Biologics
FDA has approved an expanded use for Sanofi’s Adacel (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria, and pertussis. The company says Adacel is the first and only Tdap vaccine in the U.S. approved for
Biologics
FDA commissioner Scott Gottlieb and CBER director Peter Marks say the agency is seeing a surge in cell and gene therapy products entering early development, as shown by the large upswing in the number of IND applications. In a statement, the two project that by 2020 the agency will receive
Biologics
A 6/18-6/22/18 FDA inspection at a Genetech facility located in San Diego, CA, found multiple violations in the firm’s processing of human umbilical cord blood derived cellular products that are distributed to Liveyon LLC, Yorba Linda, CA. An 11/29/18 Warning Letter says the
Biologics
A 1/16-1/26 FDA inspection at StemGenex Biologic Laboratories, San Diego, CA, determined that the company processes adipose tissue from donors for autologous use and also processes stromal vascular fraction (SVF) that is administered in a variety of ways. A 10/31 Warning Letter says the company says
Biologics
FDA has accepted for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein, as determined by biomarker testing.
Biologics
CBER has sent an untitled letter to the operator of two Web sites — http://www.ollereg.com and http://www.innovativeallergy.com — because they were promoting an unapproved product, Ollereg Oral Immunotherapy. Based on statements and claims appearing on the sites, CBER says it “appears that your product is intended
Biologics
CBER recorded 613 total recalls in FY 2018, down from the 669 total recalls recorded in FY 2017. The total 2018 recalls included two in Class 2, 346 in Class 2, and 202 in Class 3, along with 63 in mixed classes. There were 470 recalls involving blood, 14 involving
Biologics
FDA has lifted a clinical hold against a CRISPR Therapeutics and Vertex Pharmaceuticals IND for CTX001 for treating sickle cell disease. The investigational, autologous, gene-edited hematopoietic stem cell therapy is intended for patients suffering from severe hemoglobinopathies. The companies says they remain on track to initiate a Phase 1/
Biologics
HHS says it has canceled an FDA contract with Advanced Bioscience Resources to provide human fetal tissue used to develop drug testing protocols. In a brief statement, the department said it was “not sufficiently assured that the contract included the appropriate protections applicable to fetal tissue research or met all
Biologics
FDA has lifted a clinical hold against Sarepta Therapeutics against the company’s Duchenne muscular dystrophy micro-dystrophin gene therapy program. The hold was placed in July due to the presence of trace amounts of DNA fragment in research-grade third-party supplied plasmid in a manufacturing lot. “In response,
Biologics
FDA has granted Pfizer a Breakthrough Therapy designation for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077, indicated for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults aged 18 years and older. The company expects to start Phase 3 trials in a few months.
Biologics
FDA says it has awarded five grants to higher education institutions and non-profit organizations to study and recommend improvements for the continuous manufacturing of biological products, as well as similar innovative monitoring and control techniques. FDA commissioner Scott Gottlieb says advanced manufacturing technologies “hold great promise for improvements in
Biologics
FDA has issued a draft guidance describing its current thinking on civil money penalties relating to requirements to submit registration and/or results information to ClinicalTrials.gov and/or certain certifications to FDA. The draft addresses these questions: * how CBER, CDER, and CDRH intend to identify whether responsible parties have
Biologics
FDA has issued Pharming Group a complete response letter on its supplemental BLA for Ruconest [C1 esterase inhibitor (recombinant)] to expand the current indication to include prophylaxis in patients with hereditary angioedema. Based on the agency review, FDA has requested an additional clinical trial to further evaluate the effectiveness of
Biologics
CBER has published a list of 16 guidances it is planning to issue in this calendar year. The list includes seven guidances under Blood and Blood Components and nine under Tissues and Advanced Therapies. “The list includes topics that currently have no guidance associated with them, topics where updated guidance
Biologics
FDA has accepted for priority review a supplemental BLA for Keytruda, an anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.
Biologics
FDA has issued GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts. The letter states that more clinical data are required
Biologics
FDA has extended by three months the review of a Genentech supplemental BLA for Tecentriq (atezolizumab) for use in combination with Avastin (bevacizumab), carboplatin, and paclitaxel in first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC). The extension was granted to allow the agency to
Biologics
CBER has scheduled a 12/7 public workshop on Quantitation of AAV-Based Gene Therapy Products. A workshop announcement says it is to discuss best practices when measuring the concentration of AAV (adeno-associated virus) vectors and to provide FDA perspective on qualifying such assays. Workshop topics are to include
Biologics
FDA has accepted for review an Evolus BLA resubmission for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients. If approved, DWP-450 would be a competitor to Allergan’s Botox. The agency considered the resubmission a Class 2 response and has set a
Biologics
Haemonetics has recalled 10 lots of their Leukotrap RC System with RC2D Filter, intended for collecting whole blood and preparation of red blood cells and plasma or red blood cells, plasma, and platelets with pre-storage leukocyte reduction of red blood cells. Haemonetics has received reports of higher than expected
Biologics
Pfizer has petitioned FDA to issue a guidance document to clarify “appropriate sponsor communications about the nature and properties of biosimilar products.” The petition requests that the guidance permit “truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(