Biologics license application

Alladapt Immunotherapeutics Receives FDA Fast Track Designation for ADP101 for the Treatment of Mono- and Multi-Food Allergies

Retrieved on: 
Wednesday, November 22, 2023
Biologics license application, Empoasca decipiens, Allergen, Food, FDA, OIT, Salmon, Peanut, Letter, Immunoglobulin E, Food allergy, American College, Hazelnut, ACAAI, Patient, Safety, Data collection, Harmony, Therapy, Fast Track, BLA, Pharmaceutical industry

MENLO PARK, Calif., Nov. 22, 2023 (GLOBE NEWSWIRE) -- Alladapt Immunotherapeutics, Inc., a private, clinical-stage biopharmaceutical company developing prescription therapeutics to address IgE-mediated food allergy, today announced that ADP101, its investigational multi-food oral immunotherapy (mOIT) designed to simultaneously treat allergy to one or more of the world’s most significant food allergens, received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ADP101 is the most advanced multi-food OIT pharmaceutical candidate in development.

Key Points: 
  • Our team is thrilled to be at the forefront of developing a new treatment that addresses such a huge unmet need.
  • FDA’s Fast Track program is designed to expedite the development of new drugs intended to treat serious or life-threatening conditions.
  • Fast Track allows more frequent meetings and written communications with FDA to discuss the drug's development plan, clinical trial design, and data collection.
  • Alladapt is also conducting the Encore Study, an open-label extension study of the Harmony study assessing long term use of ADP101 in mono- and multi-food allergic patients.

Brainstorm Cell Therapeutics Inc. Class Action Reminder: Contact Robbins LLP for Information About the BCLI Class Action

Retrieved on: 
Tuesday, November 21, 2023
Cellular, Food, ALS, Biotechnology, Efficacy, LLP, FDA, Person, Complaint, SAN, Gene, Biologics license application, News, Viability, BLA, Pharmaceutical industry

SAN DIEGO, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) securities between August 15, 2022 and September 27, 2023.

Key Points: 
  • SAN DIEGO, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) securities between August 15, 2022 and September 27, 2023.
  • Brainstorm Cell is a biotechnology company that develops and commercializes autologous cellular therapies for the treatment of neurodegenerative diseases.
  • For more information, submit a form , email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • What Now: Similarly situated shareholders may be eligible to participate in the class action against Brainstorm Cell Therapeutics Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP.

MediWound Reports Third Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, November 21, 2023
Phase, Forecasting, Table, FDA, CHMP, Conference, Event, Adjustment, Journal, Tax, Depreciation, PMI, EMA, Burn, Conference call, Biologics license application, Patient, Partnership, Operating cost, Research, Eschar, Bromelain (pharmacology), Hospital, Incidence, Bank statement, Standard of care, Food and Drug Administration, GMP, Temperature, HERE, European Medicines Agency, Investment, Committee, BLA, Pharmaceutical industry

YAVNE, Israel, Nov. 21, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • Revenues: Revenues for the third quarter of 2023 were $4.8 million, compared to $5.8 million in the same quarter of the previous year.
  • Research and development expenses in the third quarter of 2023 were $1.5 million compared to $2.9 million in the third quarter of 2022.
  • Operating Results: Operating loss in the third quarter of 2023 was $3.0 million, compared to $3.5 million loss in the third quarter of 2022.
  • In the first quarter of 2023, the Company raised a gross amount of $27.5 million through a registered direct offering.

Sarepta Therapeutics Submits Efficacy Supplement to Expand the ELEVIDYS Label to include Duchenne Muscular Dystrophy Patients without Restriction to Age or Ambulatory Status

Retrieved on: 
Friday, December 22, 2023
FDA, Health, Research, Pharmaceutical, Science, Biotechnology, Patient, Food, Agency, Priority review, Physician, Roche, Duchenne muscular dystrophy, Disease, Sarepta Therapeutics, Biologics license application, Therapy, SRPT, Mutation, PMR, DMD, BLA, Pharmaceutical industry

The supplement was submitted to the U.S. Food and Drug Administration (FDA) with a request for Priority Review.

Key Points: 
  • The supplement was submitted to the U.S. Food and Drug Administration (FDA) with a request for Priority Review.
  • An efficacy supplement is a submitted request for a proposed change to an approved product’s labeling, including adding or modifying an indication previously filed with the FDA.
  • Sarepta has also completed the EMBARK postmarketing requirement (PMR) and submitted the PMR to FDA requesting conversion from accelerated approval to traditional approval.
  • Roche is responsible for regulatory approvals and bringing ELEVIDYS to patients across the rest of the world.

Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Retrieved on: 
Friday, December 22, 2023
Biotechnology, Pharmaceutical, Health, Oncology, MSD, Senior, Food, Leukopenia, Priority review, Hypokalemia, Daiichi Sankyo, FDA, Breakthrough therapy, PDUFA, EGFR, ILD, Anemia, Fatigue, HER3, Neutropenia, MD, Biologics license application, Recurrence, Patritumab, Weakness, Thrombocytopenia, Merck & Co., DXD, Patient, Safety, Medicine, MRK, ADC, NSCLC, BLA, Pharmaceutical industry

The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024.

Key Points: 
  • The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024.
  • The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021.
  • RTOR allows the FDA to review components of an application before submission of the complete application.
  • Twelve patients (5.3%) had confirmed treatment-related interstitial lung disease (ILD) as determined by an independent adjudication committee.

Atara Biotherapeutics Announces Closing of Expanded Global Tab-cel® Partnership with Pierre Fabre Laboratories

Retrieved on: 
Wednesday, December 20, 2023
Oncology, Health, Stem Cells, Clinical Trials, Research, Science, Biotechnology, Partnership, Food, FDA, PTLD, Trial of the century, Lymphoproliferative disorders, Biologics license application, Cancer, ATRA, USD, EBV, Patient, CD19, Epstein–Barr virus, BLA, Pharmaceutical industry

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel® or EBVALLOTM).

Key Points: 
  • Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel® or EBVALLOTM).
  • Building on the earlier partnership announced in October 2021 to commercialize tab-cel in Europe, this transaction provides Pierre Fabre Laboratories with the development, manufacturing, and commercialization rights for tab-cel in the United States and all remaining markets.
  • In addition, Pierre Fabre Laboratories will reimburse Atara for expected tab-cel global development costs through the Biologics License Application (BLA) transfer, and purchase future tab-cel inventory through the manufacturing transfer date.
  • Substantially all tab-cel manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.

SHAREHOLDER ALERT: Levi & Korsinsky Notifies Brainstorm Cell Therapeutics Inc. (BCLI) Investors of a Class Action Lawsuit and Upcoming Deadline

Retrieved on: 
Monday, November 20, 2023
Telephone, Food, LLP, CASE, COST, CLASS, NEXT, Court, Biologics license application, Cryptocurrency

NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.

Key Points: 
  • NEW YORK, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.
  • CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Brainstorm Cell investors who were adversely affected by alleged securities fraud between August 15, 2022 and September 27, 2023.
  • Follow the link below to get more information and be contacted by a member of our team:
    BCLI investors may also contact Joseph E. Levi, Esq.
  • For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

Polaris Group Initiates Rolling Submission of Biologic License Application (BLA) for ADI-PEG 20 with U.S. FDA to Treat Malignant Pleural Mesothelioma

Retrieved on: 
Friday, November 17, 2023
SAN, Chemistry, Food, BLA, Pemetrexed, Patient, FDA, Medical Affairs Bureau, MPM, Mesothelioma, Biologics license application, Pharmaceutical industry

The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.

Key Points: 
  • The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.
  • Dr. John Bomalaski, Executive Vice President of Medical Affairs at Polaris Group, commented, "Our clinical trials have demonstrated promising results, with ADI-PEG 20 showing statistically significant potential to address the medical needs of patients with malignant pleural mesothelioma.
  • Howard Chen, CEO and Chairman of Polaris Group, added, "We are fully committed to addressing the urgent medical needs of patients facing malignant pleural mesothelioma.
  • Today’s submission brings us one step closer to expanding treatment options for patients impacted by MPM in the U.S.

Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma

Retrieved on: 
Friday, November 17, 2023
Sale, Efficacy, Food, Extremities, BLA, Ernest, Denver Health Medical Center, Risk, Surgeon, Clinical trial, Meta-analysis, Amputation, Constipation, Peripheral artery disease, HAV, Thrombocytopenia, Research, Death, FDA, FACS, Army, HUMA, Standard of care, Infection, File, University, Tachycardia, Vascular surgery, Doctor of Philosophy, Anemia, Evaluation, Common, Biologics license application, Saphenous, Injury, Trial of the century, Pharmaceutical industry, Medical imaging, Medical device, Fever, MD, Patient, Safety

DURHAM, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced the presentation of positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel (HAV) in the treatment of vascular trauma, as well as results from the treatment of wartime injuries in Ukraine. The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City. Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the HAV for an indication in vascular trauma patients with the U.S. Food and Drug Administration (FDA) during the current quarter.

Key Points: 
  • The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City.
  • Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.
  • Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 trial.
  • Common adverse events reported were anemia, vascular graft thrombosis, blood loss anemia, pyrexia, thrombocytopenia, constipation, nausea peripheral edema, and tachycardia.

SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 – (NASDAQ: BCLI)

Retrieved on: 
Thursday, November 16, 2023
NEXT, Fraud, Biologics license application, Food, Holding company, Security (finance)

Appointment as lead plaintiff is not required to partake in any recovery.

Key Points: 
  • Appointment as lead plaintiff is not required to partake in any recovery.
  • DEADLINE: January 2, 2024 Shareholders should not delay in registering for this class action.
  • The deadline to seek to be a lead plaintiff is January 2, 2024.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.