Biologics
Novavax and HHS are having to clarify that FDA is requesting a post-approval study and not a clinical trial that must be conducted prior to approval of the company’s Covid-19 vaccine, which is currently available under an emergency use authorization(EUA). The company’s pending BLA is
Biologics
FDA has approved a total of 73 biosimilars across 19 unique biological molecules, but so far only 48 (66%) of these have been launched in the U.S. market, according to a new Samsung Bioepis’ biosimilar market report. On average, biosimilars have gained 52% market share within five years post
Biologics
Novavax says its Covid-19 vaccine BLA, which the company is seeking to transition from an emergency use authorization to full approval, is being held up while FDA seeks to conclude a post-marketing commitment from the company. The agency had initially set a user fee-related review action target
Biologics
FDA has granted interchangeable biosimilar status to Celltrion’s Yuflyma (adalimumab-aaty), a high-concentration, citrate-free biosimilar copy of AbbVie’s Humira. The designation permits pharmacists to substitute Yuflyma for Humira without requiring a new prescription from a healthcare provider. The original Yuflyma BLA was approved 5/2023 for
Biologics
Former CBER director Peter Marks, who recently resigned due to pressure from the Trump administration over vaccines, told Time in a 4/8 interview that he was seeing “an increasing anti-vaccine tone” before he left. “I was hoping to work through it, but it was very clear to me
Biologics
FDA has granted Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, for protecting against disease caused by influenza A H5N1. The vaccine, which is formulated with Arcturus’ proprietary LUNAR delivery technology, is designed to make many copies of mRNA within the
Biologics
FDA has accepted for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD), a serious eye condition where abnormal blood vessels grow under the retina, potentially leaking blood or fluid and causing rapid
Biologics
FDA has granted Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy. The designations are for treating adults with: * active refractory moderate-to-severe systemic lupus erythematous (SLE); * active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated
Biologics
One day before his forced resignation took effect 4/5, CBER director Peter Marks alleged in an exclusive interview with the Wall Street Journal that HHS secretary Robert F. Kennedy Jr. not only sought generation of new FDA data to support his antivaccine narratives but also reduction of regulatory safeguards
Biologics
Novavax says FDA has missed its 4/1 user fee review action target date on a BLA seeking full approval for its current Covid-19 vaccine, which is currently marketed under an emergency use authorization (EUA). “As of Tuesday, 4/1, we had responded to all of the FDA’s
Biologics
Analysis by Jim Dickinson] CBER director Peter Marks’ shocking resignation 3/28 raises an unexpected challenge to HHS secretary and vaccine skeptic Robert F. Kennedy Jr.’s fitness for office, for coercing it amid the morale-destroying consequences that President Trump’s mass firings are generating inside the agency and
Biologics
In a move that may assuage vaccine makers regarding HHS’s potential interference in vaccine reviews and approvals, Bavarian Nordic just gained FDA approval 3/31 for its freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating) for preventing smallpox and mpox [monkeypox] disease in adults 18
Biologics
The Autism Self-Advocacy Network (ASAN) is blasting HHS and secretary Robert F. Kennedy, Jr., for hiring “known conspiracy theorist and quack David Geier to run a planned study which will investigate the thoroughly disproven idea of a link between childhood vaccinations and autism.” In a statement, ASAN says that
Biologics
Johnson & Johnson says data from its Phase 3 MARIPOSA study, a head-to-head study comparing the company’s Rybrevant (amivantamab-vmjw) versus AstraZeneca’s Tagrisso (osimertinib), showed that Rybrevant plus Janssen’s Lazcluze (lazertinib) outperformed Tagrisso by a three-to-one margin, significantly extending overall survival (OS) in
Biologics
CBER director Peter Marks says that in an ideal world vaccine clinical trial designs should evaluate the investigational vaccine’s effect on disease transmission. Having such data, particularly if the vaccine has a decent effect against transmission, would be beneficial in today’s age of growing vaccine hesitancy after the
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