to receive a Priority Review Voucher.
  • EB-101 has been granted Rare Pediatric Disease, Regenerative Medicine Advanced Therapy, Breakthrough Therapy and Orphan Drug designations.

Regeneron Completes Acquisition of Decibel Therapeutics, Adding Promising Gene Therapy Programs for Hearing Loss

Retrieved on: 
Monday, September 25, 2023
STRC, Centerview Partners, CVR, Doctor of Philosophy, Hearing loss, Eastern Time Zone, Congenital hearing loss, European Medicines Agency, Gene editing, Clinical trial, GAAP, AAV, Wilmer Cutler Pickering Hale and Dorr, Wachtell, Lipton, Rosen & Katz, Gene silencing, Biologics license application, GJB2, Acquisition, Patient, CVR Partners, Computershare, Biology, Medicines and Healthcare products Regulatory Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Regeneron Pharmaceuticals, Decibel

TARRYTOWN, N.Y., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it has successfully completed its acquisition of Decibel Therapeutics, Inc., strengthening the company’s gene therapy and auditory programs.

Key Points: 
  • TARRYTOWN, N.Y., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it has successfully completed its acquisition of Decibel Therapeutics, Inc., strengthening the company’s gene therapy and auditory programs.
  • The acquisition of Decibel builds on prior collaboration between the companies and includes three ongoing gene therapy programs targeting different forms of congenital, monogenic hearing loss.
  • Preclinical programs include AAV.103 for people with GJB2-related hearing loss and AAV.104 for people with stereocilin (STRC)-related hearing loss.
  • Following its acceptance of the tendered shares, Regeneron completed its acquisition of Decibel through a second step merger of Symphony Acquisition Sub, Inc., with and into Decibel.

FDA Issues Complete Response Letter (CRL) for UDENYCA® ONBODY™ Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections

Retrieved on: 
Monday, September 25, 2023
Biologics license application, OBI, Symantec Endpoint Protection, Survival, Cancer, Research, Trial of the century, Nasopharyngeal carcinoma, CHRS, Patient, Observation, CRL, NPC, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Safety, Disease, Pharmaceutical industry

REDWOOD CITY, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies to treat cancer, announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) supplement for UDENYCA® ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA® (pegfilgrastim-cbqv), solely due to an ongoing review of inspection findings at a third-party filler. The CRL did not identify any issues with the UDENYCA® ONBODY™ clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing, and no additional data or trials have been requested. Coherus is committed to working closely with the FDA and the third-party filler to bring UDENYCA® ONBODY™ to cancer patients requiring pegfilgrastim treatment as quickly as possible.

Key Points: 
  • Coherus is committed to working closely with the FDA and the third-party filler to bring UDENYCA® ONBODY™ to cancer patients requiring pegfilgrastim treatment as quickly as possible.
  • “We are pleased the FDA has completed the review elements for the OBI and toripalimab applications,” said Dr. Theresa LaVallee, Coherus Chief Development Officer.
  • “We will work with the third-party filler to address the issues and resubmit the UDENYCA® ONBODY™ application as quickly as possible.
  • NPC is a rare cancer with high unmet medical need that has no drugs approved for treatment of this disease in the U.S.”

BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®

Retrieved on: 
Tuesday, September 19, 2023
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Biologics license application, BGNE, Prescription Drug User Fee Act, Civil service commission, Marketing, ODD, Survival, Advanced Therapy Medicinal Product, Cancer, Quality of life, Medicine, Committee, SSE, European Commission, Patient, Physician, ESCC, Diagnosis, Committee for Medicinal Products for Human Use, Rare, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, PD-L1, Food, Caregiver, Safety, Tislelizumab, Pharmaceutical industry, BeiGene

“We are excited to announce the European Commission approval and the FDA filing acceptance for tislelizumab, having recently regained full global rights to this important medicine.

Key Points: 
  • “We are excited to announce the European Commission approval and the FDA filing acceptance for tislelizumab, having recently regained full global rights to this important medicine.
  • The study enrolled 513 patients from 132 research sites in 11 countries in Europe, Asia and North America.
  • The FDA has assigned a target action date in the second half of 2024, under the Prescription Drug User Fee Act.
  • The FDA also granted tislelizumab Orphan Drug Designation (ODD) for the treatment of previously untreated advanced or metastatic ESCC.

Atara Biotherapeutics Announces Plans to Submit Tab-cel® BLA in Q2 2024 Following FDA Agreement on Comparability

Retrieved on: 
Tuesday, September 19, 2023
Oncology, Health, FDA, Research, Science, Pharmaceutical, Biotechnology, Biologics license application, Northwest Biotherapeutics, Partnership, Epstein–Barr virus, EBV, Survival, Cancer, HCT, SOT, Transplant, Patient, ATRA, Immunosuppression, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, European Commission, Vaccine, Pharmaceutical industry

Following productive discussions between Atara and the U.S. Food and Drug Administration (FDA), the FDA and Atara are now aligned on analytical comparability between manufacturing process versions.

Key Points: 
  • Following productive discussions between Atara and the U.S. Food and Drug Administration (FDA), the FDA and Atara are now aligned on analytical comparability between manufacturing process versions.
  • This alignment supports Atara's ability to pool the pivotal clinical trial data from different process versions in the Biologics License Application (BLA) submission.
  • Atara expects to submit the tab-cel BLA in Q2 2024, which will enable Atara to incorporate the latest tab-cel pivotal trial data from the ALLELE study into the BLA filing package.
  • Tabelecleucel is commercialized by Pierre Fabre in Europe as EBVALLO™ following European Commission marketing authorization in December 2022.

EQS-News: Biotest AG: US Food and Drug Administration FDA accepts marketing authorization application for immunoglobulin Yimmugo

Retrieved on: 
Saturday, September 16, 2023
Marketing, PID, Biologics license application, ITP, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Medical device

Biotest AG announced today that the Biologics License Application (BLA) for the polyspecific immunoglobulin preparation Yimmugo (IgG Next Generation) has been accepted for review by the U.S. Food and Drug Administration (FDA) after the 60-day validation phase.

Key Points: 
  • Biotest AG announced today that the Biologics License Application (BLA) for the polyspecific immunoglobulin preparation Yimmugo (IgG Next Generation) has been accepted for review by the U.S. Food and Drug Administration (FDA) after the 60-day validation phase.
  • With this filing notification the marketing authorization application will enter the next phase, in which the application dossier will be subjected to an in-depth substantive review.
  • "We are pleased that the FDA has accepted our Yimmugo dossier for review, which reflects the completeness and required level of detail of the submitted application dossier.
  • The FDA's decision on the marketing authorization application of Yimmugo is expected on June 29, 2024.

Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

Retrieved on: 
Tuesday, September 12, 2023
Infection, Biologics license application, KOL, Extremities, Surgeon, File, Amputation, Conference call, Internet, Ligation, Clinical trial, Trauma, Sale, Saphenous, Regenerative Medicine Advanced Therapy, Food and Drug Administration Amendments Act of 2007, Patient, Standard of care, Risk, HUMA, Injury, Peripheral artery disease, FDA, HAV, BLA, Conference, Food, Vaccine, Pharmaceutical industry

DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair. The single-arm clinical trial was a success and showed that the HAV in this study had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023.

Key Points: 
  • ET today -
    DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.
  • Humacyte plans to file a Biologics License Application (BLA) for the treatment of vascular trauma with the Food and Drug Administration (FDA) during the 4th quarter of 2023.
  • Patients enrolled in the study did not have the standard of care, saphenous vein, available to use as a bypass graft.
  • Human Acellular Vessel (HAV) for Vascular Trauma Repair: Top Line Phase 2/3 V005 Results and KOL Perspectives

Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate

Retrieved on: 
Thursday, September 7, 2023
Biologics license application, Partnership, GMT Games, Lyme disease, Senior, DSMB, Saint-Herblain, Vaccination, European Medicines Agency data breach, Valneva SE, PFE, Immunity, Pfizer, Marketing, Șaeș, Data monitoring committee, EMA, Euronext Paris, VLA, Adolescence, European Medicines Agency, Security agency, MAA, Marketing Authorisation Application, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, BLA, NYSE, Food, Vaccine

Saint-Herblain (France) & New York, September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.

Key Points: 
  • Saint-Herblain (France) & New York, September 7, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. (NYSE: PFE) announced today positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given as a booster.
  • Lyme disease continues to spread, representing an important unmet medical need that impacts the lives of many people in the Northern Hemisphere.
  • With each new set of positive data, we come one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.”
    The Phase 2 booster results emphasize the vaccine candidate’s potential to provide immunity against Lyme disease in pediatric and adolescent populations.
  • “Protection against Lyme disease is important for anyone who lives or spends time outdoors in areas where Lyme disease is endemic.