Drugs
Hyman, Phelps & McNamara senior medical device regulation expert Veronique Li and attorney Jeffrey Gibbs say FDA needs to improve its posting of de novo decision summaries. Writing online in their firm’s FDA Law Blog, Li and Gibbs say that whenever the agency grants a de novo request, it
Drugs
FDA has granted ReAlta Life Sciences orphan drug and fast track designations for RLS-0071 and its use in treating hospitalized patients with steroid-refractory acute graft-versus-host disease (aGvHD). The serious and often fatal complication occurs after hematopoietic stem cell transplantation when the donor's immune cells
Drugs
FDA has granted Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating unresectable or metastatic hormone receptor-positive HER2 low or HER2 ultralow breast cancer patients who have received either two lines of endocrine therapy in the metastatic setting, or one line of
Drugs
FDA has lifted a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a HER3-targeted antibody-drug conjugate for treating EGFR-mutated non–small cell lung cancer and hormone receptor–positive, HER2-negative breast cancer. The hold was in response to study
Drugs
FDA has posted a final guidance entitled “Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations on meetings between FDA and a prospective applicant preparing to submit or has already submitted an ANDA. It includes information about requesting and conducting PSG meetings with
Drugs
FDA has denied a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for Yutrepia (treprostinil) and issue a complete response letter instead. The 5/10 petition said that LGM Pharma, which United says is Liquidia’s sole active pharmaceutical ingredient (API) supplier,
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) with platinum-containing chemotherapy as neoadjuvant treatment that is followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors greater than 4 cm or node positive) non-small cell lung cancer (NSCLC). The drug is intended for use
Drugs
The Washington DC District Court has denied a Novartis motion for a temporary restraining order or a preliminary injunction to stay FDA’s approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), indicated for reducing the risk of cardiovascular death and hospitalization in adult patients with chronic
Drugs
Two Sheppard Mullin attorneys say a recent untitled letter to Bristol Myers Squibb’s Mirati unit involving communications to healthcare providers on its Krazati (adagrasib) tablets that received accelerated approval to treat some lung cancers is a “cautionary tale to sponsors of accelerated approval drugs.” Writing online in a National
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FDA says CDER’s new Advanced Manufacturing Research Facility is “a new laboratory for evaluating innovative drug manufacturing technologies and ensuring drugs produced with the technologies are safe, effective, and high-quality.” An online post says CDER uses this facility to lead regulatory science research for current and new advanced
Drugs
FDA has granted Wave Life Sciences a rare pediatric disease designation for WVE-N531 and its use in treating boys with Duchenne muscular dystrophy who are amenable to exon 53 skipping. The therapy is currently being evaluated in the registrational FORWARD-53 clinical trial, and the company says it expects
Drugs
The Biotechnology Innovation Organization (BIO) says it is critical that FDA appoint individuals to advisory committees who have the requisite expertise to consider the topics under discussion and provide expert advice to the agency. BIO’s comments are in a letter responding to an FDA request for information and comments
Drugs
FDA has granted accelerated approval to Gilead’s Livdelzi (seladelpar) to treat primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. A company statement says the approval was based primarily on
Drugs
Verrica Pharmaceuticals says it will request an end-of-Phase 2 meeting with FDA after reporting “preliminary positive results” from Part 2 of its Phase 2 clinical trial studying VP-315, a potential first-in-class oncolytic peptide for treating basal cell carcinoma. The company says it expects genomic and
Drugs
FDA has approved Incyte’s Niktimvo (axatilimab-csfr), a colony stimulating factor-1 receptor-blocking antibody, to treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in some adult and pediatric patients. An agency notice says efficacy was evaluated in the AGAVE-
Drugs
FDA and the American Society of Clinical Oncology are announcing a 10/1 joint workshop entitled “Measuring Toxicity in Reproductive Organs During Oncology Drug Development.” The workshop is intended to discuss measuring gonadal toxicity during oncology drug development. Specific topics include: * Highlighting patient voices and the importance of measuring gonadal
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) recommends that FDA revise its draft guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model to clarify several key elements. The PhRMA comment letter says that “many of the draft guidance’s recommendations are very broad and appear untethered to, and
Drugs
Raaha, a drug development consulting firm, is asking FDA not to approve an ANDA for prednisolone ophthalmic solution 1% without having long-term stability studies under refrigerated conditions. The firm’s 8/7 petition specifically asks that FDA: * require generic applicants to conduct long-term stability studies that specifically demonstrate
Drugs
An FDA review of records submitted by Nowrez & Ismail Shukri Company in Amman, Jordan, identified significant violations of current good manufacturing practice (CGMP) regulations in its production of over-the-counter finished drugs. A just-released 7/11 Warning Letter says specific violations were: * failure to have for each
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP), Procedures for Handling Requests for Proprietary Name Review, with procedures to be used by the CDER Office of Surveillance and Epidemiology (OSE), the Office of New Drugs (OND), the Office of Generic Drugs (OGD), and the Office of Prescription Drug
Drugs
Tandem Diabetes Care has issued an update on its March recall of its Apple iOS t:connect mobile app in the U.S. due to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. “This battery depletion can result in the pump
Drugs
A bipartisan group of senators has introduced the Creating Hope Reauthorization Act to encourage the development of drugs to treat rare diseases affecting children. The sponsors include Sens. Susan Collins (R-ME), Bob Casey (D-PA), Markwayne Mullin (R-OK), and Sherrod Brown (D-OH). A statement from Sen. Collins