Biologics
FDA has approved a Pfizer BLA supplement for Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for an expanded age indication to include adults 18 through 49 years of age for active immunization for preventing pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4,
Biologics
FDA reviewers say an Amgen BLA (ABP 501) for a proposed biosimilar product referencing AbbVie’s Humira for treating arthritis is highly similar to the innovator product. The agency’s Arthritis Drugs Advisory Committee will review and vote on the submission 7/12. “The comparison of the structural and functional
Biologics
Merck and Moderna Therapeutics have entered into a strategic collaboration and license agreement to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. “The collaboration will combine Merck’s established leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and GMP manufacturing capabilities to advance individually
Biologics
It appears FDA made a mistake in a 6/2-published Federal Register notice that sought Office of Management and Budget approval on an information request outlined in a 2015 draft guidance on Nonproprietary Naming of Biological Products that would have biologic and biosimilar product sponsors submitting proposed suffixes to
Biologics
Despite a recommendation by a CDC panel that MedImmune’s FluMist live attenuated influenza vaccine should not be used during the 2016-2017 flu season because new preliminary data questioned its effectiveness rate, FDA says it has decided to leave the product on the market and no further regulatory action
Biologics
Rep. Jan Schakowsky (D-IL) and Sens. Sherrod Brown (D-OH) and John McCain (R-AZ) have introduced the “Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act” that they say would foster competition and provide opportunity for more biologics to enter the marketplace and drive down costs. “In
Biologics
When FDA declares a therapy safe and effective for its labeled indication, what happens when a sister agency — in this case, the Centers for Disease Control and Prevention (CDC) — subsequently declares it ineffective for that indication and recommends use of a different product instead? That’s what happened 6/23
Biologics
FDA has approved a Protein Sciences BLA supplement to extend the shelf life for Flublok, its seasonal influenza vaccine. The shelf life has been extended to nine months from the date of manufacture — increasing the previous shelf life by three months. The longer shelf life is intended to help healthcare
Biologics
FDA has withdrawn a 6/2-published Federal Register notice that sought Office of Management and Budget approval on an information request outlined in a 2015 draft guidance on Nonproprietary Naming of Biological Products that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the
Biologics
CDER plans to release biosimilar guidance documents by the end of the year on statistical considerations for analytical similarity data, and interchangeability data standards, according to CDER associate director for therapeutic biologics Leah Christl. Speaking at a 6/20 Alliance for Health Reform biosimilar briefing, Christl said that the science
Biologics
NIH’s Recombinant DNA Advisory committee (RAC) will meet 6/21-22 to review a protocol involving the first-in-human use of gene editing via CRISPR/Cas9 technology. According to a NIH Office of Science Policy post, the T cell immunotherapy protocol involves the use of CRISPR/Cas9 to
Biologics
Six groups representing biologic prescribers have sent a letter to the Senate Health, Education, Labor and Pensions (HELP) Committee leadership commending the bipartisan sponsorship of Section 11 of S. 2700, a provision of the 21st Century Cures Act, that assures full FDA authority over the identity (name) and quality standards
Biologics
FDA has issued a final rule to explicitly allow for optional inclusion of standalone symbols without adjacent explanatory text in labeling for medical devices and certain biological products if certain conditions are met. The rule also specifies that using symbols, accompanied by adjacent explanatory text, continues to be permitted. The
Biologics
A coalition of 10 patient advocacy and research groups, including the Cystic Fibrosis, Muscular Dystrophy and National Patient Advocate foundations, the National MS Society, and the National Organization for Rare Disorders, say they oppose provisions in the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW Act)
Biologics
FDA has asked the Office of Management and Budget to approve an information request outlined in a 2015 draft guidance on Nonproprietary Naming of Biological Products that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the nonproprietary name on such products (see story). According
Biologics
FDA has posted a guidance on “Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components.” The document recognizes standardized full-length and abbreviated donor history questionnaires prepared by the AABB Donor History Task Force as an
Biologics
FDA has accepted for review a Samsung Bioepis BLA for SB2, a biosimilar candidate referencing Janssen’s Remicade (infliximab) for treating rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the U.S. If
Biologics
In a letter to FDA this week, a 70-group coalition of healthcare stakeholders, including patient and provider organizations, has urged the use of distinguishable, meaningful suffixes for biosimilars. The letter follows FDA’s departure from “a meaningful to random identifier in the agency’s approval of the second biosimilar,
Biologics
FDA has accepted for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The agency has set a user fee target action date
Biologics
Emergent BioSolutions has submitted a supplemental BLA seeking approval for manufacturing BioThrax (anthrax vaccine adsorbed) at the company’s large-scale manufacturing facility (Building 55). The submission is supported by data that demonstrate that BioThrax manufactured in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility, according
Biologics
FDA has accepted for priority review a Genentech BLA for atezolizumab for treating patients with locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-
Biologics
FDA has approved Hospira’s Inflectra (infliximab-dyyb), a biosimilar product referencing Janssen Biotech’s Remicade. This is the second biosimilar approved by the agency since the passage of the Biologics Price Competition and Innovation Act of 2009. The approval covers the following indications: * adult patients and pediatric patients (ages