Biologics
FDA has approved a Celltrion BLA for Vegzelma (bevacizumab-adcd), a biosimilar to Genentech’s Avastin (bevacizumab), for treating six cancer types: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial
Biologics
FDA has issued contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firm’s Bloomington, IN facility that performs fill operations on Moderna’s Covid-19 Bivalent booster vaccine. The inspection concluded 9/2 and it is intended to add
Biologics
Pfizer says it will file a BLA before year end for its pentavalent meningococcal vaccine (MenABCWY) seeking use in healthy individuals aged 10 through 25 years. The decision to file is based on new positive top-line results from a Phase 3 trial (NCT04440163) that the company says met all
Biologics
The International Society for Cell & Gene Therapy (ISCT) says a recent California federal court ruling in favor of the California Stem Cell Treatment Center and against FDA “is flawed and has inserted regulatory uncertainty into the cell and gene therapy market, creating opportunities for clinics offering purported treatments that
Biologics
BioMarin Pharmaceutical says it reported an adverse event to FDA about a patient participating in the company’s hemophilia A Phase 3 gene therapy trial of valoctocogene roxaparvovec (BMN 270) being diagnosed with B-cell acute lymphoblastic leukemia. “Based on BioMarin’s assessment of the case to date, including initial
Biologics
Non-profit PATH’s chief scientific officer David Kaslow has been selected as CBER Office of Vaccines Research and Review (OVRR) director, replacing Marion Gruber, who retired last year in protest over how the agency and Biden Administration were handling Covid-19 vaccine reviews and approvals. Last year, Gruber and
Biologics
FDA has approved a Revance Therapeutics BLA for Daxxify (daxibotulinumtoxinA-lanm) for injection for temporarily improving moderate-to-severe frown lines (glabellar lines) in adults. The product, which will compete against Allergan’s Botox, is being touted as the first long-acting neuromodulator that “demonstrates a median duration of six
Biologics
CBER has announced a 10/5 Webinar entitled “Study Data Standards Update for CBER: Your Guide to a Successful Submission” that will discuss the Center’s support and requirement beginning 3/15/2023 for using the Standard for the Exchange of Nonclinical Data (SEND). The one-hour Webinar will discuss
Biologics
FDA has issued Alvotech a complete response letter on its biosimilar BLA for AVT02, a monoclonal antibody that was being evaluated for biosimilarity and interchangeability to Abbott’s Humira (adalimumab). The letter cited inspection deficiencies at its Reykjavik, Iceland manufacturing facility, which must be corrected before the therapy can be
Biologics
FDA 8/31 authorized Moderna’s and Pfizer-BioNTech’s updated (bivalent) Covid-19 vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines “contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain
Biologics
A California federal judge has ruled that a stem cell treatment firm is exempt from FDA regulation. The Los Angeles Times reports the judge declined to block California Stem Cell Treatment Center from continuing to offer its treatments to customers. It says the judge accepted the center’s contention that
Biologics
Erytech Pharma says it is no longer seeking approval for Graspa (L-asparaginase encapsulated in red blood cells) in hypersensitive acute lymphoblastic leukemia (ALL) following FDA feedback that requested additional clinical data. “In multiple clinical trials, Graspa showed promising results for patients, and we were encouraged by the dialog with
Biologics
Moderna has filed a patent infringement lawsuit against Pfizer/BioNTech in Massachusetts federal court over their Comirnaty Covid-19 vaccine. Moderna alleges that the vaccine “infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s
Biologics
Iovance Biotherapeutics has begun a rolling BLA for lifileucel, a tumor infiltrating lymphocyte therapy for use in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. The company
Biologics
Pfizer says results from a Phase 3 trial of older adults for its respiratory syncytial virus (RSV) prefusion F vaccine candidate showed efficacy of 85.7% in participants with more severe disease primary endpoint of lower respiratory tract illness. A company statement says the vaccine was well-tolerated with no
Biologics
BioMarin Pharmaceutical says it will resubmit by the end of September its BLA for hemophilia A gene therapy Roctavian (valoctocogene roxaparvovec) gene therapy after announcing the European Commission just granted conditional marketing authorization for the treatment. “Typically, BLA resubmissions are followed by a six-month review procedure,” BioMarin says. “However,
Biologics
FDA commissioner Robert Califf says there will not be any advisory committee meeting to review recent submissions from Pfizer/BioNTech and Moderna that seek emergency use authorizations for new Covid-19 booster vaccines. In an 8/25 Twitter post, Califf said an “extensive discussion” was held in June by the
Biologics
The Informed Consent Action Network (ICAN) is petitioning FDA to withdraw or suspend approval for the polio vaccine IPOL for infants, toddlers, and children “until a properly controlled and properly powered double-blind trial of sufficient duration is conducted to assess the safety of this product.” The petition says the
Biologics
The House Select Subcommittee on the Coronavirus Crisis has issued its second report, documenting three instances in which Trump White House officials “executed coordinated pressure campaigns that sought to bend FDA’s coronavirus decision making to the White House’s political will.” The report documents evidence it says committee staff
Biologics
A day after Pfizer/BioNTech announced their submission of an emergency use authorization (EUA) request for a modified Covid-19 booster vaccine, Moderna 8/23 says it has submitted an EUA for a similar BA.4/BA.5 Omicron-targeting bivalent booster vaccine, mRNA-1273.222. Moderna's submission
Biologics
Pfizer and BioNTech have filed a submission seeking FDA Emergency Use Authorization for their booster dose of an Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for individuals 12 years of age and older. “The application follows guidance from the FDA to include clinical data from the companies’
Biologics
Covid-19 vaccine makers need to get data on their reformulated booster shots into FDA by the end of the month so they can begin administering them starting in September. But in order to expedite their authorization, FDA is permitting mouse data instead of human data to be submitted, which