Biologics
Gaithersburg, MD-based Novavax has announced that its recombinant nanoparticle protein-based Covid-19 vaccine demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled almost 30,000 participants across 119 sites
Biologics
FDA is permitting Johnson & Johnson (Janssen) to use two batches, but not others, of its Covid-19 vaccine substance made at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations
Biologics
With some doses of the Johnson & Johnson one-jab Covid-19 vaccine nearing their expiration date, as vaccination slows in the U.S., FDA has increased the approved refrigerated storage time from 3 months to 4.5 months. In a statement, the company acknowledged the agency’s action and
Biologics
FDA has approved Pfizer’s Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults aged 18 years and older. The company says the vaccine includes capsular polysaccharide conjugates for the 13 serotypes (1,
Biologics
FDA says Aziyo Biologics has recalled one lot of its FiberCel Fiber Viable Bone Matrix following a customer complaint from one hospital that initially reported post-surgical infection in seven of the 23 patients who received FiberCel from the specified donor lot. Four of the patients tested positive for tuberculosis,
Biologics
FDA has lifted clinical holds against Bluebird Bio’s Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease. The agency also lifted holds against the company’s Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of
Biologics
FDA has approved a ProMetic Biotherapeutics BLA for Ryplazim (plasminogen, human-tmvh) for treating patients with plasminogen deficiency Type 1 (hypoplasminogenemia), a disorder that can impair normal tissue and organ function and may lead to blindness. Those with the disease lack a protein called plasminogen, which helps the body break
Biologics
FDA has issued a clinical hold on a Ortho Regenerative Technologies Phase 1-2 clinical trial for Ortho-R, a drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair. The agency hold is related to a request for additional chemistry,
Biologics
FDA says there continues to be broad marketing of unapproved products containing regenerative medicine therapies that are intended to treat or cure a wide range of diseases or medical conditions. In an online information sheet for patients and consumers, the agency says such products require FDA approval or licensure to
Biologics
The 11th Circuit Court of Appeals has upheld a Florida federal court decision to grant summary judgment to FDA in its suit alleging that US Stem Cell Clinic, its parent company, and its chief scientific officer are providing stem cell procedures that violate the Federal Food, Drug, and Cosmetic Act.
Biologics
The Pew Charitable Trusts says FDA needs to maintain pressure on businesses offering unapproved stem cell and regenerative medicine interventions (SCRIs) and ensure that patients are protected from SCRIs that have caused harm or have the potential to cause harm. Pew says it gathered reports of adverse events linked to
Biologics
FDA acting commissioner Janet Woodcock says the once-fledgling biosimilar industry is becoming more mature following the introduction of the agency’s Biosimilar Product Development (BPD) Program three years ago. As of 5/1, 94 programs are enrolled in the BPD Program, she told the Association for Accessible Medicines annual
Biologics
A 2/1-2/11 FDA inspection at Utah Cord Bank, Sandy, UT, documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A 5/11 Warning Letter says specific deviations were: * failing to validate and approve a process according to established
Biologics
Moderna has begun a rolling BLA for its mRNA Covid-19 vaccine for use in individuals 18 years of age and older. The company says it will continue to submit data to support the BLA over the coming weeks, leading to a priority review once the submission is completed. To
Biologics
FDA has updated its guidance on Emergency Use Authorization (EUA) for Vaccines to Prevent Covid-19 to include a new section that says the agency may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency. “Additionally, given the
Biologics
Iovance Biotherapeutics says FDA regulatory feedback on potency assays for lifileucel that were submitted to the agency will delay a planned BLA for the therapy. “Following FDA feedback, Iovance will continue its ongoing work developing and validating its potency assays and plans to submit additional assay data and to meet
Biologics
Biogen says its Phase 2/3 XIRIUS study of cotoretigene toliparvovec (BIIB112), a gene therapy being investigated as a one-time therapy for patients with X-linked retinitis pigmentosa (XLRP), did not meet its primary endpoint. XLRP is a rare, inherited retinal disease that is associated with progressive vision loss
Biologics
The House Select Subcommittee on the Coronavirus Crisis will hold a hearing 5/19 that will take testimony from two Emergent BioSolutions top executives on how the company got into FDA trouble over its manufacturing of Covid-19 vaccines at its Baltimore plant. Company president Robert Kramer and executive chairman
Biologics
AstraZeneca has submitted a BLA for tezepelumab, a potential first-in-class medicine for treating severe asthma. The submission is supported by data from the PATHFINDER clinical program including the pivotal NAVIGATOR Phase 3 trial, which demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate
Biologics
FDA has announced a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid-19 vaccines and their use in the pediatric population. During the meeting, the agency will provide a status update on its approach to emergency use authorization (EUA) for Covid-19 vaccines intended for
Biologics
FDA has expanded the emergency use authorization for Pfizer-BioNTech’s Covid-19 vaccine to include adolescents aged 12 through 15 years. The expanded EUA was based effectiveness data showing the vaccine was 100% effective in preventing Covid-19. FDA says no cases of Covid-19 occurred among 1,005
Biologics
Pfizer and BioNTech have begun a rolling BLA to seek full approval of their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older. Currently the vaccine is being manufactured and distributed under an emergency use authorization due to the pandemic-related health emergency. Data to