Biologics
Omeros has completed a rolling BLA submission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The monoclonal antibody targets mannan-binding lectin-associated serine protease-2 (MASP-2), the company says. “Importantly,” it says, “inhibition of MASP-2 does not appear to interfere with the
Biologics
The Informed Consent Action Network (ICAN), generally cited as a leading anti-vaccination organization, is petitioning FDA to require changes in the study design for four Covid vaccines now in development to add additional efficacy requirements. The group’s 11/6 petition says the Phase 3 trial designs for the
Biologics
Pfizer and BioNTech have reported data from an interim efficacy analysis showing that its Covid-19 vaccine is more than 90% effective in preventing the virus based on the evaluation of 94 Covid cases in participants. Pfizer says an emergency use authorization submission could be completed later this month, which
Biologics
The Biotechnology Innovation Organization (BIO) says it appreciates efforts by CDRH and CBER to develop a guidance on patient-reported outcome (PRO) instruments for use in medical product evaluation. BIO’s comment letter says that while PROs are an important tool for collecting and reporting patient experiences, the trade group
Biologics
The CBER Office of Compliance and Biologics Quality says the Young Foundational Health Center, Largo, FL, is using a Web site, Facebook, and YouTube to market a cellular product administered intravenously for various diseases or conditions. A 10/30 Warning Letter says the product is sometimes referred to in promotional
Biologics
Regeneron Pharmaceuticals says it will temporarily stop enrolling patients requiring high-flow oxygen or mechanical ventilation in REGN-COV2 antibody cocktail treatment trials for Covid-19 because of a potential safety signal and an unfavorable risk/benefit profile at this time. The enrollment hold was based on a recommendation from
Biologics
FDA has entered into a Cooperative Research and Development Agreement with Emulate, Inc., to enable multiple studies across FDA Centers in priority research areas, including programs to evaluate Covid-19 vaccines and understand human response against SARS-CoV-2. Emulate says that under the agreement the agency will use a
Biologics
FDA has deferred a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim), indicated for treating neutropenia in patients receiving myelosuppressive anti-cancer drugs, because of a Covid-19-related travel restriction that prevents the agency from inspecting the firm’s South Korea manufacturing plant. The agency told the
Biologics
Several health experts are attacking FDA’s recent guidance on minimum requirements for Covid-19 vaccines to obtain an emergency use authorization (EUA). In comments offered during a 10/22 FDA Vaccines and Related Biological Products Advisory Committee meeting, National Center for Health Research president Diana Zuckerman said the vaccine
Biologics
FDA reportedly has completed its review of a serious illness in an AstraZeneca Covid vaccine study participant and is ready to authorize the company to resume its trial. Four sources told Reuters that the trial is likely to resume as early as this week. The news service reports that the
Biologics
FDA is expected soon to remove a clinical hold on AstraZeneca’s Covid-19 vaccine trial after it completed its review of a serious illness in a study participant, according to a report from Reuters. The hold was imposed in September after the University of Oxford, AstraZeneca’s partner in
Biologics
Merck has announced positive findings from two Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. Data from the PNEU-PATH (V114-016) and PNEU-DAY (V114-017) studies showed favorable immune responses. “Results from both studies are based
Biologics
California Gov. Gavin Newsom has formed a Scientific Safety Review Workgroup with 11 acclaimed physician-scientists living in the state to independently review the safety and efficacy of any Covid-19 vaccine that FDA approves for distribution. Newsom says the panelists will review any vaccine that receives federal approval and
Biologics
Pfizer CEO Albert Bourla says the company and its development partner BioNTech should be able to tell that their Covid-19 vaccine is effective by the end of the month, and an emergency use authorization (EUA) request could be filed as early as the third week of November. In a
Biologics
CNN says a source familiar with the AstraZeneca Covid-19 vaccine trial told the network that the company took until last week to get adverse event safety information to FDA, which placed a 9/9 clinical hold on the vaccine trial after a participant became ill with a neurological condition.
Biologics
Johnson & Johnson says it has temporarily paused all dosing in its Janssen Covid-19 vaccine candidate clinical trials due to an “unexplained illness” in a study participant. The illness is being reviewed and evaluated by the Phase 3 ENSEMBLE trial’s independent data safety monitoring board and the company’
Biologics
FDA says its review of the Web site and YouTube channel maintained by Optimal Health Stem Cell and Wellness Institute, Appleton, WI, indicates that the firm markets cellular products derived from human umbilical cord, adipose tissue, and amniotic membrane. A 10/1 Notice of Violation says that to lawfully market
Biologics
CBER director Peter Marks says FDA could deploy the rarely-used “commissioner’s finding” to disclose Covid-19 vaccine safety information if such information is not provided by a vaccine manufacturer. Marks addressed the issue when asked about the clinical hold imposed in September on an AstraZeneca investigational Covid vaccine.
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The White House 10/6 reversed its opposition to a controversial FDA guidance that outlines stricter requirements for granting an emergency use authorization (EUA) for potential Covid-19 vaccines. On 10/5, news got out that the White House still had objections to the pending guidance, first expressed in president
Biologics
FDA has issued Mesoblast a complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease. The agency letter recommended that the company conduct at least one additional randomized, controlled study in adults or children to provide further evidence of the therapy’
Biologics
Despite statements from president Trump that a new guidance from FDA on stricter requirements for Covid-19 vaccine makers will need to be approved by the White House, CBER director Peter Marks said 9/29 that vaccine makers already know the guidance’s recommendations about what data are necessary to
Biologics
FDA commissioner Stephen Hahn says agency career scientists will follow the guidance on the evaluation of Covid-19 vaccines that President Donald Trump has threatened to overrule. Speaking 9/29 at the Financial Times U.S. Pharma and Biotech Summit, Hahn said his staff will assess all vaccine applications against