Biologics
FDA commissioner Scott Gottlieb says FDA needs to develop a science-based framework that includes the regulatory tools and guidances to evaluate cell-based and recombinant technology flu vaccines. “Ultimately, our investment will provide regulatory clarity for this kind of new technology,” Gottlieb said in 3/8 testimony before a
Biologics
Verax Biomedical says FDA improperly influenced members of the Blood Products Advisory Committee at an 11/30/17 meeting in violation of the Federal Advisory Committee Act (FACA), and agency actions taken to implement recommendations from that meeting should be reversed. In a 3/5 petition, Verax asks that FDA:
Biologics
CBER researchers say they have demonstrated unexpected changes in the shape and size of multipotent stromal cells (MSCs) when preparations of the cells interact with specific engineered culture systems. An FDA news release says the finding is a step toward understanding how to accurately interpret studies that use such systems,
Biologics
FDA commissioner Scott Gottlieb says the agency is investigating why this year’s flu vaccine was not very effective against one strain — H3N2. “We’re taking steps to investigate each of [the] potential causes, rule out possible reasons for the variation in effectiveness and improve vaccine efficacy against H3N2,” he
Biologics
FDA has approved a Treos Bio IND for PolyPEPI 1018 to allow a Phase 1 study to proceed with the investigational precision cancer vaccine for patients with metastatic colorectal cancer (mCRC). The study will be conducted at Mayo Clinic in Rochester, Minnesota and University of Pisa in Italy. It will
Biologics
CBER has issued a revised a Standard Operating Policy and Procedure (SOPP) on “SOPP 8005: Formal Dispute Resolution Process,” which describes the policy for resolving procedural or scientific disputes that cannot be resolved at the review division level between sponsors and CBER review staff regarding submissions under review. The document
Biologics
CBER has issued a list of nine guidance topics it is considering for development during calendar year 2018. The document includes five guidances within the category Blood and Blood Components and four guidances within the category Tissues and Advanced Therapies. It also shows three guidance documents issued since the 7/
Biologics
FDA has granted Janssen a priority review for its supplemental BLA to use Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The agency has set a user fee review action target date of
FDA Policy/General
FDA has issued a draft guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, to assist and provide recommendations about the use, content, and circumstances for issuing public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart
Biologics
FDA has approved a GlaxoSmithKline supplemental BLA for an expanded indication for Fluarix Quadrivalent (influenza vaccine) to include use in those six months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in those three years of
Biologics
CBER director Peter Marks says the Center approved several therapeutic “firsts” in FY 2017, representing significant achievements in fulfilling its mission to ensure that safe and effective biological products and related devices are available to the public. In the Center’s annual report, Marks identifies the new therapies as Novartis’
Biologics
FDA has accepted for review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The agency granted a priority review, and set a user fee review target date of 5/1. The submission is based
Biologics
Results of a study led by FDA scientists suggest that a new technology known as high throughput sequencing (HTS) could be standardized and used for rapid screening of biologic products, including vaccines, to demonstrate absence of contamination. The technology reportedly enables scientists to sequence hundreds of millions of DNA molecules
Biologics
FDA has approved an Amgen supplemental BLA for Repatha (evolocumab) for preventing heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. Repatha is the first PCSK9 inhibitor to achieve this indication, according to the company. Approval was based on data from a cardiovascular outcomes study (FOURIER) demonstrating
Biologics
FDA has posted a draft guidance on “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document explains changes to the user fee program mandated under the Reauthorization Act of 2017, particularly the new fee structure and types of fees for which entities are responsible. It describes
Biologics
An FDA 4/3-4/28 inspection of RTI Surgical, Alachua, FL, found multiple violations in the firm’s continuing manufacture of a bone graft product consisting of a scaffold composed of human demineralized bone matrix and cortical cancellous chips or strips, copackaged with a redacted isolated bone marrow, cryopreserved
Biologics
FDA has approved a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against hepatitis B infection in adults 18 years of age and older. Approval was based on data from three Phase 3 non-inferiority trials of nearly 10,000 adults who received Heplisav-B.
Biologics
Novartis has submitted a supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion for treating adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. In August, Kymriah became the first available chimeric antigen receptor T (CAR-T)
Biologics
Biosimilar approvals should help cut healthcare spending by $54 billion over the next decade, according to a new analysis from the RAND Corporation. The cost savings projection is almost 20% greater than a similar analysis done by the researchers three years ago, “representing both improved analysis methods and rapid growth
Biologics
Octapharma USA has decided to withdrawal two lots of Octagam 10% [immune globulin intravenous (human)] liquid preparation] that is labeled with lot numbers K724B8541 and K725A8541. “Although there have been no reports of serious injury at this time,” an FDA online notice says, “Octapharma has determined through consultation with the
Biologics
FDA says that on 10/13, Octapharma, Vienna, Austria, initiated a voluntary market withdrawal of two lots of its octagam 10% [immune globulin intravenous (human)] 10% liquid preparation. “Although there have been no reports of serious injury at this time,” an FDA online notice says, “Octapharma has determined through consultation
Biologics
FDA's Cellular, Tissue and Gene Therapies Advisory Committee has voted unanimously (16 to 0) to recommend approval for a Spark Therapeutics BLA for Luxturna (voretigene neparvovec) for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy. A briefing document released in advance of