Drugs
Merck and Eisai are announcing disappointing results from the Phase 3 LEAP-015 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with chemotherapy for the first-line treatment of patients with locally advanced unresectable
Drugs
FDA has accepted for review a Biogen sNDA for a higher dose regimen of Spinraza (nusinersen) for spinal muscular atrophy (SMA). A company statement says the higher dose regimen comprises a more rapid loading regimen compared to the approved Spinraza dosing. The sNDA was based on data from the DEVOTE
Drugs
The Trump Administration’s rollback of government-wide diversity, equity and inclusion activities seems to have caught FDA in its net regarding several diversity-related initiatives and policies, including its high-profile Diversity Action Plan (DAP) draft guidance document, according to Politico’s AgencyIQ. The document has been removed from
FDA Policy/General
Former FDA associate commissioner for women’s health Susan Wood has died at her home in London at the age of 66 after battling glioblastoma (brain cancer). In 2005, Wood resigned from the agency in protest over the agency’s decision to delay over-the counter approval of the morning-
Drugs
FDA has extended by three months its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndrome. The new user fee review action target date is 4/29. The review extension is intended to allow FDA to review supplemental information provided
Drugs
FDA has granted Zai Lab an orphan drug designation to ZL-1310, a potential first-in-class DLL3 antibody-drug conjugate (ADC) for treating small cell lung cancer (SCLC). The company says ZL-1310 has “demonstrated promising objective response rates and a favorable safety profile from the ongoing Phase 1
FDA Policy/General
Three Ropes & Gray attorneys write in their 2024 FDA Enforcement Review that while the agency’s focus may shift with the new administration, “industry should continue to invest in strong regulatory compliance and quality programs that encourage the reporting and thorough investigation of potential problems and facilitate prompt corrective
Devices
Commenting on an FDA 11/20-11/21/2024 Digital Health Committee meeting, GE HealthCare says generative artificial intelligence (GenAI) and foundation models (FM) “have immense potential to revolutionize clinical care and medical technology, including medical devices.” In its letter, the company says it is “essential to implement these technologies
FDA Policy/General
Sens. Dick Durbin (D-IL) and Charles Grassley (R-IA) have reintroduced their Drug-price Transparency for Consumers (DTC) Act that would require price disclosures in prescription drug ads. The senators say their bill would empower patients and reduce spending on medications. There are six bipartisan co-sponsors of the
Drugs
FDA says it is adding a Boxed Warning for anaphylaxis, a rare but serious allergic reaction, to the labeling for Teva’s multiple sclerosis drug Copaxone (glatiramer acetate) and Glatopa, Sandoz’ generic version. An agency statement says the reaction can occur at any time while on treatment. “For most patients
Biologics
CBER director Peter Marks’ annual report for 2024 says the Center approved 24 biological devices, 17 BLAs, and 26 BLA supplements in 2024. The report also says CBER continued its focus on facilitating the development of cell and gene therapies through numerous public town halls, Webinars, and a workshop, along
Drugs
The U.S. Court of Federal Claims has granted the federal government’s motion for summary judgment in a case in which Vanda Pharmaceuticals alleged that FDA improperly disclosed the company’s trade secrets and confidential commercial and proprietary information to competitors seeking approval of generic drugs. In a 1/
FDA Policy/General
The National Treasury Employees Union (NTEU), which represents some 150,000 employees in 37 federal agencies and departments, including FDA, has filed suit in the DC federal court opposing President Donald Trump’s executive order to use Schedule F to convert federal nonpartisan career positions into “political favors for loyalists.
FDA Policy/General
The Trump Administration has placed FDA and other government health agencies under an external communications embargo until 2/1. The move, which previous administrations have also ordered in their early transition days, reportedly gives the agencies time for the new political appointees to set up their review and approval of
Drugs
FDA has lifted a 2022-placed clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lilly. The agency said at the time that the hold is related to issues surrounding the trial’s protocol design,
Drugs
Patient advocacy group Friends of Cancer Research has added former principal deputy commissioner Janet Woodcock to its board of directors. Woodcock retired late 2023 after 37 years at the agency (see earlier story). She spent over two decades as CDER director until the Covid-19 pandemic saw her move to
Drugs
FDA has granted Life Molecular Imaging a fast track designation to [18F]florbetaben for diagnosing cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis. [18F]florbetaben positron emission tomography is currently approved to detect neuritic beta amyloid plaques in the brains of patients evaluated for Alzheimer’s disease
Drugs
FDA and Atara Biotherapeutics have agreed on actions needed to release the agency’s clinical holds on Ebvallo (tabelecleucel) and ATA3219. A company statement says the clinical hold on Ebvallo, being studied as monotherapy treatment for adult and pediatric patients aged two and older with Epstein-Barr virus positive post-
Devices
FDA has cleared an Inflammatix 510(k) for its TriVerity Test System, which it describes as a first-in-class molecular test for patients with suspected acute infection or sepsis. “Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-
Drugs
A 9/26-9/29/2023 FDA inspection at Incell Corp. in San Antonio, TX, documented that the company is a contract manufacturer of a product derived from amniotic fluid. A just-released 12/12/2024 Warning Letter says the firm’s product is legally considered to be an unapproved
Drugs
FDA has issued an amended Warning Letter to Sanofi, replacing the 12/16/2024 letter addressing significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) found in a 6/12-7/9/2024 inspection at the firm’s Genzyme Corp. subsidiary in Framingham, MA. The
Drugs
FDA has approved a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants. Previously, Spravato was approved for combination use with an oral antidepressant for treating adults