Biologics
AstraZeneca is planning to seek an emergency use authorization for its Covid-19 vaccine by early April after determining that it has met FDA data requirements. The company’s 32,000-person study has accumulated data on at least 150 cases of Covid-19, according to a Reuters report. As
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A Pfizer facility in McPherson, KS, that is slated to start producing the company’s Covid-19 vaccine has a long history of mold and other contamination issues, according to inspection reports obtained by Kaiser Health News (KHN). The news service says “FDA investigators have repeatedly noted in reports that
Biologics
Govs. Jared Polis (CO) and Kate Brown (OR) are asking FDA acting commissioner Janet Woodcock to permit the pooling of Covid-19 vaccines by granting a short-term emergency waiver for experienced practitioners. In their 3/8 letter, Polis and Brown say vaccine pooling is a common practice routinely used
Biologics
FDA has granted Kite accelerated approval for Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Yescarta is the first chimeric antigen receptor T-cell therapy approved for patients with indolent FL, the company says. The approval
Biologics
FDA has accepted for review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma
Biologics
Shanghai Junshi Biosciences and Coherus Biosciences have begun a rolling BLA submission for toripalimab for treating recurrent or metastatic nasopharyngeal carcinoma (NPC). Toripalimab is the first anti-PD-1 monoclonal antibody developed and approved in China that has made it to a BLA submission in the U.S., the companies
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The National Institutes of Health (NIH) has stopped a clinical trial evaluating Covid-19 convalescent plasma in treating emergency department patients who developed mild to moderate Covid-19 symptoms. The NIH decision was recommended by the trial’s independent data and safety monitoring board, which recently examined the second planned
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An FDA advisory committee has voted 22-0 to support an emergency use authorization (EUA) for Janssen Biotech’s single intramuscular Covid-19 vaccine injection. In briefing materials released in advance of the meeting, agency reviewers determined that the vaccine “met the prespecified success criteria” in the pivotal trial. The
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GC Pharma has submitted a BLA for GC5107 (immune globulin intravenous (human),10% liquid) for treating patients with primary humoral immunodeficiency disease. The submission is based on data from a Phase 3 North America study that met its primary efficacy endpoint on the incidence rate of acute serious bacterial infections,
Biologics
Former FDA chief of staff Lauren Silvis has been added to President Joe Biden’s Covid-19 response team. Silvis was agency chief of staff under former commissioner Scott Gottlieb. Before serving as chief of staff from 5/2017 to 6/2019, she was CDRH deputy director for policy. Silvis
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FDA says it is allowing undiluted frozen vials of the Pfizer-BioNTech Covid-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. Previously, the vaccine’s preferred storage was in an ultra-low temperature freezer between
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FDA reviewers are backing an emergency use authorization (EUA) for Janssen Biotech’s single intramuscular Covid-19 vaccine injection. In briefing materials released in advance of a 2/26 advisory committee meeting discussing the vaccine’s EUA request, agency reviewers determined that the vaccine “met the prespecified success criteria” in
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The CBER Office of Compliance and Biologics Quality says that Pacific Stem Cells, Newport Beach, CA, is marketing “stem cell therapy” products for stroke, macular degeneration, Lyme disease, Parkinson’s disease, heart disease, lupus, rheumatoid arthritis, and multiple sclerosis. A 2/17 Notice of Violation says Pacific appears to administer
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A new study has found that racial/ethnic minority groups and older adults are underrepresented in U.S.-based vaccine clinical trials. “These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections,” according to the study, which was published in the 2/
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BrainStorm Cell Therapeutics says FDA told it that the “current level of clinical data does not provide the threshold of substantial evidence” that the agency is seeking to support a BLA for NurOwn (autologous MSC-NTF cells) for treating amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The FDA
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FDA says that in response to a section of the 21st Century Cures Act on developing standards for regenerative medicine therapies, it is facilitating efforts to coordinate such standards development. In an online notice, the agency says it has awarded an annual contract to Nexight Group and the Standards Coordinating
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FDA has accepted for review a Coherus BioSciences BLA for CHS-1420, a biosimilar to AbbVie’s Humira (adalimumab), indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. FDA has set a user
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FDA has approved a Pfizer supplemental BLA for Panzyga (immune globulin intravenous [human] – ifas 10% liquid preparation) to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare peripheral nerve neurological disease. Approval was based on data from a Phase 3 study in 142 patients diagnosed with CIDP. The
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Bluebird Bio has temporarily suspended its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease due to a reported “suspected unexpected serious adverse reaction” (SUSAR) of acute myeloid leukemia (AML). The company says it received a report last week that
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FDA continues to struggle to inspect firms within its user fee application review timelines. The latest company impacted is Mallinckrodt, advised by the agency that action on one of its BLAs is being deferred pending a manufacturing site inspection that can’t be conducted due to Covid-19-related travel
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Moderna says it discussing with FDA a proposal to increase Covid-19 vaccine doses in each vial from 10 to 15 doses. The move would help increase the vaccination pace in the U.S. “Implementation of any such changes would be expected to be completed in approximately a two- to
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CBER director Peter Marks says FDA is starting to think about how to resequence vaccines to cope with emerging virus variants. Appearing as a guest on an American Medical Association Webinar, Marks says that for the Pfizer and Moderna mRNA vaccines, it requires only changing a computer program to change