Drugs
Ionis Pharmaceuticals is announcing “positive topline results” from the Essence study of olezarsen in people with moderate hypertriglyceridemia. “The trial met its primary endpoint with a statistically significant placebo-adjusted 61% and 58% reduction in triglyceride (TG) levels at six months with the 80 mg and 50 mg monthly doses,
Drugs
FDA has given a Novavax BLA traditional approval of Nuvaxovid for active immunization to prevent Covid-19 after the company agreed to an agency-requested postmarketing commitment (PMC) to conduct a Phase 4 placebo-controlled trial in individuals aged 50 through 64 without high-risk conditions for severe Covid-19.
Drugs
FDA is warning that patients who stop taking oral allergy medicines cetirizine (McNeil Consumer Health’s Zyrtec) or levocetirizine (Sanofi’s Xyzal) after long-term use may experience rare but severe itching. The itching has been reported in patients who used the medicines daily, typically for at least a few
Devices
FDA has cleared a Stryker 510(k) for its OptaBlate basivertebral nerve ablation (BVNA) system and its use for procedures providing vertebrogenic pain relief. BVNA is described by the company as a minimally invasive and innovative procedure that targets a key source of this pain, particularly in patients with specific
Drugs
FDA has lifted a clinical hold against Scynexis’s ibrexafungerp that will allow it to proceed with its Phase 3 MARIO study evaluating its use as a non-azole, oral step-down for patients with invasive candidiasis and candidemia. The company says ibrexafungerp, if approved, could give healthcare providers the
Drugs
FDA has accepted for review a Travere Therapeutics supplemental NDA for traditional approval of Filspari (sparsentan) for treating focal segmental glomerulosclerosis (FSGS), a rare and serious kidney disorder. The agency has set a review action target date of 1/13/2026, and told the company that it plans to convene
Devices
FDA has cleared a Fujirebio Diagnostics 510(k) for the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is intended to detect amyloid plaques associated with Alzheimer’s disease in adult patients aged
Drugs
FDA has released briefing documents outlining issues to be discussed during a two-day (5/20-21) Oncologic Drugs Advisory Committee meeting that is reviewing four cancer drug submissions. During the morning session on 5/20, panel members will discuss a supplemental BLA for Genentech’s Columvi (glofitamab) injection and
FDA Policy/General
FDA has extended by two months its review of a PharmaTher NDA for Ketarx (ketamine) that is seeking anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. The extension allows the agency more time to review information requests, which it has classified as a minor amendment, according to the
FDA Policy/General
FDA commissioner Marty Makary is set to testify 5/22 at a Senate appropriations subcommittee hearing on the agency’s fiscal year 2026 budget request. The White House earlier this month released its budget proposal, which included a significant overall reduction in non-defense discretionary spending, but specific details about
Drugs
FDA commissioner Marty Makary is announcing a 5/20 roundtable discussion of an independent panel of scientific experts to discuss the “safety and necessity of talc as an additive in food, drug, and cosmetic products.” This public roundtable, which will be livestreamed, will “follow a transparent process grounded in gold
Drugs
FDA has approved Amneal Pharmaceuticals’ Brekiya (dihydrogotamine mesylate) injection for the acute treatment of migraine and cluster headaches in adults. The company says Brekiya is the only dihydrogotamine mesylate autoinjector that allows patients to self-administer the same medication used in hospitals.
Drugs
FDA has accepted a BioCryst NDA for its Orladeyo (berotralsat) to be used in pediatric patients aged 2 to 11 years with hereditary angioedema. A company statement says the agency granted the NDA priority review and set 9/12 as the PDUFA action date. Orladeyo is described as the only
Drugs
Merck says its Keytruda Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for treating patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1. The study is evaluating Keytruda (pembrolizumab) in combination with chemotherapy (paclitaxel) with or
Drugs
FDA has approved an Incyte supplemental BLA for Zynyz (retifanlimab-dlwr) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, the agency approved Zynyz as a
Drugs
FDA has extended by three months the PDUFA action date for Biohaven’s troriluzole to treat the rare disease spinocerebellar ataxia. A company statement says an agency decision is now expected in the fourth quarter of 2025. According to the company, FDA did not raise any new concerns in its
Drugs
FDA Oncology Center of Excellence initiatives such as Project Optimus and Project FrontRunner can help advance patient-centered regulatory decision-making through innovation and collaboration. That’s the view of IQVIA Biotech senior director David Cameron writing in an online Clinical Leader post. Cameron says the initiatives encourage a more
Devices
FDA has approved Roche’s Ventana MET (SP44) RxDx Assay, a companion diagnostic to aid in determining MET (also known as c-Met) protein expression in lung cancer patients to determine eligibility for AbbVie’s just-approved Emrelis (see earlier story). The device detects the MET protein and is scored
Devices
Nipro Renal Soultions has recalled (Class 1) its MedicaLyte Liquid Bicarbonate Concentrate, a dialysate concentrate for hemodialysis, due to the potential for the presence of visible foreign matter in the plastic bottles. Nipro Renal notified consignees on 4/11 through a “Urgent: Medical Device Recall” letter that instructed them to
Drugs
CBER Office of Therapeutic Products super office director Nicole Verdun says the agency has evolved considerably in the last 10 years to better serve as a partner in the search for new therapies for rare diseases. Speaking on a panel at the 5/9 Friends of Cancer Research public meeting
Biologics
FDA is planning to release in the “coming days” a vaccine development framework for manufacturers, commissioner Marty Makary told the Food and Drug Law Institute (FDLI) at its annual meeting in Washington, DC 5/15. The framework will outline a development roadmap for vaccine makers so they have a “predictable
Drugs
A 4/26-4/30/2024 FDA inspection at Shantou S.E.Z. Bajoie Industry Co., Ltd., in Shantou, Guangdong, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/15 Warning Letter says the specific violations were: * failure to test samples