Drugs
FDA has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and remain inadequately controlled on current therapies. This marks the first biologic approved for this specific group of COPD patients, the company says. Approval
Drugs
Four House members have introduced the Global Fairness in Drug Pricing Act to codify major portions of President Trump’s executive order on drug pricing. The legislation was introduced by Reps. Ro Khanna (D-CA), Anna Paulina Luna (R-FL), Marcy Kaptur (D-OH), and Andy Biggs (R-AZ). A
Drugs
FDA’s Oncologic Drugs Advisory Committee 5/21 was split (4 yes votes to 5 no votes) in its voting on whether UroGen Pharma’s NDA for mitomycin intravesical solution demonstrated a favorable benefit-risk profile for treating adult patients with low-grade intermediate-risk non-muscle invasive bladder cancer.
Drugs
FDA has published 34 new and 14 revised product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDAs. The agency says the latest batch of PSGs contains: * 37 PSGs for products with no approved ANDAs, including six complex products; * 13 PSGs for complex products
Drugs
Antidepressant Coalition for Education founder Morgan Stewart is petitioning FDA to make specific changes to the labeling for selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), including both branded and generic formulations. The petition specifically asks that FDA: * add a Boxed Warning to inform healthcare providers and
Drugs
FDA has approved Bayer’s Jivi, a recombinant DNA-derived, extended half-life factor VIII concentrate, for use in pediatric patients aged seven to 12 with hemophilia A (congenital factor VIII deficiency). A company statement says the approval was based on data from the Alfa-PROTECT and PROTECT Kids studies
Drugs
FDA’s Oncologic Drugs Advisory Committee 5/20 voted (8 to 1) that clinical trial data supporting a supplemental BLA for Genentech’s Columvi (glofitamab) injection are not applicable to the U.S. population. The supplement seeks Columvi’s approval for use in combination with gemcitabine and oxaliplatin for treating
Drugs
A 10/14-10/18/2024 FDA inspection at the NWL Netherlands Services drug manufacturing facility in Hillegom, Zuid-Holland, Netherlands, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/1 Warning Letter says the specific violations were: * failure to thoroughly investigate
Drugs
It’s been over two months since former Justice Department attorney Hilary Perkins was ousted (see earlier story) from her FDA chief counsel post after being on the job for two days, and the agency is still without its top lawyer. The position is now on hold until President Trump’
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
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
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
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