Drugs
The 3rd Circuit Court of Appeals says a Pennsylvania federal court correctly rejected a Department of Justice request for a conspiracy charge against KVK-Tech, a Newtown, PA, generic drug manufacturer. The lower court had said the government’s indictment failed to state the offense and the government had appealed
Drugs
FDA has denied petitions submitted by Vanda Pharmaceuticals on 1/25 and 1/27 asking that the agency revoke approval of ANDAs held by Teva and Apotex for generic forms of Hetlioz (tasimelteon) 20 mg capsules. The petitions claimed the ANDAs do not have the same labeling as the reference-
Drugs
FDA has approved a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating Demodex blepharitis, an eyelid disease caused by Demodex mite infestation. It is characterized by redness, inflammation, missing or misdirected eyelashes, horizontal itching along the eyelid base and the presence of collarettes (waste products and
Drugs
FDA says it is expanding CURE ID, a joint initiative with the National Center for Advancing Translational Sciences/National Institutes of Health, which is an Internet-based repository that allows the global community to report novel uses of existing drugs for difficult-to-treat diseases. In a “Q&A
Drugs
FDA has released the form FDA-483 issued following an 8/1-9/1/22 inspection at Catalent Indiana, a sterile human drug and biologic product manufacturer in Bloomington, IN. The 12 specific inspection observations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any
Drugs
The National Center for Health Research (NCHR) says that while it supports FDA efforts to be flexible and provide a more open application of scientific and regulatory judgment when conducting nonclinical studies that determine in vitro safety and efficacy, it cannot agree with an agency draft guidance on using generally
Drugs
An FDA update on tornado damage (see earlier story) at Pfizer’s Rocky Mount, NC sterile drug manufacturing facility says it does not expect any immediate impact on drug supplies because adequate inventories are currently at hospitals and in the distribution system. The agency says the facility supplies about “8%
Drugs
FDA has released an International Council for Harmonization-developed guidance entitled “M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” The document is intended to provide a “practical framework” for identifying, categorizing, qualifying and controlling mutagenic impurities to limit potential carcinogenic risk.
Drugs
Horizon Therapeutics says a Phase 2 clinical trial evaluating daxdilimab for treating systemic lupus erythematosus (SLE) failed to show a statistically significant separation between daxdilimab and placebo on the primary endpoint. The company says the primary endpoint was the proportion of patients to achieve a British Isles Lupus Assessment Group
Drugs
FDA has approved a Verrica Pharmaceuticals NDA for Ycanth (cantharidin) topical solution for treating molluscum contagiosum (molluscum) in adult and pediatric patients. The company says molluscum is highly contagious and is commonly transmitted in households, schools, swimming pools and other extra-curricular settings. “Since molluscum spreads through skin-to-skin
Drugs
ADC Therapeutics says it is discontinuing its Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL) because the benefit-risk profile does not support its continuation. Earlier this month, ADC said that
Drugs
The Biotechnology Innovation Organization (BIO) says that FDA’s new Rare Disease Endpoint Advancement Pilot Program will provide greater clarity on how to develop novel endpoints, and it will help identify current limitations on regulatory flexibility involving the acceptance of such endpoints. In just-posted comments to FDA, BIO says
Drugs
FDA has released the form FDA-483 issued following a 2/27-3/3 inspection at Wuxi Sta Pharmaceutical Co., a contract manufacturing organization in Wuxi, China. The one inspection observation in the document is failing to perform routine calibrations of mechanical measuring instruments according to written procedures.
Drugs
FDA is asking the DC federal court to dismiss a suit brought against the agency by Norwich Pharmaceuticals in an attempt to force FDA to approve the company’s amended ANDA for a generic form of rifaximin (Salix’ Xifaxan), to treat irritable bowel syndrome with diarrhea. In filing the suit,
Drugs
A panel at a 7/11 Friends of Cancer Research (FoCR) meeting, “Establishing Evidence: New Advancements Using ctDNA),” discussed regulatory considerations for using circulating tumor DNA (ctDNA) as an early endpoint, including mimicking the process used to establish other novel endpoints to make ctDNA a successful endpoint. A FoCR meeting
Drugs
FDA says it is working with Pfizer to monitor more closely the drug shortages impact of a 7/19 tornado that severely damaged Pfizer’s large sterile injectables site in Rocky Mount, NC. The company reported that no employees were harmed by the twister. Drug shortage expert and senior pharmacy
Drugs
FDA has granted Astria Therapeutics fast track status for STAR-0215 for treating hereditary angioedema (HAE), a rare genetic disorder that causes severe unpredictable swelling attacks throughout the body. The therapy is currently being evaluated in the ALPHA-STAR clinical trial in people with HAE, and “initial proof-of-concept
Drugs
FDA has approved a Daiichi Sankyo NDA for Vanflyta (quizartinib) in certain patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive. The approval covers Vanflyta use with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy. In
Drugs
All 23 Democrats on the House Energy and Commerce Committee are sponsoring legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). The bill also includes new tools and authorities for FDA to use in dealing with drug shortages. A statement from the committee Democrats (includes a link to
Drugs
Former CBER Office of Tissues and Advanced Therapies (OTAT) director Wilson Bryan has joined regulatory consulting firm Greenleaf Health as executive vice president for drug and biological products. Bryan earlier this year retired from the agency after serving 19 years, including the past seven years as OTAT director. As director,
Drugs
FDA has granted Ambrx Biopharma a fast track designation for ARX517 for treating patients with metastatic castration-resistant prostate cancer (mCRPC) in those whose disease progressed after treatment with an androgen receptor pathway inhibitor. The therapy is currently being studied in APEX-01, a Phase 1-2 dose escalation and
Drugs
FDA has released the form FDA-483 issued following a 5/2-5/17 inspection at SCA Pharmaceuticals, a Little Rock, AR, outsourcing facility. The inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * aseptic processing areas are deficient regarding air supply that is