Biologics
In approving an Amgen biosimilar for the first copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases (see story), FDA also simultaneously denied an Abbott petition that sought to block the action by arguing such approval would violate the U.S. Constitution’s Takings Clause. The petition argued that
Biologics
FDA has approved Amgen’s Amjevita, a biosimilar copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. This is FDA’s fourth approved biosimilar. Amjevita is approved for the following indications in adult patients: * moderately to severely active rheumatoid arthritis; * active psoriatic arthritis; * active ankylosing spondylitis (an arthritis that
Biologics
FDA has granted Sanaria a fast track designation for its preventative vaccine for malaria, Sanaria PfSPZ Vaccine. The vaccine is in clinical trials in subjects ranging in age from 6-months to adults in the U.S., Europe and Africa. The trials are intended to finalize an immunization regimen to
Biologics
FDA has posted a guidance on “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” that provides recommendations for testing living donors using an FDA-licensed donor screening test.
Biologics
The Southern Florida District Court has ruled that Apotex’s proposed filgrastim and pegfilgrastim biosimilar products will not infringe the asserted claims of Amgen’s ’138 patent (U.S. Patent. No. 8,952,138). Apotex had contended that the process described in its aBLAs falls outside the scope of the
Biologics
FDA has scheduled for 12/7 a public workshop, “The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program,” to describe the Sentinel Initiative and PRISM program, illustrate how the agency uses PRISM for regulatory responsibilities, and discuss PRISM’s future direction in terms of expansion and further integration into
Biologics
FDA has approved a Genmab supplemental BLA for the use of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for treating patients with relapsed chronic lymphocytic leukemia (CLL). The submission, which was given a priority review in May, was submitted by Novartis under a collaboration between the two companies.
Biologics
A 3/23-5/4 FDA inspection at Amniotic Therapies, Farmers Branch, TX, found multiple violations in the firm’s receiving of amniotic tissue recovered from cesarean births and processing the amnion, a structural tissue, from donors for allogenic use. The firm also produces AlphaGEMS, AlphaGEMS Micro and AlphaGEMS Nano
Biologics
FDA has approved a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgen’s Enbrel (etanercept), indicated for treating rheumatoid arthritis, plaque psoriasis, psoriatic psoriasis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. Last month, the agency’s Arthritis Drugs Advisory Committee voted 20 to 0 to support the
Biologics
FDA has accepted for review a CSL Behring BLA for its low-volume subcutaneous CSL830 (C1-esterase inhibitor (C1-INH) human) replacement therapy for preventing hereditary angioedema (HAE) attacks. The rare genetic disorder is caused by a deficiency of C1-INH, one of the proteins that work with the immune
Biologics
FDA has approved a Seqirus BLA for Afluria Quadrivalent (influenza vaccine) for use in those 18 years of age and older for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. The product comes in single-dose, preservative-free pre-
Biologics
Genmab has submitted a supplemental BLA for Darzalex (daratumumab) and its combination use with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who received at least one prior therapy. The company has asked for a priority review, and the agency granted a breakthrough therapy designation
Biologics
Responding to an FDA request for comment on its forms FDA-3486 and FDA-3486A used to report biological product deviations and human cells, tissues, and cellular and tissue-based deviations in manufacturing, AABB asks that the forms be modified to be easier to use by its members and member
Biologics
A Massachusetts federal court has issued summary judgment in favor of Celltrion Healthcare and Hospira involving patent infringement lawsuits related to their biosimilar product referencing Janssen Biotech’s Remicade (infliximab). The court found that a Janssen patent is invalid. FDA approved the product in April (see story), and the product
Biologics
AbbVie has filed suit against Amgen to block its biosimilar version of AbbVie’s blockbuster arthritis therapy Humira. Amgen’s proposed copy would infringe at least 10 patents, AbbVie says in the complaint, which seeks a court order to prevent Amgen from marketing its biosimilar. Last month, an FDA advisory
Biologics
FDA has given ADMA Biologics a complete response letter for a BLA for RI-002, an investigational therapy for treating primary immunodeficiency (PI) patients. The letter identified certain outstanding inspection issues and deficiencies at ADMA’s third-party contract manufacturers, including its contract drug substance and product manufacturer, and its
Biologics
Amgen and UCB have filed a BLA for romosozumab, an investigational monoclonal antibody for treating osteoporosis in postmenopausal women who have increased fracture risks. “Romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption,” the companies say. The
Biologics
FDA has asked Merck to submit new data and analyses from the clinical trials MODIFY I and MODIFY II that support a pending BLA for bezlotoxumab, an investigational agent for preventing Clostridium difficile (C. difficile) infection recurrence. The additional data and analyses will be considered a major amendment, resulting in
Biologics
Amgen and Allergan have announced results from a Phase 3 study evaluating the efficacy and safety of their biosimilar candidate ABP 980 compared with Genentech’s Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2-positive (HER2-positive) early breast cancer. “The results ruled out inferiority compared to
Biologics
FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has voted 18 to 0 to recommend approval of a Valeant BLA for Siliq (brodalumab) injection for treating plaque psoriasis. Fourteen panel members recommended that risk management options for “suicide ideation and behavior” outside of the approved labeling be implemented if approved.
Biologics
Novartis says its Sandoz drug unit has received a complete response letter from FDA for a biosimilar pegfilgrastim candidate (Amgen’s Neulasta). “We are working with the agency to address remaining questions,” the company briefly said in a 7/19 financial report. Sandoz reported 11/2015 that FDA had accepted
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,