Advisory Committee

Krystal Biotech Announces FDA’s 3-Month Extension of BLA PDUFA Date and Regulatory Update for B-VEC to Treat Patients with Dystrophic Epidermolysis Bullosa

Retrieved on: 
Monday, January 9, 2023
Advisory Committee, Priority review, DEB, FDA, Advisory, REMS, Food, BLA, Patient, Risk Evaluation and Mitigation Strategies, KRYS, PDUFA, Medical device, Agency

The unit did not affect processing parameters or product contact materials.

Key Points: 
  • The unit did not affect processing parameters or product contact materials.
  • The FDA considered this new information as a major amendment to the application that will require additional time for review.
  • The BLA late-cycle review meeting was completed on December 15, 2022.
  • All pre-approval inspections of clinical sites and internal manufacturing and testing facilities have been successfully completed.

Acumen Pharmaceuticals Appoints Derrell Porter, M.D., to its Board of Directors

Retrieved on: 
Wednesday, January 4, 2023
Acumen, AbbVie, Central nervous system, Perelman School of Medicine at the University of Pennsylvania, Wharton School of the University of Pennsylvania, Drug development, MBA, Wendell Pritchett, Amgen, University of California, San Francisco, ABOS, University, Therapy, McKinsey & Company, Advisory Committee, AD, Pharmaceutical industry, Neuroscience

CHARLOTTESVILLE, Va. and CARMEL, Ind., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer’s disease (AD), today announced Derrell Porter, M.D., has joined its Board of Directors.

Key Points: 
  • CHARLOTTESVILLE, Va. and CARMEL, Ind., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer’s disease (AD), today announced Derrell Porter, M.D., has joined its Board of Directors.
  • “We are thrilled to welcome Dr. Porter to our Board of Directors at a time when we’re rapidly advancing clinical development of ACU193,” said Daniel O’Connell, President and Chief Executive Officer of Acumen Pharmaceuticals.
  • Porter brings significant expertise in drug development and commercialization to the Board as we develop a novel and potentially disease-modifying treatment for Alzheimer’s disease.
  • from the Perelman School of Medicine and MBA from the Wharton School at the University of Pennsylvania, and his B.S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Veru Inc. - VERU

Retrieved on: 
Sunday, January 1, 2023
Food, Acute respiratory distress syndrome, COVID-19, News, Defense Department Advisory Committee on Women in the Services, Patient, Advisory Committee, Pharmaceutical industry

NEW YORK, Jan. 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).

Key Points: 
  • NEW YORK, Jan. 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Veru 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, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Veru Inc. - VERU

Retrieved on: 
Sunday, December 25, 2022
Food, Acute respiratory distress syndrome, COVID-19, News, Defense Department Advisory Committee on Women in the Services, Patient, Advisory Committee, Pharmaceutical industry

NEW YORK, Dec. 24, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).

Key Points: 
  • NEW YORK, Dec. 24, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Veru 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, the Pomerantz Firm pioneered the field of securities class actions.

Kendalle Burlin O’Connell Becomes MassBio® CEO

Retrieved on: 
Wednesday, January 4, 2023
Science, Thought Leadership, Other Science, Biotechnology, Research, General Health, Health, Professional Services, Civic, Ecosystem, American Cancer Society, Suffolk University Law School, Research, Science, Sacred Heart University, Global health, Growth, Economics, Policy, Axios, Juris, Advisory Committee, Boston Business Journal, Commerce, Beacon Capital Partners, Environment, Woman, Management

Today, the Massachusetts Biotechnology Council (MassBio®) Board of Directors announced Kendalle Burlin O’Connell as the organization’s new Chief Executive Officer and President.

Key Points: 
  • Today, the Massachusetts Biotechnology Council (MassBio®) Board of Directors announced Kendalle Burlin O’Connell as the organization’s new Chief Executive Officer and President.
  • “Kendalle has been instrumental in building MassBio and positioning our organization for continued growth,” said Pam Randhawa, chair of MassBio’s Board.
  • “Leading MassBio and supporting the collective efforts of our members to reshape global health is the honor a lifetime,” said Burlin O’Connell.
  • “Kendalle joined us at MassBio when we were just starting to realize our potential,” said former MassBio CEO and current board member Bob Coughlin.

BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn®

Retrieved on: 
Tuesday, December 27, 2022
European Medicines Agency, California Institute for Regenerative Medicine, EMA, Amyotrophic lateral sclerosis, Neurodegeneration, Patient, Cell, Food, Muscle & Nerve, Merit Cudkowicz, COVID-19, FDA, Safety, Inflammation, BLA, Advisory Committee, Therapy, Annual report, Brainstorm, Regenerative medicine, CIRM, Type, NTFS, Microsoft, Walking, MS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Orphan drug, Pharmaceutical industry, ALS

The Type A Meeting has been scheduled to occur on January 11, 2023.

Key Points: 
  • The Type A Meeting has been scheduled to occur on January 11, 2023.
  • "We look forward to the Type A meeting which will provide an opportunity to discuss the path forward for NurOwn in ALS, including a possible Advisory Committee Meeting," said Chaim Lebovits, Chief Executive Officer of BrainStorm.
  • BrainStorm previously completed a Phase 3 trial in approximately 200 participants with ALS ( Cudkowicz et al., 2022 Muscle and Nerve ).
  • About BrainStorm Cell Therapeutics Inc.
    BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases.

U.S. Department of Commerce Taps FuelCell Energy for the Renewable Energy and Energy Efficiency Advisory Committee

Retrieved on: 
Friday, December 16, 2022
Electricity, Commerce, FuelCell Energy, Quality of life, Advisory Committee, Carbon, Government, Safety, Biomass, Committee, Senior counsel, Atomic Energy Commission's Historical Advisory Committee, Wind, Policy, Heat, Hydrogen, Renewable energy

DANBURY, Conn., Dec. 16, 2022 (GLOBE NEWSWIRE) -- FuelCell Energy, Inc. (NASDAQ: FCEL) today announced that Alexandrea Isaac, Senior Counsel to the Company, has been appointed to the Department of Commerce Renewable Energy and Energy Efficiency Advisory Committee (“REEEAC”).

Key Points: 
  • DANBURY, Conn., Dec. 16, 2022 (GLOBE NEWSWIRE) -- FuelCell Energy, Inc. (NASDAQ: FCEL) today announced that Alexandrea Isaac, Senior Counsel to the Company, has been appointed to the Department of Commerce Renewable Energy and Energy Efficiency Advisory Committee (“REEEAC”).
  • The Committee is responsible for advising the Secretary of Commerce on the development and administration of programs and policies to expand the export competitiveness of US renewable and energy efficiency products and services.
  • REEEAC is the only federal Advisory Committee focused on export competitiveness for the renewable energy and energy efficiency sector.
  • It is essential that American companies are provided equal opportunities with our free trade partners.”
    The Committee functions solely as an advisory body, providing advice and recommendations to the Secretary on matters concerning:
    The competitiveness of the U.S. renewable energy and energy efficiency industries as it relates to their ability to export products, services, and technologies;
    Trade policy development and negotiations impacting the competitiveness of U.S. renewable energy and energy efficiency exports;
    U.S. Government policies and programs that directly impact the competitiveness of renewable energy and energy efficiency exports;
    Priority export markets for the renewable energy and energy efficiency industries, both in the short- and long-term;
    Policies and practices of foreign governments that impact the export of U.S. renewable energy and energy efficiency goods and services; and
    U.S. Government policies and programs that support the development of new markets for U.S. exports of renewable energy and energy efficiency products and services to countries with high potential, but which currently lack effective policy and market mechanisms necessary to create demand for renewable energy and energy efficiency products and services.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Veru Inc. - VERU

Retrieved on: 
Thursday, December 15, 2022
Acute respiratory distress syndrome, Advisory Committee, Defense Department Advisory Committee on Women in the Services, Food, News, COVID-19, Patient, Pharmaceutical industry

NEW YORK, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).

Key Points: 
  • NEW YORK, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Veru 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, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Veru Inc. – VERU

Retrieved on: 
Thursday, December 8, 2022
Acute respiratory distress syndrome, Advisory Committee, Defense Department Advisory Committee on Women in the Services, Food, News, COVID-19, Patient, Pharmaceutical industry

NEW YORK, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).

Key Points: 
  • NEW YORK, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Veru, Inc. (“Veru” or the “Company”) (NASDAQ: VERU).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Veru 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, the Pomerantz Firm pioneered the field of securities class actions.

Valneva Hosts Investor Day in New York City

Retrieved on: 
Tuesday, December 6, 2022
EBV, Euronext Paris, 2020 European Medicines Agency cyberattack, SRR, Marketing Authorisation Application, Inflation, RSV, BLA, EMA, Developing country, International Air Transport Association, VLA, Epstein–Barr virus infection, Advisory Committee, Food, FDA, Degenerative disease, Medicare Part D, PRV, Saint-Herblain, Chikungunya, Nordic, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Advisory Committee on Immunization Practices, VLA2001, European Medicines Agency, MAA, Mouse, Vaccine, Biologics license application, Human, Marketing, Eastern Time Zone, VBI, Medicare, Pfizer, Infection, Șaeș, Priority review, Growth, IATA, Antigen, Epithelium, COVID-19, Policy, ACIP, Q&A, Pharmaceutical industry, Valneva SE, Lyme disease

Saint-Herblain (France), December 06, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an in-person investor day today in New York City to discuss the Company’s current vaccine pipeline, commercial products, and future directions.

Key Points: 
  • Saint-Herblain (France), December 06, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, is hosting an in-person investor day today in New York City to discuss the Company’s current vaccine pipeline, commercial products, and future directions.
  • While completion of the BLA submission is expected by year end, Valneva is focused on pre-commercial and market access preparations.
  • Valneva successfully generated a stabilized pre-fusion F protein antigen, which forms the basis of the proprietary vaccine candidate VLA1554.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.