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
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
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
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
Drugs
Acella Pharmaceuticals has recalled certain lots of its NP Thyroid (levothyroxine and liothyronine) in 9.5mcg/2.25mcg, 19mcg/4.5mcg, 38mcg/9mcg, 57mcg/13.5mcg, and 75mcg/18mcg tablets because routine testing has found them to be subpotent. The product contains less than 90% of the labeled amount of
Drugs
FDA and HHS are withdrawing a policy statement on drug review transparency that was issued in the final days of the previous administration. The 1/15 policy required FDA to publish annually for each NDA/ANDA approved the total days that elapsed between initial submission and approval. It is now
Drugs
Two bipartisan U.S. Senate bills have been introduced with the stated purpose of speeding the development of and improving access to lower-cost generic drugs. The bills, which were introduced by senators Bill Cassidy (R-LA) and Tina Smith (D-MN), are intended to make changes to the Food
Drugs
FDA has issued Leo Pharma a complete response letter for tralokinumab and its use in adults with moderate-to-severe atopic dermatitis. The agency letter requested additional data relating to the therapy’s device component and did not request any new data on the clinical efficacy or safety of the
Drugs
FDA has sent a complete response letter (CRL) to Biogen for its sBLA for a new subcutaneous route of administration of Tysabri (natalizumab) to treat relapsing multiple sclerosis. The company says it is evaluating the CRL and will determine the next steps.
Drugs
A Government Accountability Office (GAO) analysis of selected branded drug prices prepared for the Senate Budget Committee says that for 20 selected branded prescription drugs, estimated U.S. prices at the retail level were more than two to four times higher than prices in Australia, Canada, and France. The report
Drugs
Academic medical center researchers from Yale and other institutions say older Americans and blacks are underrepresented in both premarketing and postmarketing trials for a variety of cancer therapeutics. “FDA should require demographic representation in premarketing and postmarketing studies that approximates the population expected to use the therapeutic by investing in