Biologics
FDA has posted a five-observation Form FDA-483 from a 4/2020 inspection at troubled contract manufacturer Emergent Biosolutions’ Baltimore manufacturing facility. Last week, Johnson & Johnson sent quality and compliance experts to help Emergent after 15 million doses of J&J’s Covid-19 vaccine (see earlier
Biologics
CBER has issued the Fiscal Year 2020 annual summary of biological product and human cells, tissues, and cellular and tissue-based products (HCT/P) reports. The annual summary gives an overview of the reports submitted during the fiscal year, including detailed information on the number and types of deviation reports.
Biologics
Two Mintz attorneys say it will be important to watch and see what new leadership at HHS and Democrats and Republicans in Congress will do with a 3/31 letter from special counsel Henry Kerner to President Joe Biden faulting the way FDA handled a Team Biologics whistleblower complaint that
Biologics
AbbVie has submitted a supplemental BLA for Skyrizi (risankizumab-rzaa) 150 mg for treating adults with active psoriatic arthritis. The submission is based on data from two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, showing that Skyrizi demonstrated significant improvements in disease activity, skin clearance and physical function
Biologics
FDA has recommended an early termination for a ERC-USA and University of California, Irvine, Phase 2 trial of ERC 1671 (Gliovac or Sitoiganap) for treating glioblastoma and recommended that the parties pursue a confirmatory Phase 3 registration trial to support a BLA application. ERC-USA says the agency advice
Biologics
FDA has permitted two Moderna Covid-19 revisions regarding the number of doses per vial available. “The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses,
Biologics
Johnson & Johnson is sending quality and compliance experts to its contract manufacturer Emergent Biosolutions after 15 million doses of its Covid-19 vaccine were determined to not meet “quality standards.” The doses were not expected to immediately be in the marketplace because the Baltimore (Bayview) manufacturing plant has been
Biologics
Special Counsel Henry Kerner says he agrees with an assertion by former FDA consumer safety officer Arie Menachem that the agency narrowly focused on procedural issues in its response downplaying Menachem’s whistleblower complaints and “disregards the fact that inspection reports detailing serious concerns were downgraded in a manner that
Biologics
Evive Biotech has submitted a BLA for Ryzneuta (also known as F-627), indicated for treating chemotherapy-induced neutropenia. Neutropenia is a common chemo side-effect that is characterized by low levels of neutrophils, a type of white blood cell that fights infection, according to the company. It says Ryzneuta
Biologics
FDA has approved for clinical trials an experimental treatment using a CRISPR-based therapy to directly correct the mutation in the beta-globin gene responsible for sickle cell disease. The technique was developed at the Innovative Genome Institute, a joint research collaboration of the University of California, Berkeley, and the
Biologics
Panelists at the recent Festival of Biologics USA conference debated the worth of clinical efficacy studies for evaluating biosimilar equivalence. A Center for Biosimilars online post says that while many experts have said the clinical studies are not sensitive enough in comparison with other tests to provide convincing evidence of
Biologics
FDA has approved a Celgene BLA for Abecma (idecabtagene vicleucel), a cell-based gene therapy for treating adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines of therapy. The agency says this is the first cell-based gene
Biologics
FDA has issued Merck a complete response letter on a supplemental BLA for Keytruda, the company’s anti-PD-1 therapy for treating patients with high-risk early-stage triple-negative breast cancer, in combination with chemotherapy as pre-operative treatment, and then continuing as a single agent as post-
Biologics
AstraZeneca has lowered its Covid-19 clinical trial vaccine efficacy rate from 79% to 76% after conducting a “primary analysis” following a data and safety monitoring board concern that the company may have included outdated information (see story) in releasing information earlier this week.“ The primary analysis is pre-specified
Biologics
FDA says an 11/16-11/25/20 Bioresearch Monitoring Program inspection at a clinical study site maintained by Michael Levin, Las Vegas, NV, as the clinical investigator for a redacted study found objectionable conditions that violated the regulations governing the proper conduct of clinical studies involving investigational new drugs.
Biologics
FDA says it is requiring the addition of language in the Warnings and Precautions section of labeling for GlaxoSmithKline’s Shingrix (zoster vaccine recombinant, adjuvanted) describing the risk for Guillain-Barré Syndrome (GBS) following administration of the shingles vaccine. An agency safety communication says the new language reports that in
Biologics
CBER has released its strategic plan for 2021-2025 containing four goals. CBER director Peter Marks says the plan is based on the Center’s mission and vision and outlines the goals, objectives, and strategies designed to further the mission and vision during the plan’s five-year term. “Our
Biologics
AstraZeneca is being scrutinized over data it presented in a press release about its Covid-19 vaccine. In the release, the company touted data showing efficacy of 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease and hospitalization (see story). Late 3/21, the study’s
Biologics
AstraZeneca is likely weeks away from seeking an FDA emergency use authorization for its Covid-19 vaccine after reporting interim data from a U.S. Phase 3 trial showing efficacy of 79% at preventing symptomatic Covid-19 and 100% efficacy at preventing severe disease and hospitalization. The company said vaccine
Biologics
CBER’s Office of Compliance and Biologics Quality has issued Reno Integrative Medical Center an untitled letter after reviewing the institution’s Web site (www.renointegrativemedicalcenter.com) and determining its cancer immunotherapy product is a human cell, tissue, or cellular or tissue-based product requiring an approved BLA. The letter
Biologics
Leaked documents from a cyberattack at the European Medicines Agency (EMA) late last year provide a rare glimpse into how the regulatory agency and regulators at FDA and Health Canada collaborated on a review issue involving Pfizer-BioNTech’s Covid-19 vaccine. The hacked documents were anonymously sent to The
Biologics
There is a growing list of European countries that have temporarily suspended administering AstraZeneca’s Covid-19 vaccine due to concerns about reports of blood clots in people who received it. Denmark, Iceland, and Norway had earlier indicated a temporary hold on administering the two-dose vaccine. By Monday (3/