Biologics
FDA has approved a Johnson & Johnson supplemental BLA for Tremfya (guselkumab) and its use in treating adults with moderately to severely active Crohn’s disease, a chronic gastrointestinal tract disorder. Tremfya is described by the company as the only approved dual-acting monoclonal antibody that blocks interleukin (IL)-23
Biologics
Orca Bio says its pivotal Phase 3 Precision-T study of Orca-T, an investigational allogeneic T-cell immunotherapy, in certain leukemia patients met its primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD). “At one year, the rate
Biologics
Despite an HHS decision to cancel (see earlier story) a 3/13-planned Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to select the strains and the composition of next season’s influenza vaccines, the agency convened an interagency meeting on the same date to adopt recommendations for vaccine
Biologics
FDA has accepted for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy. DMD primarily affects males and leads to progressive muscle weakness, loss of mobility, and eventually life-threatening cardiac and respiratory complications. The agency has set a user fee
Biologics
An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and immune globulin subcutaneous due to a higher rate of allergic/hypersensitivity-type reactions, some of which were considered medically significant. “Hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products,” the
Biologics
FDA has approved a Celltrion BLA for Omlyclo, the first interchangeable biosimilar to Genentech’s Xolair (omalizumab). The biosimilar is approved for treating the following conditions: * Moderate to severe persistent asthma in patients greater than six years of age whose asthma symptoms are not well controlled with inhaled corticosteroids. * Chronic
Biologics
FDA has approved a Neurotech Pharmaceuticals BLA for Encelto (revakinagene taroretcel-lwey) for treating macular telangiectasia Type 2 (MacTel), a neurodegenerative disease of the retina in adults that causes progressive and irreversible vision loss. The gene therapy uses an “encapsulated cell therapy technology designed to continually deliver therapeutic doses of
Biologics
FDA has accepted for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis (LN). The agency has set a user fee review action target date of 10/2025. The submission is based on data from the Phase 3 REGENCY trial. “The study demonstrated a statistically significant and clinically
Biologics
FDA has approved a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgen’s Prolia, and Osenvelt (denosumab-bmwo), a biosimilar to Amgen’s Xgeva. The approval covers all indications of the reference products. Approval is based on “robust clinical evidence,” including data from Phase 3 clinical trials in
Biologics
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should make sure its recent draft guidance entitled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” aligns with other relevant guidances developed by the Internation Conference on Harmonization. Specifically, PhRMA says the protocol deviations guidance should align with
Biologics
FDA has approved an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-induced allergic rhinitis, with or without conjunctivitis, to now include children ages five through 11 years. Previously, the product was approved for use in patients aged 12
Biologics
In a move suggestive of HHS secretary and vaccine skeptic Robert F. Kennedy Jr.’s interference in FDA regulatory activities involving vaccines, the agency 2/26 abruptly canceled a 3/13-planned Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting that would otherwise select the strains and the composition
Biologics
FDA has released the form FDA-483 issued following an 11/11-11/19/2024 inspection at the firm’s vaccine manufacturing facility in Incheon, South Korea. The form’s specific inspection observations were: * failure to have in writing and/or follow responsibilities and procedures for quality units to ensure
Biologics
Two stakeholders have submitted specific, line-by-line, technical comments on an FDA draft guidance on protocol deviations for clinical investigations of drugs, biological products, and devices. The comments were submitted by Labcorp and AstraZeneca.
Biologics
FDA has accepted for priority review a Precigen BLA for PRGN-2012 (zopapogene imadenovec), an investigational adenoverse gene therapy for treating adults with recurrent respiratory papillomatosis (RRP). PRGN-2012 is designed to “elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11,” the company says.
Biologics
A 6/7-6/12/2024 FDA inspection at Sperm Bank, Inc., doing business as Fertility Center of California in San Diego, CA, documented significant deviations from regulations for human cells, tissues, and cellular and tissue-based products. A 2/14 Warning Letter says specific deviations of concern were: * failure
Biologics
FDA has declined to approve an Invivyd request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of Covid-19 EUA for Pemgarda (pemivibart). The request sought authorization to provide a treatment option for mild-to-moderate Covid-19 in adults and adolescents who are immune compromised
Biologics
In a Hyman, Phelps & McNamara FDA Law Blog post, principal regulatory device and biologics expert Richard Lewis, who was an FDA reviewer and compliance officer during the 2018-2019 five-week government shutdown, describes what such a funding gap means for the agency and its regulated industries. The post
FDA Policy/General
In a guest Med Device Online column, ERA Sciences executive director Eva Kelly lists and analyzes FDA’s top five citation issues for data quality in 2024. The issues were: * governance and standard operating procedure weaknesses; * validation deficiencies; * system inventory gaps; * missing records or data missing key ALCOA++ (attributable, legible,
Biologics
FDA has approved a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis which commonly cause invasive meningococcal disease (IMD), according to the company. “The vaccine combines the
Biologics
Shortly after Robert F. Kennedy, Jr., was confirmed as HHS secretary, Citizens MAHA (Mobilizing Advocacy to Heal America) filed a petition asking HHS and FDA to “suspend and revoke emergency use authorization and biologics licensure for mRNA Covid-19 vaccines and to conduct a comprehensive safety review due to unprecedented
Biologics
FDA has placed a clinical hold on a Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna’s trivalent vaccine against norovirus (mRNA-1403) after a case of Guillain-Barré syndrome was reported. It is a two-season vaccine and the Northern Hemisphere portion of the study is