China Biologic Products

Scinai Immunotherapeutics Announces $1.33 Million Registered Direct Offering

Retrieved on: 
Friday, September 15, 2023

The closing of the offering is expected to occur on or about September 19, 2023, subject to the satisfaction of customary closing conditions.

Key Points: 
  • The closing of the offering is expected to occur on or about September 19, 2023, subject to the satisfaction of customary closing conditions.
  • The gross proceeds to the Company from the offering are expected to be approximately $1.33 million, before deducting the placement agent’s fees and other offering expenses payable by the Company.
  • The offering of the ADSs (or ADS equivalents) in the registered direct offering is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
  • A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC.

Scinai Immunotherapeutics Innovative Plaque Psoriasis Treatment Shows Encouraging Preclinical Results

Retrieved on: 
Wednesday, September 13, 2023

JERUSALEM, Sept. 13, 2023 (GLOBE NEWSWIRE) -- via IBN – Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases, today announces encouraging results in a preclinical study of Scinai’s anti‑interleukin 17 (IL‑17) NanoAbs as a treatment for plaque psoriasis.

Key Points: 
  • Results from ex-vivo study in human psoriatic skin anticipated in Q4 2023; In-vivo animal study results anticipated in early 2024
    JERUSALEM, Sept. 13, 2023 (GLOBE NEWSWIRE) -- via IBN – Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative inflammation and immunology (I&I) biological products primarily for the treatment of autoimmune and infectious diseases, today announces encouraging results in a preclinical study of Scinai’s anti‑interleukin 17 (IL‑17) NanoAbs as a treatment for plaque psoriasis.
  • These results suggest NanoAbs’ therapeutic potential to relieve symptoms of plaque psoriasis.
  • Research shows that targeting IL-17F isoform in addition to IL-17A provides higher efficacy in treating plaque psoriasis.
  • Scinai recently started to evaluate the anti-IL-17 NanoAbs in a full human skin model induced for plaque psoriasis to evaluate the effective dose and schedule of treatment, with in-vivo animal studies anticipated in early 2024.

BioRestorative Therapies Enters into Supply Agreement with Evolutionary Biologics

Retrieved on: 
Tuesday, September 12, 2023

MELVILLE, N.Y., Sept. 12, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc . (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ), a clinical stage company focused on stem cell-based therapies, today announced that it has entered into a supply agreement with Evolutionary Biologics, a supplier of biologic-based cosmetics.

Key Points: 
  • (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ), a clinical stage company focused on stem cell-based therapies, today announced that it has entered into a supply agreement with Evolutionary Biologics, a supplier of biologic-based cosmetics.
  • Pursuant to the supply agreement, BioRestorative, using its cGMP ISO-7 certified clean room, will manufacture tissue-based biologics for Evolutionary Biologics for cosmetic and aesthetic applications.
  • Jim Morrison, Chief Executive Officer of Evolutionary Biologics, a division of Emergent Health Corp, (EMGE) stated “we are very excited to be working with Biorestorative Therapies.
  • This partnership will undoubtedly provide Evolutionary Biologics with a competitive advantage in the large and fast-growing biologics cosmetic marketplace".

FDA Approves First Biosimilar to Treat Multiple Sclerosis

Retrieved on: 
Thursday, August 24, 2023

SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).

Key Points: 
  • SILVER SPRING, Md., Aug. 24, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).
  • "Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis," said Paul R. Lee, M.D., Ph.D., director of the Division of Neurology 2 in the FDA's Center for Drug Evaluation and Research.
  • This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.
  • The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

Retrieved on: 
Monday, August 21, 2023

The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

Key Points: 
  • The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.
  • "This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease."
  • In one study, approximately 3,600 pregnant individuals received a single dose of Abrysvo and approximately 3,600 pregnant individuals received a placebo.
  • In the second study, approximately 100 pregnant individuals received Abrysvo and approximately 100 pregnant individuals received placebo.

Orthobiologics Show Great Promise for Less Invasive Treatment of Certain Musculoskeletal Conditions

Retrieved on: 
Tuesday, August 15, 2023

ROSEMONT, Ill., Aug. 15, 2023 /PRNewswire/ -- As orthopaedic medicine continues to advance through innovation, research and evidence-based medicine, the complexities and unknowns about newer treatments such as orthobiologics, may leave patients wondering if it is a viable treatment option for them. Orthobiologics, sometimes referred to as regenerative medicine, have shown great promise to treat conditions such as osteoarthritis; however, patients are seeking resources to understand if the treatment is right for them. To educate patients, the American Academy of Orthopaedic Surgeons (AAOS) developed an FAQ published on OrthoInfo.org, that outlines what orthobiologics are and the potential risks and benefits.

Key Points: 
  • Orthobiologics, sometimes referred to as regenerative medicine, have shown great promise to treat conditions such as osteoarthritis; however, patients are seeking resources to understand if the treatment is right for them.
  • To educate patients, the American Academy of Orthopaedic Surgeons (AAOS) developed an FAQ published on OrthoInfo.org , that outlines what orthobiologics are and the potential risks and benefits.
  • The regenerative therapies touted in radio ads or featured on highway billboards may not be grounded in science."
  • Dr. Dragoo recommends patients work with a reputable physician, ideally one who does clinical research in this area and tracks their patient-outcome results.

Wilson Bryan, M.D., Former Director of FDA CBER’s Office of Tissues and Advanced Therapies, Joins Greenleaf

Retrieved on: 
Wednesday, July 19, 2023

Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that Wilson Bryan, M.D., has joined as Executive Vice President, Drug and Biological Products.

Key Points: 
  • Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that Wilson Bryan, M.D., has joined as Executive Vice President, Drug and Biological Products.
  • His experience enhances Greenleaf’s cell and gene therapy capabilities and brings added perspective to the firm’s strategic advising on drug, biologic, and medical device regulation more broadly.
  • As a neurologist and neuromuscular specialist, Wilson deepens Greenleaf’s expertise in those fields as well.
  • Wilson received his medical degree from the University of Chicago Pritzker School of Medicine.

FDA Approves New Drug to Prevent RSV in Babies and Toddlers

Retrieved on: 
Monday, July 17, 2023

"Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system."

Key Points: 
  • "Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system."
  • Premature infants, and those with chronic lung disease of prematurity or significant congenital heart disease, are at highest risk for severe RSV disease.
  • One dose of Beyfortus, administered as a single intramuscular injection prior to or during RSV season, may provide protection during the RSV season.
  • The safety and pharmacokinetic data from Trial 05 provided evidence for the use of Beyfortus to prevent MA RSV LRTI in this population.

Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

Retrieved on: 
Wednesday, July 12, 2023

Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).
  • This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
  • DRL_RI is being developed as a biosimilar of Rituxan® / MabThera® (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody.
  • generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States.

Aridis’ AR-301 Monoclonal Antibody is Among the First Biologics to Receive FDA’s Qualified Infectious Diseases Product (QIDP) Designation

Retrieved on: 
Wednesday, July 12, 2023

"Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.

Key Points: 
  • "Our AR-301 program will now benefit from the FDA's priority review, in addition to previously awarded Fast-Track status, allowing for accelerated drug development and regulatory review processes.
  • This sought-after designation positions our AR-301 program extremely well as we continue to advance it through a confirmatory Phase 3 trial and license application."
  • AR-301 specifically targets S. aureus alpha-toxin, which has been implicated in the pathogenesis of pneumonia caused by S. aureus bacteria.
  • Aridis received positive feedback from the FDA in May 2023 on the Company's proposed single confirmatory Phase 3 study of AR-301.