Drugs
Members of the FDA Cardiovascular and Renal Drugs Advisory Committee has voted 12-1 that Novartis’ Entresto (sacubitril/valsartan) is worthy of an expanded indication to treat heart failure with preserved ejection fraction, even though a trial designed to prove efficacy for this patient group narrowly missed the mark. The
Drugs
A YourEncore white paper says that although a data strategy is critical to the successful completion of clinical trials, only one-third of companies responding to a survey said they had such a strategy. “Each company should invest the time and resources to develop a comprehensive strategy,” the paper says.
Drugs
Sens. Chuck Grassley (R-IA) and Ron Wyden (D-OR) have released a report identifying $65 million in payments made by manufacturers of opioids and opioid-related products to groups focused on pain issues. In a statement (contains a link to the full report), the senators say the opioid manufacturers
Drugs
FDA has released the FDA-483 containing 15 observations issued following a 10/13-10/29 inspection at Advanced Nutriceuticals, an Indianapolis, IN, producer of sterile drug products. The inspection observations were: * performing aseptic processing outside of a certified ISO 5 area; * the ISO classified aseptic processing area was located
Drugs
Gilead Sciences and Galapagos are scrapping the U.S. development of Jyseleca (filgotinib) for Rheumatoid Arthritis (RA) after a recent meeting with FDA to discuss an 8/18 NDA complete response letter over testicular toxicity concerns. FDA told the companies that “substantial additional clinical studies” would be required to support
Drugs
FDA says its review of the Etsy.com Web site maintained by Desert Alchemist, Tucson, AZ, indicates that the firm takes orders for eight products that are considered to be drugs under the Federal Food, Drug, and Cosmetic Act because they are intended for use in the cure, mitigation, treatment,
Drugs
FDA says its review of a Web site and Facebook page for JC Ayur Life, Yorba Linda, CA, determined that the company takes orders for its product “Heritage of Ayurveda Dia-Tonic Incudil Herbal Dietary Supplement.” A 10/29 Warning Letter says the product is considered to be a drug
Drugs
In response to an FDA clinical hold, Regeneron says it is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in trials for odronextamab. The company says FDA asked that it amend the trial protocols to further reduce the incidence of ≥Grade 3 cytokine release syndrome
Drugs
Writing online for Drug & Device Law, attorneys Dick Dean and Emmanuel Sanders (Tucker Ellis) speculate whether recent changes in personnel on the Supreme Court could bring an end to Wyeth v. Levine, the case that held that a jury can second-guess whether an FDA-approved label is adequate.
Drugs
FDA has approved an Athenex NDA for Klisyri (tirbanibulin) for the topical treatment of actinic keratosis on the face or scalp. Approval is based on data from two pivotal, randomized, double-blind, vehicle-controlled Phase 3 studies (KX01-AK-003 and KX01-AK-004) that evaluated tirbanibulin ointment 1% in
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Mesoblast says the DREAM-HF Phase 3 trial of its allogenic cell therapy rexlemestrocel-L (Revascor) in 537 patients with advanced chronic heart failure demonstrated a 60% reduction in the incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier stage
Drugs
The American Civil Liberties Union (ACLU) is criticizing a second Trump administration Supreme Court petition to uphold an FDA requirement that patients seeking an early abortion pill go to a health center to sign a form and obtain the drug, even during the Covid-19 pandemic. The ACLU says the
Drugs
FDA has granted Gannex a fast track designation for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42, which the company describes as a novel non-steroidal, selective, potent Farnesoid X Receptor agonist. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis, Gannex says. It
Drugs
FDA has approved a shorter two-hour infusion time for Genentech’s Ocrevus (ocrelizumab) — dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The dosing approval was based on data from the randomized, double-blind
Drugs
A new FDA Web site posting discusses the agency’s surrogate endpoint (SE) table that was mandated by the 21st Century Cures Act of 2016. The table is intended to increase transparency by informing stakeholders about the development of novel SEs. “It also provides consistency in the application of existing
Drugs
FDA has granted Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pain. The company says it is currently enrolling patients with this condition in a Phase 2 proof-of-concept study and it is preparing to initiate a second Phase 2 clinical
Drugs
Sanofi and GlaxoSmithKline have announced a delay in their Covid-19 vaccine program to improve immune response in older adults. “Phase 1/2 study interim results showed an immune response comparable to patients who recovered from Covid-19 in adults aged 18 to 49 years, but a low immune response
Drugs
The International Council on Harmonization (ICH) says the electronic Common Technical Document (eCTD) v4.0 question-and-answer and specification change request document v1.4 reached Step 4 of the ICH process this month. An ICH statement says the document is a summary of questions received by the eCTD implementation
Drugs
At the 10/13 meeting of the PDUFA 7 FDA and the industry negotiation regulatory decision tools subgroup, FDA discussed the Complex Innovative Trial Design (CID) program and its PDUFA 6 pilot. A meeting summary says FDA discussed a need to build upon the current pilot to provide time, expertise,
Drugs
AvKare (Pulaski, TN) has withdrawn one lot of sildenafil 100 mg tablets and one lot of trazodone 100mg tablets due to a product mix-up that led them to be inadvertently packaged together during bottling at a third-party facility. Unintentional consumption of sildenafil may pose serious health risks because
Drugs
Torrent Pharmaceuticals has recalled one lot of anagrelide capsules due to a dissolution test failure detected during routine quality testing. “Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body,” a recall notice says. “For seriously ill patients with
Drugs
Oblato says that in discussions with FDA officials on the company’s plan for a Phase 1/2 clinical trial to start developing a new treatment for diffuse intrinsic pontine clioma (DIPG), a rare pediatric disease, using the company’s OKN-007, the agency gave consent for matters such as