Biologics
Korea-based Hugel has resubmitted its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown) lines. The company received a complete response letter in April, and it says the resubmission addresses “facility management and supplementary work” that the agency's letter requested. Hugel expects a review
Biologics
Four members of Congress from Michigan are calling on FDA to do more to stop the threat of bone graft infections across the U.S. In an 8/29 letter to FDA commissioner Robert Califf, Reps. John Moolenaar (R-MI) and Debbie Dingell (D-MI) and Sens. Gary Peters and
Biologics
FDA has renewed its funding for the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) under a new five-year $50 million cooperative agreement. A university statement says M-CERSI is a partnership between two University of Maryland campuses and is the oldest of the
Biologics
Abeona Therapeutics says it will file a BLA for EB-101, a cell therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), after completing a pre-BLA meeting with FDA. The meeting resulted in an “alignment” with the agency that EB-101’s clinical efficacy and safety data appear adequate
Biologics
AbbVie has submitted a supplemental BLA for Skyrizi (risankizumab) 1,200 mg intravenous (IV) (induction dose) and 180 mg and 360 mg subcutaneous (maintenance doses) for treating adults with moderately to severely active ulcerative colitis. Currently, the drug is approved for treating plaque psoriasis, psoriatic arthritis and Crohn’s disease.
Biologics
FDA has approved a Sandoz BLA for Tyruko (natalizumab-sztn), the first biosimilar to Biogen’s Tysabri (natalizumab) injection for treating adults with relapsing forms of multiple sclerosis. “Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active
Biologics
FDA has approved a new indication for Pfizer’s Abrysvo (respiratory syncytial virus vaccine) for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in infants from birth through six months of age. An agency statement says Abrysvo is approved for use
Biologics
FDA has extended by three months the review of a Valneva BLA for VLA1553, the company’s chikungunya virus vaccine candidate to allow “sufficient time to align and agree on the Phase 4 program necessary under the accelerated approval pathway,” according to the company. No additional clinical data have been
Biologics
A study by the Annenberg Public Policy Center of the University of Pennsylvania finds that people are more likely to recommend that a pregnant family member or friend be vaccinated to protect the infant from respiratory syncytial virus (RSV) if they are shown a chart outlining the FDA vaccine approval
Biologics
FDA has released a draft guidance entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” The document provides recommendations to industry on formal meetings about the development and review of biosimilar or interchangeable biosimilar products. It discusses the principles of good meeting management practices and describes
Biologics
FDA and the International Pharmaceutical Regulators Program’s (IPRP) Biosimilars Working Group is hosting a 9/12-13 virtual workshop on “Increasing the Efficiency of Biosimilar Development Programs — Reevaluating the Need for Comparative Clinical Efficacy Studies.” An FDA notice says that the workshop’s public sessions will discuss the experience
Biologics
FDA has approved an expanded indication for Merck’s Ebola vaccine Ervebo (Ebola Zaire vaccine, live) to include its use in individuals 12 months of age and older. The vaccine was previously approved for use in individuals 18 years of age and older for prevention of disease caused by Zaire
Biologics
An 8/2-8/12/22 FDA inspection at RenatiLabs in Erlanger, KY, determined that the firm manufactures WJMAX, a product derived from human umbilical cord, for allogeneic use. A just-released 6/1 Warning Letter says the product is distributed directly to doctors throughout the U.S. to administer
Biologics
The Advanced Medical Technology Association (AdvaMed) says decentralized clinical trials can facilitate diversity in clinical trials. Commenting on an FDA draft guidance on decentralized clinical trials for drugs, biological products, or medical devices, AdvaMed says the document can facilitate recruitment of diverse populations in clinical trials and may help expedite
Biologics
FDA has posted a final guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments (BUSFA 3) of 2022.” The document provides information on the types of user fees authorized by BsUFA 3, how FDA determines which products are subject to a fee, and FDA’s policies regarding exceptions
Biologics
Merck says its investigational 21-valent pneumococcal conjugate vaccine V116 met key immunogenicity and safety endpoints in two Phase 3 trials. V116 was tested on vaccine-naïve and previously vaccinated individuals. The company says that if V116 is approved, it would be the first pneumococcal conjugate vaccine specifically designed for
Biologics
A 10/2/21-11/10/21 inspection at Stratus Biosystems, doing business as CellGenuity Regenerative Science in Grapevine, TX, documented that the firm manufactures products for allogeneic use, including an umbilical cord and amniotic membrane-derived product and an amniotic fluid-derived product. A 6/5 Warning Letter says
Biologics
Syndax Pharmaceuticals and Incyte say they plan to file by the end of the year a BLA for axatilimab, for use in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy. Just-reported pivotal trial (AGAVE-201) data showed that
Biologics
FDA has approved an Emergent BioSolutions BLA for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in people aged 18 through 65 years. Approval was based on data in animal models of inhalational anthrax, the company says, adding that
Biologics
Vir Biotechnology says its VIR-2482 failed to meet primary and secondary endpoints in the Phase 2 PENINSULA trial to prevent symptomatic influenza A illness. A company statement says VIR-2482 was generally well tolerated and no safety signals were identified. VIR-2482 is described as an investigational hemagglutinin intramuscularly
Biologics
The Government Accountability Office (GAO) says its study of regenerative medicine led to the development of 11 policy options, several of which involve FDA. GAO says it conducted an assessment of current and emerging regenerative medicine technologies and therapeutic applications. The report looks at (1) current and emerging regenerative medicine
Biologics
FDA has approved an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age. Approval of the monoclonal antibody was based on data