Drugs
Aldeyra Therapeutics says the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis “achieved statistical significance for the primary endpoint and all secondary endpoints.” The trial enrolled 131 allergic conjunctivitis patients and the primary efficacy endpoint was change from baseline in patient-
Drugs
FDA has told a Florida federal court that it expects to decide by 10/31 whether to approve a Florida plan to import some drugs from Canada. Public radio station WUSF reports the agency statement led the federal judge to stay key parts of a state lawsuit against the agency
Drugs
In a 6/12 letter to customers, Pfizer advises there is a “limited supply and impending stock out” for selected Bicillin L-A (penicillin G benzathine injectable suspension) and Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) prefilled syringes. The letter estimates that all Bicillin C-
Drugs
The CDER Biomarker Qualification Program has issued a Biomarker Letter of Support for four pancreatic injury safety biomarkers identified and evaluated by the Critical Path Institute (C-Path)’s Predictive Safety Testing Consortium (PSTC). C-Path says the biomarkers will help increase the ability to detect and monitor drug-induced
Drugs
Attorneys Dominick DiSabatino and Cortney Inman (SheppardMullin) say FDA appears to have two goals for its recently announced proposed rule to require manufacturers to provide a one-page Patient Medication Information (PMI) for each drug prescribed. The goals, they say, are: * standardization of patient-facing prescription drug product labeling; and
Drugs
2seventy bio says Seattle Children’s has paused the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in acute myeloid leukemia following a fatal adverse event. A company statement says the study couples 2seventy bio’s DARIC T cell platform with Seattle Children’s expertise in oncology
Drugs
FDA has approved an Amneal Pharmaceuticals 505(b)(2) for Pemrydi RTU, a ready-to-use formulation of pemetrexed for injection that does not require reconstitution, dilution, or refrigeration. The injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL. “By eliminating formulation
Drugs
FDA has given Starton Therapeutics the green light to proceed with a Phase 1b clinical trial of its Star-LLD investigational continuous delivery lenalidomide in multiple myeloma. The trial in second-line transplant-ineligible patients is designed to assess the combination of Star-LLD, Velcade, and dexamethasone, according to the
Drugs
An FDA review of the Web site and social media pages maintained by A&Z Pharmaceutical in Hauppauge, NY, determined that the firm takes orders for Chewable Calcium 600 mg with Vitamin D for Kids in Orange Flavor. A 6/1 Warning Letter lists quotes from the Website making
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says pages at the Xeris Recorlev Web site make false or misleading claims and representations about the safety and efficacy of Recorlev (levoketoconazole) tablets, oral. A 6/7 Notice of Violation says the violations “are especially concerning from a public health perspective
Drugs
The FDA Accelerating Rare disease Cures (ARC) program used its first year to strengthen internal and external partnerships with stakeholders and engaged with outside experts to help find solutions for the challenges in rare disease drug development. That’s the report of CDER associate director for rare diseases Kerry Jo
Drugs
Viatris is petitioning FDA to require additional pharmacokinetic (PK) and pharmacodynamic (PD) studies to support an NDA submitted by ARS Pharmaceuticals for neffy (epinephrine nasal spray) or ARS-1 intranasal epinephrine for the emergency treatment of Type 1 allergic reactions, including anaphylaxis, in adults and some children. The petition says
Drugs
FDA has approved Ipsen’s Bylvay (odevixibat) for an expanded use — treating cholestatic pruritus in patients aged 12 months and older with Alagille syndrome (ALGS). The once-daily, non-systemic ileal bile acid transport inhibitor acts locally in the small intestine and has minimal systemic exposure, according to the company.
Drugs
FDA has published a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests. The document describes the policies used in the Office of Pharmaceutical Quality, the Office of Compliance, and the Office of Generic Drugs for assessing requests for
Drugs
FDA has approved an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) to treat functional constipation in pediatric patients aged six to 17 years. Linzess is the first treatment for this condition and the recommended dosage is 72 mcg orally once daily, according to an agency release. Commonly experienced by children
Drugs
FDA has accepted for review a Phathom Pharmaceuticals NDA resubmission for vonoprazan, a first-in-class potassium-competitive acid blocker to treat erosive gastroesophageal reflux disease (erosive esophagitis). The company says the resubmission responds to an agency 2/2023 complete response letter relating to specifications and controls for a nitrosamine
Drugs
FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee 6/9 voted 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogen’s Leqembi (lecanemab) in the early treatment of Alzheimer’s disease. Eisai received accelerated approval for Leqembi 1/
Drugs
Senators Mike Braun (R-IN), Kirsten Gillibrand (D-NY), Lisa Murkowski (R-AK), Kevin Cramer (R-ND) and Roger Wicker (R-MS) have introduced the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (ALS/Lou Gehrig’s Disease) and other life-threatening diseases receive early access
Drugs
Novartis says a current FDA guidance on patient preference information (PPI) pertains only to medical device development. “A common guidance on PPI that applies to devices, drugs, and drug-device combinations would help medicine developers in consistently applying the same principles and methods throughout medical product development,” the company says
Drugs
FDA has published a guidance, Assessing User Fees Under the Generic Drug User Fee Amendments of 2022, with an explanation of the new fee structure and types of fees for which entities are responsible under changes made in the GDUFA 3 reauthorization in 2022. The document describes the types of
Drugs
FDA has approved a Novaliq NDA for Vevye (cyclosporine ophthalmic solution) 0.1% for treating the signs and symptoms of dry eye disease. Approval was based on data from 1,369 patients with dry eye disease, which demonstrated that the product was safe, well tolerated, and has a consistent, and
Drugs
Attorneys Dominic DiSabatino and Audrey Crowell (SheppardMullin) say the most notable change in two FDA draft guidances clarifying its approach to requirements and incentives for pediatric drug development is the agency’s intent to increase the clinical trial requirements for obtaining pediatric exclusivity. Writing in an online post, DiSabatino and