Drugs
FDA has extended for three years its research collaboration with CN Bio, which will now focus on exploring CN Bio’s “lung-on-a-chip” using the PhysioMimix platform to appraise the system’s use for the evaluation of inhaled drug products and assessing additional applications for CN Bio’s
Drugs
FDA has just released the establishment inspection report issued following a 10/7-10/16/20 agency inspection at Juno Therapeutics, Bothell, WA. The report says no previous inspections had been conducted. The six inspection observations in the FDA-483 portion of the report were: * failing to thoroughly review any
Drugs
FDA reviewers are questioning the adequacy of a single Phase 3 trial submitted to support a ChemoCentryx NDA for avacopan, an oral small molecule C5a receptor inhibitor indicated for treating adult patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV). In a briefing document for a 5/6 advisory
Devices
FDA has cleared a Genesis Software Innovations 510(k) for its PreView 3D Shoulder Arthroplasty Planning Software. The device is intended for orthopedic surgeons to develop pre-operative shoulder plans based on CT imaging studies. It assists with surgical planning by showing a representation of the patient’s shoulder anatomy
Drugs
Former CDER Division of Cardiovascular and Renal Products deputy director Stephen Grant has joined NDA Partners as an expert consultant. During his more than 20-year career at the agency, Grant served on CDER Office of Compliance’s Medical and Scientific Affairs staff, Office of Therapeutics Research and Review as
Drugs
FDA has accepted for review an Amgen supplemental NDA for Otezla (apremilast) for treating adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The agency has set a user fee review action date of 12/19. The submission is based on data from the
Biologics
Three U.S. senators have introduced S.1508 (text not yet available) to “harness real-world evidence (RWE) gathered during emergency use authorization to support future approvals for drugs, biologics, and medical devices at FDA.” The bill is sponsored by Sens. Roger Marshall (R-KS), Tina Smith (D-MN), and
Drugs
Pfizer says it has paused enrollment in a registration-enabling Phase 2 study of elranatamab after FDA requested additional data on three cases of peripheral neuropathy observed in the ongoing Phase 1 MagnetisMM-1 study. Patients experiencing clinical benefit from elranatamab may continue treatment, the company says in a 5/
Drugs
ViiV Healthcare has begun a rolling NDA submission for cabotegravir, a long-acting, injectable drug for preventing human immunodeficiency virus (HIV). The submission will be based on data from two Phase 2b/3 studies, HPTN 083 and HPTN 084. HPTN 083 evaluated the safety and efficacy of long-acting cabotegravir
Devices
Stryker has petitioned FDA to exempt powered patient transport from premarket notification under section 510(k). The 4/30 petition says: * the devices do not have a significant history of false or misleading claims or risks associated with their inherent characteristics; * characteristics of the devices necessary for their safe and
Drugs
Siga Technologies has filed an NDA for Tpoxx (tecovirimat), an intravenous formulation for treating human smallpox disease in adults and pediatric patients weighing 13 kg or more. The oral formulation was approved 7/2018. The IV formulation was designed to enable patients who are too sick or unable to swallow
Drugs
FDA says that Unived Inc., Irvine, CA, is marketing several products that are considered to be drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. A just-released 4/7 Warning Letter lists claims made on the firm’s Web site that provide
Drugs
FDA says Immune & Genetics Protocols, Ocala, FL, is marketing Immune Bio Green Cell, which is considered to be a drug because it is intended for use in curing, mitigating, treating, or preventing disease. A just-released 3/30 Warning Letter lists some Web site claims the company makes for
Devices
FDA is announcing a 6/10 virtual public workshop entitled “Orthopedic Device Postmarket Review.” The workshop is intended to discuss FDA’s postmarket programs and activities related to orthopedic devices, such as recalls, Medical Device Reporting, post-approval and postmarket surveillance studies, inspections, and postmarket approval reporting. “Presenters will discuss
Drugs
CDER Office of Generic Drugs Office of Research and Standards director Robert Lionberger says the agency has used GDUFA and other techniques to encourage the development of complex generic drugs. In an online post, Lionberger reviews activities under GDUFA 1 and 2 to improve the scientific foundation for complex generics.
Drugs
FDA has awarded two 2021 grants under the CDER Standard Core Clinical Outcome Assessments and their Related Endpoints pilot program that was launched in 2019. An agency notice says the pilot is to support the development of publicly available core sets of clinical outcome assessments and their related endpoints for
Drugs
Pfizer says it will ask FDA by the end of the month to convert its Covid-19 vaccine’s emergency use authorization to a full BLA approval. The submission will include safety and efficacy data through six months, according to the company. In April, Pfizer and development partner BioNTech announced
FDA Policy/General
Federal Register notice: HHS and FDA are withdrawing a 1/15 Statement of Policy directing the agency to publish certain information regarding the timeline for its review of drug product applications. To view the notice, click here.
Drugs
FDA has approved AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Approval was based on data from the DAPA-CKD trial, which
Drugs
FDA has accepted for review an Intra-Cellular Therapies supplemental NDA for lumateperone, indicated for treating depressive episodes associated with Bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The agency has set user fee review action target date of 12/17.
Drugs
HutchMed has completed a rolling NDA submission for surufatinib for treating pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs). The NDA is supported by data from two Phase 3 studies of surufatinib in NET conducted in China (SANET-p1 and SANET-ep2), and by data from a surufatinib study
Drugs
An International Council for Harmonization (ICH) expert working group is holding two meetings (5/18-19) to provide an update on the progress to revise its ICH E6 good clinical practice guideline. Last month, an ICH management committee released a draft version of the guideline (see earlier story). ICH says