Drugs
A study (REDUCE-IT) funded by Amarin Pharma shows that among patients with elevated triglyceride levels despite use of statins, the risk of ischemic events, including cardiovascular death, is significantly lower among those receiving 2 g of icosapent ethyl twice daily than among those receiving placebo. Researchers from Harvard Medical
Drugs
The Supreme Court will hear oral arguments 1/7 as part of Merck’s appeal of a 3rd Circuit Court of Appeals ruling that allowed hundreds of state-based liability claims involving alleged failure to adequately warn of fracture risk associated with Fosamax (alendronate sodium) to go to trial. Chemical
Drugs
FDA has chosen a Phase 2/3 efficacy and safety trial for Wave Life Science’s Duchenne muscular dystrophy (DMD) drug suvodirsen to be part of the agency’s pilot program for complex innovative trial designs. Suvodirsen is an investigational therapy for boys with DMD who are amenable to exon
Drugs
FDA has approved an expanded indication for Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include treating pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. Approval is based on data from the Phase 2 study, CA180-
Drugs
FDA has approved a Slayback Pharma ANDA for hydroxyprogesterone caproate injection 1,250 mg/5mL, a generic form of Amag Pharmaceuticals’ Makena, indicated to reduce the risk of preterm birth in some women. The company says it will soon launch its generic product, which is the only Makena generic approved
Drugs
FDA has released the FDA-483 issued following a 9/10-10/12/18 inspection at Intact Pharmaceuticals, an outsourcing facility in New Milford, CT. The 11 inspection observations were: * aseptic processing areas are deficient regarding systems for maintaining any equipment used to control aseptic conditions; * aseptic processing areas are
Drugs
Adamis Pharmaceuticals has submitted a 505(b)(2) NDA for its naloxone pre-filled single dose syringe product candidate, indicated for treating opioid overdose. Naloxone works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness, the company says. Adamis recently gained
Drugs
FDA has approved Alexion Pharmaceuticals’ Ultomiris (ravulizumab) to treat adult patients with paroxysmal hemoglobinuria (PNH). An agency announcement says PNH is a rare acquired disorder that leads to the rupture or destruction of red blood cells (hemolysis). Ultomiris is described as a long-acting complement inhibitor that prevents hemolysis. Its
Drugs
FDA says Torrent Pharmaceuticals has recalled two lots of losartan potassium 100 mg tablets due to presence of N-nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs. An agency notice says that not all Torrent losartan-containing medications distributed in the U.S. are being recalled,
Drugs
FDA has partially granted an Allergan petition (submitted by Hyman Phelps & McNamara) seeking added bioequivalence assurances for irritable bowel syndrome drug Linzess (linaclotide). The petition urged the agency to require ANDA applicants seeking approval for generic Linzess to “demonstrate bioequivalence to Linzess in a clinical endpoint bioequivalence study.” In
Drugs
FDA has updated the list of off-patent, off-exclusivity drugs without an approved generic that it maintains to improve transparency and encourage development and submission of applications under an abbreviated pathway for drugs with limited competition. The list includes approved NDAs for drug products that are not protected by
Drugs
FDA has published interim acceptable levels of nitrosamine impurities in angiotensin II receptor blockers (ARBs) for manufacturers to use to ensure that finished drug products are safe for patients. An agency notice says FDA evaluated safety data for N-nitrosodiemthylamine (NDMA) and N-nitrosodiethylamine (NDEA) to determine an interim acceptable
Drugs
FDA has approved Celltrion’s Herzuma (transtuzumab-pkrb) as a biosimilar to Genentech’s Herceptin (transtuzumab) for patients with HER2-overexpressing breast cancer. An agency notice says Herzuma is a HER2/neu receptor antagonist indicated to treat HER2-overexpressing breast cancer. The Herzuma prescribing information says common expected side effects
Drugs
FDA has published a finalized guidance, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, that revises and replaces a 5/2007 draft guidance. The document gives recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in NDAs, BLAs, or supplements.
Drugs
FDA has approved Stemline Therapeutics’ Elzonris (tagraxofusp-erzs) infusion to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients age two and older. An agency announcement says BPDCN is an aggressive and rare disease of the bone marrow and blood that can affect multiple organs, including the
Drugs
Washington Legal Foundation (WLF) has called on the Centers for Medicare and Medicaid Services (CMS) to withdraw its proposed rule that would require drug makers to convey the wholesale acquisition cost of any prescription drug or biological product advertised in direct-to-consumer television ads. The advocacy group’s comment
Drugs
Sen. Elizabeth Warren (D-MA) introduced at the end of 2018 the Affordable Drug Manufacturing Act that would authorize HHS to manufacture select generic drugs and offer them to consumers at a fair price, guaranteeing affordable patient access. Rep. Jan Schakowsky (D-IL) was to introduce companion legislation in the
Drugs
FDA says Aurobindo Pharma has recalled two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. The agency notice says that Aurobindo is recalling
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to strengthen a mandated post-marketing study for Bayer’s Essure permanent birth control device that was withdrawn from the market 12/31/18. In a statement, Gottlieb says the agency worked with Bayer to see that it implements several
Drugs
FDA has approved a Celltrion BLA for Herzuma (trastuzumab-pkrb) as a biosimilar to Genentech’s Herceptin (trastuzumab) for patients with HER2-overexpressing breast cancer. Common adverse events include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected side effects of Herzuma include worsening
Drugs
Senators Richard Blumenthal (D-CT), Kamala Harris (D-CA), Jeff Merkley (D-OR), and Amy Klobuchar (D-MN) have introduced the Curbing Unreasonable Rises and Excessively (CURE) High Drug Prices Act today to prohibit unjustified drug price increases. The measure would give HHS the authority to block such increases and
Drugs
FDA’s authority to obtain equitable remedies in injunction suits may be in jeopardy in light of federal court questions in a Federal Trade Commission (FTC) case against Shire. Attorneys Jennifer Thomas and John Fleder (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that the Shire