Drugs
FDA has announced the first nine voucher recipients under the recently launched Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public
Drugs
FDA has approved Azurity Pharmaceuticals’ Ferabright (ferumoxytol injection), an iron-based contrast agent for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant brain tumors. The product is designed to help radiologists visualize lesions with a disrupted blood-brain barrier, enhancing the detection and delineation
Drugs
A controversial FDA safety communication on acetaminophen and autism — issued immediately after a 9/22 press conference featuring president Donald Trump, HHS secretary Robert F. Kennedy Jr., and FDA commissioner Marty Makary — has drawn sharp concern from legal experts who say the agency appears to be moving away from long-
Drugs
FDA has accepted for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tablet) plus prednisone for treating BRCA-mutated metastatic castration-sensitive prostate cancer. If approved, the company says the regimen would become the first PARP-based precision medicine combination for this
Drugs
Novartis is reporting favorable data on its oral complement inhibitor Fabhalta (iptacopan) in certain patients with IgA nephropathy (IgAN). Its Phase 3 APPLAUSE-IgAN trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful slowing of kidney function decline in adults with IgAN, Novartis says. The study measured
Drugs
Johnson & Johnson says initial results from the Phase 3 MajesTEC-3 study of the combination of Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) showed the combination significantly improved progression-free survival and overall survival versus standard of care in relapsed/refractory multiple myeloma. A company statement
Drugs
FDA is laying the groundwork for a future where real-world evidence (RWE) and artificial intelligence (AI) work together to deliver better outcomes for patients and more efficient pathways for innovation. That’s the takeaway posted in a blog by Adrienne Lenz, the principal medical device regulation expert at Hyman,
Drugs
FDA has filed a response urging the Supreme Court to reject Vanda Pharmaceuticals’ petition challenging the agency’s decision to deny fast-track status for its experimental drug tradipitant for gastroparesis. Vanda had argued that FDA improperly evaluated its application, claiming the drug itself — not the broader development program — should
Drugs
FDA has released the form FDA-483 issued following a 7/7-7/17 inspection at the Lupin drug manufacturing facility in Pithampur, Madhya Pradesh, India. The three inspection observations were: * failure to test each component for conformity with all appropriate written specifications for purity, strength, and quality; * failure to
Drugs
FDA has granted Minovia Therapeutics an orphan drug designation for its lead investigational therapy, MNV-201, for myelodysplastic syndrome (MDS). MNV-201 is described by the company as a first-in-class mitochondrial cell therapy that uses Minovia’s Mitochondrial Augmentation Technology to introduce healthy mitochondria into a patient’s
Drugs
FDA has accepted for review a Chiesi NDA for a single-inhaler triple therapy designed for the maintenance treatment of asthma in adults. The device combines beclomethasone dipropionate, an inhaled corticosteroid; formoterol fumarate, a long-acting beta-agonist; and glycopyrrolate, an anticholinergic, in a single pressurized metered-dose inhaler administered
Drugs
Former FDA principal deputy commissioner Namandjé N. Bumpus has been chosen by Charles River Laboratories to chair a new global scientific advisory board to guide the company’s strategy in advancing “new approach methodologies” (NAMs), non-clinical tools designed to improve the predictability of safety and efficacy while reducing reliance
Drugs
Lilly says its oral GLP-1 investigational drug orforglipron demonstrated superior glycemic control in the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. A company statement says ACHIEVE-2 was the second head-to-head trial that evaluated orforglipron versus dapagliflozin (AstraZeneca’s Farxiga), an SGLT-2 inhibitor, in adults
Drugs
FDA has released the form FDA-483 issued following a 9/19-9/26 inspection at the Hetero Labs Unit 9 active pharmaceutical ingredient (API) manufacturing facility in Narasapuram Village, India. The six observations in the 12-page report were: * failure to maintain in writing and fully follow the responsibilities
Drugs
FDA has granted Akamis Bio a fast-track designation to NG-350A for treating mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC). The intravenously delivered oncolytic immunotherapy is designed to “drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in
Drugs
Rocky Mountain Cancer Center oncologist John Burke says a recent FDA guidance on approaches to assessment of overall survival in oncology clinical trials is likely to change future oncology trial designs potentially with both positive and negative effects. In a Targeted Oncology article, Burke lists these three important points from
Drugs
FDA has approved a bioLytical Laboratories PMA for the INSTI HIV Self Test, described by the company as the first at-home HIV test in the U.S. that delivers results in 60 seconds or less. The single-use, rapid, in vitro diagnostic qualitative immunoassay is intended for use in
Drugs
FDA says its review of a brochure posted on a Web site maintained by Allovate Therapeutics in New York, NY, found that it describes Allerdent, an allergenic toothpaste available for home delivery. A 9/30 Warning Letter says the product is an unapproved new drug and an unlicensed biological product
Drugs
FDA has accepted for review a Cingulate NDA for CTx-1301 (dexmethylphenidate), a once-daily stimulant designed to treat attention-deficit/hyperactivity disorder in children and adults. CTx-1301 uses Cingulate’s precision timed release technology to deliver three timed doses of dexmethylphenidate throughout the day, according to the company.
Drugs
Astellas Pharma says its Phase 2 GLEAM study evaluating zolbetuximab in combination with standard chemotherapy for metastatic pancreatic cancer failed to meet its primary endpoint of improving overall survival. The randomized, open-label trial compared zolbetuximab plus gemcitabine and nab-paclitaxel with chemotherapy alone in patients with CLDN18.2-positive
Drugs
FDA has published a guidance, Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias, with recommendations for data sets containing elements for response assessments and summary level response outcomes used to evaluate efficacy in clinical trials of drugs and biological products submitted to
Drugs
Pfizer says its Tukysa (tucatinib) achieved a statistically significant and clinically meaningful improvement in progression-free survival in the HER2CLIMB-05 trial evaluating Tukysa versus placebo, both in combination with first-line standard of care maintenance therapy (Genentech’s Herceptin (trastuzumab) plus Genentech’s Perjeta (pertuzumab) following chemotherapy-based induction