Drugs
A Texas federal grand jury has indicted Sanjay Kumar of Bihar, India, on charges of selling and shipping tens of thousands of dollars worth of counterfeit cancer drugs into the U.S. A Department of Justice statement says Kumar and his co-conspirators allegedly arranged for the sale and shipment
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The CDER Quantitative Medicine Center of Excellence (QM CoE), which opened 3/25 to foster the integration of quantitative methods across CDER and help advance therapeutic medical product development and inform regulatory decision-making, says it has new resources available. The resources are: * a quick reference Fact Sheet with a
Drugs
CDER says it used artificial intelligence/machine learning (AI/ML) in 2022 to identify a suitable patient population for emergency use authorization of Sobi’s Kineret (anakinra), an interleukin-1 inhibitor indicated to treat Covid-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing
Drugs
FDA has granted Zymedi an orphan drug designation for ZMA001, a proposed first-in-class antibody treatment in development for pulmonary arterial hypertension (PAH), an inflammatory vascular disease that the company says is characterized by the remodeling and narrowing of pulmonary arterioles due to various causes. “The infiltration of immune
Drugs
FDA and Health Canada are alerting healthcare providers and facilities about the safe use of Megadyne Medical Products’ Mega 2000 and Mega Soft Patient Return Electrodes, which have been at the center for four recalls since 6/2023 over reports of burn injuries in pediatric and adult patients and healthcare
Drugs
Researchers from FDA and several other entities say overall survival (OS) remains a critical indication of safety for regulatory decisions and a key aspect of FDA’s Project Endpoint. Writing in Clinical Cancer Research, the researchers say it is unfortunate that in the pursuit of earlier endpoints, many registrational clinical
Drugs
FDA has published the International Council for Harmonization M13A consensus guideline, Bioequivalence for Immediate-Release Solid Oral Dosage Forms, with recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered immediate-release solid dosage forms designed to deliver drugs to the systemic circulation, such as
Drugs
Axinn attorneys Matthew Murphy and Aaron Savit say a recent regulatory decision on a generic form of Novartis’ chronic heart failure drug Entresto (sacubitril/valsartan) may signal some agency flexibility to consider novel carve-in labeling modifications as part of a Section viii skinny labeling strategy. Writing in an online
Drugs
Federal Register notice: FDA is announcing the rates for prescription drug user fees for fiscal year 2025. They are: * Application requiring clinical data — $4.3 million * Application not requiring clinical data — $2.155 million * Program fee — $403,889 To view the notice, click here.
Drugs
The CDER Office of Surveillance and Epidemiology (OSE) 2023 annual report says OSE contributed to 55 novel drug and therapeutic biologic approvals in 2023. The report says OSE staff also were either the signal identifier or safety lead for about 80% of the 206 newly identified safety signals for marketed
Drugs
FDA has accepted for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pain. “Suzetrigine has the potential to be the first new class of medicine to treat acute pain in over 20 years,” the company says, adding that
Drugs
FDA has cleared a Varian 510(k) for its IntelliBlate microwave ablation system, intended for ablating soft tissue. “IntelliBlate produces large, controlled spherical ablation zones,” the company says, adding that the device has the option to utilize single or dual probes, with each having linked or independent controls. The device
Drugs
Aquestive Therapeutics has petitioned FDA to not approve any application for a nasal spray drug product that omits studies characterizing food effects if the active moiety, when separately approved for oral use, has demonstrated a food effect. The 7/29 petition specifically asks that the agency: * refuse to approve any
Drugs
FDA says the Amazon and Walmart Web sites are illegally selling chemical peel drug products that are unapproved new drugs. In 7/25 Warning Letters, FDA says Amazon markets the MOOYAM TCA 50% and Skin Beauty Solutions lactic acid skin peel 90%, while Walmart markets the Skin Beauty Solutions product.
Drugs
FDA has denied a Public Citizen 11/6/2019 petition asking that it and the Drug Enforcement Administration (DEA) open proceedings to reschedule tramadol from Schedule 4 of the Controlled Substances Act to Schedule 2 “because the drug has a high potential for abuse, with use potentially leading to severe
Drugs
FDA has accepted for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drug’s expanded use in treating newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Currently, Scemblix is approved for adult patients with Ph+ CML-CP who
Drugs
FDA has extended by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukemia. The agency says the extension is necessary to review supplemental information provided in response to its requests.
Drugs
AstraZeneca says data from its Phase 3 AMPLIFY trial showed that Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia. Regarding the
Drugs
A Kaleo social media post about Auvi-Q (epinephrine injection) was cited earlier this month by FDA because it presented benefit information but failed to include any risk information. CDER’s Office of Prescription Drug Promotion (OPDP) said in a just-posted untitled letter that the social media post thus
Drugs
FDA has issued Carie Boyd Pharmaceuticals a six-observation Form FDA-483 after inspecting its Irving, TX outsourcing facility last month. Agency investigators found that the firm’s procedures designed to prevent microbiological contamination of sterile drug products were inadequate. The firm was also cited for failing to thoroughly review
Drugs
FDA has approved an Alpha Cognition NDA for ZUNVEYL (benzgalantamine) for treating mild-to-moderate Alzheimer’s disease (AD). The drug has been designed with a dual mechanism of action to eliminate drug absorption in the gastrointestinal (GI) tract, “potentially addressing certain tolerability issues with leading AD medications, combined with
Drugs
FDA has approved a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata, a common autoimmune disease in which hair loss is thought to occur due to the collapse of “immune privilege,” according to the company. This collapse leads to the immune